bDMARDs Quick Reference Guide

Tocilizumab (IV)

Tocilizumab (IV)

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Active ingredient

Tocilizumab

Mechanism of action

Interleukin (IL) -6 inhibitor

Molecule type

IgG monoclonal antibody (humanised)

PBS listed indications

Active giant cell arteritis (subcutaneous therapy only)

Severe active juvenile idiopathic arthritis*

Severe active rheumatoid arthritis

*Paediatric dosing information is outside the scope of this guide. Please refer to paediatric specific references if required.

Reference product (brand)

Actemra IV

Biosimilar brands

None

Administration information

Mode of administration

IV infusion

Administration devices and strengths

Vial for IV infusion 80mg/4mL, 200mg/10mL, 400mg/20mL

Frequency of administration

Every 4 weeks

Storage

Store at 2-8oC (refrigerate do not freeze).

Infusion solution is stable for 24 hours at 30oC.

Standard dosing

IV infusion for rheumatoid arthritis: 8mg/kg (maximum dose 800mg) every 4 weeks via IV infusion over 1 hour.

Treatment with csDMARDs (e.g., methotrexate) may continue during treatment with tocilizumab.

Dose variations

Patients with rheumatoid arthritis who are in remission or have low disease activity may have their dose of tocilizumab down-titrated by their rheumatologist.

  • Dose reduction - 50% of standard dose
  • Dose interval increase - stepwise increase in dose interval

Special notes

Monitor for possible hypersensitivity reactions during and for at least 30 minutes after the infusion.

 

Monitor lipids 4-8 weeks after first dose. Patients should then be managed according to local clinical guidelines for management of hyperlipidaemia if needed. Dyslipidaemia due to treatment with tocilizumab has not been shown to precipitate cardiovascular risk.

 

Measure liver function tests (ALT and AST) every 4–8 weeks for the first 6 months of treatment, then every 3 months. If ALT or AST are confirmed to be:

  • >1–3 times upper limit of normal (ULN), with careful monitoring, dose at IV 4 mg/kg or interrupt treatment until they are normal.
  • >3 times ULN, interrupt treatment until <3 times ULN, then proceed as for >1–3 times ULN above (if recurs after restarting, stop tocilizumab).
  • >5 times ULN, stop tocilizumab.

Measure platelets and absolute neutrophil count (ANC) after 4–8 weeks; then repeat every 3 months or according to clinical practice. If:

  • ANC 0.5–1x109/L, interrupt treatment until >1x109/L, then resume with IV 4 mg/kg initially.
  • platelet count is 50–100x109/L, interrupt treatment until >100x109/L, then resume at IV 4 mg/kg initially.
  • ANC <0.5x109/L or platelets <50x109/L, stop tocilizumab.

 

Patients who have had previous TNF-alpha inhibitor treatment may be at greater risk of infections and neutropenia with tocilizumab.

 

Tocilizumab should be used with caution in serious or untreated infection, e.g. sepsis, abscess, hepatitis B, active TB (before completing TB treatment). Use cautiously in those at increased risk of infection because tocilizumab may increase this risk; it also suppresses symptoms of infection (eg fever, inflammation) and the increase in C reactive protein.
Patients with suspected latent or active TB should be treated in consultation with an Infectious Diseases physician.

 

The risk of GI perforation is increased by tocilizumab; be aware that GI inflammation may be more difficult to diagnose (milder symptoms, increase in C‑reactive protein may be suppressed).

 

Live vaccines should not be given concurrently with tocilizumab.

References

Pharmaceutical benefits Scheme (PBS) listing. Available from https://www.pbs.gov.au/medicine/item/11613F-11616J [accessed 7/10/21]

Product information. Available from https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-PI-02292-1 [accessed 7/10/21]

Australian Medicines Handbook 2020 (online). Adelaide: Australian Medicines Handbook Pty Ltd; 2020 July. Available from: https://amhonline.amh.net.au/  [accessed 12/5/21]

NPS Medicinewise. Down-titration strategies. Available from https://www.nps.org.au/bdmards/rheumatology-conditions/titration-strategies [accessed 11/5/21]