Etelcalcetide
SELECT Generic Medicine Info Patient Medicine Information
Generic Medicine Info Patient Medicine Information
This information is not country-specific. Please refer to the Malaysia prescribing information.
Generic Medicine Info
Indications and Dosage
Secondary hyperparathyroidism 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.
Serum Ca below the lower limit of normal range. Concomitant use with cinacalcet.
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.
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).
Monitoring Parameters
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.
Symptoms: Hypocalcaemia with or without clinical symptoms. Management: Supportive treatment.
Increased risk of hypocalcaemia with other medicines known to reduce serum calcium.
Potentially Fatal: Severe hypocalcaemia with cinacalcet.
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.
Source: National Center for Biotechnology Information. PubChem Database. Etelcalcetide, CID=71511839, https://pubchem.ncbi.nlm.nih.gov/compound/Etelcalcetide (accessed on Jan. 22, 2020)
Store between 2-8°C. Protect from light.
Other Agents Affecting Metabolism
H05BX04 - etelcalcetide ; Belongs to the class of other anti-parathyroid agents. Used in the management of calcium homeostasis.
Anon. Etelcalcetide. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 14/03/2019.
Anon. Etelcalcetide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 14/03/2019.
Buckingham R (ed). Etelcalcetide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/03/2019.
Joint Formulary Committee. Etelcalcetide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/03/2019.
Parsabiv Injection, Solution (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 14/03/2019.
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