Rebif

Interferon beta-1a
Information provided by Serono, makers of Rebif

What is Rebif® and how does it work?

Rebif® is a recombinant form of interferon beta manufactured through a process that makes it similar to the interferon beta produced naturally by the human body. Interferons help modulate the body's immune system and help fight disease and reduce inflammation.

Rebif® has been proven to slow the course of relapsing forms of multiple sclerosis. In clinical studies, Rebif® 44 mcg three times a week by subcutaneous injection has been shown to slow progression of disability and reduce the frequency of disease attacks in RRMS. Additionally, it was shown to statistically significantly reduce the number of active brain lesions and T2 lesion volume (or area) as measured on an MRI.

How do I take Rebif®?

Rebif® does not require mixing or preparation. It is the only interferon available in ready-to-use, pre-filled syringes. It can also can be administered using Rebiject® an autoinjector developed exclusively for use with Rebif® and designed to help simplify self-administration and ensure proper injection technique.

The recommended dosage of Rebif® for the treatment of relapsing forms of multiple sclerosis is 44 mcg three times per week by subcutaneous injection. Rebif® is also available as 22 mcg three times per week by subcutaneous injection for titration and dose adjustment.

Clinical Trials

People taking Rebif® during clinical trials had fewer relapses, less disability and required less steroid treatment than patients taking placebo.

In clinical trials, Rebif® effectively slowed the progression of disability in RRMS. When MRIs (brain scans) of those taking Rebif® were compared with the scans of those taking placebo, the brain scans of those taking Rebif® showed significantly less lesion activity and T2 lesion volume (or area)1. The exact relationship between MRI findings and the clinical status of patients is unknown.

Serono, the maker of Rebif®, has completed a number of international, multi-center, controlled clinical trials of Rebif®. This extensive research program has included more than 3,000 patients worldwide. Two of these studies (the PRISMS study and the EVIDENCE study) were submitted to the U.S. Food and Drug Administration (FDA) and form the basis of FDA approval of Rebif® for the treatment of relapsing forms of MS in the US:

Rebif® significantly reduces the frequency of exacerbations and slows the progression of disability. In addition, Rebif® reduces MRI-assessed lesion activity and T2 lesion volume (or area).1 The exact relationship between MRI findings and the clinical status of patients is unknown.

Rebif® 44 mcg three times a week by subcutaneous injection demonstrated superior efficacy over Avonex® 30 mcg once a week by intramuscular injection in reducing the frequency of relapses at 24 weeks.2 This superiority allows Rebif® to gain market approval under the terms of the Orphan Drug Act and makes it available for use in the U.S.

For more information on the results of these studies visit Rebif® Clinical Trials

Potential Side Effects of Rebif® (interferon beta-1a) Therapy

All medications have some side effects and Rebif® is no exception. However, the vast majority of side effects associated with Rebif® are mild and manageable.

The common side effects of Rebif® are injection site disorders (soreness, redness, pain, bruising or swelling), flu-like symptoms (fever, chills, sweating, muscle aches and fatigue), abdominal pain, depression, liver enzyme elevations, and blood problems. The most frequently reported adverse reactions resulting in clinical intervention were injection site disorders, flu-like symptoms, depression and elevation of liver enzymes.

Other possible side effects of Rebif® include thyroid problems and less severe allergic reactions. Some patients have had hives, rash, skin bumps or itching while they were taking Rebif®. If a patient thinks they are having an allergic reaction they should stop using Rebif® immediately and contact their doctor.

How to Manage Flu-like Symptoms and Injection Site Reactions

With a little planning, flu-like symptoms should be manageable. They tend to be more obvious when first starting Rebif® therapy, then they may taper off as the body becomes more accustomed to treatment. Night-time injections are recommended to allow the patient to sleep through many of the symptoms. Take a non-prescription analgesic/fever reducer as directed before injecting Rebif® to help reduce symptoms.

Swelling, redness and irritation may occur at the injection site. Management techniques include:

Using the proper injection technique
Applying ice to the area before and after the injection to help reduce swelling.
Gently massage the area for a few minutes afterwards to help disperse the medicine and reduce irritation.
Change the injection site each time Rebif® is injected to lessen the chance of a serious skin reaction.

Two hours after injection, check the site for redness, swelling, or tenderness. Patients should contact their doctor if the skin reaction does not clear up in a few days.

Contraindications

Rebif® should not be used by patients with prior hypersensitivity or allergic reaction to natural or recombinant interferon, human albumin, mannitol, sodium acetate, acetic acid or sodium hydroxide.

Risk to Pregnancy

Women should avoid becoming pregnant while taking Rebif® until they have talked with their doctor. If a woman becomes pregnant while taking Rebif®, she should stop using Rebif® immediately and contact her doctor. Rebif® may cause harm to, or loss of, a pregnancy. The woman and her doctor need to decide whether the potential benefit of taking Rebif® is greater than the risks to the pregnancy.

Was this information helpful? Then please consider making a donation. We are a small, independent nonprofit agency and are dependent on donations from our supporters. Thank you from all the staff at the MSA.

1 PRISMS Study Group. Randomized, double blind, placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-1504.
2 Results of Comparative Efficacy Trial using two formulations of interferon beta-1a in RRMS. P. Coyle. 17th World Congress of Neurology Abs. Full data presented at a late breaker session, June 22, 2001.




	Rebif Interferon beta-1a Information provided by Serono, makers of Rebif What is Rebif® and how does it work? Rebif® is a recombinant form of interferon beta manufactured through a process that makes it similar to the interferon beta produced naturally by the human body. Interferons help modulate the body's immune system and help fight disease and reduce inflammation. Rebif® has been proven to slow the course of relapsing forms of multiple sclerosis. In clinical studies, Rebif® 44 mcg three times a week by subcutaneous injection has been shown to slow progression of disability and reduce the frequency of disease attacks in RRMS. Additionally, it was shown to statistically significantly reduce the number of active brain lesions and T2 lesion volume (or area) as measured on an MRI. How do I take Rebif®? Rebif® does not require mixing or preparation. It is the only interferon available in ready-to-use, pre-filled syringes. It can also can be administered using Rebiject® an autoinjector developed exclusively for use with Rebif® and designed to help simplify self-administration and ensure proper injection technique. The recommended dosage of Rebif® for the treatment of relapsing forms of multiple sclerosis is 44 mcg three times per week by subcutaneous injection. Rebif® is also available as 22 mcg three times per week by subcutaneous injection for titration and dose adjustment. Clinical Trials People taking Rebif® during clinical trials had fewer relapses, less disability and required less steroid treatment than patients taking placebo. In clinical trials, Rebif® effectively slowed the progression of disability in RRMS. When MRIs (brain scans) of those taking Rebif® were compared with the scans of those taking placebo, the brain scans of those taking Rebif® showed significantly less lesion activity and T2 lesion volume (or area)1. The exact relationship between MRI findings and the clinical status of patients is unknown. Serono, the maker of Rebif®, has completed a number of international, multi-center, controlled clinical trials of Rebif®. This extensive research program has included more than 3,000 patients worldwide. Two of these studies (the PRISMS study and the EVIDENCE study) were submitted to the U.S. Food and Drug Administration (FDA) and form the basis of FDA approval of Rebif® for the treatment of relapsing forms of MS in the US: Rebif® significantly reduces the frequency of exacerbations and slows the progression of disability. In addition, Rebif® reduces MRI-assessed lesion activity and T2 lesion volume (or area).1 The exact relationship between MRI findings and the clinical status of patients is unknown. Rebif® 44 mcg three times a week by subcutaneous injection demonstrated superior efficacy over Avonex® 30 mcg once a week by intramuscular injection in reducing the frequency of relapses at 24 weeks.2 This superiority allows Rebif® to gain market approval under the terms of the Orphan Drug Act and makes it available for use in the U.S. For more information on the results of these studies visit Rebif® Clinical Trials Potential Side Effects of Rebif® (interferon beta-1a) Therapy All medications have some side effects and Rebif® is no exception. However, the vast majority of side effects associated with Rebif® are mild and manageable. The common side effects of Rebif® are injection site disorders (soreness, redness, pain, bruising or swelling), flu-like symptoms (fever, chills, sweating, muscle aches and fatigue), abdominal pain, depression, liver enzyme elevations, and blood problems. The most frequently reported adverse reactions resulting in clinical intervention were injection site disorders, flu-like symptoms, depression and elevation of liver enzymes. Other possible side effects of Rebif® include thyroid problems and less severe allergic reactions. Some patients have had hives, rash, skin bumps or itching while they were taking Rebif®. If a patient thinks they are having an allergic reaction they should stop using Rebif® immediately and contact their doctor. How to Manage Flu-like Symptoms and Injection Site Reactions With a little planning, flu-like symptoms should be manageable. They tend to be more obvious when first starting Rebif® therapy, then they may taper off as the body becomes more accustomed to treatment. Night-time injections are recommended to allow the patient to sleep through many of the symptoms. Take a non-prescription analgesic/fever reducer as directed before injecting Rebif® to help reduce symptoms. Swelling, redness and irritation may occur at the injection site. Management techniques include: Using the proper injection technique Applying ice to the area before and after the injection to help reduce swelling. Gently massage the area for a few minutes afterwards to help disperse the medicine and reduce irritation. Change the injection site each time Rebif® is injected to lessen the chance of a serious skin reaction. Two hours after injection, check the site for redness, swelling, or tenderness. Patients should contact their doctor if the skin reaction does not clear up in a few days. Contraindications Rebif® should not be used by patients with prior hypersensitivity or allergic reaction to natural or recombinant interferon, human albumin, mannitol, sodium acetate, acetic acid or sodium hydroxide. Risk to Pregnancy Women should avoid becoming pregnant while taking Rebif® until they have talked with their doctor. If a woman becomes pregnant while taking Rebif®, she should stop using Rebif® immediately and contact her doctor. Rebif® may cause harm to, or loss of, a pregnancy. The woman and her doctor need to decide whether the potential benefit of taking Rebif® is greater than the risks to the pregnancy. Was this information helpful? Then please consider making a donation. We are a small, independent nonprofit agency and are dependent on donations from our supporters. Thank you from all the staff at the MSA. 1 PRISMS Study Group. Randomized, double blind, placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-1504. 2 Results of Comparative Efficacy Trial using two formulations of interferon beta-1a in RRMS. P. Coyle. 17th World Congress of Neurology Abs. Full data presented at a late breaker session, June 22, 2001.
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