Rebif^® (interferon beta-1a) is indicated 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. Efficacy of Rebif^® in chronic progressive multiple sclerosis has not been established.

Dosages of Rebif^® shown to be safe and effective are 22 mcg and 44 mcg injected subcutaneously three times per week. Rebif^® should be administered, if possible, at the same time (preferably in the late afternoon or evening) on the same three days (e.g. Monday, Wednesday, and Friday) at least 48 hours apart each week (see CLINICAL STUDIES). Generally, patients should be started at 20% of the prescribed dose tiw and increased over a 4-week period to the targeted dose, either 22 mcg or 44 mcg tiw (see Table 4). Following the administration of each dose, any residual product remaining in the syringe should be discarded in a safe and proper manner.

A Rebif^® Titration Pack containing 6 doses of 8.8 mcg (0.2 mL) and 6 doses of 22 mcg (0.5 mL) is available for use during the titration period.

Leukopenia or elevated liver function tests may necessitate dose reductions of 20 - 50% until toxicity is resolved (see WARNINGS: Hepatic Injury and PRECAUTIONS: General).

Rebif^® is intended for use under the guidance and supervision of a physician. It is recommended that physicians or qualified medical personnel train patients in the proper technique for self-administering subcutaneous injections using the prefilled syringe. Patients should be advised to rotate sites for sc injections (see PRECAUTIONS: Information for Patients). Concurrent use of analgesics and/or antipyretics may help ameliorate flu-like symptoms on treatment days. Rebif^® should be inspected visually for particulate matter and discoloration prior to administration.

Rebif^® should be stored refrigerated between 2-8°C (36-46°F). DO NOT FREEZE. If a refrigerator is not available, Rebif^® may be stored at or below 25°C/77°F for up to 30 days and away from heat and light.

Do not use beyond the expiration date printed on packages. Rebif^® contains no preservatives. Each syringe is intended for single use. Unused portions should be discarded.

Rebif^® is supplied as a sterile, preservative-free solution packaged in graduated, ready to use in 0.2 mL or 0.5 mL prefilled syringes with 29- gauge, 0.5 inch needle for subcutaneous injection. The following package presentations are available.

Rebif® (interferon beta -1a) Titration Pack, NDC 44087-8822-1

- Six Rebif® 8.8 mcg prefilled syringes and Six Rebif® 22 mcg prefilled syringes

- One Rebif^® 22 mcg prefilled syringes, NDC 44087-0022-1

- Twelve Rebif^® 22 mcg prefilled syringes, NDC 44087-0022-3

- One Rebif^® 44 mcg prefilled syringe, NDC 44087-0044-1

- Twelve Rebif^® 44 mcg prefilled syringes, NDC 44087-0044-3

1. PRISMS Study Group. Randomized double-blind placebo-controlled study of interferon ß-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-1504.

2. Panitch H. Goodin DS, Francis G. et al. Randomized, comparative study of interferon ß-1a treatment regimens in MS. The EVIDENCE Trial. Neurology 2002; 59:1496-1506

Manufacturer: Serono, Inc. Rockland, MA 02370 U.S. Licence #1574

Co-Marketed by: Serono, Inc., Rockland, MA 02370
Pfizer Inc, New York, NY 10017

FDA Revision: 06/30/2005

*Avonex® is a registered trademark of Biogen Idec Inc.

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