The Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Zarxio (filgrastim-sndz; Sandoz) to update the Warnings and Precautions section of the drug label.
The supplement proposed the inclusion of glomerulonephritis in the Warnings and Precautions section as well as in the Post Marketing Experience section. Also, the supplement includes a correction in the inconsistency between the data regarding injection sites in the prescribing information and in step 9 of the IFU and corresponding figure F, to include upper outer areas of the buttock.
In general, the incidence of glomerulonephritis resolved after dose reduction or discontinuation of filgrastim products. If glomerulonephritis is suspected, clinicians are to evaluate for cause. If causality is likely, it is recommended to consider dose reduction or interruption of Zarxio.
Zarxio, a leukocyte growth factor, is indicated to decrease incidence of infection in patients with nonmyeloid malignancies receiving certain myelosuppressive anti-cancer drugs; to reduce time to neutrophil recovery and fever duration after induction or consolidation chemotherapy treatment of adults with AML; to reduce duration of neutropenia and related sequelae in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone-marrow transplantation (BMT); to mobilize hematopoietic progenitor cells (PBPC) into peripheral blood for collection by leukapheresis; and to reduce the incidence and duration of neutropenia sequelae in severe chronic neutropenia (SCN).
It is available as 300mcg/0.5mL and 480mcg/0.8mL strengths in 1- and 10-count single-use prefilled syringes.
For more information call (844) 726-3691 or visit Zarxio.com