Update on the National Shortage of Bleomycin Sulfate for Injection

• FLASCO
• September 16, 2016
• Drugs

The FDA announced efforts to help mitigate the shortage of Bleomycin Sulfate for Injection. The agency will be coordinating with Amneal Bioscience to import its Bleomycin Sulfate Powder for Injection, which contains the same active ingredients as the FDA-approved Bleomycin Sulfate for Injection.

In April, the FDA posted information on its website regarding a national shortage. The shortage is due to issues with manufacturing, raw materials and increased demand.

There are two key differences in the package inserts for these. The FDA-approved label uses different units from the Amneal Biosciences and Amneal label does not include an indication for malignant pleural effusions. Additionally, the FDA label provides weight-based dosing information as well as body surface area-based dosage, whereas the imported product from Amneal’s label contains only surface area-based dosage.

Important Note: Each vial of Amneal Biosciences’ product contains 15,000 IU of Bleomycin Sulfate Powder for Injection, which is equivalent to Bleomycin Sulfate USP 15 units  (1000 IU of Bleomycin Sulfate Powder for Injection = 1 unit Bleomycin USP). Prescribers and pharmacists must be alert to this difference in labeled units in order to prevent medication errors. Appropriate quality assurance measures should be enacted to reduce the risk of medications errors.

For more information read the full letter for healthcare professionals.