The information in this medication sheet has been adapted from the FDA-approved prescribing information for Rebif.
Rebif is a medication manufactured by a biotechnological process from one of the naturally-occurring interferons (a type of protein). It is made up of exactly the same amino acids (major components of proteins) as the interferon beta found in the human body. A controlled clinical trial in relapsing-remitting MS compared three groups—those receiving 22mcg three times per week, those receiving 44mcg three times a week, and those receiving placebo. Over the two-year study, the two experimental groups demonstrated a lower relapse rate, prolonged time to first relapse, a higher proportion of relapse-free patients, a lower number of active lesions on MRI, and delay in progression of disability, when compared to the placebo group. Rebif currently available at the 44mcg dose in pre-filled syringes ready for subcutaneous injection.
Approval by the U.S. Food and Drug Administration (FDA)
Rebif is approved for the treatment of patients with relapsing forms of MS to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability.
Reporting on the outcome of the EVIDENCE trial, which compared Rebif and Avonex (both interferon beta-1a), the FDA added the following information to the labeling of Rebif:
“Patients treated with Rebif 44 mcg [micrograms] sc [delivered subcutaneously] tiw [3 times per week] were more likely to remain relapse-free at 24 and 48 weeks than were patients treated with Avonex 30 mcg im [delivered intramuscularly] qw [once per week].”
- Rebif is given three times a week subcutaneously (between the fat layer just under the skin and the muscles beneath). The physician or nurse will instruct you in the injection procedure, using a specially designed set of training materials. Do not attempt to inject yourself until you are sure that you understand the procedures.
- Rebif may be administered in three forms -- a pre-filled syringe with or without Rebiject II (an autoinjector), or Rebif Rebidose (in the U.S.), a single-dose auto-injector that is meant to be discarded after use.
- When beginning treatment, it is recommended that you start at 8.8 mcg three times a week and gradually increase over a 4-week period to the 44mcg dose in order to reduce the side effects. A starter kit with 22mcg syringes is available to facilitate the gradual increase in dose.
- Rebif should be administered at the same time of day, on the same days of the week, preferably in the late afternoon. Doses must be at least 48 hours apart.
- Rebif should be stored in the refrigerator. Storage at room temperature without exposure to heat or light is permissible for up to 30 days. Do not allow the medication to freeze.
- Do not reuse needles or syringes. Dispose of the syringes as directed by your physician and keep them out of the reach of children.
- Since flu-like symptoms are a fairly common side effect during the initial weeks of treatment, it is recommended that the injection be given at bedtime. Taking acetaminophen (Tylenol®) or ibuprofen (Advil®) immediately prior to each injection and during the 24 hours following the injection will also help to relieve the flu-like symptoms.
Warnings and Precautions
In response to post-marketing findings (events that have been reported by patients and doctors since Rebif was approved for use), the FDA has added warnings and precautions to the prescribing information for this medication:
Depression and Suicide
There was no increase in depression reported by people receiving Rebif in the clinical trial. However, some patients treated with interferons, including Rebif, have become seriously depressed or become suicidal, and depression and suicidal thoughts are known to occur with some frequency in MS. It is recommended that individuals with a history of severe depressive disorder be closely monitored while taking Rebif. Anyone who experiences significant feelings of sadness or helplessness, or feels like hurting him- or herself or others, should speak with a friend or family member right away and contact the physician as soon as possible.
Rebif, like other interferon medications, can affect liver functions. In post-marketing studies, a few people have developed severe liver injury. Periodic blood tests to measure liver functions are recommended for any person taking an interferon medication.
Some people taking Rebif have developed a severe allergic reaction that interferes with breathing. An allergic reaction can occur after the first dose, or not until after several doses. Less severe reactions—including itching, skin bumps, a rash, or swelling of the mouth and tongue can also occur. Anyone who develops any kind of allergic reaction should stop the medication immediately and contact his or her physician.
Rebif should be used with caution in individuals with a seizure disorder since seizures have been associated with the use of beta interferon medications.
- Depression and Suicide
- Because of the potential of Rebif to affect the levels of white blood cells, red blood cells, and platelets in a person’s system, blood tests are recommended at regular intervals. Thyroid function tests are recommended every 6 months in patients with a history of thyroid dysfunction.
- Rebif should not be used during pregnancy or breast-feeding, or by any woman who is trying to become pregnant. Women taking Rebif should use birth control measures at all times. If you want to become pregnant while being treated with Rebif, discuss the matter with your physician. If you become pregnant while using Rebif, stop the treatment and contact your physician.
Possible Side Effects
- Common side effects include flu-like symptoms (fatigue, chills, fever, muscle aches, and sweating) and injection site reactions (swelling, redness, discoloration, and pain). Most of these symptoms tend to disappear over time. If they continue, become more severe, or cause significant discomfort, be sure to talk them over with your physician. Contact your physician if the injection sites become inflamed, hardened, or lumpy, and do not inject into any area that has become hardened or lumpy.
- Symptoms of depression, including ongoing sadness, anxiety, loss of interest in daily activities, irritability, low self-esteem, guilt, poor concentration, indecisiveness, confusion, and eating and sleep disturbances, should be reported promptly to your doctor.