for: Secondary Hyperparathyroidism
Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV- etelcalcetide hydrochloride injection, solution
Amgen Inc
1 INDICATIONS AND USAGE
PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Limitations of Use:
PARSABIV 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.
2 D OSAGE AND ADMINISTRATION
2.1 Recommended Dosing
Ensure corrected serum calcium is at or above the lower limit of normal prior to PARSABIV initiation, a PARSABIV dose increase, or re-initiation of PARSABIV therapy after a dosing interruption [ see Dosage and Administration ( 2.2) and Warnings and Precautions ( 5.1) ].
The recommended starting dose of PARSABIV is 5 mg administered by intravenous (IV) bolus injection three times per week at the end of hemodialysis treatment.
The maintenance dose of PARSABIV is individualized and determined by titration based on parathyroid hormone (PTH) and corrected serum calcium response [ see Dosage and Administration ( 2.2) ]. The maintenance dose is the dose that maintains PTH levels within the recommended target range and corrected serum calcium within the normal range. 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.
Administer PARSABIV only at the end of hemodialysis treatment.
If a regularly scheduled hemodialysis treatment is missed, DO NOT administer any missed doses. Resume PARSABIV at the end of the next hemodialysis treatment at the prescribed dose. If doses of PARSABIV are missed for more than 2 weeks, re-initiate PARSABIV at the recommended starting dose of 5 mg (or 2.5 mg if that was the patient's last dose).
DOSAGE FORMS AND STRENGTHS
PARSABIV is a single-dose, clear, and colorless solution available as follows:
Injection: 2.5 mg/0.5 mL solution in a single-dose vial
Injection: 5 mg/mL solution in a single-dose vial
Injection: 10 mg/2 mL solution (5 mg/mL) in a single-dose vial