FDA Approves Granix Injection for Self-Administration

Teva’s Granix (tbo-filgrastim) Injection has been approved by the FDA for self-administration by patients and caregivers, the company announced in a press release.

Granix is a leukocyte growth factor that is indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

While Granix has been available in the United States since November 2013, the current syringe is indicated exclusively for administration by a health care professional. The FDA’s latest approval will allow physicians to prescribe Granix for home use.

“In partnership with their physician, patients will be able to decide whether administering GRANIX via self-injection at home or by a healthcare professional is the right course for them,” said Lee S. Schwartzberg, MD, FACP, Division Chief of Hematology Oncology at the University of Tennessee Health Science Center, in a press release. “Selecting a course of self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers.”

Teva intends to release a Granix syringe for self-administration in early 2015.