AVONEX® (Interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease 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. Safety and efficacy in patients with chronic progressive multiple sclerosis have not been established.

The recommended dosage of AVONEX® (Interferon beta-1a) is 30 mcg injected intramuscularly once a week.

AVONEX® is intended for use under the guidance and supervision of a physician. Patients may self-inject only if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in intramuscular injection technique. Sites for injection include the thigh or upper arm (see Medication Guide).

A 25 gauge, 1“ needle for intramuscular injection may be substituted for the 23 gauge, 1 ¼” needle by the prescribing physician, if deemed appropriate.

Reconstitution of AVONEX® Vials

Use appropriate aseptic technique during the preparation of AVONEX® . To reconstitute lyophilized AVONEX® , use a sterile syringe and MICRO PIN® to inject 1.1 mL of the supplied diluent, Sterile Water for Injection, USP, into the AVONEX® vial. Gently swirl the vial of AVONEX® to dissolve the drug completely. DO NOT SHAKE. The reconstituted solution should be clear to slightly yellow without particles. Inspect the reconstituted product visually prior to use. Discard the product if it contains particulate matter or is discolored. Each vial of reconstituted solution contains 30 mcg/1.0 mL Interferon beta-1a.

Withdraw 1.0 mL of reconstituted solution from the vial into a sterile syringe. Replace the cover on the MICRO PIN®, attach the sterile needle and inject the solution intramuscularly. The AVONEX® and diluent vials are for single-use only; unused portions should be discarded.

Using AVONEX® Prefilled Syringes

The AVONEX® prefilled syringe should be held upright (cap faces up). Remove the cap by bending it at a 90° angle until it snaps free. Attach the needle and inject the solution intramuscularly. The AVONEX® prefilled syringe is for single-use only.

30 mcg Lyophilized Powder Vial

A vial of AVONEX® is supplied as a lyophilized powder in a single-use vial containing 33 mcg (6.6 million IU) of Interferon beta-1a; 16.5 mg Albumin (Human), USP; 6.4 mg Sodium Chloride, USP; 6.3 mg Dibasic Sodium Phosphate, USP; and 1.3 mg Monobasic Sodium Phosphate, USP, and is preservative-free. Diluent is supplied in a single-use vial (Sterile Water for Injection, USP).

AVONEX® lyophilized vials are available in the following package configuration (NDC 59627-001-03): A package containing four Administration Dose Packs (each containing one vial of AVONEX® , one 10 mL diluent vial, two alcohol wipes, one gauze pad, one 3 mL syringe, one MICRO PIN®* vial access pin, one 23 gauge, 1¼ inch needle, and one adhesive bandage).

30 mcg Prefilled Syringe

A prefilled syringe of AVONEX® is supplied as a sterile liquid albumin-free formulation containing 30 mcg of Interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP; 0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025 mg Polysorbate 20 in Water for Injection, USP. Each prefilled glass syringe contains 0.5 mL for IM injection.

AVONEX® prefilled syringes are available in the following package configuration (NDC 59627-002-05): A package containing four Administration Dose Packs (each containing one single-use syringe of AVONEX® and one 23 gauge, 1¼ inch needle), and a recloseable accessory pouch containing 4 alcohol wipes, 4 gauze pads, and 4 adhesive bandages.

Stability and Storage

30 mcg Lyophilized Powder Vial

Vials of AVONEX® should be stored in a 2-8°C (36-46°F) refrigerator. Should refrigeration be unavailable, vials of AVONEX® can be stored at 25°C (77°F) for a period of up to 30 days. DO NOT EXPOSE TO HIGH TEMPERATURES. DO NOT FREEZE. Protect from light. Do not use beyond the expiration date stamped on the vial. Following reconstitution, it is recommended the product be used as soon as possible within 6 hours stored at 2-8°C (36-46°F). DO NOT FREEZE RECONSTITUTED AVONEX® .

30 mcg Prefilled Syringe

AVONEX® in prefilled syringes should be stored in a 2-8°C (36-46°F) refrigerator. Once removed from the refrigerator, AVONEX® in a prefilled syringe should be allowed to warm to room temperature (about 30 minutes). Do not use external heat sources such as hot water to warm AVONEX® in a prefilled syringe. Should refrigeration be unavailable, AVONEX® in a prefilled syringe can be stored at ≤ 25°C (77°F) for a period up to 7 days. Once the product is removed from the refrigerator, it must not be stored above 25°C (77°F). If the product has been exposed to conditions other than those recommended, DISCARD THE PRODUCT and DO NOT USE. DO NOT EXPOSE TO HIGH TEMPERATURES. DO NOT FREEZE. Protect from light. Do not use beyond the expiration date stamped on the syringe.

AVONEX® (Interferon beta-1a), Manufactured by: BIOGEN IDEC INC. 14 Cambridge Center Cambridge, MA 02142 USA, ©2006 Biogen Idec Inc. All rights reserved. 1-800-456-2255, U.S. Patent Pending, I63005-9 (Issue Date XX/2006), Rx only, *Micro Pin® is the trademark of B. Braun Medical Inc. FDA revision date: 2/2/2007

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