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Etelcalcetide parenteral

Updated 2 Feb 2023 | Calcimimetics

Presentation

Injections of etelcalcetide.

Drugs List

  • etelcalcetide 10mg/2ml injection solution
  • etelcalcetide 2.5mg/0.5ml injection solution
  • etelcalcetide 5mg/1ml injection solution
  • PARSABIV 10mg/2ml injection solution
  • PARSABIV 2.5mg/0.5ml injection solution
  • PARSABIV 5mg/1ml injection solution
  • Therapeutic Indications

    Uses

    Secondary hyperparathyroidism in chronic renal failure pts on haemodialysis

    Dosage

    Adults

    Initial dose: 5mg given as a bolus injection three times a week.
    Maintenance dose: 2.5mg to 15mg three times a week, titrated according to response. The dose may be increased in 2.5mg or 5mg increments, no more frequently than every four weeks.
    Maximum dose: 15mg three times a week.

    Additional Dosage Information

    Dose adjustments based on parathyroid hormone (PTH)
    If PTH is below 100pg/ml, the dose should be reduced or temporarily stopped (if PTH does not increase following dose reduction). Once PTH returns to more than 150pg/ml and pre-dialysis serum corrected calcium is greater than or equal to 8.3mg/dL, etelcalcetide should be reinstated at a lower dose. If the patient's last administered dose was 2.5mg, reinitiated at 2.5mg if PTH is greater than 300pg/ml, and the most recent pre-dialysis serum corrected calcium is greater than or equal to 8.3mg/dL.

    Dose adjustments base on serum calcium
    If the corrected serum calcium level falls below the lower limit of the normal range (8.3mg/dL or 2.08mmol/L using a Roche modular analyser), consider the following management:
    Corrected serum calcium value of less than 8.3mg/dL and more than or equal to 7.5mg/dL - Initiate or increase calcium supplements, calcium-containing phosphate binders and/or vitamin D sterols.
    - Increase the calcium concentration of the dialysate.
    - Consider reducing etelcalcetide dose.
    Corrected serum calcium value of less than 7.5mg/dL
    - Discontinue etelcalcetide and re-initiate only when corrected serum calcium levels are greater than or equal to 8.3mg/dL.
    - Initiate or increase calcium supplements, calcium-containing phosphate binders and/or vitamin D sterols.
    - Increase the calcium concentration of the dialysate.
    - Reintroduce etelcalcetide at a dose 5mg lower than the last administered dose. If the last administered dose was 2.5mg or 5mg, give 2.5mg.

    Missed doses
    Do not administer any additional doses if a regularly administered dose is missed. If doses are missed for more than two weeks, administer etelcalcetide at 5mg (or 2.5mg if that was the patients last dose) and titrate according to response.

    Administration

    Administer into the venous line of the dialysis circuit at the end of the haemodialysis treatment during rinse-back. This is to be followed by an injection of at least 150ml of rinse-back volume.

    If rinse-back is completed and etelcalcetide was not administered, then it may be administered intravenously followed by at least 10ml saline flush volume.

    Contraindications

    Children under 18 years
    Within 7 days of discontinuing cinacalcet
    Breastfeeding
    Hypocalcaemia
    Long QT syndrome
    Pregnancy
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Congestive cardiac failure
    Electrolyte imbalance
    History of cardiac arrest
    History of seizures
    History of torsade de pointes

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Correct serum calcium levels before commencing treatment
    May reduce seizure threshold
    Do not dilute
    Monitor parathyroid hormone levels before and during treatment
    Monitor serum calcium at initiation and dose adjustments
    Perform ECG before and during treatment
    Monitor calcium levels at least monthly
    Monitor serum electrolytes
    Risk of adynamic bone development if PTH below 100pg/ml
    Advise patient to report signs of hypocalcaemia
    Antibodies to ingredient may develop
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias

    Significant reductions in serum calcium levels may result in decreased myocardial performance, hypotension, and congestive heart failure. As etelcalcetide may affect serum calcium levels, patients with a history of congestive heart failure should be closely monitored.

    Decreases in serum calcium may result in a lowered seizure threshold. In patients with a history of convulsion disorders, serum calcium levels should be closely monitored.

    Calcium should be measured within 1 week of etelcalcetide initiation or dose adjustment. Once the patient has been stabilised on a relevant dose, corrected serum calcium should be measured every 4 weeks.

    Parathyroid hormone should be measured four weeks after dose initiation or adjustment and every one to three months during maintenance therapy.

    If parathyroid hormone levels chronically fall below 100pg/ml, adynamic bone may develop. Vitamin D sterols and/or etelcalcetide should be reduced or discontinued if parathyroid hormone levels fall below the target range.

    Pregnancy and Lactation

    Pregnancy

    Etelcalcetide is contraindicated during pregnancy.

    The manufacturer advises the use of etelcalcetide should be avoided during pregnancy as a precautionary measure. At the time of writing, there is a limited amount of data on the use of etelcalcetide during pregnancy. Information from animal studies does not indicated adverse effects in regard to reproductive toxicity.

    Lactation

    Etelcalcetide is contraindicated during breastfeeding.

    The manufacturer advises a decision is made on whether to discontinue breastfeeding or to discontinue etelcalcetide, after assessing the risk to benefit ratio. It is not known if etelcalcetide is expressed in breast milk. Information from animal studies using rats show that etelcalcetide is excreted in milk.

    Side Effects

    Decrease in plasma calcium
    Diarrhoea
    Headache
    Hyperkalaemia
    Hypersensitivity reactions including anaphylaxis
    Hypocalcaemia
    Hypophosphataemia
    Hypotension
    Muscle spasm
    Myalgia
    Nausea
    Paraesthesia
    Prolongation of QT interval
    Seizures
    Vomiting
    Worsening heart failure

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: August 2019

    Reference Sources

    Summary of Product Characteristics: Parsabiv. Amgen Ltd. Revised February 2019.

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