Drug Guide
Etelcalcetide
Classification
Therapeutic: Calcium-sensing receptor agonist
Pharmacological: Peptide
FDA Approved Indications
- Secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on hemodialysis
Mechanism of Action
Etelcalcetide is a calcimimetic that activates the calcium-sensing receptor (CaSR) on parathyroid cells, reducing parathyroid hormone (PTH) secretion.
Dosage and Administration
Adult: Initially, 5 mg three times weekly at the end of hemodialysis session, titrated as needed up to 15 mg or more based on PTH levels.
Pediatric: Not approved for pediatric use.
Geriatric: Adjust dose based on response and tolerability, no specific guidelines.
Renal Impairment: Use in dialysis-dependent CKD patients; no dose adjustment specified.
Hepatic Impairment: Data lacking, use with caution.
Pharmacokinetics
Absorption: Administered intravenously; absorption not applicable.
Distribution: Limited data; believed to be confined mainly to plasma.
Metabolism: Metabolized by proteolytic enzymes to inactive metabolites.
Excretion: Primarily excreted via urine as inactive peptides; clearance not significantly affected by renal impairment.
Half Life: Approximately 3-4 days.
Contraindications
- Hypersensitivity to etelcalcetide or any component.
Precautions
- Monitor for hypocalcemia, cardiac arrhythmias, especially in patients with existing cardiovascular disease.
- Use with caution in patients with a history of hypocalcemia.
Adverse Reactions - Common
- Muscle spasms, paresthesias (Unknown)
- Nausea, vomiting (Unknown)
Adverse Reactions - Serious
- Hypocalcemia (Rare but serious)
- QT interval prolongation and cardiac arrhythmias (Rare)
Drug-Drug Interactions
- Other drugs that prolong QT interval (e.g., antiarrhythmics, certain antibiotics)
Drug-Food Interactions
- None specifically noted.
Drug-Herb Interactions
- None established.
Nursing Implications
Assessment: Monitor serum calcium, PTH, and magnesium levels regularly.
Diagnoses:
- Risk for electrolyte imbalance
Implementation: Administer IV at end of dialysis session as prescribed; monitor vital signs and electrocardiogram (ECG) in at-risk patients.
Evaluation: Assess PTH levels and signs of hypocalcemia; adjust dose accordingly.
Patient/Family Teaching
- Teach patients to report symptoms of hypocalcemia such as muscle cramps or tingling.
- Inform about potential for cardiac arrhythmias and importance of regular monitoring.
Special Considerations
Black Box Warnings:
- Potential for hypocalcemia leading to QT prolongation and arrhythmias.
Genetic Factors: None established.
Lab Test Interference: None known.
Overdose Management
Signs/Symptoms: Severe hypocalcemia, arrhythmias, muscle spasms.
Treatment: Administer calcium intravenously, monitor cardiac rhythm, and provide supportive care.
Storage and Handling
Storage: Store refrigerated at 2-8°C. Do not freeze.
Stability: Stable for up to 24 hours at room temperature.