Parsabiv Generic Name & Formulations
Etelcalcetide 2.5mg/0.5mL, 5mg/mL, 10mg/2mL; soln for IV inj; preservative-free.
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
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.
Parsabiv Boxed Warnings
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.
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
Decreased blood calcium, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia (may be severe), paresthesia.
Parsabiv Clinical Trials
Parsabiv Patient Counseling