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.

Avonex is a disease-modifying therapy (DMT) used to treat relapsing multiple sclerosis (MS) in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Avonex injection (interferon beta-1a injection) is given intramuscularly (into a muscle), usually once weekly at bedtime.

For people living with MS, Avonex helps manage the disease by resembling the mechanism of action of interferons, which are proteins naturally produced by our immune system that help regulate the body’s immune response and fight viral infections.

• Avonex contains interferon beta 1-a, which is a man-made form of interferon that works in the same way, binding to specific receptors on cell surfaces and decreasing the activity of immune cells that attack the myelin sheath, reducing inflammation in the central nervous system, and helping to suppress the autoimmune response that characterizes MS.
• Avonex belongs to the drug class called interferons. It may also be called an immunomodulator.

Important: Avonex injection will not cure MS; it will only decrease the frequency of relapse symptoms.

Avonex (interferon beta-1a) gained FDA approval on May 17, 1996. There is no Avonex generic (more correctly called a biosimilar).

• Another form of interferon beta-1a, called Rebif, also used for MS, is given 3 times a week by subcutaneous (under the skin) injection.

Avonex and MS

Multiple sclerosis (MS) is an autoimmune disease that occurs when the immune system attacks the myelin sheath protecting nerve fibers, disrupting brain-body communication and causing MS symptoms like vision problems, muscle weakness, and coordination difficulties.

Avonex for MS addresses this disease process by modulating the immune response. The interferon beta-1a reduces immune attacks on myelin, decreases central nervous system inflammation, and prevents new MS lesions. For MS patients, this means fewer relapses, reduced disease activity, and slower disability progression.

Warnings

Liver Damage: Avonex injection can harm your liver. Call your doctor if you have symptoms such as nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Mental Health: Some MS patients using interferon beta-1a have thoughts about suicide. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before using Avonex injection, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, heart disease, chest pain (angina), congestive heart failure, a heart rhythm disorder, or a history of depression or suicidal behavior.

Before taking this medicine

Do not use Avonex injection if you are allergic to natural or recombinant interferon beta or albumin.

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

• depression, mental illness, or suicidal thoughts or actions;
• liver disease;
• bleeding problems or a blood clot;
• low blood cell counts;
• heart disease;
• a thyroid disorder;
• a latex allergy;
• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
• a seizure; or
• if you drink alcohol.

Plasma-derived products: Some brands of interferon beta-1a contain donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.

Interferon beta-1a is not approved for use by anyone younger than 18 years old.

How to Give an Avonex Injection

Use Avonex 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.

Avonex Injection Guidelines:

• Frequency: Once weekly at bedtime, on the same day each week (such as every Monday)
• Method: Intramuscular injection into a muscle
• Injection devices: Available as a prefilled syringe or a prefilled autoinjector pen
• Site rotation: Use a different place each time you give an injection.

Avonex Injection Site Safety:

• Injection site reactions can occur with Avonex injections, including injection site necrosis
• About 2 hours after the Avonex injection, check for skin redness, swelling, or pain
• Report immediately: Any break in skin with blue-black discoloration, swelling, or drainage
• Call your doctor if the injection site reaction doesn’t go away within a few days.

Storage Instructions:

• Store in refrigerator, protect from light, do not freeze
• Prefilled syringe/autoinjector: Remove 30 minutes before injection to reach room temperature
• Do not leave the prefilled syringe/autoinjector out of the refrigerator for longer than 7 days.

Avonex Side Effects

Get emergency medical help if you have signs of an allergic reaction to Avonex (hives, itching, anxiety, difficult 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).

Life-threatening blood clots: Interferon beta-1a can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Call your doctor at once if you have:

• pain, swelling, bruising, redness, oozing, or skin changes where the injection was given;
• a light-headed feeling, like you might pass out;
• unusual changes in mood or behavior (feeling hopeless, anxious, nervous, irritable, or depressed);
• thoughts about suicide or hurting yourself;
• easy bruising, unusual bleeding;
• a seizure;
• heart problems – swelling, rapid weight gain, feeling short of breath, rapid heartbeats, chest pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – nausea, loss of appetite, tiredness, confusion, easy bruising or bleeding, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes);
• signs of infection – fever, chills, cough with mucus, bloody diarrhea, pain or burning when you urinate; or
• thyroid problems – mood swings, trouble sleeping, tiredness, hunger, diarrhea, pounding heartbeats, muscle weakness, sweating, dry skin, thinning hair, menstrual changes, weight changes, puffiness in your face, feeling more sensitive to hot or cold temperatures
• breathing difficulties. Pulmonary arterial hypertension can occur with interferon beta products,
  including Avonex. Symptoms may include new or increasing fatigue or shortness of breath.

Common Avonex side effects may include:

• low blood cell counts;
• skin changes where the injection was given;
• depression;
• abnormal liver function tests;
• stomach pain; or
• flu symptoms – headache, fever, chills, chest pain, back pain, tiredness, weakness, muscle aches.

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

Dosing Information

Usual Adult Maintenance Dose of Avonex for MS

• 30 mcg intramuscularly once a week.

Titrate the dose as follows to reduce the incidence and severity of influenza-like symptoms:

• Week 1: 7.5 mcg intramuscularly once weekly
• Week 2: 15 mcg intramuscularly once weekly
• Week 3: 22.5 mcg intramuscularly once weekly
• Week 4+: 30 mcg intramuscularly once weekly.

Available forms: Avonex injection is available as a single-dose prefilled syringe and single-dose prefilled autoinjector.

Missed Dose

Use the medicine as soon as you can, but do not inject Avonex two days in a row. Do not use two doses at one time.

Overdose

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Avonex?

Other drugs may interact with interferon beta-1a, 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.

Avonex Injection Ingredients

Active ingredient: interferon beta-1a
Inactive ingredients: Avonex Single-Dose Prefilled Syringe: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection.

Inactive ingredients: Avonex Single-Dose Prefilled Autoinjector Pen: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection. 

Who makes Avonex?

Biogen Inc. makes Avonex.

Frequently Asked Questions

How long does it take for Avonex to work?

Avonex typically takes 3-6 months to show its full effect in reducing MS relapses. Some patients may notice improvements in fatigue and overall well-being within the first few weeks, but the medication’s primary benefit of reducing relapse frequency and slowing disability progression becomes more apparent over time. It’s important to continue treatment even if you don’t immediately notice changes, as the medication works to prevent future MS activity.

Can I travel with Avonex injections?

Yes, you can travel with Avonex, but it requires careful planning. Keep medication in its original packaging with prescription labels. For air travel, pack Avonex in carry-on luggage with a cooling pack (but not frozen). Bring a doctor’s letter explaining your medical need for the injection.

For international travel, research medication regulations in your destination country. Consider bringing extra supplies in case of delays. Avonex can be stored at room temperature for up to 7 days (prefilled syringe) or 30 days (vial) if refrigeration isn’t available.

What’s the difference between Avonex and Rebif?

Both Avonex and Rebif contain interferon beta-1a, but they differ in dosing and administration. Avonex is given once weekly by intramuscular injection (into the muscle), while Rebif is given three times weekly by subcutaneous injection (under the skin). Rebif typically has a higher cumulative weekly dose.

Both medications have similar effectiveness for MS treatment, but some patients may prefer the less frequent Avonex injections, while others may tolerate the smaller, more frequent Rebif doses better. Your neurologist can help determine which is best for your situation.

How can I manage flu-like symptoms from Avonex?

Flu-like symptoms are common, especially when starting Avonex, but usually improve over time. To minimize symptoms: take Avonex at bedtime so you sleep through the worst effects, pre-treat with over-the-counter pain relievers like acetaminophen or ibuprofen 30 minutes before injection and continue for 24 hours after, stay well-hydrated, use a heating pad for muscle aches, and ensure adequate rest.

The dose titration schedule (starting with lower doses) also helps reduce these symptoms. Most patients find flu-like effects diminish significantly after 2-3 months of treatment.

Can I drink alcohol while taking Avonex?

While there’s no absolute prohibition on alcohol with Avonex, you should use caution. Both Avonex and alcohol can affect liver function, so combining them may increase the risk of liver problems. Additionally, alcohol can worsen some MS symptoms like fatigue, balance problems, and depression. If you choose to drink, do so in moderation and discuss your alcohol consumption with your healthcare provider, especially if you have any liver function abnormalities or are taking other medications.

How to administer the Avonex injection?

Avonex is given by intramuscular injection, typically in the thigh (vastus lateralis muscle) or upper arm (deltoid muscle). Rotate between different sites to prevent tissue damage and injection site reactions.

For thigh injections, alternate between left and right thighs, and vary the exact location within each thigh. If using the upper arm, you may need assistance from someone else for proper injection technique.

Keep a record of injection sites to ensure proper rotation. Never inject into areas that are red, bruised, infected, or have scar tissue.

What blood tests do I need while taking Avonex?

Regular monitoring is essential while taking Avonex. Typical tests include: complete blood count (CBC) to check for low white blood cells, red blood cells, or platelets; liver function tests to monitor for hepatotoxicity; and thyroid function tests since Avonex can affect thyroid function. Initially, these tests may be done monthly for the first few months, then every 3-6 months once you’re stable. Your neurologist will determine the appropriate testing schedule based on your individual situation and any side effects you experience.

Can I get pregnant while taking Avonex?

If you’re planning to become pregnant or become pregnant while taking Avonex, discuss this immediately with your healthcare provider. Avonex is pregnancy category C, meaning effects on pregnancy aren’t fully known. Some studies suggest interferons may increase risk of miscarriage.

Your neurologist will weigh the benefits of continued MS treatment against potential risks to pregnancy. There are alternative MS treatments that may be safer during pregnancy. Don’t stop Avonex abruptly without medical supervision, as this could lead to MS relapses.

Is there financial assistance available for Avonex?

Yes, several options exist to help with Avonex costs. Biogen, the manufacturer, offers the Avonex Patient Support Program which may provide co-pay assistance for eligible patients with commercial insurance. The program may cover up to a certain amount per prescription.

Additionally, patient assistance programs are available for uninsured or underinsured patients who meet income requirements. The National MS Society also provides information about financial assistance programs. Contact Biogen’s patient support services or speak with your healthcare provider’s financial counselor to explore available options.

What should I do if I experience injection site reactions?

Mild injection site reactions (redness, swelling, pain) are common and usually resolve within a few days. Apply ice before injection and heat afterward to minimize discomfort. However, watch for signs of serious reactions: persistent pain, increasing redness or swelling after 2-3 days, skin breakdown or ulceration, blue-black discoloration, or drainage from the injection site. These could indicate injection site necrosis, which requires immediate medical attention.

Always rotate injection sites and never inject into irritated or damaged skin. If reactions persist or worsen, contact your healthcare provider.

Can I receive vaccines while taking Avonex?

Generally, inactivated (killed) vaccines are safe while taking Avonex, but live vaccines should typically be avoided as they may pose risks for people on immunomodulatory therapy. Common safe vaccines include the flu shot (inactivated), the pneumonia vaccine, and the hepatitis B vaccine.

However, timing and specific recommendations can vary. Always inform healthcare providers that you’re taking Avonex before receiving any vaccine. Your neurologist and primary care provider should coordinate your vaccination schedule to ensure optimal protection while maintaining MS treatment safety.

Avonex 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 Avonex.Avonex (interferon beta-1a) – Biogen Inc.

What is Rebif?

Rebif is used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

• The generic name for Rebif is interferon beta-1a.
• Rebif is injected under the skin (subcutaneously), usually 3 times a week, such as on a Monday, Wednesday, and Friday.

Rebif’s mechanism of action resembles that of interferons which are proteins naturally produced by our immune system that help regulate the body’s immune response and fight viral infections. Rebif is a man-made form of interferon that works in the same way, binding to specific receptors on cell surfaces and decreasing the activity of immune cells that attack the myelin sheath, reducing inflammation in the central nervous system, and helping to suppress the autoimmune response that characterizes MS.

Rebif belongs to the drug class called interferons. It may also be called an immunomodulator. Rebif will not cure MS, it will only decrease the frequency of relapse symptoms.

Rebif gained FDA approval on March 7, 2002. Another brand of interferon beta-1a given intramuscularly (into a muscle) called Avonex, was the first interferon beta-1a to be approved (May 17, 1996). There is no Rebif generic.

Rebif side effects

The most common side effects of Rebif are:

• flu-like symptoms such as:
  • muscle aches
  • fever
  • tiredness
  • chills.
• stomach pain
• changes in your liver tests.

Serious side effects and warnings

Rebif can cause the following serious side effects.

Behavioral health problems including depression and suicidal thoughts. You may have mood problems while taking Rebif, for example, depression (feeling hopeless or feeling bad about yourself), or thoughts of hurting yourself or suicide. Contact your healthcare provider immediately.

Liver problems or liver failure has been reported in people taking Rebif. Contact your healthcare provider immediately if you develop any of the following symptoms:

• nausea
• loss of appetite
• tiredness
• dark-colored urine and pale stools
• yellowing of your skin or the white part of your eye
• bleeding more easily than normal
• confusion
• sleepiness.

Rebif may cause serious allergic and skin reactions. Contact your healthcare provider or seek emergency medical attention if you develop any of the following symptoms:

• itching
• swelling of your face, eyes, lips, tongue or throat
• trouble breathing
• anxiousness
• feeling faint
• skin rash, hives, sores in your mouth, or skin blisters and peels.

Injection site problems. Rebif may cause redness, pain, itching, or swelling at the place where your injection was given. Call your healthcare provider immediately if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.

Blood problems. Rebif can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems.

Pulmonary arterial hypertension. Pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) can occur with interferon beta products, including Rebif. Symptoms may include new fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.

Thrombotic microangiopathy (TMA). TMA is a condition that involves injury to the smallest blood vessels in your body and this has been reported with Rebif. TMA can also cause injury to your red blood cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking Rebif if you develop TMA.

Seizures. Some people have had seizures while taking Rebif.

Autoimmune diseases. Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use Rebif.

Eye Disorders: Retinal disorders (such as retinopathy, cotton wool spots, or obstruction of
the retinal artery or vein) have been reported with Rebif. See your healthcare provider immediately if you have any changes in your vision or eye pain.

During your treatment with Rebif see your healthcare provider regularly and have regular blood tests to check for side effects.

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

Before taking

Do not take Rebif if you are allergic to interferon beta-1a, human albumin, Rebif, Avonex, or any inactive ingredients in the injection (see below for a list of inactive ingredients).

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

• mental illness, including depression and suicidal behavior
• liver problems
• bleeding problems or blood clots
• low blood cell counts
• seizures (epilepsy)
• thyroid problems
• drink alcohol
• you are pregnant or plan to become pregnant
• you are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Rebif can harm your unborn baby.

Breastfeeding

Rebif may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while taking this medicine.

How should I use Rebif?

See the Instructions for Use that come with the Rebif Package Insert.

• Your healthcare provider should show you how to prepare, measure, and inject your dose of Rebif before you use it for the first time.

How to inject Rebif for subcutaneous use

Rebif is given by injection under the skin (subcutaneous injection) on the same 3 days a week, for example, Monday, Wednesday, and Friday.

• Your injections should be at least 48 hours apart.
• Try to inject Rebif at the same time the three days that you have chosen to inject it (for example, always around 10am on Monday, Wednesday, and Friday).
• The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, your stomach or buttocks.
  • Do not use the area near your waistline or within 2 inches of your navel. If you are very thin, use only the thigh or outer surface of the arm for the injection.
• Inject Rebif exactly as your healthcare provider tells you.

Your healthcare provider will tell you how much Rebif to inject and may change the dose based on how your body responds. 

• Do not change your dose unless your healthcare provider tells you to.
• Change (rotate) the injection site you choose with each injection. This will help decrease the chance that you will have an injection site reaction.
• Do not inject Rebif into an area of the body where the skin is irritated, reddened, bruised, infected, or scarred in any way.

Rebif comes as a:

• prefilled syringe
• single-use prefilled autoinjector (Rebif Rebidose).

Your healthcare provider will decide which is best for you. Always use a new, unopened, prefilled syringe or autoinjector for each injection. Do not reuse prefilled syringes or autoinjectors.

Rebif dosing information

The recommended dose of Rebif for MS is either 22 micrograms or 44 micrograms injected subcutaneously, 3 times a week.

Titration: Generally, the starting dose should be 20% of the prescribed dose three times per week, and increased over 4 weeks to the targeted recommended dose of either 22 micrograms or 44 micrograms injected subcutaneously three times per week. Your healthcare provider will calculate this dose for you.

Pain and/or fever-relieving medicines on treatment days may help reduce side effects such as flu-like symptoms.

What other drugs will affect Rebif?

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Rebif and other medicines may affect each other causing side effects. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storage

Store Rebif in the refrigerator between 36°F to 46°F (2°C to 8°C).

Do not freeze Rebif.

If you cannot refrigerate your Rebif pen or autoinjector, you can store it at temperatures above 36°F and below 77°F (2°C to 25°C) for up to 30 days.

Keep Rebif away from heat and light.

Rebif ingredients

Active ingredient: Rebif

Inactive ingredients: albumin (human), mannitol, sodium acetate, water for injection

Single-dose Rebif prefilled syringe is available as 8.8 mcg in 0.2 mL, and 22 mcg or 44 mcg in 0.5 mL.

Single-dose Rebif autoinjector is available as 8.8 mcg in 0.2 mL, and 22 mcg or 44 mcg in 0.5 mL.

Who makes Rebif?

EMD Serono Inc. makes Rebif.

Rebif 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 Rebif.Avonex (interferon beta-1a) – Biogen Inc.