Rebif

REBIF — interferon beta-1a
REBIF REBIDOSE — interferon beta-1a
REBIF- interferon beta-1a injection, solution
REBIF — interferon beta-1a injection, solution
REBIF REBIDOSE- interferon beta-1a injection, solution
EMD Serono, Inc.

1 INDICATIONS AND USAGE

REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

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 Dose *
Week of Use Dose Syringe to Use Amount of syringe
*
Use only prefilled syringes, not autoinjectors, to titrate to the 22 mcg Prescribed Dose
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
Table 2: Titration Schedule for a 44 mcg Prescribed Dose *
Week of Use Dose Syringe or Autoinjector to Use Amount of syringe or autoinjector
*
Prefilled syringes or autoinjectors can be used to titrate to the 44 mcg Prescribed Dose
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

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 (5.2, 5.5) and Adverse Reactions (6)].

2.2 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 healthcare provider should determine the injection technique.

The initial injection should be performed under the supervision of an appropriately qualified healthcare 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
  • ‚Äč rotate site of injection with each dose to minimize the likelihood of severe injection site reactions, including necrosis or localized infection [see Warnings and Precautions (5.4)]
  • 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

2.3 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.

3 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

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