Drug Action
Etelcalcetide reduces parathyroid hormone secretion, which leads to a decrease in serum calcium concentrations.
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Drug reference
Etelcalcetide reduces parathyroid hormone secretion, which leads to a decrease in serum calcium concentrations.
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Secondary hyperparathyroidism in patients with chronic kidney disease on haemodialysis ▶BY INTRAVENOUS INJECTION ▶Adult: Initially 5 mg 3 times a week, then increased in steps of 2.5–5 mg if required, dose to be increased at intervals of at least 4 weeks; usual maintenance 2.5–15 mg 3 times a week, max. dose 15 mg 3 times a week; consult product literature for information on missed doses, and for dose adjustment due to parathyroid hormone levels or serum-calcium concentrations
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Conditions that may worsen with hypocalcaemia. hypocalcaemia (do not initiate if serum- calcium concentration is less than the lower limit of normal range). switching from cinacalcet (do not initiate until 7 days after the last dose of cinacalcet) CAUTIONS, FURTHER INFORMATION ▶Conditions that may worsen with hypocalcaemia Manufacturer advises caution with use in patients with conditions that may worsen with hypocalcaemia, including predisposition to QT-interval prolongation, history of seizures, and history of congestive heart failure—serum-calcium concentration should be closely monitored. History of nephrolithiasis. sarcoidosis
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NICE decisions ▶Etelcalcetide for treating secondary hyperparathyroidism (June 2017) NICE TA448 Etelcalcetide is recommended as an option for treating secondary hyperparathyroidism in patients with chronic kidney disease on haemodialysis, only if treatment with a calcimimetic is indicated but cinacalcet is not suitable, and the manufacturer provides etelcalcetide with the discount agreed in the patient access scheme. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/TA448 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (September 2017) that etelcalcetide (Parsabiv ®) is not recommended for use within NHS Scotland for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on haemodialysis as the economic case was not demonstrated.
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Conditions associated with hypercalcaemia (e.g. some forms of malignant disease). conditions associated with hypercalciuria (e.g. some forms of malignant disease)
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→Appendix 1: etelcalcetide
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▶Common or very common Diarrhoea. electrolyte imbalance . headache. heart failure aggravated. hypotension. muscle complaints. nausea. paraesthesia. QT interval prolongation. vomiting SIDE-EFFECTS, FURTHER INFORMATION Manufacturer advises if formation of anti-etelcalcetide antibodies with a clinically significant effect is suspected, contact manufacturer to discuss antibody testing. ▶Uncommon Constipation. diarrhoea. hypercalcaemia. nausea
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Manufacturer advises avoid—limited information available.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises monitor parathyroid hormone level 4 weeks after treatment initiation or dose adjustment and approximately every 1–3 months during maintenance treatment; monitor serum-calcium concentration before treatment initiation, within 1 week of initiation or dose adjustment, and then approximately every 4 weeks during maintenance treatment. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C)—consult product literature for further information regarding storage outside refrigerator.
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Use with caution. eiiii F above
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Parsabiv (Amgen Ltd) A Etelcalcetide (as Etelcalcetide hydrochloride) 5 mg per 1 ml Parsabiv 2.5mg/0.5ml solution for injection vials | 6 vial P £136.87 Parsabiv 10mg/2ml solution for injection vials | 6 vial P £327.84 Parsabiv 5mg/1ml solution for injection vials | 6 vial P £163.92 1.1b Hypocalcaemia ELECTROLYTES AND MINERALS › CALCIUM Calcium salts f
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Manufacturer advises patients and their carers should be told to seek medical advice if symptoms of hypocalcaemia occur.
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Initially 5 mg 3 times a week, then increased in
First-line fragment. Read the complete Indications and Dose section above.
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