etecalcitide

REMS

Secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Hypocalcemia;
Lactation: Lactation.

Use Cautiously in:

Congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, hypokalemia, hypomagnesemia, bradycardia, or concomitant use of QT interval prolonging medications (↑ risk for torsades de pointes);
Seizure disorder;
Gastritis, esophagitis, ulcers, or severe vomiting (↑ risk of GI bleeding);
OB: Safety not established in pregnancy;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: HF, hypotension, QT INTERVAL PROLONGATION, TORSADES DE POINTES

F and E: hypocalcemia, hypophosphatemia

GI: diarrhea, nausea, GI BLEEDING, vomiting

MS: muscle spasms, adynamic bone, myalgia

Neuro: headache, paresthesia, SEIZURES

Misc: HYPERSENSITIVITY REACTIONS(INCLUDING ANAPHYLAXIS AND FACIAL EDEMA)

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with cinacalcet may lead to life-threatening hypocalcemia; discontinue cinacalcet for ≥7 days before initiating etecalcitide at 5 mg 3 times weekly.

Availability ⬆ ⬇

Solution for injection: 5 mg/mL

Route/Dosage ⬆ ⬇

IV (Adults ): 5 mg 3 times weekly at end of hemodialysis session; titrate dose based on PTH and corrected serum calcium concentrations (max = 15 mg 3 times weekly).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Increases sensitivity of calcium-sensing receptors located on the surface of chief cells of parathyroid gland to levels of extracellular calcium. This decreases parathyroid hormone (PTH) production with resultant decrease in serum calcium.

Therapeutic effects:

Decreased PTH, serum calcium, and serum phosphate concentrations.

Classifications ⬆ ⬇

Therapeutic Classification: hypocalcemics

Pharmacologic Classification: calcimimetic agents

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Biotransformed in blood by reversible disulfide exchange with endogenous thiols to predominantly form conjugates with serum albumin. Primarily eliminated by hemodialysis.

Half-Life: 3–4 days.

Time/Action Profile ⬆ ⬇

(effect on PTH levels)

ROUTE	ONSET	PEAK	DURATION
IV	30 min	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose of etecalcitide to patient.
Advise patient to notify health care professional if signs and symptoms of hypocalcemia, heart failure, or upper GI bleeding occur.
Inform patient of need for regular blood tests for monitor safety and efficacy of etecalcitide.
Rep: Advise female patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy.

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Indications ⬇