Etelcalcetide Application Scope

Etelcalcetide is a calcimimetic agent used for the treatment of the following conditions:

Secondary Hyperparathyroidism (SHPT): For patients with chronic kidney disease (CKD) undergoing hemodialysis to control serum parathyroid hormone (PTH) levels.

Etelcalcetide Characteristics

Ingredients:

Active ingredient: Etelcalcetide
Excipients: May include water for injection, sodium chloride, etc., depending on the formulation.

Properties:

Appearance: Clear, colorless to slightly yellow solution.
Dosage form: Injection.

Specification:

Dosage per vial: Common specifications include 2.5 mg/0.5 mL, 5 mg/1 mL, or 10 mg/2 mL.

Packaging Specification:

Each box typically contains one or multiple vials of injection.

Storage:

Storage temperature: 2°C to 8°C (36°F to 46°F).
Protect from light and avoid freezing.

Expiry Date:

Refer to the expiration date on the packaging; do not use if expired.

Executive Standard:

Complies with relevant standards from the FDA (U.S. Food and Drug Administration) or NMPA (China National Medical Products Administration).

Approval Number:

Refer to the approval number on the packaging.

Date of Revision:

Refer to the latest revision date on the drug leaflet.

Manufacturer:

Amgen Inc. or its authorized manufacturers.

Guidelines For The Use Of Etelcalcetide

Dosage and Administration:

Recommended dose: Adjust based on serum PTH levels and clinical response. The usual starting dose is 5 mg, administered intravenously three times per week after dialysis.
Dose adjustment: Titrate based on serum PTH levels, calcium levels, and patient tolerance. The maximum dose should not exceed 15 mg per administration.
Administration method: Administered intravenously by a healthcare professional after dialysis.

Adverse Reactions:
Common adverse reactions include:

Hypocalcemia
Muscle spasms
Diarrhea
Nausea
Vomiting
Headache
Hyperkalemia

If severe adverse reactions occur (e.g., severe hypocalcemia, arrhythmias), discontinue use immediately and seek medical attention.

Contraindications:

Hypersensitivity to Etelcalcetide or any excipients.
Patients with hypocalcemia.

Precautions:

Regularly monitor serum PTH, calcium, and phosphorus levels during treatment.
Pregnant or breastfeeding women should use under medical supervision.
Safety and efficacy in pediatric patients have not been established.

Etelcalcetide Interactions

Drug Interactions:

Other calcium-lowering agents or vitamin D analogs: May increase the risk of hypocalcemia; use with caution.
Strong CYP450 inhibitors or inducers: Etelcalcetide is not metabolized by hepatic enzymes, and no significant interactions are expected.
Medications containing aluminum, magnesium, or calcium: May affect the absorption of Etelcalcetide; consider staggered administration.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.