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Etelcalcetide

Class
Anti-parathyroid hormone agents
Subclass
Calcimimetics
Substance name
Etelcalcetide
Brand names
Parsabiv®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment of secondary hyperparathyroidism in patients with CKDOn hemodialysis
5 mg IV 3× per week
Indications for use
Labeled indications
Adults
Treatment of secondary hyperparathyroidism in patients with CKD (on hemodialysis)
Safety risks
Boxed warnings
Exacerbation of HF
Use extreme caution with pre-existing HF along with hypocalcemia. Evaluate patients' cardiovascular status before initiating Etelcalcetide, especially in those with a history of HF or cardiac dysfunction. Consider discontinuing or adjusting Etelcalcetide, provide appropriate HF management, and closely monitor the patient's cardiovascular status, under medical supervision.
Contraindications
Known hypersensitivity to etelcalcetide or any of its excipients
Administer Etelcalcetide under medical supervision with appropriate monitoring for signs of anaphylactic reactions.
Pre-existing hypocalcemia
Monitor serum calcium levels before and during Etelcalcetide treatment, and manage hypocalcemia risk factors appropriately.
Warnings and precautions
Gastrointestinal bleeding
Use caution with a history of gastritis, esophagitis, peptic ulcer disease, or severe vomiting. Assess patients for risk factors of gastrointestinal bleeding, including a history of bleeding disorders or concurrent use of anticoagulants, and monitor them closely during treatment. Discontinue Etelcalcetide, initiate appropriate medical treatment for bleeding.
Seizures
Use caution with a history of seizure disorder or if they develop hypocalcemia during treatment with etelcalcetide. Use Etelcalcetide cautiously in patients with a history of seizures or predisposing factors, and consider alternative treatments if appropriate. Assess their severity, consider adjusting the Etelcalcetide dose, and provide appropriate medical intervention for seizure management, under medical supervision.
Ventricular arrhythmias
Use caution with congenital long QT syndrome, history of QT prolongation, family history of long QT syndrome or SCD. Monitor cardiac function and electrolyte levels during Etelcalcetide treatment, especially in patients at risk for ventricular arrhythmias. Consider discontinuing or adjusting Etelcalcetide, provide appropriate medical management for arrhythmias, and closely monitor the patient's cardiac status.
Specific populations
Renal impairment
eGFR 20-50 mL/min/1.73 m²
Only used in hemodialysis.
eGFR 10-20 mL/min/1.73 m²
Only used in hemodialysis.
eGFR < 10 mL/min/1.73 m²
Only used in hemodialysis.
Renal replacement therapy
Continuous renal replacement
Intermittent hemodialysis
Use acceptable. No dose adjustment required.
Peritoneal dialysis
Hepatic impairment
Any severity
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
Diarrhea, muscle cramps, nausea
Common 1-10%
↓ serum calcium, ↓ serum phosphate, ↑QTc interval, headache, hypoesthesia, itching, myalgia, paresthesia, skin rash, vomiting, urticaria
Unknown frequency
Gastrointestinal bleeding, heart failure, osteodystrophy, seizure
Interactions
Drug(s)
Check Interactions
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