Trade name Parsabiv.

Dosage Form: injection, solution.

Indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

A calcimimetic agent that allosterically modulates the calcium-sensing receptor (CaSR).

Binds to the CaSR and enhances activation of the receptor by extracellular calcium.

Activation of the CaSR on parathyroid chief cells decreases PTH secretion.

Has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations.

It is essential to ensure serum calcium is at or above the lower limit of normal prior to initiation, a dose increase, or re-initiation of therapy after a dosing int2242uption.

The recommended starting dose is 5 mg administered by intravenous (IV) bolus injection three times per week at the end of hemodialysis treatment.

The maintenance dose is individualized and determined by titration based on parathyroid hormone (PTH) and corrected serum calcium response.

The lowest maintenance dose of Parsabiv is 2.5 mg three times per week, and the highest maintenance dose of Parsabiv is 15 mg three times per week.

Administered at the end of hemodialysis treatment.

Monitor corrected serum calcium and PTH levels during dose initiation, dose adjustment, and dose maintenance.

At the maintenance dose, PTH levels should be within the recommended target range and corrected serum calcium within the normal range.

It is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of the hemodialysis treatment during rinse back or intravenously after rinse back.

When switching from Cinacalcet to Parsabiv, the former should be discontinued for at least 7 days prior to starting Parsabiv, and initiate Parsabiv treatment at a starting dose of 5 mg.

Lowers serum calcium and can lead to hypocalcemia, sometimes severe.

Significant lowering of 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

Patients should be monitored for serum calcium and QT intervals.

Significant reductions in corrected serum calcium may lower the threshold for seizures.

Concurrent administration with another oral calcium-sensing receptor agonist could result in severe, life-threatening hypocalcemia.

Patients switching from cinacalcet should discontinue cinacalcet for at least 7 days prior to initiating treatment.

Cases of hypotension, congestive heart failure, and decreased myocardial performance have been reported.

Adynamic bone may develop if PTH levels are chronically suppressed.

Other adverse reactions associated in < 5% of patients:

Hyperkalemia: 3% and 4%.

Hospitalization for Heart Failure: 2%

Myalgia: 2%

Hypophosphatemia: 0.2%.

Hypersensitivity occurs in 4.4%, manifesting in pruritic rash, urticaria, and face edema.

7.1% of patients with secondary hyperparathyroidism treated with Parsabiv for up to 6 months tested positive for binding anti-etelcalcetide antibodies.

No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with pre-existing or developing anti-etelcalcetide antibodies.

There are no available data on the use of Parsabiv in pregnant women.

No data regarding its presence in human milk or effects on the breastfed infant or on milk production.

No clinically significant differences in safety or efficacy has been noted between patients ≥ 65 years and younger patients (≥ 18 and < 65 years old).

Etelcalcetide injection is supplied in a single-dose vial containing 5 mg/mL of etelcalcetide as a sterile, preservative-free, ready-to-use clear and colorless solution for intravenous injection.

Following intravenous bolus administration, PTH levels decreases within 30 minutes post-dose.

The extent and duration of the reduction in PTH increased with increasing dose, and PTH levels correlated with plasma etelcalcetide concentrations in hemodialysis patients.

The reduction PTH levels is maintained throughout the 6-month dosing period when administered by intravenous bolus three times a week.

Cleared by renal excretion in patients with normal renal function, while hemodialysis is the major elimination pathway in chronic kidney disease patients on hemodialysis.

Pharmacokinetics in patients ≥ 65 years of age and in patients < 65 years of age is similar.

Does not inhibit or induce CYP450 enzymes, and is not a substrate of CYP450 enzymes.

Patients should report symptoms of hypocalcemia, including paresthesias, myalgias, muscle spasms, and seizures.

It may worsen preexisting heart failure.

Not recommended while breastfeeding.

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