Regdanvimab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of regdanvimab.
Drugs List
Therapeutic Indications
Uses
Coronavirus disease 2019 (COVID-19) - treatment
Treatment of adults with coronavirus 2019 (COVID-19) who do not require supplemental oxygen and who are at risk of progressing to severe COVID-19.
Dosage
The volume of regdanvimab is calculated as follows:
Calculation to determine the total volume (ml) of regdanvimab to be administered
Patient's body weight (kg) x regdanvimab dose (40mg/kg) divided by vial concentration (60mg/ml).
Calculation to determine the total number of regdanvimab vials needed
Total regdanvimab volume (ml) to be administered divided by total volume per vial (16ml/vial).
Adults
Recommended single dose of 40mg/kg.
Maximum recommended dose of 8g.
Administration
For intravenous infusion only. Dilute and administer intravenously over 60 minutes
Contraindications
Children under 18 years
Precautions and Warnings
Breastfeeding
Pregnancy
Monitor patient throughout infusion and for at least 1 hour afterwards
Concentrate must be diluted and used as an infusion
If adverse reactions occur, reduce rate or temporarily stop infusion
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Monitor for hypersensitivity reactions during infusion
Monitor patient for infusion-associated reactions (IARs)
Pregnancy and Lactation
Pregnancy
Use regdanvimab with caution during pregnancy.
The manufacturer does not recommend using regdanvimab unless the expected benefit to the mother justifies the potential risk to the foetus. A the time of writing there is limited published information regarding the use of regdanvimab during pregnancy. Potential risks are unknown. However, human immunoglobulin GI (IgGI) antibodies are known to cross the placental barrier; therefore regdanvimab has the potential to be transferred from the mother to developing foetus.
Lactation
Use regdanvimab with caution during breastfeeding.
The manufacturer states the use of regdanvimab may be considered during breastfeeding when clinically indicated. The presence of regdanvimab in human breast milk and the effects on exposed infants are unknown.
Side Effects
Chest discomfort
Cough
Dyspnoea
Fever
Hypertension
Infusion related reaction
Palpitations
Presyncope
Pruritus
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: January 2022
Reference Sources
Summary of Product Characteristics: Regkirona 60mg/ml concentrate for solution for infusion. Celltrion Healthcare Hungary Kft. Revised November 2021.
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