Etelcalcetide


Concise Prescribing Info
Indications/Uses
Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Dosage/Direction for Use
Adult : IV Initial: 5 mg via bolus inj 3 times weekly, at the end of each dialysis session. Individualise dose and titrate in steps of 2.5-5 mg at intervals of at least 4 weeks to Max 15 mg 3 times weekly, to achieve the desired PTH target.
Dosage Details
Intravenous
Secondary hyperparathyroisim in patients with chronic kidney disease on dialysis
Adult: Initially, 5 mg via bolus inj 3 times weekly at the end of each dialysis session. Individualise dose and titrate in steps of 2.5-5 mg at intervals of at least 4 weeks to Max 15 mg 3 times weekly, to achieve the desired PTH target. Dose reduction, dosing interruption, or discontinuation may be required according to PTH and serum Ca levels (refer to detailed product guideline). In patients switching from cinacalcet: Initially, 5 mg. Discontinue cinacalcet at least 7 days before initiation of therapy.
Contraindications
Serum Ca below the lower limit of normal range. Concomitant use with cinacalcet.
Special Precautions
Patient with heart failure, history of seizure disorder; risk factors for gastrointestinal bleeding; conditions that may worsen hypocalcaemia; hypotension, congestive, congenital long QT syndrome, history of QT-interval prolongation, family history of long QT syndrome or sudden cardiac death. Not indicated in patient with parathyroid carcinoma, primary hyperparathyroidism or with CKD, not on haemodialysis.
Adverse Reactions
Significant: Hypocalcaemia, hypocalcaemia-related events (e.g. convulsions, worsening of heart failure, hypotension, CHF), adynamic bone disease, gastrointestinal bleeding, immunogenicity.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
Metabolism and nutrition disorders: Hypophosphataemia, hyperkalaemia.
Musculoskeletal and connective tissue disorders: Muscle spasm, myalgia.
Nervous system disorders: Headache, paraesthesia.
Potentially Fatal: Severe hypocalcaemia-related events (e.g. QT-interval prolongation, ventricular arrhythmia).
MonitoringParameters
Monitor PTH levels before treatment initiation, then 4 weeks after initiation or subsequent dose adjustment, and every 1-3 months thereafter; serum Ca levels prior to treatment initiation, then within 1 week following therapy or subsequent dose adjustment, and every 4 weeks thereafter. Monitor for signs and symptoms of hypocalcaemia, gastrointestinal bleeding/ulceration, worsening of nausea and vomiting, and heart failure.
Overdosage
Symptoms: Hypocalcaemia with or without clinical symptoms. Management: Supportive treatment.
Drug Interactions
Increased risk of hypocalcaemia with other medicines known to reduce serum calcium.
Potentially Fatal: Severe hypocalcaemia with cinacalcet.
Action
Description: Etelcalcetide, a synthetic peptide calcimimetic agent, allosterically binds to and activates the calcium-sensing receptors (CaSR) on the parathyroid gland leading to a reduction in parathyroid hormone (PTH) secretion, serum calcium and serum phosphate concentrations.
Onset: Decreased PTH levels: Within 30 minutes.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 7-8 weeks.
Distribution: Volume of distribution: Approx 796 L. Plasma protein binding: Mainly to albumin.
Metabolism: Metabolised in the blood via reversible disulphide exchange with endogenous thiols to form conjugates with serum albumin.
Excretion: Via dialysate (approx 60%); urine (3.2%); faeces (4.5%). Elimination half-life: 3-4 days.
Chemical Structure

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Storage
Store between 2-8°C. Protect from light.
ATC Classification
H05BX04 - etelcalcetide ; Belongs to the class of other anti-parathyroid agents. Used in the management of calcium homeostasis.
Disclaimer: This information is independently developed by MIMS based on Etelcalcetide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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