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PARSABIV
Secondary hyperparathyroidism or hypocalcemia
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Drug Name:

PARSABIV Rx

Generic Name and Formulations:
Etelcalcetide 2.5mg/0.5mL, 5mg/mL, 10mg/2mL; soln for IV inj; preservative-free.

Company:
Amgen, Inc.

Therapeutic Use:

Indications for PARSABIV:

Secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis.

Limitations Of use:

Not recommended in adults with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis.

Adult:

Give at the end of hemodialysis. Initially 5mg as IV bolus inj 3 times weekly. Maintenance: 2.5mg–15mg 3 times weekly based on PTH target range and corrected serum calcium response within normal range. May increase in 2.5mg or 5mg increments no sooner than every 4 weeks; max 15mg 3 times weekly. Monitoring and dose adjustment: see full labeling. Switching from cinacalcet: initially 5mg.

Children:

Not established.

Warnings/Precautions:

Hypocalcemia: may increase risk of QT prolongation and ventricular arrhythmias in congenital or family history of long QT syndrome or sudden cardiac death, history of QT prolongation and other predispositions; monitor closely. Seizure disorders. Measure corrected serum calcium prior to initiation; do not start if below lower limit of normal. Monitor serum calcium within 1 week of initiation or dose adjustment and every 4 weeks during treatment (see full labeling). If serum calcium is below lower limit of normal or symptoms of hypocalcemia occurs, initiate or increase calcium supplementation. Monitor for adynamic bone disease; if PTH levels fall below target range, reduce dose (Vit.D sterols and/or etelcalcetide) or discontinue; resume at lower dose. Monitor closely for worsening heart failure. Known gastritis, esophagitis, ulcers, severe vomiting: monitor for worsening GI reactions, bleeding, and ulcerations. Pregnancy. Nursing mothers: not recommended.

Interactions:

See Adults. Risk of severe hypocalcemia with concomitant other oral calcium-sensing receptor agonist. When switching from cinacalcet, discontinue cinacalcet for at least 7 days prior to initiation.

Pharmacological Class:

Calcimimetic.

Adverse Reactions:

Decreased blood calcium, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia (may be severe), paresthesia.

Generic Availability:

NO

How Supplied:

Single-dose vials—10

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