Medication Monitor

Generic Name (Trade Name—Company)
November 7, 2019


Sandoz receives approval for pegfilgrastim biosimilar

Sandoz announced FDA approval of pegfilgrastim-bmez, its biosimilar to pegfilgrastim (Neulasta), to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Pegfilgrastim is a long-acting form of filgrastim, which is very similar to a natural protein, granulocyte-colony stimulating factor, produced by a person's own body.

The recommended dosage for patients with cancer receiving myelosuppressive chemotherapy is 6 mg administered subcutaneously once per chemotherapy cycle. The agent should not be administered between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Weight-based dosing should be used for pediatric patients weighing less than 45 kg; see the prescribing information for instructions.

Warnings and precautions include fatal splenic rupture; acute respiratory distress syndrome; serious allergic reactions, including anaphylaxis; fatal sickle cell crises; and glomerulonephritis.

The drug's most common adverse reactions are bone pain and pain in extremity.