Etelcalcetide Disease Interactions

The use of etelcalcetide lowers serum calcium and can lead to hypocalcemia, sometimes severe. A decrease in serum calcium can cause paresthesias, myalgias, muscle spasms, seizures, QT interval prolongation, and ventricular arrhythmia. Patients with congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia. Closely monitor corrected serum calcium and QT interval in patients at risk receiving etelcalcetide.

The use of etelcalcetide may increase the risk of upper gastrointestinal (GI) bleeding. Patients with risks factors for upper GI bleeding (such as known gastritis, esophagitis, ulcers, or severe vomiting) may be at increased risk for GI bleeding while receiving etelcalcetide treatment. It is recommended to monitor patients for worsening of GI adverse reactions such as nausea and vomiting and for signs and symptoms of GI bleeding and ulcerations during therapy with etelcalcetide. Promptly evaluate and treat any suspected GI bleeding according to medical guidelines.

The use of etelcalcetide may cause hypotension, congestive heart failure, and decreased myocardial performance and worsening heart failure. Reductions in corrected serum calcium may be associated with congestive heart failure. Close monitoring is recommended for worsening signs and symptoms of heart failure.

The use of etelcalcetide may cause seizures due to significant reductions in corrected serum calcium. Patients with a history of seizure disorder may be at increased risk for seizures if they develop hypocalcemia due to etelcalcetide therapy. It is recommended to measure corrected serum calcium prior to and within 1 week after initiation or dose adjustment and every 4 weeks during treatment. Do not initiate in patients if the corrected serum calcium is less than the lower limit of normal. Close monitor corrected serum calcium in patients with seizure disorders receiving etelcalcetide. Dose reduction or discontinuation of therapy may be necessary if corrected serum calcium falls below the lower limit of normal or symptoms of hypocalcemia develop.