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Tocilizumab for ADULT patients with severe COVID-19 with suspected hyperinflammation
Who can administer
May be administered by registered competent doctor or nurse/midwife
Important information
- See HSE website- for guidance on patient selection
- Tocilizumab is an experimental medicine in the context of management of severe COVID-19 disease (unlicensed drug)
- It should only be considered in patients who have severe COVID-19 with suspected hyperinflammation following consultant level multidisciplinary specialist input (critical care medicine, infection specialists, haematology)
- Must have access to facilities for managing hypersensitivity reactions including anaphylaxis
- In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Available preparations
RoActemra 80mg per 4ml vial
RoActemra 200mg per 10ml vial
RoActemra 400mg per 20ml vial
Reconstitution
Already in solution
Infusion fluids
Sodium chloride 0.9%
Methods of intravenous administration
Intermittent intravenous infusion (Administer using an electronically controlled infusion device)
- Gloves, protective eyewear and a mask should be worn by those handling this drug (ref 1)
- Withdraw from a 100ml bag of infusion fluid a volume equal to the volume of tocilizumab concentrate required for the patient's dose
- Withdraw the required amount of tocilizumab concentrate from the vial and place in the 100ml infusion bag. This should be a final volume of 100ml
- To mix the solution, gently invert the infusion bag to avoid foaming
- Administer over 1 hour
Dose in adults
COVID-19
- For patients greater than or equal to 30kg give 8mg per kg, to a maximum of 800mg per dose
- Dose rounding to the nearest vial size is recommended
- Maximum single dose 800mg
- In exceptional circumstances, one additional dose may be considered no sooner than 8 hours after the initial dose if there has not been sufficient clinical improvement
- The decision to give a second dose must only be made following consultant level multi-disciplinary specialist input
Renal impairment (COVID-19 patients)
- No dose adjustment required
- In renal replacement therapies (APD,CAPD,HD/HDF/Highflux/CAV/VVHD)- unknown dialysability - use normal dose with caution
Hepatic impairment
- The safety and efficacy has not been studied in patients with hepatic impairment. No advice available from manufacturer re dose adjustments
Monitoring
COVID-19 specific monitoring (Serial monitoring of the following)
- Full Blood Count
- Ferritin
- C-Reactive Protein
- Fibrinogen
- D-dimers
- ALT and AST
- IL-6 (if available)
- Procalcitonin (if available; to help outrule bacterial superinfection)
Standard monitoring requirements
- Monitor the patient for infusion-related reactions
- Patients may be pre-treated with antihistamines, hydrocortisone, and/or paracetamol to decrease the risk of infusion related reactions (this is part of the licensed recommendations for tocilizumab)- not known if required for this indication- clinical decision
Storage
- Store between 2 and 80C, do not freeze
- Keep the container in the outer container (to protect from light)
References
SPC (RoActemra) 23rd August 2018
1: Information on file from Roche 14/4/16
2: Email on file from Prof Mike O Dwyer and John Given 23rd March 2020
3: Interim recommendations for the use of Tocilizumab in the management of patients who have severe COVID-19 with suspected hyperinflammation, HSE 20th March 2020 (Updated 31st March) - but see link now for updated guidance
Therapeutic classification
Monoclonal antibody