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.

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.

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.

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.