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Rebif (Interferon Beta-1a) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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.

Table 4: Schedule for Patient Titration

Recommended
Titration
(% of final dose)
Titration dose for Rebif® 22 mcg Titration dose for Rebif® 44 mcg Injection Volume
Weeks 1-2 20 % 4.4 mcg 8.8 mcg 0.1 mL
Weeks 3-4 50 % 11 mcg 22 mcg 0.25 mL
Weeks 5+ 100 % 22 mcg 44 mcg 0.5 mL

Leukopenia or elevated liver function tests may necessitate dose reductions of 20-50% until toxicity is resolved (see WARNINGS: Hepatic Injury, 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 pre-filled 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.

Stability and Storage

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.

HOW SUPPLIED

Rebif® is supplied as a sterile, preservative-free solution packaged in graduated, ready to use 0.5 mL pre-filled syringes with 27-gauge, 0.5 inch needle for subcutaneous injection. The following package presentations are available.

Rebif® (interferon beta -1a) 22 mcg Pre-filled syringe

  • One Rebif® 22 mcg pre-filled syringe, NDC 44087-0022-1
  • Twelve Rebif® 22 mcg pre-filled syringes, NDC 44087-0022-3

Rebif® (interferon beta -1a) 44 mcg Pre-filled syringe

  • One Rebif® 44 mcg pre-filled syringe, NDC 44087-0044-1
  • Twelve Rebif® 44 mcg pre-filled syringes, NDC 44087-0044-3

RX only.

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