Expanded Indications for Gazyva
November 16, 2017 – The U.S. FDA has approved an expanded indication for Gazyva® (obinutuzumab), manufactured by Genentech, to treat adults who have stage II bulky, stage III, or stage IV advanced follicular lymphoma that has not previously been treated.
Gazyva should be given in conjunction with chemotherapy for the first six to eight cycles of treatment. These cycles last 28 days each. Recommended dosing is 1,000mg per treatment. The drug is administered via intravenous (IV) infusion. For the first cycle, a Gazyva is given on the first, eighth, and fifteenth days. During the next five to seven cycles, it is given on the first day only. Thereafter, Gazyva can be administered once every two months for up to two years. Chemotherapy is discontinued after the first six to eight cycles if the patient responds to the combination therapy.
A black box warning cautions that patients using Gazyva have experienced reactivation of hepatitis B despite previous treatment for the virus. In addition, there is a black box warning that patients on Gazyva have developed progressive multifocal leukoencephalopathy (PML), a rare viral infection that damages the brain, and can be fatal or lead to severe disability.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.