Parsabiv Approved to Treat Secondary Hyperparathyroidism
February 7, 2017 – The U.S. FDA approved Parsabiv™ (etelcalcetide), manufactured by Amgen. It is indicated to treat secondary hyperparathyroidism (HPT) for adults with chronic kidney disease (CKD) on hemodialysis. Secondary HPT is a condition that results from over production of parathyroid hormone (PTH) from the parathyroid glands, which are stimulated by low kidney function. In response, additional calcium and other minerals are lost from bones into the blood. Parsabiv acts like calcium at receptors on the parathyroid glands to decrease PTH release. Given as an intravenous (IV) infusion, it can be injected into the tubing used for dialysis after each dialysis treatment ends. Single-use vials containing 2.5mg, 5mg or 10mg of Parsabiv will be available. Recommended initial dose is 5mg three times a week. Maintenance doses range from 2.5mg to 15mg three times a week as long as calcium blood levels are too high. Both calcium and PTH levels should be tested after beginning Parsabiv, with dosing changes and about once a month during therapy. Parsabiv works similar to Amgen’s oral product, Sensipar® (cinacalcet), which is expected to face generic competition in September 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.