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Betaseron (Interferon Beta-1B) - Indications and Dosage

 
 



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.

DOSAGE AND ADMINISTRATION

The recommended dose of Betaseron is 0.25 mg injected subcutaneously every other day.

Generally, patients should be started at 0.0625 mg (0.25 mL) subcutaneously every other day, and increased over a six week period to 0.25 mg (1.0 mL) every other day (see Table 3).

Table 3. Schedule for Dose Titration

Recommended

Titration

Betaseron

Dose

Volume
Weeks 1-2 25% 0.0625 mg 0.25 mL
Weeks 3-4 50% 0.125 mg 0.50 mL
Weeks 5-6 75% 0.1875 mg 0.75 mL
Week 7+ 100% 0.25 mg 1.0 mL

To reconstitute lyophilized Betaseron for injection, attach the prefilled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the Betaseron vial using the vial adapter. Slowly inject 1.2 mL of diluent into the Betaseron vial. Gently swirl the vial to dissolve the drug 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. Visually inspect the reconstituted product before use; discard the product if it contains particulate matter or is discolored. Verify that the vial is not cracked or damaged. Do not use cracked or damaged vials. Keeping the syringe and vial adapter in place, turn the assembly over so that the vial is on top. Withdraw the appropriate dose of Betaseron solution. Remove the vial from the vial adapter before injecting Betaseron. One mL of reconstituted Betaseron solution contains 0.25 mg of Interferon beta-1b/mL.

Betaseron 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. Patients should be advised to rotate sites for subcutaneous injections (see PRECAUTIONS, Instruction on Self-injection Technique and Procedures). Concurrent use of analgesics and/or antipyretics may help ameliorate flu-like symptoms on treatment days. Betaseron should be visually inspected for particulate matter and discoloration prior to administration.

Stability and Storage

The reconstituted product contains no preservative. Before reconstitution with diluent, store Betaseron at room temperature 25C (77F). Excursions of 15 to 30C (59 to 86F) are permitted. After reconstitution, if not used immediately, the product should be refrigerated and used within three hours. Do not freeze.

HOW SUPPLIED

Betaseron is supplied as a lyophilized powder containing 0.3 mg of Interferon beta-1b, 15 mg Albumin (Human), USP, and 15 mg Mannitol, USP. Drug is packaged in a clear glass, single-use vial (3 mL capacity). A pre-filled single-use syringe containing 1.2 mL of diluent (Sodium Chloride, 0.54% solution), two alcohol prep pads, and one vial adapter with attached 30 gauge needle are included for each vial of drug. Betaseron and the diluent are for single-use only. Unused portions should be discarded. Store at room temperature.

NDC # 50419-523-35 14 blister units, 0.3 mg/vial.

Rx Only.

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