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.
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