Rebif Rebidose
Pronunciation: re-bif re-bee-dose
Generic name: interferon beta-1a
Dosage form: single-dose prefilled autoinjector for subcutaneous use
Drug class: Interferons
What is Rebif Rebidose?
Rebif Rebidose 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 Rebidose is a single-dose, prefilled, autoinjector that is injected under the skin (subcutaneously), usually in the upper thigh or stomach area. Your healthcare provider can teach you how to self-administer it.
- The generic name for Rebif Rebidose is interferon beta-1a.
- Rebif Rebidose is usually injected 3 times a week, such as on a Monday, Wednesday, and Friday.
Rebif Rebidose’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 Rebidose 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 Rebidose belongs to the drug class called interferons. It may also be called an immunomodulator. Rebif Rebidose will not cure MS, it will only decrease the frequency of relapse symptoms.
Rebif Rebidose gained FDA approval on January 3, 2013. Rebif (as a prefilled syringe) was first approved on March 7, 2002. There is no Rebif Rebidose generic.
Rebif Rebidose side effects
The most common side effects of Rebif Rebidose are:
- flu-like symptoms such as:
- muscle aches
- fever
- tiredness
- chills.
- stomach pain
- changes in your liver tests.
Serious side effects and warnings
Rebif Rebidose can cause the following serious side effects.
Behavioral health problems including depression and suicidal thoughts. You may have mood problems while taking Rebif Rebidose, 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 Rebidose. 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 Rebidose 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 Rebidose 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 Rebidose 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 Rebidose. 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 Rebidose. 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 Rebidose if you develop TMA.
Seizures. Some people have had seizures while taking Rebif Rebidose.
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 Rebidose.
Eye Disorders: Retinal disorders (such as retinopathy, cotton wool spots, or obstruction of
the retinal artery or vein) have been reported with Rebif Rebidose. See your healthcare provider immediately if you have any changes in your vision or eye pain.
During your treatment with Rebif Rebidose 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 Rebidose. 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.
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Before taking
Do not take Rebif Rebidose if you are allergic to interferon beta-1a, human albumin, Rebif, Rebif Rebidose, Avonex, or any inactive ingredients in the injection (see below for a list of inactive ingredients).
Before you take Rebif Rebidose, 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 Rebidose can harm your unborn baby.
Breastfeeding
Rebif Rebidose 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 Rebidose?
See the Instructions for Use that come with the Rebif and Rebif Rebidose Package Insert.
- Your healthcare provider should show you how to prepare and inject your dose using the Rebif Rebidose autoinjector before you use it for the first time.
How to inject Rebif Rebidose
Rebif Rebidose 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 Rebidose 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 Rebidose exactly as your healthcare provider tells you.
Your healthcare provider will tell you how much Rebif Rebidose 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 Rebidose into an area of the body where the skin is irritated, reddened, bruised, infected, or scarred in any way.
Rebif Rebidose is available in the following 3 strengths: Rebif Rebidose 8.8 mcg in 0.2 mL single-dose autoinjector Rebif Rebidose 22 mcg in 0.5 mL single-dose autoinjector Rebif Rebidose 44 mcg in 0.5 mL single-dose autoinjector Check that your pharmacy has dispensed the right strength for you.
Always use a new, unopened, prefilled autoinjector for each injection. Do not reuse autoinjectors.
See the Rebif and Rebif Rebidose Package Insert for complete administration instructions.
Rebif Rebidose dosing information
The recommended dose of Rebif Rebidose 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.
See the Rebif and Rebif Rebidose Prescribing Information for full dosing instructions.
What other drugs will affect Rebif Rebidose?
Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Rebif Rebidose 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 Rebidose in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze Rebif Rebidose.
If you cannot refrigerate your Rebif Rebidose 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 Rebidose away from heat and light.
Rebif Rebidose ingredients
Active ingredient: Rebif Rebidose
Inactive ingredients: albumin (human), mannitol, sodium acetate, water for injection
Single-dose Rebif Rebidose autoinjector is available as 8.8 mcg in 0.2 mL, and 22 mcg or 44 mcg in 0.5 mL.
Who makes Rebif Rebidose?
EMD Serono Inc. makes Rebif Rebidose.
Rebif rebidose 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 Rebidose.
Avonex (interferon beta-1a) - Biogen Inc.
Formulation type | Strength |
---|---|
Autoinjector | 30 mcg/0.5 mL |
Pre-Filled Syringe | 30 mcg/0.5 mL |
Single-Dose Vial | 30 mcg Discontinued |
View Avonex information in detail.
Rebif (interferon beta-1a) - EMD Serono, Inc.
Formulation type | Strength |
---|---|
Autoinjector | 22 mcg/0.5 mL |
Autoinjector | 44 mcg/0.5 mL |
Autoinjector | 8.8 mcg/0.2 mL |
Pre-Filled Syringe | 22 mcg/0.5 mL |
Pre-Filled Syringe | 44 mcg/0.5 mL |
Pre-Filled Syringe | 8.8 mcg/0.2 mL |
View Rebif information in detail.
References
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.