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Casirivimab and imdevimab parenteral

Presentation

Parenteral formulations of casirivimab and imdevimab.

These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.

Drugs List

  • casirivimab and imdevimab 120mg+120mg/ml solution for infusion vial (11.1ml + 11.1ml)
  • RONAPREVE 120mg+120mg/1ml solution for infusion vial (11.1ml + 11.1ml)
  • Therapeutic Indications

    Uses

    Coronavirus disease 2019 (COVID-19) - treatment
    Coronavirus disease 2019 (COVID-19): Prophylaxis

    Dosage

    Adults

    Treatment
    600mg of casirivimab and 600mg imdevimab to be given as soon as a positive viral test for SARS-CoV-2 is confirmed.

    Prevention- single dose
    600mg of casirivimab and 600mg imdevimab to be given as soon as possible after exposure to SARS-CoV-2.

    Prevention- repeat dose
    Intended for those who require ongoing prevention e.g. those unlikely to be protected by vaccination due to a medical condition.

    Initial dose is 600mg of casirivimab and 600mg imdevimab. Subsequent doses are 300mg of casirivimab and 300mg imdevimab once every four weeks.

    Additional Dosage Information

    Missed Dose
    If a dose is missed, it should be administered as soon as possible, adjusting the schedule to ensure adequate time between doses.

    Administration

    Repeat dosing regimens for prevention of COVID-19 allow for switching from intravenous infusion to subcutaneous injection or vice versa over the course of treatment.

    Intravenous infusion
    Casirivimab and imdevimab both must be diluted and administered together as a single intravenous infusion.

    Subcutaneous injection
    Casirivimab and imdevimab must be administered consecutively by subcutaneous injection at a different injection site: the upper thighs, the upper outer arms, or the abdomen, except for 5cm around the navel. The waistline should be avoided.

    It is also recommended to use different quadrants of the abdomen or upper thighs or upper outer arms to space apart each 2.5ml subcutaneous injection of casirivimab and imdevimab.

    Contraindications

    Children under 12 years
    Weight below 40kg
    Severe hepatic impairment

    Precautions and Warnings

    Females of childbearing potential
    Breastfeeding
    Moderate hepatic impairment
    Pregnancy
    Severe renal impairment

    Monitor patient throughout infusion and for at least 1 hour afterwards
    Treatment to be initiated and supervised by a specialist
    Contains polysorbate
    Aseptic technique should be used throughout
    Avoid injection into broken or bruised skin
    Avoid injection into scar tissue
    Do not use if solution is discoloured or particulates are apparent
    Record name and batch number of administered product
    Resuscitation facilities must be immediately available
    Suspend treatment or reduce rate until infusion reactions resolve
    Warm to room temperature prior to use
    Interrupt therapy/reduce infusion rate if infusion-related reactions occur
    Discontinue if severe hypersensitivity reactions occur

    Pregnancy and Lactation

    Pregnancy

    Use casirivimab and imdevimab with caution during pregnancy.

    The manufacturer does not recommend using casirivimab and imdevimab during pregnancy. At the time of writing there is limited published information regarding the use of casirivimab and imdevimab during pregnancy. However, human immunoglobulin G1 antibodies are known to cross the placenta and therefore transfer of casirivimab and imdevimab across the placenta can be expected.

    Potential risks are unknown, therefore the manufacturer states that casirivimab and imdevimab should only be used where the potential benefit of casirivimab and imdevimab outweighs the potential risk to the foetus.

    Lactation

    Use casirivimab and imdevimab with caution during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking casirivimab and imdevimab. The presence of casirivimab and imdevimab in human breast milk is unknown but due to their large molecular weight, transfer expected to be low.

    Effects on exposed infants are unknown, therefore the manufacturer states that casirivimab and imdevimab should only be used where the potential benefit of casirivimab and imdevimab outweighs the potential risk to the child or infant.

    Side Effects

    Anaphylaxis
    Chills
    Dizziness
    Ecchymosis
    Erythema
    Flushing
    Hypersensitivity reactions
    Infusion related reaction
    Local reaction at injection site
    Lymphadenopathy
    Nausea
    Oedema
    Pain
    Pruritus
    Rash
    Syncope
    Tenderness (non-specified)
    Urticaria

    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: November 2021

    Reference Sources

    Summary of Product Characteristics: Ronapreve 120 mg/ml solution for injection or infusion. Roche Products Limited. Revised August 2021.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
    Casirivimab. Last revised: 21 June 2021
    Last accessed: 23 November 2021

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
    Imdevimab. Last revised: 21 June 2021
    Last accessed: 23 November 2021

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