Posted from: Friday, July 06, 2018 - 04:22 PM - Present

Mircera Receives New Pediatric Indication

June 7, 2018 – The U.S. FDA has approved a new indication for Mircera® (methoxy polyethylene glycol-epoetin beta), manufactured by Roche and Vifor Pharma. A type of erythropoiesis-stimulating agent (ESA), Mircera is now indicated to treat anemia in patients 5 to 17 years of age with chronic kidney disease (CKD) who are on hemodialysis and converting from another ESA after their hemoglobin level has been stabilized.

Approval for the new indication was based on clinical trials that established the safety and efficacy of Mircera in pediatric patients, as well as dosing. Under the pediatric indication, Mircera must be administered via intravenous (IV) injection once every four weeks. The dosage amount is based on the total weekly epoetin alfa or darbepoetin alfa dose at time of conversion.

Mircera carries a black box warning that ESAs can increase the risk of death and adverse cardiovascular events and stroke. An additional black box warning cautions that Mircera is not recommended to treat anemia caused by cancer chemotherapy. A third black box warning indicates that ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients who had breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.

Initially approved in 2007, Mircera is also indicated to treat anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis.

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.

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.


Last Updated Thursday, September 19, 2019 - 04:45 AM.