Etelcalcetide

PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: 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 CKD who are not on hemodialysis and is not recommended for use in these populations. 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.

Etelcalcetide is a calcimimetic agent that allosterically modulates the calcium-sensing receptor (CaSR). Etelcalcetide binds to the CaSR and enhances activation of the receptor by extracellular calcium. Activation of the CaSR on parathyroid chief cells decreases PTH secretion.

Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation, dose increase, or re-initiation. The recommended starting dose is 5 mg administered by intravenous 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 dose range is 2.5 to 15 mg three times per week. The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks. Measure serum calcium within 1 week after initiation or dose adjustment and every 4 weeks for maintenance. Measure PTH after 4 weeks from initiation or dose adjustment. Decrease or temporarily discontinue PARSABIV in individuals with PTH levels below the target range.

PARSABIV is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity PARSABIV is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred with PARSABIV.

Hypocalcemia: Sometimes severe. Severe hypocalcemia can cause paresthesias, myalgias, muscle spasms, seizures, QT prolongation, and ventricular arrhythmias. Patients predisposed to QT interval prolongation, ventricular arrhythmias, and seizures may be at increased risk and require close monitoring. Educate patients on the symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur. Worsening Heart Failure: Reductions in corrected serum calcium may be associated with congestive heart failure, however, a causal relationship to PARSABIV could not be completely excluded. Closely monitor patients for worsening signs and symptoms of heart failure. Upper Gastrointestinal (GI) Bleeding: Patients with risk factors for upper GI bleeding may be at increased risk. Monitor patients and promptly evaluate and treat any suspected GI bleeding.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Hypocalcemia Worsening Heart Failure Upper Gastrointestinal Bleeding Adynamic Bone The most common adverse reactions (≥ 5%) were blood calcium decreased, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia.

Store in the original carton in refrigerator at 2°C to 8°C (36°F to 46°F) to protect from light. Once removed from the refrigerator: Do not expose to temperatures above 25°C (77°F). Use within 7 days if stored in the original carton.