Expanded Age Indication for Yervoy
July 24, 2017 – The U.S. FDA has approved a new pediatric indication for Yervoy® (ipilimumab) injection, manufactured by Bristol-Myers Squibb, for intravenous (IV) use. As the result of an FDA review of clinical studies conducted with teens and children, Yervoy is now indicated to treat advanced stages of metastatic melanoma in patients 12 years of age and older. Recommended dosing is 3mg/kg, regardless of the patient’s age. A full course of treatment requires four doses delivered by IV infusion over a 90-minute period once every three weeks.
Yervoy carries a boxed warning that it can cause immune-mediated adverse reactions, which may involve any organ system and be life-threatening. Patients’ adrenal, hormone, liver, thyroid, and other functions should be tested before Yervoy is initiated, and before each dose.
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.