Parsabiv

Parsabiv

etelcalcetide

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Etelcalcetide
Indications/Uses
Secondary hyperparathyroidism in adults w/ CKD on haemodialysis therapy.
Dosage/Direction for Use
Initially 5 mg bolus inj 3 times wkly. Dose titration: May be increased in 2.5 mg or 5 mg increments no more frequently than every 4 wk to max dose of 15 mg 3 times wkly.
Contraindications
Hypersensitivity. Do not initiate if corrected serum Ca is less than LLN range.
Special Precautions
Reduce or discontinue dose if PTH levels decrease below recommended target range. Not recommended in patients w/ parathyroid carcinoma, primary hyperparathyroidism or w/ CKD who are not on hemodialysis. Measure serum Ca levels prior to initiating treatment, w/in 1 wk of initiation or dose adjustment & every 4 wk during treatment; in patients w/ congenital long QT syndrome, previous history of QT prolongation, family history of long QT syndrome or sudden cardiac death, & other conditions that predispose to QT prolongation & ventricular arrhythmia; history of convulsion disorder, CHF. Concomitant use w/ drugs known to lower serum Ca & cinacalcet. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Decreased blood Ca; nausea, vomiting, diarrhoea; muscle spasms. Hypocalcaemia, hyperkalaemia, hypophosphataemia; headache, paraesthesia; worsening heart failure, QT prolongation; hypotension; myalgia.
Drug Interactions
May result in increased risk of hypocalcaemia w/ drugs known to reduce serum Ca. Concomitant use w/ cinacalcet.
MIMS Class
Other Agents Affecting Metabolism
ATC Classification
H05BX04 - etelcalcetide ; Belongs to the class of other anti-parathyroid agents. Used in the management of calcium homeostasis.
Presentation/Packing
Form
Parsabiv soln for inj 2.5 mg/0.5 mL
Packing/Price
10 × 1's
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