Parsabiv

— THERAPEUTIC CATEGORIES —
  • Secondary hyperparathyroidism or hypocalcemia

Parsabiv Generic Name & Formulations

General Description

Etelcalcetide 2.5mg/0.5mL, 5mg/mL, 10mg/2mL; soln for IV inj; preservative-free.

Pharmacological Class

Calcimimetic.

How Supplied

Single-dose vials—10

Manufacturer

Generic Availability

NO

Parsabiv Indications

Indications

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.

Parsabiv Dosage and Administration

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.

Parsabiv Contraindications

Not Applicable

Parsabiv Boxed Warnings

Not Applicable

Parsabiv Warnings/Precautions

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.

Parsabiv Pharmacokinetics

See Literature

Parsabiv Interactions

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.

Parsabiv Adverse Reactions

Adverse Reactions

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

Parsabiv Clinical Trials

See Literature

Parsabiv Note

Not Applicable

Parsabiv Patient Counseling

See Literature

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