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Snapshot of Rebif® (Interferon beta-1a)

Rebif®: Descriptives1
Method of administration Subcutaneous (under the skin) injection
Indication For the treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability
Needle size ½" length
Delivery Information Prefilled syringes
Injection aid(s) Autoinjection device available2
Pregnancy category Category C1 (when administered to pregnant animals, there was some harm to the fetus)3
Black box warning No

Rebif®: Common side effects/reactions1
Clinically significant difference in flu-like symptoms when compared to placebo (an inactive substance) Yes
Fatigue/Malaise (bodily discomfort) increased while on therapy Yes
Warning for use in people with depression Yes
Warning for use in people with suicidal thoughts Yes
Warning or precaution for liver impairment Yes
Recommended monitoring of liver function or complete blood count Yes
Associated with localized skin reactions Yes
Associated with neutralizing antibodies (proteins produced by the body that may decrease the effectiveness of therapy) Yes

Additional important information about Rebif4

Before beginning treatment, patients should discuss with their doctor the potential benefits and risks associated with Rebif. Let your doctor know if you have a history of depression, seizures, liver disease, thyroid problems, and blood count or bleeding problems or if you have had previous allergic reactions to medications. Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Rebif and other medicines may affect each other causing serious side effects. Talk to your doctor before you take any new medicines. Rebif is not recommended for women who are or plan to become pregnant.

Potential serious side effects of Rebif include depression, liver problems, risk to pregnancy, injection site problems and severe allergic reactions. Allergic reactions are rare and may be associated with difficulty breathing and loss of consciousness, which requires immediate medical attention. The most common side effects with Rebif are injection site reactions, flu-like symptoms (fever, chills, muscle aches, tiredness), depression, abdominal pain, increased liver enzymes, and blood cell count decreases. Let your doctor know immediately if you have any of these symptoms or feel sad, tired, hot or cold, experience hives, rashes, bruising, yellowing of the skin, or a change in body weight (gain or loss).

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References:
  1. Rebif® prescribing information, 9/05. Serono, Inc.
  2. Rebif® Web site. Available at: http://www.rebif.com/rebif_guide/regimen/admin/ra511.jsp. Accessed April 26, 2006.
  3. FDA Web site. Available at: http://www.fda.gov/cder/handbook/categc.htm. Accessed April 26, 2006.
  4. Rebif® Web site. Available at: http://www.rebif.com/rebif_guide/ra320.jsp. Accessed April 26, 2006.

Rebif® is a registered trademark of Serono, Inc.