• Etelcalcetide belongs to a group of medications called calcimimetics that imitates the action of calcium on tissues.
• Etelcalcetide has been approved by US FDA on Feb.2017 for the treatment of secondary hyperparathyroidism (HPT) in adults who suffer chronic kidney disease and undergo hemodialysis.
• Secondary hyperparathyroidism is a condition in which the body produces the excess parathyroid hormone in response to a low level of calcium in the blood which is usually observed in chronic kidney disease patients.
• Etelcalcetide acts by activating the calcium-sensing receptor in the parathyroid gland and signals the body to produce less parathyroid hormone, thereby decreasing the level of calcium and phosphorus in the blood.
Etelcalcetide is not recommended in
• Patients allergic to etelcalcetide drug
• Pregnancy and breastfeeding women
• Patients with low blood calcium levels
• Parathyroid carcinoma
• Primary hyperparathyroidism
• Chronic kidney disease but not on hemodialysis
• The recommended adult dose is as follows:
• The 5mg injection is administered as an intravenous bolus injection three times a week at the end of hemodialysis procedure.
• The dose can be increased by 2.5 to 5 mg every 4 weeks till the parathyroid hormone and serum calcium levels are normal.
• The maintenance dose varies from 2.5mg to 15mg three times a week.
Switching from Cinacalcet:
• Cinacalcet therapy should be stopped 1 week before starting etelcalcetide treatment.
• If a scheduled hemodialysis procedure is missed, do not administer etelcalcetide.
• Initiate etelcalcetide therapy only at the end of the next hemodialysis treatment.
• When an etelcalcetide dose is missed for more than 2 weeks, then re-initiate the treatment with a dose of 5 mg, or 2.5 mg if it was the patient’s last dose.
• Etelcalcetide comes as a solution which has to be injected intravenously as a bolus.
• It should not be mixed or diluted before administration.
• Patients should be monitored for low blood calcium levels or symptoms caused by it such as seizures, muscle spasm, myalgia, and paresthesias. The blood parathyroid hormone level should also be monitored regularly.
• Etelcalcetide therapy may worsen the existing heart failure or cause ventricular arrhythmia especially in patients with ECG abnormalities like congenital long QT syndrome. A strict monitoring is required in such cases.
• Patients with gastritis, stomach ulcers or other upper gastrointestinal bleeding cases should be monitored during etelcalcetide treatment because of the possible gastrointestinal bleeding associated with the therapy.
• The dose of etelcalcetide should be reduced or the treatment should be discontinued temporarily when adynamic bone disease occurs due to the parathyroid hormone suppression.
• It should be used with caution in patients with seizures since low blood calcium levels can trigger seizures.
• Common: Diarrhea, nausea, vomiting, low blood calcium level, muscle spasm
• Skin: Rashes, hives, itching, swelling of the face
• Central nervous system: Headache, paresthesia
• Cardiovascular: Heart failure, ECG abnormalities, low blood pressure
• Endocrine: Decreased levels of phosphate and calcium levels in blood, increase in blood potassium levels
• Others: Blood vomiting, black or bright red stools, muscle pain, allergic reaction
• Patients should be advised to report to the emergency center in case of symptoms such as wheezing, blue skin color, severe itching or cough during the treatment.
• Combination of etelcalcetide with cinacalcet should be avoided because of the additional calcium lowering effect.
• Etelcalcetide vials should be stored at 2 to 8 ° C in the original carton.
• If removed from cold storage, it should be used within 1 week if stored in original carton or within 4 hours if removed from the original carton.
• It should not be exposed to higher temperatures such as above 25°C or direct sunlight when removed from the original container.
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