etecalcitide

e-tel-KAL-se-tide

Therapeutic Classification: hypocalcemics

Pharmacologic Classification: calcimimetic agents

REMS

Secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.

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.

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.

(effect on PTH levels)

ROUTE	ONSET	PEAK	DURATION
IV	30 min	unknown	unknown

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.

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)

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.

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).

Solution for injection: 5 mg/mL

Monitor for signs and symptoms of hypocalcemia (paresthesia, myalgia, muscle spasms, seizures, QT interval prolongation, ventricular arrhythmia) during therapy.
Monitor for signs and symptoms of developing or worsening heart failure periodically during therapy.
Monitor for signs and symptoms of upper GI bleeding (gastritis, esophagitis, ulcers, severe vomiting) periodically during therapy. Evaluate and treat suspected bleeding promptly.
Monitor for signs and symptoms of hypersensitivity (pruritic rash, urticaria, facial edema) during therapy.

Lab Test Considerations:

Monitor corrected serum calcium levels 1 wk after dose initiation or adjustment and every 4 wk during maintenance and closely in patients at risk for QT interval prolongation or seizures, and in patients taking other therapies known to lower serum calcium. If corrected serum calcium level <lower limit of normal or symptoms of hypocalcemia occur, start or ↑ calcium supplements (calcium, calcium-containing phosphate binders, vitamin D sterols, increases in dialysate calcium concentration). May require dose ↓ or discontinuation of etecalcitide.
- Monitor parathyroid hormone levels 4 wk after dose initiation or adjustment and based on clinical practice during maintenance. Chronically suppressed PTH levels may lead to development of adynamic bone. If PTH levels <recommended target range, ↓ dose of vitamin D sterols and/or ↓ or discontinue etecalcitide therapy. After discontinuation, resume therapy at lower dose to maintain PTH levels in target range.
- May cause hypophosphatemia.

Ensure serum calcium is at or above lower limit of normal before etecalcitide initiation, dose ↑, or re-initiation. If corrected serum calcium is within normal range and PTH level is above recommended target range based on patient's PTH level,↑ etecalcitide dose in 2.5–mg or 5–mg increments no more frequently than every 4 wk up to a maximum dose of 15 mg three times/wk. If PTH level is below target range,↓ dose or temporarily discontinue etecalcitide. If corrected serum calcium level is below lower limit of normal but at or above 7.5 mg/dL without symptoms of hypocalcemia, consider ↓ dose or temporarily discontinuing etecalcitide or use concomitant therapies to ↑ corrected serum calcium levels. If dose is stopped, then re-initiate etecalcitide at lower dose when PTH is within target range and hypocalcemia has been corrected. If corrected serum calcium <7.5 mg/dL or patient reports symptoms of hypocalcemia, stop etecalcitide and treat hypocalcemia. When corrected serum calcium is within normal limits, symptoms of hypocalcemia resolved, and predisposing factors for hypocalcemia addressed, re-initiate etecalcitide at 5 mg lower than last administered dose. If last dose was 2.5 mg or 5 mg, re-initiate at dose of 2.5 mg.
- Administer at end of hemodialysis treatment. If hemodialysis treatment is missed, do not administer any missed doses. Resume at end of next hemodialysis session. If doses are missed for ≥2 wk, re-initiate etecalcitide at starting dose of 5 mg.
IV Push: Do not mix or dilute prior to administration. Solution is clear and colorless; do not administer if discolored or contains particulate matter. When removed from refrigerator, stable for 7 days if stored in original carton and 4 hrs if protected from light and removed from original carton.
Rate: Administer as a IV bolus into venous line of dialysis circuit at end of hemodialysis treatment during rinse back or IV after rinse back. Administer sufficient volume of saline (150 mL of rinse back), after etecalcitide injection into the dialysis tubing. If etecalcitide is administered after rinse back, administer IV followed by at least 10 mL of saline flush.

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.

Parathyroid hormone level within recommended target range and corrected serum calcium level within normal range.

Parsabiv

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US Brand Names ⬆