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

 
 



INDICATIONS AND USAGE

EXTAVIA (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 EXTAVIA 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 mL) every other day (see Table 1).

Table 1. Schedule for Dose Titration
Recommended
Titration
EXTAVIA
Dose
Volume
Weeks 1-2 25% 0.0625 mg 0.25 mL
Weeks 3-4 50% 0.125 mg 0.5 mL
Weeks 5-6 75% 0.1875 mg 0.75 mL
Week 7+ 100% 0.25 mg 1 mL

To reconstitute lyophilized EXTAVIA for injection, attach the prefilled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the EXTAVIA vial using the vial adapter. Slowly inject 1.2 mL of diluent into the EXTAVIA 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. Keeping the syringe and vial adapter in place, turn the assembly over so that the vial is on top. Withdraw the appropriate dose of EXTAVIA solution. Remove the vial from the vial adapter before injecting EXTAVIA. One mL of reconstituted EXTAVIA solution contains 0.25 mg of Interferon beta-1b/mL.

EXTAVIA 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 Patient Counseling Information 17.6). Concurrent use of analgesics and/or antipyretics may help ameliorate flu-like symptoms on treatment days. EXTAVIA should be visually inspected for particulate matter and discoloration prior to administration.

DOSAGE FORMS AND STRENGTHS

EXTAVIA 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 27 gauge needle are included for each vial of drug. EXTAVIA and the diluent are for single-use only. Unused portions should be discarded. Store at room temperature.

HOW SUPPLIED/STORAGE AND HANDLING

The reconstituted product contains no preservative. Before reconstitution with diluent, store EXTAVIA 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.

EXTAVIA 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 27 gauge needle are included for each vial of drug. EXTAVIA and the diluent are for single-use only. Unused portions should be discarded. Store at room temperature.

15 blister units, 0.3 mg/vial…………………….…….NDC 0078-0569-12

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