Parsabiv Special Precautions





Agencia Lei Va Hong
Full Prescribing Info
Special Precautions
Hypocalcaemia: Parsabiv treatment should not be initiated in patients if the corrected serum calcium is less than the lower limit of the normal range (see Contraindications).
Potential manifestations of hypocalcaemia include paraesthesias, myalgias, muscle spasm and seizures.
Since etelcalcetide lowers serum calcium, patients should be advised to seek medical attention if they experience symptoms of hypocalcaemia and should be monitored for the occurrence of hypocalcaemia (see Dosage & Administration). Serum calcium levels should be measured prior to initiating treatment, within 1 week of initiation or dose adjustment of Parsabiv and every 4 weeks during treatment. If clinically meaningful decreases in corrected serum calcium levels occur, steps should be taken to increase serum calcium levels (see Dosage & Administration).
Ventricular arrhythmia and QT prolongation secondary to hypocalcaemia: Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia (see Adverse Reactions). Serum calcium levels should be closely monitored in patients with congenital long QT syndrome, previous history of QT prolongation, family history of long QT syndrome or sudden cardiac death and other conditions that predispose to QT prolongation and ventricular arrhythmia while being treated with Parsabiv.
Convulsions: Cases of seizures have been reported in patients treated with Parsabiv (see Adverse Reactions). The threshold for seizures may be lowered by significant reductions in serum calcium levels. Serum calcium levels should be closely monitored in patients with a history of a convulsion disorder while being treated with Parsabiv.
Worsening heart failure: Decreased myocardial performance, hypotension, and congestive heart failure (CHF) may be associated with significant reductions in serum calcium levels. Serum calcium levels should be monitored in patients with a history of congestive heart failure while being treated with Parsabiv (see Dosage & Administration), which may be associated with reductions in serum calcium levels.
Co-administration with other medicinal products: Administer Parsabiv with caution in patients receiving any other medicinal products known to lower serum calcium. Closely monitor serum calcium (see Interactions).
Patients receiving Parsabiv should not be given cinacalcet. Concurrent administration may result in severe hypocalcaemia.
Adynamic bone: Adynamic bone may develop if PTH levels are chronically suppressed below 100 pg/mL. If PTH levels decrease below the recommended target range, the dose of vitamin D sterols and/or Parsabiv should be reduced or therapy discontinued. After discontinuation, therapy can be resumed at a lower dose to maintain PTH in the target range (see Dosage & Administration).
Immunogenicity: In clinical studies, 7.1% of patients with SHPT treated with Parsabiv for up to 6 months tested positive for binding antibodies. 80.3% of these had pre-existing antibodies. No evidence of altered pharmacokinetic profile, clinical response or safety profile was associated with pre-existing or developing anti-etelcalcetide antibodies.
Excipient with known effect: Parsabiv contains less than 1 mmol sodium per vial, that is to say essentially sodium-free.
Effects on ability to drive and use machines: Parsabiv has no or negligible influence on the ability to drive and use machines. However, certain potential manifestations of hypocalcaemia may affect the ability to drive and use machines.
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