Rebif

Rebif (interferon beta-1a) is used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Rebif is injected subcutaneously (under the skin) 3 times a week.

There are 3 injection options for Rebif:

• Rebif prefilled syringe Ready to use No mixing or assembly required
• Rebiject II autoinjector Works with the Rebif prefilled syringe Ability to adjust the injection depth into the skin Available at no additional cost.
• Rebif Rebidose autoinjector Portable, prefilled, single-use autoinjector The needle remains hidden before and after injecting

Rebif (interferon beta-1a) is a synthetic form of interferon, a protein naturally produced by the immune system. It works by binding to specific cell surface receptors, reducing the activity of immune cells that attack the myelin sheath, suppressing the autoimmune response characteristic of MS, and decreasing inflammation in the central nervous system. Rebif belongs to the drug class called interferons and is classified as an immunomodulator. It does not cure MS but reduces the frequency of relapses.

Rebif gained FDA approval on March 7, 2002. There is no Rebif generic.

See the Instructions for Use that come with the Rebif Package Insert. For the Rebif Rebidose autoinjector, read theInstructions for Use that come with the Rebif Rebidose autoinjector.

• 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. Take them at the same time each day.
• 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 inject more than your healthcare provider tells you to.
• 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 (Rebif)
• single-use prefilled autoinjector (Rebif Rebidose autoinjector).

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

See the Rebif Medication Guide for complete administration instructions.

Do not take Rebif if you are allergic to interferon beta, human albumin, 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.

Common 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 have 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.
• Allergic and skin reactions. 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.
• Decreased Peripheral Blood Counts. 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.

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. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Rebif for MS

• Starting Dose and 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 mcg or 44 mcg injected subcutaneously three times per week.
• Maintenance: 22 micrograms or 44 micrograms subcutaneously, 3 times a week.

See the Rebif Prescribing Information for full dosing instructions.

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.

Store Rebif in the refrigerator between 36°F and 46°F (2°C and 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.

Active ingredient: interferon beta-1a

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.

Rebif is manufactured by EMD Serono Inc., Boston, MA 02210.