Rebif FAQs

How Rebif works

Side effects with Rebif

How to take Rebif

Living with Rebif

How Rebif works

Q. What is Rebif^® (interferon beta-1a)?

A. Rebif is a brand name for a product called interferon beta-1a. Interferons belong to a family of proteins that occur naturally in the body. These proteins help direct the body's immune system. Rebif is manufactured through a biotechnology process that makes it similar to the structure of the natural interferon beta-1a produced by the body.

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Q. How does Rebif work?

A. The precise way Rebif works is not known. Interferons, like Rebif, have many actions that affect the immune system. Some of these properties are thought to maintain and preserve nerve function. In this way, Rebif may help reduce the damage to the vital components of the central nervous system. Although there is no cure forMS, Rebif has been proven to slow the course of the disease.

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Q. How effective is Rebif?

A. Rebif was studied in one of the largest placebo-controlled clinical evaluations of interferon beta-1a in relapsing-remitting MS to date. Called the PRISMS* Study, it measured the response of 560 patients over the course of two years of treatment. Patients who received Rebif did significantly better than patients who received placebo. Rebif is a treatment to have been proven effective in all three of the following key areas:

• Rebif reduced all MRI ^† lesion activity and area.
• Rebif reduced the frequency of flare-ups (relapses).
• Rebif slowed the progression of disability.

*PRISMS Study: Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis.

^†The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

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Q. What is a placebo-controlled study?

A. Clinical studies are designed to find out if a drug is more effective than taking nothing at all. To do this, researchers often use one group of patients who are on the active drug and compare their results against a "control group", that is, people taking a placebo (inactive drug). By having the two groups, this design eliminates bias and enables researchers to determine whether or not the active drug is truly effective in treating an illness. This is a standard type of study required by the FDA in the drug approval process.

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Q. Has Rebif been studied against any other MS drug?

A. Yes. The EVIDENCE* Study compared Rebif (interferon beta-1a) and Avonex^® (interferon beta-1a). During this 48-week study, Rebif was dosed at 44 mcg given three times a week by subcutaneous (under the skin) injection to a group of 339 people. Avonex was dosed at 30 mcg given once a week by intramuscular injection to a group of 338 people. The results at 24 weeks showed that the people taking Rebif had fewer relapses than the Avonex patients. These results enabled Rebif to be granted an exception to the Orphan Drug^† status of Avonex based on efficacy.

Follow-up data beyond 48 weeks is now available for the majority of the patients, and the average total follow-up time of this comparative phase was 64 weeks. The results from this final comparative phase of the EVIDENCE study are consistent with the 24- and 48-week findings, and show that Rebif is more efficacious than Avonex (interferon beta -1a) on relapse and MRI measures over an average of 64 weeks in patients with RRMS.

Compared to Avonex, side effects were generally similar despite the higher, more frequent dosing of Rebif 44 mcg tiw with three exceptions. As to be expected with higher, more frequent dosing, people taking Rebif had a greater number of injection-site reactions (85% Rebif vs 33% Avonex), liver disorders (18% Rebif vs 10% Avonex), and white blood cell disorders (13.6% Rebif vs 5.3% Avonex). However, the rate of discontinuation or serious adverse events were similar for the two drugs. Flu-like symptoms were significantly higher for people taking Avonex than for people taking Rebif (45% Rebif vs. 53% Avonex).

*EVIDENCE Study: Evidence for Interferon Dose Response: European-North American Comparative Efficacy Study.

^†Orphan Drug Status is granted by the FDA to products for rare diseases, providing exclusive marketing rights in the U.S. for seven years unless another drug demonstrates greater effectiveness or safety.

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Side effects with Rebif

Please refer to the Medication Guide.

Q. What are the potential serious side effects?

A. Like all medications for relapsing MS, there are some side effects with Rebif as well. Before you start taking Rebif, talk with your doctor about the possible benefits and side effects of Rebif. The potential serious side effects include:

Depression. This is not uncommon in people with MS. However, if you are feeling noticeably sadder or helpless, or feel like hurting yourself or others, you should tell a family member or friend right away and call your doctor as soon as possible. Inform your doctor if you have ever had any mental illness, including depression, and if you take any medications for depression.

Liver problems. Your liver may be affected by taking Rebif and a few patients have developed severe liver injury. Your healthcare provider may ask you to have regular blood tests to make sure that your liver is working properly. If your skin or the whites of your eyes become yellow or if you are bruising easily you should call your doctor right away.

Risk to pregnancy. If you become pregnant while taking Rebif you should stop using Rebif immediately and call your doctor. Rebif may cause you to lose your baby (miscarry) or may cause harm to your unborn child. You and your doctor will need to decide whether the potential benefit of taking Rebif is greater than the risks are to your unborn child.

Allergic reactions. Some patients taking Rebif have had severe allergic reactions leading to difficulty in breathing and loss of consciousness. If you think you are having an allergic reaction, you should stop therapy immediately and contact your doctor. Allergic reactions can happen after the first dose or after you have taken Rebif many times.

Injection-site reactions. Rebif may cause redness, pain, or swelling at the injection site. A few patients have developed infections or an area of severe skin damage (necrosis). If one of your injection sites becomes swollen, painful, or infected and does not heal within a few days, call your doctor.

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Q. What are the common side effects of Rebif?

A. There are some common side effects with Rebif. The most common, injection-site reactions and flu-like symptoms, are generally expected with injectable interferons. Here are the common side effects:

Injection-site reactions. Soreness, redness, pain, bruising, or swelling may occur at the place of the injection.

Flu-like symptoms. Most patients have flu-like symptoms (i.e. fever, chills, sweating, muscle aches, and fatigue).

Depression. Some patients taking interferons have become very depressed and/or anxious. If you feel very sad or hopeless, you should tell a friend or family member right away and call your doctor immediately.

Liver problems. Your liver may be affected by taking Rebif and a few patients have developed severe liver injury. Your healthcare provider may ask you to have regular blood tests to make sure that your liver is working properly. If your skin or the whites of your eyes become yellow or if you are bruising easily you should call your doctor right away.

Blood abnormalities. Rebif may affect your blood cell counts, so you may be asked to have regular blood tests to make sure your blood cell levels have not dropped. If you have difficulty fighting an infection, feel tired or sluggish, or bruise or bleed easily, contact your doctor.

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Q. What can I do about flu-like symptoms?

A. With a little planning and guidance from your healthcare professional, you should be able to manage flu-like symptoms. These tend to be more obvious when you first start taking Rebif. Then they might taper off as your body becomes more accustomed to treatment.

• Nighttime injections are recommended to allow you to sleep through many of these symptoms.
• Take a non-prescription pain reliever/fever reducer recommended by your doctor before or after injecting Rebif to help reduce symptoms.

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Q. What can I do about injection-site reactions?

A. Swelling, redness, and irritation may occur at the injection site. Talk to your doctor about how to minimize these reactions. Some suggestions include:

• Bring Rebif^® (interferon beta-1a) to room temperature to reduce irritation by removing from the refrigerator 1 to 4 hours before injection.
• Use the proper injection technique.
• Apply ice to area before and after injection.
• Gently massage area after injection for at least 2 minutes. This helps disperse medicine and reduce irritation.
• Inject only into healthy tissue.
• Wait at least 7 days before injecting in the same spot.
• Check the site for redness, tenderness, or swelling 2 hours after injection. If you have a skin reaction and it doesn't clear up in a few days, contact your doctor or nurse.

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Q. Are there any other possible side effects of Rebif?

A. You should also be aware of other potential but less common side effects that have been reported by some people taking Rebif. They include:

Thyroid problems. Your thyroid function may change, and you may be asked to have regular blood tests to monitor your thyroid function. Symptoms of thyroid change include feeling cold or hot all the time and/or an unexplained change in your weight. Contact your doctor if you experience these symptoms.

Less severe allergic reactions. Some patients have had hives, rash, skin bumps, or itching while they were taking Rebif. If you think you are having an allergic reaction, stop using Rebif immediately and contact your doctor.

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How to take Rebif

Please refer to the Medication Guide.

Q. How do I take Rebif?

A. Rebif is injected just under the skin (subcutaneous injection). Rebif is available in ready-to-use pre-filled syringes, so you don't have to worry about mixing any solutions before injection. No extra syringes, needles, needle assembly, or other materials are needed.

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Q. How often do I take Rebif?

A. Rebif injections should be taken on the same three days a week. Injections should be at least 48 hours apart. Many people choose to take their injections on Monday, Wednesday, and Friday, so that they have injection-free weekends. After you decide which three days work best for your lifestyle, stick with those to help make your injections part of your weekly routine.

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Q. What should I do if I forget to take an injection?

A. If it has been two days since your last injection, take your injection as soon as you remember it. Then skip a day and take the next one. If it has been more than three days, contact your doctor.

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Q: What should I do if I take the wrong dose?

A: If you accidentally take the wrong dose, call your doctor right away.

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Q. Where should I give my injections?

A. It is important to plan where on your body you are injecting each time. Do not inject in the same place twice in a row, and be sure to wait at least seven days before using a particular spot again. This will help lessen the chance of having a serious skin reaction at the spot where you inject Rebif. Rotate between injection sites, moving between different areas of the arms, legs, abdomen, and buttocks. Please refer to the diagram on the Medication Guide.

It's a good idea to keep a record of your injection sites on a calendar. The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, such as your thighs, the outer surface of your upper arms, your stomach, or buttocks. Do not use the area near your navel or waistline. If you are very thin, use only the thigh or outer surface of the arm for injection.

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Q. Is it all right to inject Rebif into a site that is red or irritated?

A. Do not inject Rebif into an area of your body where the skin is irritated, reddened, bruised, infected, or abnormal in any way. Consult your doctor about any such area you find.

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Q. How are Rebif syringes provided?

A. The syringes are provided in convenient weekly or monthly supply packs. Your doctor will explain what your starting dose should be and how to increase to recommended dose.

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Q. How do I learn how to give myself injections?

A. Your healthcare provider may teach you and/or your care partner the proper way to inject Rebif. Your doctor may also refer you to MS LifeLines^® so you can arrange for a MS LifeLines Nurse Educator to visit your home, at no charge, to provide instruction. Do not give yourself an injection until you or your care partner are comfortable with the dosing and injection process.

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Q. What is Rebiject II?

A. Rebiject II is an autoinjection device designed for use only with Rebif. Rebiject II is the latest generation of this technology, which is designed to help make injections easier to manage. Rebiject II is available free of charge for Rebif patients through the MS LifeLines^® Support Program by calling toll free at 1-877-447-3243.

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Q. How do I store my Rebif?

A. Rebif should be stored in the refrigerator at 2°–8°C/36°–46°F. Do not freeze. If a refrigerator is not available, Rebif may be stored at or below room temperature (25°C/77°F) for up to 30 days and away from heat and light.

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Q. Can I warm up Rebif before I take it?

A. You can remove one syringe from the refrigerator one to four hours before your injection. This will give it time to come to room temperature and may help reduce discomfort. Rebif syringes should not be warmed in the microwave or placed into boiling water.

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Living with Rebif

Q. Can I take other drugs while I'm taking Rebif?

A. Always consult your doctor before taking any new or additional medications. The combination of Rebif and other drugs for the treatment of relapsing forms of MS has not been clinically tested. Interactions between different medications can be unsafe, so you must talk to your doctor about any new therapies you are considering. Never mix Rebif with other drugs in the same syringe.

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Q. Can I travel and still take Rebif?

A. If you will be spending time away from home, taking your Rebif along should be easy. First, pack the supplies you'll need for your trip. A handy travel kit that can carry all your injection supplies is available free through the MS LifeLines support program. If a refrigerator is not available while you are traveling, Rebif may be stored at or below room temperature (25°C/77°F) for up to 30 days and away from heat and light. For this reason, the travel kit provides a reusable ice pack to help maintain Rebif syringes at the correct temperature while you travel.

Rebif should be stored in the refrigerator 2°-8°C/36°-46°F. Do not freeze. You should check the temperature of the refrigerator you are using while traveling to avoid unintentionally freezing Rebif. For small hotel refrigerators, store Rebif away from the unit's cooling element and small freezer compartment.

If you are traveling by car, don't leave Rebif on the dash, in the glove box, or in the trunk. This is important even if you have it in the insulated pack provided in the travel kit. Keep your syringes with you in the climate-controlled area of the car.

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Q. Can I take Rebif on an airplane?

A. If you are flying, plan to carry your Rebif syringes onboard with you in your carry-on luggage. Be sure to check the latest FAA regulations regarding traveling with injectable medicines. These are subject to change and may require certain documentation.

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Q. What if I become pregnant while I am taking Rebif?

A. Be sure to tell your doctor if you are or plan to become pregnant. If you become pregnant while taking Rebif (interferon beta-1a) you should stop using Rebif immediately and call your doctor. Rebif may cause you to lose your baby (miscarry) or may cause harm to unborn child. You and your doctor will need to decide whether the potential benefit of taking Rebif is greater than the risks are to your unborn child.

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Q. Is there a patient assistance program for financially needy people without insurance/limited insurance who have been prescribed Rebif?

A. Yes. We are committed to meeting the needs of the MS community and recognize that some people may need assistance paying for their Rebif. For assistance, please call the MSLifeLines Support Program toll free at 1-877-447-3243 Monday through Friday, 8 AM to 8 PM ET.

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Avonex is a registered trademark of Biogen Idec.