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Rebif

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Rebif

Rebif

INDICATIONS

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 three times per week and increased over a 4-week period to the targeted dose, either 22 mcg three times per week (see Table 4) or 44 mcg three times per week (see Table 5). Patients prescribed a targeted dose of 22 mcg three times per week should use the pre-filled syringes for titration. Following the administration of each dose, any residual product remaining in the syringe should be discarded in a safe and proper manner.

A 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 in both Rebif® pre-filled syringes and Rebif® Rebidose® autoinjectors.

Table 4: Titration Sc ledule for a 22 mcg Prescribed Dose*

Week of Use Dose Syringe to Use Amount of syringe
Week 1 Titration 4.4 mcg 8.8 mcg syringe Use half of syringe
Week 2 Titration 4.4 mcg 8.8 mcg syringe Use half of syringe
Week 3 Titration 11 mcg 22 mcg syringe Use half of syringe
Week 4 Titration 11 mcg 22 mcg syringe Use half of syringe
Week 5 and on 22 mcg 22 mcg syringe or autoinjector Use full syringe or autoinjector
*Only pre-filled syringes can be used to titrate to 22 mcg Prescribed Dose

Table 5: Titration Schedule for a 44 mcg Prescribed Dose**

Week of Use Dose Syringe or Autoinjector to Use Amount of syringe or autoinjector
Week 1 Titration 8.8 mcg 8.8 mcg syringe or autoinjector Use full syringe or autoinjector
Week 2 Titration 8.8 mcg 8.8 mcg syringe or autoinjector Use full syringe or autoinjector
Week 3 Titration 22 mcg 22 mcg syringe or autoinjector Use full syringe or autoinjector
Week 4 Titration 22 mcg 22 mcg syringe or autoinjector Use full syringe or autoinjector
Week 5 and on 44 mcg 44 mcg syringe or autoinjector Use full syringe or autoinjector
**Pre-filled syringes or autoinjectors can be used to titrate to 44 mcg Prescribed Dose

Leukopenia or elevated liver function tests may necessitate dose reduction or discontinuation of Rebif® administration until toxicity is resolved (see WARNINGS: Hepatic Injury, PRECAUTIONS: General and ADVERSE REACTIONS).

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 selfadministering subcutaneous (sc) injections using the pre-filled syringe or injection device approved for use with Rebif®. Injection depth of the Rebif® Rebidose® autoinjector is fixed at 8 mm; the health care provider should determine the injection technique. Patients should be advised to rotate sites for sc injections (see PATIENT INFORMATION). 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 36°F to 46°F (2°C to 8°C ). DO NOT FREEZE. If a refrigerator is not available, Rebif® may be stored between 36°F to 77°F (2°C to 25°C) 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 pre-filled syringe and Rebif® Rebidose® autoinjector is intended for single use. Unused portions should be discarded.

HOW SUPPLIED

Rebif® is supplied as a sterile, preservative-free solution packaged in two different delivery options:

  • Pre-filled Syringes: graduated, ready to use in 0.2 mL or 0.5 mL with 29-gauge 0.5 inch needle for subcutaneous injections.
  • Rebif® Rebidose® Autoinjectors: pre-assembled, ready to use in 0.2 mL or 0.5 mL with 29-gauge, 0.5 inch needle for subcutaneous injections.

The following package presentations are available:

Pre-Filled Syringes

Rebif® (interferon beta -1a) Titration Pack, NDC 44087-8822-1
  • Six Rebif® 8.8 mcg pre-filled syringes and Six Rebif® 22 mcg pre-filled syringe
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

Rebif® Rebidose® Autoinjectors

Rebif® (interferon beta-1a) Titration Pack, NDC 44087-0188-1
  • Six Rebif® 8.8 mcg autoinjectors with lime-green injector buttons and Six Rebif® 22 mcg with yellow injector buttons.
Rebif® (interferon beta-1a) 22 mcg Rebif® Rebidose® Autoinjector
  • Twelve Rebif® 22 mcg autoinjectors with yellow injector buttons, NDC 44087-3322-1
Rebif® (interferon beta-1a) 44 mcg Rebif® Rebidose® Autoinjector
  • Twelve Rebif® 44 mcg autoinjectors with teal-blue injector buttons, NDC 44087-3344-1

Manufactured by EMD Serono, Inc. Rockland, MA 02370 U.S. License # 1773. Marketed by: EMD Serono, Inc. Pfizer Inc., Rockland, MA 02370 New York, NY 10017. Revised: April 2013

Last reviewed on RxList: 5/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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