Parsabiv

Parsabiv

etelcalcetide

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Etelcalcetide HCl
Indications/Uses
Secondary hyperparathyroidism (SHPT) in adult patients w/ chronic kidney disease (CKD) on haemodialysis therapy.
Dosage/Direction for Use
Initially 5 mg 3x wkly by bolus or IV inj. Dose titration should be made so that doses are individualized between 2.5 & 15 mg. The dose may be increased in 2.5 or 5 mg increments no more frequently than every 4 wk to max dose of 15 mg 3x wkly. Administer Parsabiv into the venous line of the dialysis circuit at the end of haemodialysis treatment during rinse-back or IV after rinse-back.
Contraindications
Hypersensitivity. Do not initiate treatment if corrected serum Ca is less than the lower limit of the normal range.
Special Precautions
Risk of hypocalcaemia. Measure serum Ca prior to treatment initiation, w/in 1 wk of initiation or dose adjustment & every 4 wk during treatment. Ventricular arrhythmia & QT prolongation secondary to hypocalcaemia. Patients w/ history of convulsion disorder or CHF. Risk of adynamic bone in patients w/ PTH <100 pg/mL. +ve for binding Abs in patients w/ SHPT. Co-administration w/ other medicinal products known to lower serum Ca. Hepatic impairment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Decreased blood Ca; nausea, vomiting, diarrhoea; muscle spasms. Hypocalcaemia, hyperkalaemia, hypophosphataemia; headache, paraesthesia; QT prolongation, worsening heart failure; hypotension; myalgia.
Drug Interactions
Increased risk of severe hypocalcaemia w/ medicinal products known to reduce serum Ca levels. Patients receiving Parsabiv should not be given cinacalcet.
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
Form
Parsabiv soln for inj 5 mg/mL
Packing/Price
10 × 1's
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