Mutamycin Generics Launched
March 20, 2018 – Drug manufacturer Mylan has launched its generics for Bristol-Myers Squibb’s Mutamycin® (mitomycin) 5mg, 10mg, and 20mg vials. The drug is indicated to treat disseminated adenocarcinoma of the stomach and pancreas when used in combination with chemotherapy.
Recommended dosing with mitomycin is once every six to eight weeks via intravenous (IV) infusion. Mitomycin should not be used as a single-agent or primary therapy, or in place of appropriate surgical or radiotherapy treatments. An antibiotic, it attacks tumors by inhibiting cell replication, which can slow or stop the spread of cancer in the body.
A black box warning cautions that mitomycin can cause severe side effects, including bone marrow suppression, anemia, and irreversible renal failure. For these reasons, it should only be administered under the supervision of a healthcare professional with experience in the use of chemotherapeutic agents to treat cancer. Regular testing should be conducted to monitor for side effects.
According to IQVIA, total U.S. sales for brand name Mutamycin were approximately $59 million during the twelve-month period ending on January 31, 2018.
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.