Carbidopa and levodopa may be used alone or in combination with other medication to treat symptoms of Parkinson’s disease, such as stiffness or tremors in adults.

Carbidopa and levodopa is also used in adults to treat Parkinson’s disease caused by infection, carbon monoxide poisoning or manganese intoxication.

Carbidopa and levodopa may also be used for purposes not listed in this medication guide.

Carbidopa and levodopa side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, aggressive, more active or talkative, or have thoughts about suicide or hurting yourself.

Some people taking carbidopa and levodopa have fallen asleep during normal daytime activities such as working or driving after starting carbidopa and levodopa and up to a year after. Tell your doctor if you have any problems with daytime sleepiness.

Carbidopa and levodopa may cause serious side effects. Call your doctor at once if you have:

• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• uncontrolled muscle movements, blurred vision, eye pain or redness, seeing halos around lights; or
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Your dose may be reduced or permanently discontinued if you have certain side effects.

Common side effects of carbidopa and levodopa may include:

• uncontrolled muscle movements;
• dry mouth, anxiety, headache, dizziness;
• drops in blood pressure or feeling light-headed when standing up;
• sleep problems (insomnia), strange dreams, muscle contractions; or
• nausea, vomiting, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Do not use this medicine if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Some people have thoughts about suicide while taking carbidopa and levodopa. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Before taking this medicine

You should not use carbidopa and levodopa if you are allergic to it or any of its ingredients, or if you have narrow-angle glaucoma.

Do not use carbidopa and levodopa if you have used a MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take carbidopa and levodopa.

If you already take levodopa, you must stop taking it at least 12 hours before you start taking carbidopa and levodopa.

Tell your doctor if you have or have ever had:

• an endocrine disease, heart disease, high blood pressure, or heart attack;
• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• skin cancer (melanoma), a stomach or intestinal ulcer;
• glaucoma, depression, mental illness, or psychosis;
• if you received general anesthesia; or
• liver or kidney disease.

The orally disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU). Ask your doctor about your risk.

Some people have thoughts about suicide while taking carbidopa and levodopa. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.

It is not known if carbidopa and levodopa will harm an unborn baby. The benefit of this treatment may outweigh any risks to the mother and baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using carbidopa and levodopa.

How should I take carbidopa and levodopa?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Stop taking any other medications that contain carbidopa and levodopa when you start taking the extended-release form.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Take this medicine at evenly spaced intervals. Follow your doctor’s instructions about whether to take your medication with food or on an empty stomach.

Swallow the capsule whole and do not crush, chew, break, or open it. The tablet is sometimes broken in half to give the correct dose. Always swallow a whole or half tablet without chewing or crushing.

If you cannot swallow an extended-release capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Remove an orally disintegrating tablet from the package with dry hands only when you are ready to use the medicine. Allow the orally disintegrating tablet to dissolve in your mouth without chewing.

It may take up to several weeks before your symptoms improve. Tell your doctor if your symptoms do not improve or if the effects of this medicine wear off quickly between doses.

Carbidopa and levodopa will most likely darken the color of your saliva, urine, or sweat to an orange or red color. This is a normal effect and is not harmful. This may also cause stains to your underwear that may be permanent.

You may need frequent medical tests and your doctor will need to check your progress on a regular basis.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using carbidopa and levodopa.

Do not stop using carbidopa and levodopa suddenly, or you could have unpleasant withdrawal symptoms (such as agitation, confusion, tingling). Ask your doctor before stopping the medicine.

You may need to follow a special diet. Learn about the foods you should eat or avoid.

Store tightly closed at room temperature, away from moisture, heat, and light.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking carbidopa and levodopa?

Avoid driving or hazardous activity until you know how carbidopa and levodopa will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Also avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol with this medicine can cause side effects.

Avoid taking iron supplements, high-fat, or high-calorie meals before or after taking carbidopa and levodopa. These can make it harder for your body to absorb carbidopa and levodopa.

What other drugs will affect carbidopa and levodopa?

Using carbidopa and levodopa with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

When you start or stop taking carbidopa and levodopa, your doctor may need to adjust the doses of other medicines you use on a regular basis.

Tell your doctor about all your other medicines, especially:

• phenytoin, metoclopramide;
• papaverine, isoniazid, selegiline, reserpine, tetrabenazine;
• vitamin or mineral supplements that contain iron; or
• medicine to treat blood pressure, nausea or vomiting, anxiety, mood disorders, or mental illness such as schizophrenia.

Carbamazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and nerve pain, such as trigeminal neuralgia and diabetic neuropathy.

Carbamazepine is also used to treat bipolar disorder.

Carbamazepine may also be used for purposes not listed in this medication guide.

Warnings

You should not take carbamazepine if you have a history of bone marrow suppression, if you are allergic to it, or take an antidepressant such as amitriptyline, desipramine, doxepin, imipramine, or nortriptyline.

TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE. Some drugs can raise or lower your blood levels of carbamazepine, which may cause side effects or make this medicine less effective. Carbamazepine can also affect blood levels of certain other drugs, making them less effective or increasing side effects.

Carbamazepine may cause serious blood problems or a life-threatening skin rash or allergic reaction. Call your doctor if you have a fever, unusual weakness, bleeding, bruising, or a skin rash that causes blistering and peeling.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop taking this medicine without asking your doctor first, even if you feel fine.

If you are pregnant, do not start or stop taking carbamazepine without your doctor’s advice.

Before taking this medicine

You should not take carbamazepine if you have a history of bone marrow suppression, or if you are allergic to carbamazepine or to an antidepressant such as amitriptyline, desipramine, doxepin, imipramine, or nortriptyline.

Do not use carbamazepine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Carbamazepine may cause severe or life-threatening skin rash, and especially in people of Asian ancestry. Your doctor may recommend a blood test before you start the medication to determine your risk.

Tell your doctor if you have ever had:

• heart problems;
• liver or kidney disease;
• glaucoma;
• porphyria;
• low sodium levels;
• depression, mood disorder; or
• suicidal thoughts or actions.

You may have thoughts about suicide while taking carbamazepine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Carbamazepine may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. The benefit of preventing seizures may outweigh any risks to the baby.

Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby.

Carbamazepine can make birth control pills or implants less effective. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy.

You should not breastfeed while you are using carbamazepine.

How should I take carbamazepine?

Take carbamazepine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take with food.

Swallow the extended-release tablet or capsule whole and do not crush, chew, or break it. Tell your doctor if you cannot swallow a pill whole.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and call your doctor promptly if this medicine seems to stop working as well in preventing your seizures.

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

Do not stop using carbamazepine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe drowsiness, weak or shallow breathing, and loss of consciousness.

What to avoid

Drinking alcohol with this medicine can cause side effects, and can also increase your risk of seizures.

Grapefruit may interact with carbamazepine and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Carbamazepine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Carbamazepine side effects

Get emergency medical help if you have signs of an allergic reaction to carbamazepine (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• a skin rash, no matter how mild;
• loss of appetite, right-sided upper stomach pain, dark urine;
• slow, fast, or pounding heartbeats;
• anemia or other blood problems – fever, chills, sore throat, mouth sores, bleeding gums, nosebleeds, pale skin, easy bruising, unusual tiredness, feeling light-headed or short of breath; or
• low levels of sodium in the body – headache, confusion, severe weakness, feeling unsteady, increased seizures.

Common carbamazepine side effects may include:

• dizziness, loss of coordination, problems with walking;
• nausea, vomiting; or
• drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect carbamazepine?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Using carbamazepine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with carbamazepine, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Briviact (brivaracetam) is an anti-epileptic drug (also called an anticonvulsant) that may be used to treat partial onset seizures in adults and children 1 month and older with epilepsy.

• Briviact is often used along with other seizure medicines to give better control over seizures.

Briviact works in the brain to help control seizures and is thought to target a specific protein called SV2A that helps nerve cells communicate with each other. By attaching to this protein, Briviact helps balance the brain’s electrical activity and this mechanism can stop the sudden bursts of electricity that cause seizures.

Briviact gained FDA approval on February 18, 2016. There is currently no Briviact generic available.

Is Briviact a controlled substance?

Briviact is a federally controlled substance (Schedule V) because it can be abused or lead to dependence.

Keep Briviact in a safe place to prevent misuse and abuse. Selling or giving away Briviact may harm others and is against the law. 

Briviact side effects

The most common side effects of Briviact are:

• sleepiness
• dizziness
• feeling tired
• nausea and vomiting.

Side effects of Briviact in children 1 month to less than 16 years of age are similar to those seen in adults.

Serious side effects and warnings

Briviact may cause the following serious side effects.

Suicidal thoughts and behaviors. Like other antiepileptic drugs, Briviact may cause suicidal thoughts or actions in a very small number of people; about 1 in 500 people taking it. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• new or worse depression
• feeling agitated or restless
• trouble sleeping (insomnia)
• acting aggressive, feeling angry, or being violent
• an extreme increase in activity and talking (mania)
• attempts to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting on dangerous impulses
• other unusual changes in behavior or mood.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Briviact without first talking to a healthcare provider. Stopping Briviact suddenly can cause seizures that will not stop (status epilepticus). 

Nervous system problems. Drowsiness, tiredness, and dizziness are common with Briviact but can be severe. Do not drive or operate machinery until you know how Briviact affects you. Briviact can also cause problems with balance and coordination.

Mental (psychiatric) symptoms. Briviact can cause mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. Irritability and anxiety are common with Briviact and can be severe. People who take Briviact can also get psychotic symptoms such as hallucinations (seeing or hearing things that are not there), delusions (false or strange thoughts or beliefs), and unusual behavior.

Get emergency medical help if you have signs of an allergic reaction to Briviact: hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

These are not all the possible side effects of Briviact. For more information, ask your healthcare provider or
pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Briviact if you are allergic to brivaracetam, Briviact, or any of the inactive ingredients in the formulation you are taking/receiving.

Before taking Briviact, tell your healthcare provider about all of your medical conditions, including if you:

• have or had depression, mood problems, or suicidal thoughts or behavior
• have liver problems
• have abused or been dependent on prescription medicines, street drugs, or alcohol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Briviact is not approved for use by anyone younger than 1 month of age.

Pregnancy

It is not known if Briviact will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Briviact. You and your healthcare provider will have to decide if you should take Briviact while you are pregnant. Follow your doctor’s instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor’s advice, and tell your doctor right away if you become pregnant.

If you do become pregnant while taking Briviact, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Briviact and other antiepileptic medicines during pregnancy.

Breastfeeding

Briviact passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briviact.

How should I take Briviact?

Take Briviact exactly as prescribed by your doctor. Your healthcare provider will tell you how much Briviact to take and when to take it. Your healthcare provider may change your dose if needed. Do not change your dose without talking to your healthcare provider.

• Briviact is usually taken/given 2 times a day.

Take Briviact oral tablets or oral solution with or without food.

• Swallow Briviact tablets whole with a liquid and do not chew or crush the tablets before swallowing.
• Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Briviact injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Briviact may be habit-forming and is a federally controlled substance (Schedule V). Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not stop using Briviact suddenly, even if you feel fine. Stopping suddenly may cause serious medical problems or increased seizures. Follow your doctor’s instructions about tapering your dose.

Briviact dosing information

Usual Briviact Adult Dose for Epilepsy

Initial oral dose: Briviact 50 mg orally 2 times a day

• Adjust the dose up or down based on individual patient tolerability and response.

Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability

Maximum dose: 200 mg/day

IV Administration: Briviact 50 mg by IV injection over 2 to 15 minutes

• May be used when oral administration is temporarily not feasible.
• Administer at the same dose and frequency as oral formulations.
• Experience with IV injection is limited to 4 consecutive days of treatment.

Usual Briviact Child Dose for Epilepsy

Briviact doses are based on weight in children. Your child’s dose needs may change if the child gains or loses weight.

Briviact ablets, oral solution, and injection can be used interchangeably.

1 month to 16 years

Weight: Less than 11 kg: Initial dose: Briviact 0.75 to 1.5 mg/kg orally twice a day; Maintenance dose: 0.75 to 3 mg/kg orally twice a day
Weight: 11 kg to less than 20 kg: Initial dose: Briviact 0.5 to 1.25 mg/kg orally twice a day; Maintenance dose: 0.5 to 2.5 mg/kg orally twice a day
Weight: 20 kg to less than 50 kg: Initial dose: Briviact 0.5 to 1 mg/kg orally twice a day; Maintenance dose: 0.5 to 2 mg/kg orally twice a day
Weight: 50 kg or greater: Initial dose: Briviact 25 to 50 mg orally twice a day; Maintenance dose: 25 to 100 mg orally twice a day

16 years of age and older

Initial dose: Briviact 50 mg orally 2 times a day.
Maintenance dose: 25 mg to 100 mg orally twice a day.

IV Administration may be used in patients 16 years or older when oral administration is temporarily not feasible.

• Administer at the same dose and same frequency as oral formulations.
• Experience with the IV injection is limited to 4 consecutive days of treatment.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I take too much Briviact?

If you take too much Briviact call your Poison Control Center or go to the nearest emergency room right away. 

What to avoid

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

What other drugs will affect Briviact?

Other drugs may interact with brivaracetam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines. Especially tell your healthcare provider if you take:

• Rifampin — the dosage of Briviact may need to be increased
• Carbamazepine — the dosage of carbamazepine may need to be reduced
• Phenytoin — the dosage of phenytoin may need to be reduced.

Levetiracetam — Briviact had no added therapeutic benefit when coadministered with levetiracetam.

When you start or stop taking Briviact, your doctor may need to adjust the doses of any other medicines you take regularly.

Not all possible drug interactions are listed here. See the Briviact Prescribing Information for a full list of interactions. 

Storage

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. Throw away unused liquid after 5 months.

Briviact ingredients

Active ingredient: brivaracetam

Tablet inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, and magnesium stearate.

Tablet film coating contains the inactive ingredients listed below:

• 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide
• 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide
• 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide
• 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. 

Oral solution inactive ingredients: sodium citrate, anhydrous citric acid, methylparaben, sodium
carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water.

Briumvi is used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is given as an intravenous infusion every 6 months by a healthcare provider.

Clinical trials report that Briumvi is superior to teriflunomide at reducing relapses and significantly reducing brain lesions on magnetic resonance imaging (MRI).

• 49 % to 59 % fewer relapses were reported with Briumvi vs teriflunomide in 2 clinical trials.
• Both studies also reported near complete (97%) suppression of brain lesions (T1 Gd+ lesions) per MRI over 2 years.
• Zero relapses were reported in 86% to 87% of people taking Briumvi.

Briumvi (ublituximab-xiiy) gained FDA approval on December 28, 2022. There is no generic or biosimilar.

How does Briumvi work?

Briumvi’s mechanism of action involves targeting and destroying B cells (a type of immune cell) in the body. It does this by binding to a protein called CD20 on the B cells’ surface. By reducing B cells, Briumvi helps mitigate the immune system’s effect on the nervous system, which drives MS symptoms. 

Briumvi belongs to the drug class called CD20 monoclonal antibodies.

Briumvi side effects

The most common Briumvi side effects are:

• infusion reactions, which may include symptoms such as dizziness, nausea, light-headed, itchy, sweaty, headache, chest tightness, back pain, trouble breathing, or swelling in your face;
• cold sores around your mouth (herpes infections), skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• pain in your hands and feet;
• sleep problems (insomnia); or
• tiredness.

Serious side effects and warnings

Briumvi can cause the following serious side effects.

Infusion reactions. Infusion reactions are one of the most common side effects of Briumvi. Infusion reactions can be serious and may require you to be hospitalized. You will be monitored during your infusion and may be monitored after each infusion of Briumvi for signs and symptoms of an infusion reaction. Tell your healthcare provider if you get any of these symptoms:

• fever
• itchy skin
• wheezing
• chills
• dizziness
• nausea
• headache
• feeling faint
• abdominal pain
• flu-like symptoms
• swelling of the tongue or throat
• throat irritation
• fast heartbeat
• trouble breathing
• red face or skin
• hives.

These infusion reactions can happen over 24 hours after your infusion. You must call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion.

Infections. Infections are a common side effect, and upper respiratory tract infections are one of the most common side effects of Briumvi. Briumvi increases your risk of getting infections caused by bacteria or viruses that may be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection, including fever, chills, a cough that does not go away, or painful urination. Your healthcare provider should delay your treatment with Briumvi until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with Briumvi, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had a hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Briumvi. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Briumvi.

Weakened immune system: Briumvi taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Progressive Multifocal Leukoencephalopathy (PML): PML may happen with Briumvi. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These symptoms may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, and changes in thinking and memory, which may lead to confusion, and personality changes.

Low immunoglobulins: Briumvi may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Briumvi may also cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Briumvi, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

It is not known if Briumvi is safe or effective in children.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before receiving this medicine

Do not receive Briumvi if you:

• have had a life-threatening allergic reaction to ublituximab, Briumvi, or any of the inactive ingredients in the infusion
• have an active hepatitis B virus (HBV) infection.

Before receiving, tell your healthcare provider about all your medical conditions, including if you:

• have or think you have an infection
• take or plan to take medicines that affect your immune system. These medicines may increase your risk of getting an infection
• have ever had hepatitis B or you are a carrier of the hepatitis B virus
• have had a recent vaccination or are scheduled to receive any vaccinations.
  • Make sure all your vaccinations are up to date before starting Briumvi. You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Briumvi. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Briumvi and until your healthcare provider tells you that your immune system is no longer weakened.
  • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Briumvi. If you would like to receive any non-live vaccines while you are being treated with Briumvi, talk to your healthcare provider.
  • If you have a baby and you received Briumvi during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Briumvi so they can decide when your baby should be vaccinated.
• are pregnant, think that you might be pregnant, or plan to become pregnant
• are breastfeeding, or plan to breastfeed.

Pregnancy

Briumvi may harm your unborn baby. You should use birth control (contraception) during treatment with Briumvi and for at least 6 months after your last infusion of Briumvi. Talk with your healthcare provider about what birth control method is right for you during this time. You may need to have a negative pregnancy test before each infusion of Briumvi.

Pregnancy Registry. There is a pregnancy registry for women who take Briumvi during pregnancy. If you become pregnant while receiving Briumvi or within 6 months following the last dose of Briumvi, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Briumvi Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can enroll you in this registry by calling 1-877-411-4546 or visiting www.briumvipregnancyregistry.com.

Breastfeeding

It is not known if Briumvi passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briumvi.  

How will I receive Briumvi?

Briumvi is given through a needle placed in your vein (intravenous infusion) in your arm.

• Your healthcare provider may do a pregnancy test before each infusion of Briumvi.
• Before treatment with Briumvi, you will receive a corticosteroid and an antihistamine medicine to help reduce the risk of infusion reactions by making them less frequent and less severe.
• You may also receive other medicines to help reduce the risk of an infusion reaction.

Your first dose of Briumvi will last about 4 hours.

• Your second dose of Briumvi will be given 2 weeks after your first dose. This infusion will last about 1 hour.
• Your next doses of Briumvi will be given as 1 infusion every 24 weeks. These infusions will last about 1 hour.  

Dosing information

Dose of Briumvi for Multiple Sclerosis (Adults):

• First Infusion: 150 mg IV over at least 4 hours.
• Second Infusion (2 weeks after the first infusion): 450 mg IV over at least 1 hour.
• Subsequent Infusions (24 weeks after the first infusion and every 24 weeks thereafter): 450 mg IV every 24 weeks over at least 1 hour.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Briumvi injection.

What should I avoid while receiving Briumvi?

Avoid receiving a “live” vaccine while you are being treated with Briumvi, and for at least 4 weeks before your treatment. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid receiving a “non-live” vaccine for at least 2 weeks before your treatment with Briumvi.

What other drugs will affect Briumvi?

Tell your doctor about all your other medicines, especially:

• Drugs that weaken the immune system, such as cancer medications, steroids, and medicines to prevent organ transplant rejection.

Botox is used to smooth wrinkles and treat or prevent certain medical conditions, such as chronic migraines, severe underarm sweating, overactive bladder, strabismus, and muscle spasticity.

• Effects typically last for 3 to 4 months.
• Botox has a well-established safety profile when administered by a licensed provider.
• FDA-approved.

Botox Injection Uses

Botox Cosmetic is FDA-approved for use in Appearance Medicine for:

• Frown lines
• Crow’s feet
• Forehead wrinkles
• Neck bands

It may also be used off-label for bunny lines and jaw slimming .

Botox Therapeutic is FDA-approved for the following medical conditions:

• Overactive bladder (OAB) and urinary incontinence
• Chronic migraine prevention (15+ headache days/month)
• Muscle spasticity in adults and children 2+
• Cervical dystonia (neck muscle spasms)
• Severe underarm sweating (axillary hyperhidrosis)
• Eye conditions: blepharospasm, strabismus
• Neurogenic detrusor overactivity in children 5+.

Important Note: Although these formulations contain the same active ingredient, they are not interchangeable.

Pharmacist Tip

To ensure your Botox treatment is safe and effective, always get your injections from a licensed healthcare professional. This protects you from counterfeit Botox and minimizes side effect risks.

Results

Before and After Botox Cosmetic

What to Expect During Botox Treatment

Botox injections typically take just 10-30 minutes in your doctor’s office.

• Most people describe the sensation as a slight pinch, with minimal discomfort and no downtime.
• You’ll see initial results within 3-7 days, with full effects visible at 2 weeks.

How Much Does Botox Cost?

Botox Cosmetic treatments typically cost $300-$600 per treatment area and are not usually covered by insurance.

Botox Medical treatments are often covered by insurance when medically necessary for conditions like chronic migraine, overactive bladder, or cervical dystonia. Prior authorization may be required.

Financial support can be provided by AbbVie Patient Access Support in certain circumstances. 

Primary Medical Uses

• Overactive bladder (OAB) and urinary incontinence
• Chronic migraine prevention (15+ headache days/month)
• Muscle spasticity in adults and children 2+
• Cervical dystonia (neck muscle spasms)
• Severe underarm sweating (axillary hyperhidrosis)
• Eye conditions: blepharospasm, strabismus
• Neurogenic detrusor overactivity in children 5+

Primary Cosmetic Uses

• Frown lines (glabellar lines)
• Crow’s feet (lateral canthal lines)
• Forehead wrinkles
• Neck bands (platysma bands)

How Does Botox Work?

Botox (onabotulinumtoxinA) works by temporarily blocking nerve signals to muscles or sweat glands, relaxing them and providing cosmetic improvement for facial wrinkles and lines, and therapeutic relief from certain medical conditions.

For Medical Conditions:

• Relaxes overactive muscles (spasticity, dystonia)
• Improves bladder capacity (overactive bladder)
• Prevents migraine headaches (chronic migraine)
• Reduces excessive sweating (hyperhidrosis)
• Corrects eye alignment (strabismus)
• Controls muscle spasms (blepharospasm).

For Cosmetic Enhancement:

• Smooths forehead lines and crow’s feet
• Reduces frown lines between eyebrows
• Softens neck bands (platysma)
• Creates a refreshed, youthful appearance.

Side Effects

Common Side Effects

The most common side effects of Botox are:

• Mild injection site reactions (slight bruising, tenderness)
• Temporary headache 
• Mild fatigue.

These typically resolve within 24-48 hours.

Medical Use Specific Side Effects

Bladder Treatment:

• Urinary tract infections
• Painful urination
• Incomplete bladder emptying (may require temporary catheterization)
• Blood/bacteria in urine (pediatric patients).

Eye Treatment:

• Double vision or blurred vision
• Drooping eyelids (ptosis)
• Decreased eyesight
• Dry eyes
• Eyelid swelling

Serious Side Effects & Important Safety Information

Botox carries a Boxed Warning for distant spread of toxin effect.

Distant Spread of Toxin Effects (Boxed Warning)

Life-threatening botulism-like symptoms can rarely occur when onabotulinumtoxinA spreads away from the injection site. Seek urgent medical attention if you experience:

• Muscle weakness throughout the body
• Difficulty breathing or swallowing
• Vision problems: double vision, drooping eyelids
• Speech difficulties (dysarthria)
• Voice changes (dysphonia)
• Loss of bladder control.

Respiratory & Swallowing Problems

Respiratory and swallowing problems can occur hours to weeks after a Botox injection. People with pre-existing breathing/swallowing problems are at a higher risk. Severe cases may require a feeding tube, and rarely, death may occur if there are severe complications.

Allergic Reactions

Allergic reactions may happen with Botox. Seek immediate medical attention if you develop:

• Itching, rash, hives
• Wheezing or asthma symptoms
• Dizziness or fainting.

Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all the possible side effects of Botox. For more information, ask your doctor or pharmacist. Call your healthcare provider for medical advice about side effects.

Before Receiving

Absolute Contraindications

Do NOT receive Botox if you have:

• An allergy to onabotulinumtoxinA or the other ingredients in Botox Cosmetic or Botox Therapeutic
• An active skin infection at the injection site
• A previous allergic reaction to other botulinum products such as:
  • Dysport (abobotulinumtoxinA)
  • Xeomin (incobotulinumtoxinA)
  • Myobloc (rimabotulinumtoxin B)
  • Jeuveau (prabotulinumtoxinA-xvfs)
  • Daxxify (daxibotulinumtoxinA-lanm)
  • Letybo (letibotulinumtoxinA-wlbg).

Caution Needed

Tell your healthcare provider about all your medical conditions, including if you have:

• Neuromuscular disorders: ALS, myasthenia gravis, Lambert-Eaton syndrome
• Breathing problems: asthma, emphysema
• Swallowing difficulties
• Bleeding disorders
• Planned surgery or recent facial surgery
• Drooping eyelids or facial asymmetry
• Pregnancy plans. It is not known if Botox or Botox Cosmetic can harm your unborn baby
• Breastfeeding plans. It is not known if Botox or Botox Cosmetic passes into breastmilk.

How is Botox Administered?

Before Treatment

You’ll meet with a certified provider for a consultation. They’ll review your medical history, check for allergies, evaluate the treatment area, and go over the consent process and what to expect.

During Treatment

Your provider will clean the injection sites and administer Botox using very fine needles. The process takes 5 to 30 minutes, depending on the treatment area. Discomfort is minimal, and anesthesia typically isn’t needed.

After Treatment

Don’t rub the injection sites. Stay upright for 4 hours. Avoid exercise and facial treatments for 24 hours. Your provider will schedule a follow-up as needed.

Results Timeline

Initial effects start within 24 to 48 hours. Noticeable improvement appears in 3 to 7 days. Results peak at 2 weeks and gradually wear off over 3 to 6 months. Repeat treatments can be done as needed, with at least 3 months between sessions.

Age Restrictions

Botox is not approved for those aged:

• <18 years with urinary incontinence, chronic migraine, or overactive bladder 
• <18 years for cosmetic purposes
• <5 years with NDO
• <16 years with cervical dystonia
• <12 years with strabismus or blepharospasm
• <2 years with spasticity.

Botox for Medical Use Has Not Been Established For:

• Episodic migraine (≤14 days/month)
• Severe sweating anywhere other than your armpits.

What should I avoid while receiving Botox?

Botox may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving the injection. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Avoid exercise and facial treatments for 24 hours.

Botox Cosmetic FDA Approvals: Dosing Information

Frown Lines (Glabellar Lines)

• Dosage: 20 Units (5 injection sites)
• Target: Corrugator and procerus muscles
• Results: Smoother forehead appearance

Crow’s Feet (Lateral Canthal Lines)

• Dosage: 24 Units (6 injection sites total)
• Target: Orbicularis oculi muscle
• Results: Reduced eye wrinkles

Forehead Lines

• Dosage: 40 Units total (5 injection sites forehead + 5 injection sites glabellar)
• Target: Frontalis muscle
• Results: Smoother forehead wrinkles

Platysma Bands (Neck Bands)

• Dosage: 26-36 Units total (18-28 injection sites)
• Target: Platysma muscle
• Results: Reduced vertical neck banding

Off-Label Cosmetic Uses

While not FDA-approved, common uses include:

• Lip lines (perioral wrinkles)
• Bunny lines (nasal wrinkles)
• Masseter Botox (jawline slimming)
• Gummy smile correction.

Botox Medical FDA Approvals: Dosing Information

Overactive Bladder (OAB) Treatment

• Indication: Adults with inadequate response to anticholinergics
• Dosage: 100 Units (5 units across 20 injection sites)
• Benefits: Reduces urgency, frequency, and incontinence

Neurogenic Detrusor Overactivity

• Adult dosage: 200 Units (6-7 units across 30 injection sites)
• Pediatric dosage (≥5 years): Weight-based dosing
• Conditions: Spinal cord injury, multiple sclerosis

Chronic Migraine Prevention

• Indication: Adults with 15+ headache days/month
• Dosage: 155 Units divided among 7 head/neck muscles
• Injection sites: 31 sites total
• Effectiveness: Reduces migraine frequency and severity
• Not approved for episodic migraine (≤14 days/month)

Muscle Spasticity Treatment

• Adult upper limb: Up to 400 Units
• Adult lower limb: 300-400 Units
• Pediatric spasticity (≥2 years): 3-8 Units/kg
• Conditions: Post-stroke, cerebral palsy, brain injury

Cervical Dystonia (Torticollis)

• Average dose: 198-300 Units split between affected muscles
• Benefits: Reduces abnormal head position and neck pain
• Duration: 3-4 months between treatments

Severe Axillary Hyperhidrosis

• Dosage: 50 Units per armpit (split over 10 to 20 sites per armpit)
• Indication: Inadequate response to topical treatments
• Effectiveness: Significantly reduces underarm sweating
• Not approved for severe sweating anywhere other than your armpits.

Eye Conditions

Blepharospasm (Eyelid Spasms)

• Dosage: 1.25-2.5 Units per site (3 sites per eye)
• Age: Adults and children 12+

Strabismus (Crossed Eyes)

• Dosage: Dosage varies based on prism diopter correction or previous response.
• Age: Adults and children 12+

Botox vs. Other Treatments

What other drugs affect Botox?

Tell your doctor about all your medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Botox with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received Botox in the past. Especially tell your doctor if you:

• Have received any other botulinum toxin product in the last four months
• Have received injections of botulinum toxin, such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg) in the past. This may not be a complete list of all botulinum toxin products. Be sure your doctor knows exactly which product you received
• Have recently received an antibiotic by injection
• Take muscle relaxants
• Take an allergy or cold medicine
• Take a sleep medicine
• Take antiplatelets (aspirin-like products) or anti-coagulants (blood thinners).

Ask your doctor if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Ingredients

Botox Therapeutic Ingredients

Active ingredient: onabotulinumtoxinA

Inactive ingredients: human albumin and sodium chloride.

Available as 100 Units or 200 Units as a vacuum-dried powder in a single-dose vial.

Botox Cosmetic Ingredients

Active ingredient: onabotulinumtoxinA

Inactive ingredients: human albumin and sodium chloride.

Available as 50 Units or 100 Units in a vacuum-dried powder in a single-dose vial for reconstitution.

Manufacturer

Botox is made by AbbVie, which acquired the previous manufacturer, Allergan, in 2020. AbbVie is headquartered in North Chicago, Illinois, USA.

Common Questions About Botox

What is Botox?

Botox is a cosmetic treatment used to reduce the appearance of facial wrinkles and treat medical conditions like migraines and excessive sweating.

How much does Botox cost?

The price varies, but most providers charge between $10 and $25 per unit. A typical session costs between $300 and $600, depending on the area being treated.

How long does Botox last?

Results typically appear within 1 to 2 weeks and last about 3 to 4 months, though this can vary.

What are the side effects of Botox?

Common side effects include mild bruising or redness. Serious side effects are rare but may include drooping eyelids or difficulty swallowing.

Will I look frozen or unnatural?

When properly administered by a skilled provider, Botox provides natural-looking results while maintaining facial expression

Can I get Botox while pregnant?

Safety in pregnancy is unknown; discuss with your healthcare provider.

Botox Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Botox.Botox (onabotulinumtoxinA) – AbbVie Inc.

Botox C

Betaseron is used for relapsing forms of multiple sclerosis (MS), including relapsing-remitting multiple sclerosis (RRMS), isolated syndrome, and active secondary progressive disease in adults. Betaseron (interferon beta-1b) helps to reduce the number of flare-ups and clinical symptoms in relapsing forms of multiple sclerosis, but it will not cure MS. Betaseron injection works as it is similar to a protein in the body called interferon, which is involved in inflammation.

Betaseron is given as an injection under the skin every other day.

Betaseron injection received FDA approval on July 23, 1993, and can now be used to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis.

Betaseron side effects

Common Betaseron side effects may include:

• low white blood cell counts;
• abnormal liver function tests;
• headache, weakness;
• sleep problems (insomnia);
• stomach pain;
• muscle pain, stiffness, or weakness;
• rash;
• flu symptoms; or
• a skin reaction where the medicine was injected.

Serious Betaseron side effects
Allergic reactions Get emergency medical help if you have signs of an allergic reaction to Betaseron injection: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Liver problems including liver failure Symptoms of liver problems include yellowing of eyes, itchy skin, nausea or vomiting, feeling very tired, flu-like symptoms, and bruising easily or bleeding problems.

Depression Some patients using interferon medicines have become very depressed or had thoughts of suicide. Report any new or worsening symptoms of depression to your doctor, such as mood or behavior changes, anxiety, trouble sleeping, hallucinations, or if you feel impulsive, hostile, aggressive, depressed, or have thoughts about suicide or hurting yourself.

Other serious side effects Stop using Betaseron injection and call your doctor at once if you have:

• fever, chills, sweating, tiredness, body aches;
• a seizure;
• pain, swelling, redness, or skin changes where an injection was given;
• heart problems – chest tightness, swelling, rapid weight gain, trouble lying flat in bed, feeling short of breath;
• liver problems – nausea, vomiting, itching, easy bruising, unusual bleeding, dark urine, jaundice (yellowing of your skin or eyes); or
• new or worsening symptoms of lupus – joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Betaseron may be harmful to an unborn baby or may cause a miscarriage. Do not use Betaseron if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using Betaseron, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, a bleeding or blood-clotting disorder, anemia (low red blood cells), or a history of depression or suicidal behavior.

Serious allergic reactions can happen quickly and may happen after your first dose of Betaseron or after you have taken Betaseron many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using Betaseron if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Interferon beta-1b can harm your liver. Call your doctor at once if you have nausea, vomiting, itching, bruising or bleeding, or yellowing of your skin or eyes.

To be sure Betaseron is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.

Before taking this medicine

You should not use Betaseron if you are allergic to interferon beta, albumin, or mannitol.

To make sure Betaseron is safe for you, tell your doctor if you have:

• liver disease;
• heart problems;
• a seizure;
• depression, anxiety, or sleep problems;
• a bleeding or blood-clotting disorder;
• low white blood cell (WBC) counts;
• anemia (lack of red blood cells); or
• an allergy to latex.

Tell your doctor if you are pregnant or breastfeeding.

How should I use Betaseron?

Use Betaseron exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Betaseron is injected under the skin, usually every other day. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject Betaseron. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

You will need frequent medical tests.

Store unmixed Betaseron and the diluent at cool room temperature away from moisture and heat.

After mixing, store the medicine in the refrigerator and use within 3 hours. Do not freeze.

Each single-use vial (bottle) or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside. Throw away any Betaseron that is not used within 3 months.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Betaseron Dosing information

Usual Betaseron Adult Dose for Multiple Sclerosis:

Initial dose: 0.0625 mg subcutaneously every other day, and increased (in 25% increments) every 2 weeks, over a 6 week period, to maintenance dose
Maintenance dose: 0.25 mg subcutaneously every other day

Schedule for dose titration:
Weeks 1 and 2: 0.0625 mg subcutaneously every other day (25% of recommended dose)
Weeks 3 and 4: 0.125 mg subcutaneously every other day (50% of recommended dose)
Weeks 5 and 6: 0.1875 mg subcutaneously every other day (75% of recommended dose)
Week 7 and beyond: 0.25 mg subcutaneously every other day (100% of recommended dose)

Betaseron Use: For the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Then wait at least 48 hours (2 days) before using another injection, and restart your dosing schedule at that time. Do not use more than one injection every 48 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Betaseron?

Avoid injecting this medicine into skin that is sore, red, or infected.

Avoid drinking alcohol. It may increase your risk of liver problems.

What other drugs will affect Betaseron?

Other drugs may interact with interferon beta-1b, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Ingredients

Active ingredient: interferon beta-1b

Inactive ingredients: albumin (human), mannitol Diluent contains sodium chloride solution.

Company

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981

Betaseron Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Betaseron.Betaseron (interferon beta-1b) – Bayer HealthCare Pharmaceuticals Inc.

Benztropine is used with other medicines to treat symptoms of Parkinson’s disease, such as stiffness or tremors.

Benztropine is also used to treat Parkinson-like symptoms caused by using certain medicines.

Benztropine may also be used for purposes not listed in this medication guide.

Benztropine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Benztropine may cause serious side effects. Call your doctor at once if you have:

• dry mouth that causes trouble talking or swallowing;
• little or no urination;
• uncontrolled muscle movements;
• vomiting, severe constipation;
• fast heartbeats;
• muscle weakness;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• confusion, hallucinations; or
• severe skin rash.

Common side effects of benztropine may include:

• dry mouth;
• blurred vision;
• constipation; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use benztropine if you are allergic to it.

Not approved for use by anyone younger than 3 years old.

Tell your doctor if you have ever had:

• an enlarged prostate;
• urination problems;
• glaucoma; or
• muscle problems.

Older adults may be more sensitive to the effects of benztropine.

It is not known if benztropine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are breastfeeding.

How should I take benztropine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Benztropine oral is taken by mouth.

Benztropine is usually taken at bedtime.

Benztropine injection is given in a muscle or vein if you are unable to take the medicine by mouth.

Drink plenty of water to prevent dry mouth while taking benztropine.

Dry mouth may lead to gum disease or cavities. Brush and floss your teeth regularly and visit your dentist for routine dental care.

Call your doctor if your symptoms do not improve, or if they get worse.

Your symptoms may get worse if you stop using benztropine suddenly. Ask your doctor before stopping any of your anti-Parkinson medications.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose may cause drowsiness, confusion, nervousness, hallucinations, fast heart rate, vomiting, numbness in your fingers, hot or dry skin, or fainting.

What should I avoid while taking benztropine?

Avoid driving or hazardous activity until you know how benztropine will affect you. Your reactions could be impaired.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Benztropine can decrease sweating and you may be more prone to heat stroke.

What other drugs will affect benztropine?

Tell your doctor about all your other medicines, especially:

• other medicine to treat Parkinson’s disease;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• bronchodilator asthma medication.

Belsomra (suvorexant) is used to treat insomnia, to help if you fall asleep faster and stay asleep longer, so you have have a better nights sleep. Belsomra works on orexin receptors which plays a role in wakefulness, and helps regulate your sleep and wake cycle. Belsomra is a dual orexin receptor antagonists (DORAs).

Belsomra is a controlled substance, Schedule IV. Schedule IV controlled substances have a low potential for drug abuse and low risk of dependence. But some patients with a history of abuse or addiction may still be at an increased risk of abuse.

Belsomra is a tablet that you take half an hour before you go to bed.

Belsomra side effects

Common Belsomra side effects include strange dreams or drowsiness during the day after taking this medicine.

Serious Belsomra side effects

Get emergency medical help if you have signs of an allergic reaction to Belsomra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Call your doctor at once if you have:

• trouble moving or talking when you first wake up;
• a weak feeling in your legs;
• unusual thoughts or behavior;
• anxiety, agitation, depression;
• memory problems;
• confusion, hallucinations; or
• thoughts about hurting yourself.

You may be more likely to have side effects if you are overweight.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Do not take more Belsomra than your doctor has prescribed.

You should not use Belsomra if you have narcolepsy.

Take Belsomra 30 minutes before bedtime. Never take this medicine if you do not have 7 hours to sleep before being active again.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. If this happens to you, call your doctor right away.

Before taking this medicine

You should not use Belsomra if you are allergic to suvorexant, or if you have narcolepsy.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• depression, mental illness, or thoughts about suicide;
• drug or alcohol abuse or addiction;
• breathing problems, sleep apnea (breathing stops during sleep);
• liver disease;
• sudden muscle weakness;
• excessive sleepiness during normal waking hours; or
• if you have ever fallen asleep at unexpected times.

Tell your doctor if you are pregnant or breastfeeding.

Belsomra is not approved for use by anyone younger than 18 years old.

How should I take Belsomra?

Take Belsomra exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Belsomra may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take Belsomra only once per night, 30 minutes before bedtime.

You may take Belsomra with or without food. Avoid taking the medicine shortly after eating a meal, or the medicine may take longer to work.

Belsomra will make you fall asleep. Never take this medicine if you do not have 7 hours to sleep before being active again.

You may have trouble speaking or moving while you are falling asleep. It may take longer for you to wake up, speak, or move around when you wake up. You may feel like you are still dreaming for several minutes after waking.

Call your doctor if your insomnia symptoms do not improve, or if they get worse after using Belsomra for 7 to 10 nights in a row.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Dosing information

Usual Adult Dose for Insomnia:

10 mg orally once a day at bedtime
Maximum dose: 20 mg once a day

Comments:
-Take within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening.
-If 10 mg is well-tolerated but not effective, the dose can be increased.
-Time to effect may be delayed if taken with or soon after a meal.

Use: Insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

What happens if I miss a dose?

Since Belsomra is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medicine if you do not have 7 hours to sleep before being active again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

For at least 8 hours after taking Belsomra, do not drive or do anything that requires you to be alert. Your reactions may be impaired.

Avoid drinking alcohol. Do not take Belsomra if you have consumed alcohol within a few hours before getting ready for sleep.

What other drugs will affect Belsomra?

Using Belsomra with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Banzel is a seizure medication, also called an anti-epileptic or anticonvulsant.

Banzel is used together with other medicines to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Banzel is for use in adults and children who are at least 1 year old.

Warnings

You should not use Banzel if you have a severe liver disease, or a genetic heart rhythm disorder called short QT syndrome.

You should not stop taking Banzel suddenly, unless your doctor tells you to stop the medicine because of a serious side effect.

Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms.

Before taking this medicine

You should not use Banzel if you are allergic to rufinamide, or if you have:

• a genetic heart rhythm disorder called short QT syndrome; or
• severe liver disease.

To make sure Banzel is safe for you, tell your doctor if you have ever had:

• heart disease;
• liver disease;
• kidney disease (or if you are on dialysis); or
• depression, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Banzel. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of rufinamide on the baby.

Banzel can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using rufinamide, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Banzel should not be given to a child younger than 1 year old.

How should I take Banzel?

Take Banzel exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take Banzel with food.

The tablet may be swallowed whole, crushed, or cut in half.

Shake the oral suspension (liquid) well just before you measure a dose.

Measure the liquid using the dosing syringe and bottle adapter provided with this medicine. Insert the adapter into the bottle and snap it into place. Insert the syringe into the adapter and turn the bottle upside down. To measure your dose, pull the plunger to the correct number of milliliters marked on the side of the syringe. Rinse the syringe with water after each use.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your seizures get worse or you have them more often while taking Banzel.

You should not stop using Banzel suddenly, unless your doctor tells you to stop the medicine because of a serious side effect. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions very carefully.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Store the liquid medicine in an upright position. Do not try to remove the bottle adapter once it is in place. Throw away Banzel liquid 90 days after you first opened the bottle, even if there is medicine left inside.

In case of emergency, wear or carry medical identification to let others know you use rufinamide.

Dosing information

Usual Adult Dose for Lennox-Gastaut Syndrome:

Initial dose: 400 to 800 mg orally per day in 2 equally divided doses
-Titrate in 400 to 800 mg increments every other day until a maximum daily dose of 3200 mg/day is reached
Maintenance dose: 1600 mg orally twice a day

Comments:
-It is not known if doses lower than 3200 mg/day are effective.
-For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.

Usual Pediatric Dose for Lennox-Gastaut Syndrome:

1 year of age or older:
Initial dose: 10 mg/kg/day orally in 2 equally divided doses
-Titrate in 10 mg/kg increments every other day to a target dose of 45 mg/kg/day
Maintenance dose: 45 mg/kg orally per day in 2 equally divided doses
Maximum dose: 3200 mg/day

Comments:
-It is not known if doses lower than 45 mg/kg (not to exceed 3200 mg/day) are effective.
-For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Drinking alcohol can increase certain side effects of rufinamide.

Banzel side effects

Get emergency medical help if you have signs of an allergic reaction to Banzel: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• loss of balance or coordination;
• trouble walking; or
• worsening or increased seizures.

Common Banzel side effects may include:

• headache;
• dizziness, drowsiness;
• nausea; or
• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Banzel?

Using Banzel with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• valproic acid (Depakene, Stavzor).

This list is not complete. Other drugs may interact with rufinamide, including prescription and over-the-counter medicines, vitamins, and herbal products.

Baclofen belongs to a class of medications called skeletal muscle relaxants. Baclofen is an antispasmodic agent that acts on spinal cord nerves and decreases the number and severity of muscle spasms in patients with certain conditions affecting the spinal cord.

Baclofen is used in adults and children at least 12 years old to treat certain types of spasticity (muscle stiffness and tightness) and muscle pain in people with multiple sclerosis or a spinal cord injury or other spinal cord diseases.

Baclofen relieves pain and improves muscle movement.

Warnings

Do not use baclofen at a time when you need muscle tone for safe balance and movement during certain activities. Baclofen may make you drowsy. Do not drive or operate heavy machinery until you know how this medicine affects you.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms.

Ask your doctor about the safe use of alcoholic beverages while you are taking baclofen. Alcohol can make the side effects from baclofen worse.

Before taking this medicine

You should not use this medicine if you are allergic to baclofen.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• mental illness or psychosis;
• epilepsy or other seizure disorder;
• problems with balance;
• cerebral palsy;
• Parkinson’s disease;
• schizophrenia or a confused state;
• high blood pressure, or fast heart rate;
• a rheumatic disease;
• a stroke or blood clot; or
• kidney disease.

Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your own risk.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. If you take baclofen while pregnant or breastfeeding, withdrawal symptoms such as tremors, stiff muscles, or seizure may occur in the baby.

How should I take baclofen?

Take baclofen exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Shake the oral suspension (liquid).

Measure a dose with the supplied measuring device (not a kitchen spoon).

Shake and pour the entire oral granules packet to dissolve in your mouth or swallow whole at once, with or without liquids.

You may also mix the granules with liquids (milk, or apple juice) or soft food (apple sauce, yogurt, or pudding).

The oral granules can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your symptoms do not improve, or if they get worse.

You may have withdrawal symptoms if you stop using baclofen suddenly. Ask your doctor before stopping the medicine.

Store the oral suspension (liquid) at room temperature away from moisture and heat. Throw Fleqsuvy away after 2 months of first opening.

Store Ozobax in the refrigerator, do not freeze.

Dosing information

Usual Adult Dose for Spasticity:

Oral:
-Initial dose: The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day for 3 days
-Maintenance dose: Should be individualized.
-Maximum dose: 80 mg/day (20 mg orally 4 times a day).

Usual Pediatric Dose for Spasticity:

12 years and older:
Oral:
-Initial dose: The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day for 3 days
-Maintenance dose: Should be individualized.
-Maximum dose: 80 mg/day (20 mg orally 4 times a day)

Comments:
-The lowest dose compatible with an optimal response is recommended.
-Slowly withdraw therapy if benefits are not evident after a reasonable period.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include increasing drowsiness, dizziness, sleepiness, trouble focusing on objects, shallow breathing, seizure, or muscle weakness leading to loss of consciousness.

What should I avoid while taking baclofen?

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how baclofen will affect you. Your reactions could be impaired.

Do not share this medicine with another person, even if they have the same symptoms you have.

Baclofen side effects

Get emergency medical help if you have signs of an allergic reaction to baclofen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Baclofen may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness, breathing problems;
• confusion, hallucinations;
• muscle weakness, itching, tingling, or twitching in your hands, arms, feet, or legs; or
• fever.

Azilect works by increasing the levels of certain chemicals in the brain.

Azilect is used to treat symptoms of Parkinson’s disease (stiffness, tremors, spasms, poor muscle control).

Azilect is sometimes used with another medicine called levodopa.

Warnings

Do not Azilect if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, selegiline, or tranylcypromine.

Tell your doctor about all medicines you have used in the 2-week period before you start taking Azilect. Many drugs can interact with rasagiline, and some drugs should not be used together.

Before you take this medicine, tell your doctor if you have liver disease.

There are many other drugs that can cause serious medical problems if you take them together with Azilect. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

While you are taking this medicine and for 2 weeks after you stop taking it, you may not be able to eat certain types of cheese. Follow your doctor’s instructions. Rasagiline may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking this medicine

You should not take Azilect if you are allergic to rasagiline.

Do not use Azilect if you have used any other MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, selegiline, tranylcypromine, and others.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Azilect. Your doctor may change your treatment plan if you also use:

• cyclobenzaprine (a muscle relaxer);
• dextromethorphan (contained in many over-the-counter cough medicines);
• meperidine (Demerol);
• methadone;
• St. John’s wort; or
• tramadol (Ultram, Ultracet).

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with rasagiline and cause a serious condition called serotonin syndrome.

To make sure Azilect is safe for you, tell your doctor if you have ever had:

• high or low blood pressure;
• liver or kidney disease; or
• if you take ciprofloxacin (an antibiotic).

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I take Azilect?

Take Azilect exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you take Azilect alone, your dose may be different than if you take it with other Parkinson’s medications. Follow your doctor’s dosing instructions very carefully.

Azilect may be only part of a complete program of treatment that also includes a special diet. Follow the diet plan created for you by your doctor or nutrition counselor.

Get familiar with the list of foods you should avoid to help prevent certain side effects of rasagiline.

Call your doctor if your Parkinson’s symptoms do not improve, or if they get worse while using Azilect.

Store at room temperature away from moisture and heat.

Do not stop using Azilect suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Dosing information

Usual Adult Dose for Parkinson’s Disease:

Monotherapy:
Recommended dose: 1 mg orally once a day

Adjunct therapy:
Initial dose (in patients on concomitant levodopa): 0.5 mg orally once a day
Initial dose (in patients not on concomitant levodopa): 1 mg orally once a day
Maintenance dose: 0.5 mg to 1 mg orally once a day

Maximum dose: 1 mg orally once a day

Comments: May be used as adjunct therapy in patients on levodopa therapy, with or without other drugs used in the treatment of Parkinson’s disease.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of rasagiline can be fatal.

Overdose symptoms may include drowsiness, dizziness, severe headache, rapid pulse, feeling agitated or irritable, muscle spasms in your neck or jaw, sweating, cold or clammy skin, shallow breathing, fainting, or seizure (convulsions). These symptoms may be delayed for 12 to 24 hours after an overdose.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid drinking alcohol, especially red wine, vermouth, and tap beers or ale.

Also avoid eating foods that are high in tyramine, such as aged cheeses, fava beans, soy sauce, herring, pickled or processed meats and fish, and meats that are aged, dried, smoked, or fermented. Eating tyramine while you are taking Azilect can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

Azilect side effects

Get emergency medical help if you have signs of an allergic reaction to Azilect: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears;
• extreme drowsiness or falling asleep suddenly, even after feeling alert;
• unusual changes in mood or behavior;
• hallucinations;
• a light-headed feeling, like you might pass out; or
• worsening symptoms of Parkinson’s disease (especially uncontrolled muscle movements).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Some people taking Azilect with levodopa have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Azilect side effects may include:

• depressed mood;
• sleep problems (insomnia), strange dreams;
• involuntary muscle movements;
• loss of appetite, weight loss;
• indigestion, stomach pain, nausea, vomiting, constipation;
• joint pain or stiffness;
• rash;
• cough or other flu symptoms;
• dry mouth; or
• swelling in your hands or feet.

Austedo (deutetrabenazine) is a prescription medicine used to treat chorea associated with Huntington’s disease and tardive dyskinesia (TD), which are involuntary movement disorders. Austedo helps reduce uncontrolled movements and improve the quality of life for patients; however, it does not cure the underlying condition causing the movement disorder. 

Austedo works by regulating the storage and release of natural chemical messengers (neurotransmitters) from nerves, to help control symptoms such as twitching, jerking, or facial tics. It does this by targeting and blocking a protein in the brain called VMAT2, which is responsible for moving neurotransmitters (chemical messengers) into nerve cell storage areas.

Austedo’s drug class is a VMAT2 inhibitor (vesicular monoamine transporter 2 inhibitor).

Austedo tablets are taken twice daily, and the Austedo XR (extended-release) tablets are taken once daily.

What is Tardive dyskinesia (TD) and chorea associated with Huntington’s disease 

Tardive dyskinesia (TD) is a nervous system disorder that causes repetitive, uncontrolled muscle movements, usually in the face (chewing, lip smacking, frowning, tongue movement, blinking, or eye movement). Tardive dyskinesia can develop due to using certain medicines.

Chorea associated with Huntington’s disease is sudden, involuntary movements usually of the arms, legs, face, and tongue. It is an inherited disease that causes the progressive breakdown of nerve cells in the brain. Austedo is not a cure for Huntington’s disease and will only treat the symptom of chorea; it does not treat other symptoms of this condition.

Austedo side effects

Common Austedo side effects may include:

• drowsiness;
• tiredness;
• dry mouth;
• runny or stuffy nose, sore throat;
• sleep problems (insomnia); or
• diarrhea.

Serious Austedo side effects

Get emergency medical help if you have signs of an allergic reaction to Austedo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people have thoughts about suicide while taking Austedo for Huntington’s disease. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Some side effects may actually be signs that your Huntington’s disease is progressing. Your doctor will need to check your progress on a regular basis.

Deutetrabenazine may cause other serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• severe restlessness or agitation;
• tremors, shaking;
• muscle stiffness;
• problems with balance or coordination; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What is the cost of Austedo tablets?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Austedo price guide or Austedo XR price guide pages for more information about the cost of this medicine.

Who is eligible for the Austedo Coupon or Copay Card?

You are eligible for the Austedo Copay Card if you have commercial or private insurance, a valid prescription, and are a resident of the United States or the United States territories. 

You are not eligible for an Austedo Copay Card if you are enrolled in Medicare, Medigap, Medicaid, VA, DOD, TRICARE, Puerto Rico Government Health Insurance Plan, and Medicare-eligible patient enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.

How can I apply for the AustedoCopay Card?

You can apply for the Austedo Copay Card or Coupon online; there is a link on the Austedo Price Guide page. 

Check the terms and conditions for the Austedo Savings Card online.

Warnings 

QTc Prolongation. This medicine may prolong the QT interval, but the degree of QT prolongation is not clinically significant when administered within the recommended dosage range.  Austedo tablets and XR tablets should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias associated with a prolonged QT interval. 

Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: 

• slow heart rate (bradycardia),
• low potassium levels (hypokalemia), 
• low magnesium blood levels (hypomagnesemia), 
• having a congenital prolongation of the QT interval, and
• concomitant use of other drugs that prolong the QTc interval.

Depression and Suicide. Some people have thoughts about suicide while taking Austedo tablets and extended-release tablets; stay alert to changes in your mood, feelings, thoughts, or behaviors. Tell your doctor right away if you have any sudden changes in mood or behavior or thoughts about suicide.

You should not use this medicine if you have Huntington’s disease and you have untreated or uncontrolled depression, or if you have thoughts about suicide.

Other medicines. Do not use this medicine if you have taken reserpine (Serpalan, Renese-R) in the past 20 days, or if you have used an MAO inhibitor (isocarboxazid, linezolid, rasagiline, selegiline, and others) in the past 14 days. See the Interactions section for more interactions with this medicine.

Before taking this medicine

You should not use Austedo if you are allergic to the active ingredient, deutetrabenazine, inactive ingredients, or if you have:

• untreated or uncontrolled depression;
• thoughts about suicide or hurting yourself;
• if you have recently taken tetrabenazine or valbenazine; or
• liver impairment.

Do not use this medicine if you have taken reserpine in the past 20 days, or if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• depression, anxiety, nervousness, or agitation;
• mental illness or psychosis;
• suicidal thoughts or actions;
• breast cancer;
• a heart rhythm disorder;
• long QT syndrome (in you or a family member);
• an electrolyte imbalance (such as low blood levels of potassium or magnesium); or
• liver disease.

People with Huntington’s disease may have a higher risk of depression and suicidal thoughts or behaviors. Taking this medicine may further increase this risk. However, the benefits of taking this medicine (improvement in daily living) may outweigh any suicidal risks.

Taking this medicine may cause symptoms similar to Parkinson’s disease (resting tremor, stiff muscles, slow movements, difficulty maintaining balance, and walking). Ask your doctor about your risk.

Your doctor will need to check your progress on a regular basis. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or breastfeeding.

How should I take this medicine?

Take Austedo as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you are switching from a similar medicine called tetrabenazine, take your first dose of Austedo one day after your last dose of tetrabenazine.

Austedo tablets are usually taken twice daily with food and a whole glass of water. Swallow the tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet whole.

You may need medical tests to check your heart function using an electrocardiograph or ECG (sometimes called an EKG).

Do not stop the medicine without your doctor’s advice. If you stop taking Austedo for longer than 1 week, do not start taking it again without your doctor’s advice.

Store at room temperature away from moisture and heat. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.

Austedo dose information

Austedo dose

Initial dose: 6 mg twice daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day in divided doses.
Maximum Dose: 48 mg/day in divided doses.
Important Administration Instructions: 

• Take Austedo tablets with food
• Swallow whole. Do not chew, crush, or break tablets
• Take total daily dosages of 12 mg or above in two divided doses.

Austedo XR dose

Initial Dose: 12 mg once daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day.
Maximum Dose:  48 mg/day
Important Administration Instructions:

• Take XR tablets with or without food 
• Swallow whole. Do not chew, crush, or break tablets.
• Take Austedo XR once daily. 

General dosing information

Switching Between Austedo and Austedo XR When switching between Austedo tablets (twice daily) and Austedo XR extended-release tablets (once daily), switch to the same total daily dosage.

Dose modifications: Dose modifications may be required when taking other medications due to drug interactions.

Discontinuation and Interruption of Treatment: Treatment with this medicine can be discontinued without tapering. Following treatment interruption of greater than one week, this therapy should be re-titrated when resumed. For treatment interruption of less than one week, treatment can be resumed at the previous maintenance dose without titration.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line ,

Overdose symptoms may include involuntary muscle movements, tremors, rapid eye movements, nausea, vomiting, diarrhea, flushing, sweating, severe drowsiness, confusion, hallucinations, or feeling light-headed.

What should I avoid while taking this medicine?

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Drinking alcohol with this medicine can cause side effects.

What other drugs will affect this medicine?

Austedo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using Austedo with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with the active ingredient deutetrabenazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

What is Aubagio?

Aubagio is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Aubagio may help reduce the relapse rate, slow disability progression, and also slow lesion size growth, compared to placebo treatment. Aubagio tablets are taken once daily with or without food.

Aubagio affects the immune system and reduces swelling and inflammation in the nervous system. Aubagio works by lowering the number of lymphocytes that cause inflammation and damage to the nerves. This helps to slow the progression of RRMS and reduce the relapse rate.

In RRMS, a type of white blood cell called lymphocytes mistakenly attacks the protective coating (myelin) that surrounds your neurons, which causes inflammation of the neurons and loss of myelin. The neurons are unable to work properly, causing the symptoms of RRMS.

Aubagio is not a cure for MS; it helps slow disease progression and reduces relapse rate.

Aubagio received FDA approval on September 12, 2012. The generic for Aubagio is called teriflunomide and is also now available.

Aubagio side effects

Common Aubagio side effects may include:

• headache;
• nausea, diarrhea;
• thinning hair; or
• abnormal liver function tests.

Serious Abagio side effects

Get emergency medical help if you have signs of an allergic reaction to Aubagio (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using this medicine and call your doctor at once if you have:

• numbness or tingling in your hands or feet that feels different from your MS symptoms;
• trouble breathing, new or worsening cough with or without fever;
• signs of infection – fever, chills, body aches, nausea, vomiting, feeling tired, or
• liver problems – upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

Do not use Aubagio if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends.

Teriflunomide can cause severe liver problems. You should not use this medicine if you have severe liver disease or if you are also taking leflunomide (Arava). Tell your doctor if you have a history of liver disease.

Call your doctor at once if you have signs of liver problems: upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Your doctor may need to test your liver function up to 6 months before you start taking Aubagio and then every month when you first start taking this medicine.

Teriflunomide can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. While using Aubagio, you may need blood tests every 6 months. Your blood pressure will also need to be checked often.

After you stop taking Aubagio, the drug could stay in your body for up to 2 years. You may need to be treated with other medications to help your body eliminate teriflunomide quickly. Follow your doctor’s instructions.

Before taking this medicine

You should not use Aubagio if you are allergic to teriflunomide or leflunomide, or if:

• you have severe liver disease or
• you are also taking leflunomide (Arava).

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;
• high blood sugar;
• high blood pressure;
• skin problems when taking medicines;
• a fever, or uncontrolled infections;
• breathing problems;
• tuberculosis; or
• nerve problems, such as neuropathy.

Pregnancy

Do not use Aubagio if you are pregnant or may become pregnant You will need to have a negative pregnancy test before starting this treatment. Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking Aubagio, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

Avoid getting pregnant until after you stop taking this medicine and undergo a “drug elimination” procedure to help rid your body of this medicine. Stop taking Aubagio and call your doctor right away if you miss a period or think you might be pregnant. If you inadvertently become pregnant while receiving Aubagio or within 2 years of stopping it, there is a pregnancy surveillance program for Aubagio. You or your healthcare provider can report the pregnancy by calling 1-800-745- 4447. This is to track the outcome of the pregnancy and to evaluate any effects of teriflunomide on the baby.

If you are a man, use effective birth control to prevent pregnancy if your sex partner is able to get pregnant. After your treatment ends, keep using birth control until you have received the medications to help your body eliminate teriflunomide.

Breastfeeding

You should not breastfeed while using this medicine.

How should I take Aubagio?

Before you start treatment with Aubagio, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Aubagio with or without food.

Your blood pressure will need to be checked often.

Teriflunomide can lower your blood cell counts. Your blood will need to be tested often. Your treatment may be delayed based on the results.

After you stop taking Aubagio, you may need to be treated with other medicines to help your body eliminate teriflunomide quickly. If you do not undergo this drug elimination procedure, teriflunomide could stay in your body for up to 2 years. Follow your doctor’s instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking this medicine.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

7 mg or 14 mg orally once a day

Use: Treatment of patients with relapsing forms of multiple sclerosis.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using Aubagio, and for at least 6 months after you stop taking it. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Aubagio?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can interact with teriflunomide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.