"The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).
Sandoz has received FDA approval to market "...
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.
DOSAGE AND ADMINISTRATION
The recommended dose of REBIF is either 22 mcg or 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.
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 1) or 44 mcg three times per week (see Table 2). Patients prescribed a targeted dose of 22 mcg three times per week should use the prefilled syringes for titration.
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 prefilled syringes and REBIF Rebidose autoinjectors.
Table 1: Titration Schedule for a 22 mcg Prescribed
|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 after||22 mcg||22 mcg syringe or autoinjector||Use full syringe or autoinjector|
|*Use only prefilled syringes, not autoinjectors, to titrate to the 22 mcg Prescribed Dose|
Table 2: Titration Schedule for a 44 mcg Prescribed
|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 after||44 mcg||44 mcg syringe or autoinjector||Use full syringe or autoinjector|
|**Prefilled syringes or autoinjectors can be used to titrate to the 44 mcg Prescribed Dose|
Decreased peripheral blood counts or elevated liver function tests may necessitate dose reduction or discontinuation of REBIF administration until toxicity is resolved [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Important Administration Instructions
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 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.
The initial injection should be performed under the supervision of an appropriately qualified health care provider.
Appropriate instruction for self-injection or injection by another person should be provided to the patient or their caregiver, including careful review of the REBIF Medication Guide and the REBIF Rebidose autoinjector Instructions for Use that accompanies the product. Users should demonstrate competency in all aspects of the injection prior to independent use. If a patient is to self-administer REBIF, the physical and cognitive ability of that patient to self-administer and properly dispose of prefilled syringes or the REBIF Rebidose autoinjectors should be assessed. Patients with severe neurological deficits should not self-administer injections without assistance from a trained caregiver.
Advise patients and caregivers to:
- visually inspect REBIF for particulate matter and discoloration prior to administration
- use aseptic technique when administering REBIF
- rotate site of injection with each dose to minimize the likelihood of severe injection site reactions or necrosis [see WARNINGS AND PRECAUTIONS]
- use a puncture-resistant container for safe disposal of used needles, prefilled syringes and REBIF Rebidose autoinjectors
- do not re-use needles, syringes or REBIF Rebidose autoinjectors
Premedication For Flu-like Symptoms
Concurrent use of analgesics and/or antipyretics may help ameliorate flu-like symptoms associated with REBIF use on treatment days.
Dosage Forms And Strengths
- Injection: 8.8 mcg per 0.2 mL in a graduated, single-dose REBIF prefilled syringe
- Injection: 22 mcg per 0.5 mL in a graduated, single-dose REBIF prefilled syringe
- Injection: 44 mcg per 0.5 mL in a graduated, single-dose REBIF prefilled syringe
- Injection: 8.8 mcg per 0.2 mL in a single-dose prefilled REBIF Rebidose autoinjector
- Injection: 22 mcg per 0.5 mL in a single-dose prefilled REBIF Rebidose autoinjector
- Injection: 44 mcg per 0.5 mL in a single-dose prefilled REBIF Rebidose autoinjector
Storage And Handling
REBIF is supplied as a sterile solution containing no preservative available in the following package presentations:
- REBIF (interferon beta -1a) Titration Pack, NDC 44087-8822-1
- Six REBIF 8.8 mcg prefilled syringes and Six REBIF 22 mcg prefilled syringes
- REBIF (interferon beta -1a) 22 mcg Prefilled syringe
- One REBIF 22 mcg prefilled syringe, NDC 44087-0022-1
- Twelve REBIF 22 mcg prefilled syringes, NDC 44087-0022-3
- REBIF (interferon beta -1a) 44 mcg Prefilled syringe
- One REBIF 44 mcg prefilled syringe, NDC 44087-0044-1
- Twelve REBIF 44 mcg prefilled syringes, NDC 44087-0044-3
REBIF Rebidose Autoinjectors
- REBIF Rebidose
(interferon beta-1a) Titration Pack, NDC 44087-0188-1
- Six REBIF Rebidose 8.8 mcg autoinjectors with lime-green injector buttons and Six REBIF Rebidose 22 mcg with yellow injector buttons.
- REBIF Rebidose (interferon beta-1a) 22 mcg
- Twelve REBIF Rebidose 22 mcg autoinjectors with yellow injector buttons, NDC 44087-3322-1
- REBIF Rebidose (interferon beta-1a) 44 mcg
- Twelve REBIF Rebidose 44 mcg autoinjectors with teal-green injector buttons, NDC 44087-3344-1
REBIF should be stored refrigerated between 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. If needed, 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, but refrigeration is preferred.
Do not use beyond the expiration date printed on packages. REBIF contains no preservatives. Each prefilled syringe and REBIF Rebidose autoinjector is intended for a single dose. Unused portions should be discarded.
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 2014
Last reviewed on RxList: 5/12/2014
This monograph has been modified to include the generic and brand name in many instances.
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