Alkeran: Package Insert / Prescribing Info

Principal Display Panel

NDC 52609-3001-0

ALKERAN®

(melphalan hydrochloride)

for Injection

SINGLE-USE

Rx only

One vial of Alkeran for injection containing sterile, nonpyrogenic, freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone.

One vial of sterile, nonpyrogenic diluent containing 0.2 g sodium citrate, 6.0 mL propylene glycol, 0.52 mL ethanol (96%), and Water for Injection to a total of 10 mL.

For Intravenous Infusion.

Reconstitute with enclosed diluent. See enclosed package insert for additional reconstitution and administration instructions.

See prescribing information for Dosage and Administration.

Store at controlled room temperature, 15o to 30oC (59o to 86oF) and protect from light.

Add diluent rapidly.

Immediately shake vial vigorously.

ALKERAN and Diluent

Manufactured by: GlaxoSmithKline

Research Triangle Park, NC 27709

Distributed by: ApoPharma USA Inc

Rockville, MD 20850

10000000101311 Rev. 11/11