Hyperparathyroidism, secondary

Calcimimetic:
a synthetic peptide calcimimetic, allosterically activates the calcium-sensing receptor (CaSR) on the parathyroid gland, resulting in decreased PTH secretion, and serum calcium and phosphorus levels in patients with secondary hyperparathyroidism on hemodialysis

Onset of action:
Within 30 minutes
Distribution
1. Vd:~796 L
Metabolism
Undergoes biotransformation in blood by reversible disulfide exchange with endogenous thiols to predominantly form conjugates with serum albumin; majority of these biotransformed moieties circulating in plasma exist as serum albumin peptide conjugates
Excretion
Urine
Pharmakodynamics
Half-life Elimination:
1. 18.4 to 20 hours(Healthy patients)
2. 3 to 4 days(CKD patients on hemodialysis)

Hypersensitivity to etelcalcetide or any component of the formulation.

Adverse events were observed in animal reproduction studies at doses which also caused maternal toxicity (including hypocalcemia).

It is not known if etelcalcetide is present in breast milk. Due to the potential for hypocalcemia in a breastfeeding infant, breastfeeding is not recommended by the manufacturer.

Common(>10%):
Endocrine & metabolic: Hypocalcemia (≤79%; serum calcium <7 m/dL: 8%), hypophosphatemia (1% to 18%)
1% to 10%:
Cardiovascular: Prolonged QT interval on ECG (1% to 5%), cardiac failure (2%)Central nervous system: Headache (8%), paresthesia (6%)Endocrine & metabolic: Hyperkalemia (4%)Gastrointestinal: Vomiting (9%)Hypersensitivity: Hypersensitivity reaction (4%)Immunologic: Antibody development (7%)Neuromuscular & skeletal: Myalgia (2%)
Post marketing:
Anaphylaxis, cardiac insufficiency, hypotension

Hyperparathyroidism, secondary (chronic kidney disease patients on hemodialysis):
Initial: 5 mg IV bolus 3 times per week at the end of hemodialysis.
Dosage adjustments:
Titrate dose in 2.5 mg or 5 mg increments not more frequently than every 4 weeks to a dose that maintains PTH levels within recommended target range and corrected serum calcium within the normal range; maximum maintenance dose: 15 mg three times per week; minimum maintenance dose: 2.5 mg three times per week.Missed dose:
If hemodialysis is missed, do not administer. Resume etelcalcetide at the end of the next hemodialysis treatment. If doses are missed for >2 weeks, re-initiate with 5 mg (or 2.5 mg if that was the patient's last dose) 3 times per week.