Betaseron is indicated for use in ambulatory patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations. (See CLINICAL PHARMACOLOGY, Clinical Trials section.) Relapsing-remitting MS is characterized by recurrent attacks of neurologic dysfunction followed by complete or incomplete recovery. The safety and efficacy of Betaseron in chronic-progressive MS has not been evaluated.

The recommended dose of Betaseron for the treatment of ambulatory relapsing-remitting MS is 0.25 mg injected subcutaneously every other day. Limited data regarding the activity of a lower dose are presented above (see CLINICAL PHARMACOLOGY, Clinical Trials).

Evidence of efficacy beyond 2 years is not known since the primary evidence of efficacy derives from a 2-year, double-blind, placebo-controlled clinical trial (see CLINICAL PHARMACOLOGY, Clinical Trials). Safety data are not available beyond the third year. Patients were discontinued from this trial due to unremitting disease progression of 6 months or greater.

To reconstitute lyophilized Betaseron for injection, use a sterile syringe and needle to inject 1.2 mL of the diluent supplied, Sodium Chloride, 0.54% Solution, into the Betaseron vial. Gently swirl the vial of Betaseron to dissolve the drug completely; do not shake. Inspect the reconstituted product visually and discard the product before use if it contains particulate matter or is discolored. After reconstitution with accompanying diluent, Betaseron vials contain 0.25 mg Interferon beta-1b/mL of solution.

Withdraw 1 mL of reconstituted solution from the vial into a sterile syringe fitted with a 27-gauge needle and inject the solution subcutaneously. Sites for self-injection include arms, abdomen, hips, and thighs. A vial is suitable for single use only; unused portions should be discarded. (See PATIENT INFORMATION: Betaseron sheet for PATIENT INFORMATION: SELF-INJECTION PROCEDURE.)

Stability: The reconstituted product contains no preservative. Before reconstitution with diluent, store at 2° to 8°C (36° to 46°F). After reconstitution, if not used immediately, the product should be refrigerated and used within 3 hours. Avoid freezing.

If refrigeration is not possible, vials of Betaseron and diluent should be kept as cool as possible, below 30°C (86°F), away from heat and light, and used within 7 days.

Betaseron is supplied as a lyophilized powder containing 0.3 mg of Interferon beta-1b, 15 mg Albumin Human USP, and 15 mg dextrose, USP. Drug is packaged in a clear glass, single-use vial (3 mL capacity); a separate vial containing 2 mL of diluent (Sodium Chloride, 0.54% solution) is included for each vial of drug. Store under refrigeration, between 2° to 8°C (36° to 46°F).

NDC 50419-521-03 0.3 mg/vial

NDC 50419-521-15 15 vials, 0.3 mg/vial

Caution: Federal law prohibits dispensing without prescription.

REFERENCES

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