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Extavia

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Extavia

Indications
Dosage
How Supplied

INDICATIONS

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 (interferon beta-1b kit) 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 (interferon beta-1b kit) for injection, attach the prefilled syringe containing the diluent (Sodium Chloride, 0.54% Solution) to the EXTAVIA (interferon beta-1b kit) vial using the vial adapter. Slowly inject 1.2 mL of diluent into the EXTAVIA (interferon beta-1b kit) 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 (interferon beta-1b kit) solution. Remove the vial from the vial adapter before injecting EXTAVIA (interferon beta-1b kit) . One mL of reconstituted EXTAVIA solution contains 0.25 mg of interferon beta-1b/mL.

EXTAVIA (interferon beta-1b kit) 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). Concurrent use of analgesics and/or antipyretics may help ameliorate flu-like symptoms on treatment days. EXTAVIA (interferon beta-1b kit) should be visually inspected for particulate matter and discoloration prior to administration.

HOW SUPPLIED

Dosage Forms And Strengths

EXTAVIA (interferon beta-1b kit) 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 (interferon beta-1b kit) and the diluent are for single-use only. Unused portions should be discarded. Store at room temperature.

The reconstituted product contains no preservative. Before reconstitution with diluent, store EXTAVIA (interferon beta-1b kit) at room temperature 25°C (77°F). Excursions of 15° to 30°C (59° to 86°F) are permitted. After reconstitution, if not used immediately, the product should be refrigerated and used within three hours. Do not freeze.

EXTAVIA (interferon beta-1b kit) 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 (interferon beta-1b kit) 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

Manufactured by: Bayer HealthCare Pharmaceuticals Inc. Montville, NJ 07045. Manufactured For: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.

Last reviewed on RxList: 9/16/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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