Vial Form and Extended Indication Approved for Granix
July 31, 2018 – The U.S. FDA has approved a new vial form and extended indication for Granix® (tbo-filgrastim), manufactured by Teva Pharmaceuticals. Under the expanded indication, Granix may now be used to treat patients as young as one month old to reduce the length of neutropenia (low white blood cell count). Eligible patients must have non-myeloid malignancies and be receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of neutropenia with fever.
White blood cells play a key role in the immune system’s ability to function properly. A low white blood cell count raises a patient’s risk of severe infections. Originally approved in 2013 as a biosimilar to Amgen’s Neupogen® (filgrastim), Granix was previously available only in prefilled syringes of either 300mcg/0.5mL or 480mcg/0.8mL. The new vial form contains 300mcg/mL or 480mcg/1.6mL per vial.
Granix should be given at least 24 hours following the administration of a myelosuppressive drug. It is administered via subcutaneous injection once daily until neutrophil (white blood cell) counts reach an acceptable level. Recommended dosing is based on weight.
Teva Pharmaceuticals is expected to launch the vial form of Granix in 2018.