Tocilizumab Intravenous for Adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

For use in COVID-19 - see separate monograph
Treatment with Tocilizumab should not be initiated in patients with active infections and treatment should be interrupted if a patient develops a serious infection until the infection is controlled
Must have access to facilities for managing hypersensitivity reactions including anaphylaxis - See QPulse document: Infusion related patient reaction in nurse-led settings CLN-NM-0118
Patient alert card must be provided - Email: ireland.drug_surveillance_centre@roche.com
Patient guides are also available - use the above email contact
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

RoActemra 80mg per 4ml vial

RoActemra 200mg per 10ml vial

RoActemra 400mg per 20ml vial

Already in solution

Sodium chloride 0.9%

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 1,2)}
Withdraw from a 100ml bag of infusion fluid a volume equal to the volume of RoActemra concentrate required for the patient's dose
Withdraw the required amount of RoActemra concentrate 0.4ml/kg (=8mg/kg) 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

Rheumatoid arthritis

Give 8mg/kg once every four weeks (maximum single dose = 800mg)
Dose adjustments are recommended in patients with liver enzyme abnormalities, low absolute neutrophil count (ANC) and low platelet count. Refer to product information

Cytokine Release Syndrome (CRS)

Tocilizumab can be given alone or in combination with corticosteroids
Patients weighing 30kg or more
- Give 8 mg/kg
- If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses of tocilizumab may be administered
- The interval between consecutive doses should be at least 8 hours
- Doses exceeding 800 mg per infusion are not recommended in CRS patients

Patients must be monitored closely for infections and screened for latent TB prior to starting therapy (does not apply to CRS indication)
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
See under Further information regarding LFTs, FBC's and lipids

For individuals whose body weight is more than 100kg, doses exceeding 800mg per infusion are not recommended
Caution should be exercised in patients with hepatic impairment or disease
The use of the drug has not been studied in patients with renal impairment, and so renal function should be monitored closely in these patients
Liver enzymes should be monitored every 4 to 8 weeks for the first 6 months of treatment, followed by every 12 weeks thereafter
Caution is advised in patients with a low neutrophil or platelet count. Neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy, and thereafter according to standard clinical practice.
Elevations in lipid parameters may occur so these should be measured 4 to 8 weeks after initiation of therapy and managed accordingly

SPC (RoActemra) 29th March 2021

1: Information on file from Roche 14/4/16

2: Injectable Medicines guide, downloaded from Medusa 26/10/2021

Monoclonal antibody