FDA Approves Parsabiv for Secondary Hyperparathyroidism

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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In February, manufacturer Amgen announced that the FDA approved Parsabiv (etelcalcetide) for secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on hemodialysis.

Secondary hyperparathyroidism is a condition that lowers calcium levels, causing your parathyroid glands to overproduce the parathyroid hormone. This can cause cardiovascular, neurological and immune system complications. Secondary hyperparathyroidism is especially seen in patients with CKD, but can also be caused by severe vitamin D or calcium deficiency.

What is chronic kidney disease (CKD)?

Chronic kidney disease is a condition characterized by the gradual loss of kidney function over time. It can be caused by diabetes, high blood pressure, inflammation of the kidneys, kidney infections, or urine backup into the kidneys.

How is Parsabiv to be used?

The recommended dose of Parsabiv is 5 mg, by intravenous bolus injection three times a week. Injections should be done at the end of hemodialysis, a treatment that filters waste and removes extra fluid in the kidneys.

Parsabiv will be available as an injection in the strengths of 2.5 mg/0.5 ml, 5 mg/1 ml, and 10 mg/2 ml. Your doctor will determine your specific dose of Parsabiv.

Parsabiv is the first treatment approved in 12 years for secondary hyperparathyroidism. It is also the only medication that mimics calcium and can be given intravenously. Parsabiv was also approved by the European Commission in November of 2016.

What side are effects associated with Parsabiv?

The most common side effects include diarrhea and nausea.

How can I save on Parsabiv?

Manufacturer Amgen has two programs to help patients afford Parsabiv. For commercially insured patients, the Parsabiv Co-Pay card can help you reduce your copay to as little as $5. For more information, see Parsabiv’s website here, or call 1-888-762-6436.

Eligible uninsured patients can receive Parsabiv free for up to one year with Amgen’s Safety Net Foundation Patient Assistance program. For more information visit the Safety Net Foundation’s website here, or call 1-888-762-6436.

You can also learn more about Parsabiv in the press announcement here.

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