BETASERON- interferon beta-1b
Bayer HealthCare Pharmaceuticals Inc.
1 INDICATIONS AND USAGE
BETASERON (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
2 DOSAGE The recommended starting dose is 0.0625 mg (0.25 mL) subcutaneously every other day, with dose increases over a six-week period to the recommended dose of 0.25 mg (1 mL) every other day (see Table 1).
2.2 Reconstitution of the Lyophilized Powder
(a) Prior to reconstitution, verify that the vial containing lyophilized BETASERON is not cracked or damaged. Do not use cracked or damaged vials.
(b) To reconstitute lyophilized BETASERON for injection, attach the pre-filled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the BETASERON vial using the vial adapter.
(c) Slowly inject 1.2 mL of diluent into the BETASERON vial.
(d) Gently swirl the vial to dissolve the lyophilized powder completely; do not shake. Foaming may occur during reconstitution or if the vial is swirled or shaken too vigorously. If foaming occurs, allow the vial to sit undisturbed until the foam settles.
(e) 1 mL of reconstituted BETASERON solution contains 0.25 mg of interferon beta-1b.
(f) After reconstitution, if not used immediately, refrigerate the reconstituted BETASERON solution at 35�F to 46�F (2�C to 8�C) and use within three hours. Do not freeze.
3 DOSAGE FORMS AND STRENGTHS
For injection: 0.3 mg lyophilized powder in a single-use vial for reconstitution.
4 CONTRAINDICATIONS
BETASERON is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation.
DESCRIPTION
BETASERON (interferon beta-1b) is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material.
The specific activity of BETASERON is approximately 32 million international units (IU)/mg interferon beta-1b. Each vial contains 0.3 mg of interferon beta-1b. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and Albumin (Human), USP (15 mg each/vial) are added as stabilizers.
Lyophilized BETASERON is a sterile, white to off-white powder, for subcutaneous injection after reconstitution with the diluent supplied (Sodium Chloride, 0.54% Solution). Albumin (Human) USP and Mannitol, USP (15 mg each/vial) are added as stabilizers.
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
BETASERON is supplied as a lyophilized powder in a clear glass, single-use vial (3 mL capacity). Each carton contains 5 single-use cartons (NDC 50419-524-05) or 14 single-use cartons (NDC 50419-524-35).
Each single-use carton contains:
A single-use vial containing 0.3 mg BETASERON (interferon beta-1b)
interferon beta-1b (in-ter-feer-on beta-one-be)
Read the Instructions for Use that come with your BETASERON before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. Before you use BETASERON for the first time, make sure your healthcare provider shows you the right way to use it.
Supplies needed for your BETASERON Injection (See Figure A).
�
1 single-use carton containing:
�
A vial of BETASERON
�
A pre-filled diluent syringe
�
A vial adapter with a 30-gauge needle attached (in the blister pack)
�
2 alcohol prep pads
