bDMARDs Quick Reference Guide
| Rheumatology | Ankylosing spondylitis Severe psoriatic arthritis Severe active rheumatoid arthritis |
| Dermatology | Severe chronic plaque psoriasis |
| Gastroenterology | Acute severe ulcerative colitis* Moderate to severe ulcerative colitis* Moderate to severe Crohn disease* Severe Crohn disease Complex refractory fistulising Crohn disease |
*Paediatric dosing information is outside the scope of this guide. Please refer to paediatric specific references if required
Inflectra, Renflexis
| Indication | PBS item code | Brands funded |
| Ankylosing spondylitis | 11482H 11489Q 5753T 6448J | Inflectra Remicade Renflexis |
| 11486M Public - streamlined authority (9481) 11488P Private - streamlined authority (9621) | Inflectra Renflexis | |
| Severe psoriatic arthritis | 11497D 11498E 5756Y 6496X | Inflectra Remicade Renflexis |
| 11514B Public - streamlined authority (9188) 11515C Private - streamlined authority (9472) | Inflectra Renflexis | |
| Severe active rheumatoid arthritis | 11481G 11487N 5757B 6397Q | Inflectra Remicade Renflexis |
| 11483J Private - streamlined authority (12067) 11490R Public - streamlined authority (12075) | Inflectra Renflexis | |
| Severe chronic plaque psoriasis | 11590B 11606W 5758C 9617E | Inflectra Remicade Renflexis |
| 11595G Private - streamlined authority (9602) 11605T Public - streamlined authority (8844) | Inflectra Renflexis | |
| Acute severe ulcerative colitis | 10057H Private - streamlined authority (9632) 10067W Public - streamlined authority (4524) | Inflectra Remicade Renflexis |
| Moderate to severe ulcerative colitis | 10184B 10196P 11459D 11797X 5755X 9612X | Inflectra Remicade Renflexis |
| 11461F Public - streamlined authority (12042) 11796W Private - streamlined authority (12074) | Inflectra Renflexis | |
| Moderate to severe Crohn disease | 11445J 11448M
| Inflectra Remicade Renflexis |
| 11449N Public - streamlined authority (9668) 11450P Private - streamlined authority (9775) | Inflectra Renflexis | |
| Severe Crohn disease | 11389K 11399Y 9613Y 5754W | Inflectra Remicade Remflexis |
| 11396T Private - streamlined authority (12051) 11400B Public - streamlined authority (12069) | Inflectra Renflexis | |
| Complex refractory fistulising Crohn disease | 11412P 11424G 9654D 9674E | Inflectra Remicade Renflexis |
| 11423F Public - streamlined authority (9787) 11432Q Private - streamlined authority (9732) | Inflectra Renflexis |
Vial containing powder for injection 100mg
Store at 2-8oC (refrigerate do not freeze)
The product information for Remicade indicates that it may be stored at temperatures of up to a maximum of 30oC for a single period of up to 12 months; but not exceeding the original expiry date (new expiration date should be written on the carton). Upon removal from refrigeration, Remicade cannot be returned to refrigerated storage.
The product information for Renflexis and Inflectra do not contain this additional storage information.
Prepared infliximab infusions are stable for 24 hours when stored between 2-30oC. As no preservative is present, it is recommended the infusion begin within 3 hours after preparation.
Rheumatoid arthritis: 3mg/kg, repeat at 2 and 6 weeks after initial infusion, then every 8 weeks.
Ankylosing spondylitis and psoriatic arthritis: 5mg/kg, repeat at 2 and 6 weeks after initial infusion, then every 8 weeks.
Plaque psoriasis: 5mg/kg, repeat at 2 and 6 weeks after initial infusion, then every 8 weeks.
Crohn disease and ulcerative colitis: 5mg/kg, repeat at 2 and 6 weeks after initial infusion, then every 8 weeks.
Treatment with csDMARDs (e.g., methotrexate) may continue during treatment with infliximab.
Rheumatoid arthritis: Consider increasing dose in 1.5mg/kg increments to a maximum of 7.5mg/kg if response is inadequate after 12 weeks or response is lost during maintenance.
This dosing may be outside PBS funding. Specialist prescribers may arrange supply through alternate pathways.
Patients with rheumatoid arthritis who are in remission or have low disease activity may have their dose of infliximab down-titrated by their rheumatologist.
Crohn disease and ulcerative colitis: higher doses may be used, commonly 5mg/kg 6 weekly or 7.5mg/kg or 10mg/kg 8 weekly if response is inadequate or lost during treatment.
This dosing may be outside PBS funding. Specialist prescribers may arrange supply through alternate pathways.
Initial infliximab infusions must be given over a period of not less than 2 hours. Infusion reactions are common and are most likely to occur within a few hours and with the first and second infusion. Monitor the patient during and for at least 2 hours after the infusion for dyspnoea, urticaria, hypotension, flushing and headache. Slow or stop the infusion if necessary.
Patients who tolerate three 2-hour infusions may cautiously receive future infusions over at least 1 hour. Check your local guidelines. If an infusion reaction occurs in association with the shortened infusion time, then a slower infusion rate should be considered for future infusions.
Therapeutic drug level monitoring of infliximab can be used to guide management of Crohn disease and ulcerative colitis. A steady state trough level of 3-8 microgram/mL is commonly used with higher levels targeted in certain situations.
Infliximab is not recommended for patients with serious or untreated infection, e.g. sepsis, abscess, hepatitis B, active TB (before completing TB treatment).
May reactivate inactive hepatitis B and latent TB (begin TB treatment before starting a TNF-alpha inhibitor).
Patients with suspected latent or active TB should be treated in consultation with an Infectious Diseases physician.
Treatment with another cytokine modulator (e.g. TNF-alpha inhibitor, abatacept, anakinra, rituximab, tocilizumab) is not recommended due to increased risk of infection.
TNF-alpha inhibitors like infliximab are contraindicated with anakinra.
Infliximab is contraindicated in moderate or severe heart failure (NYHA class III–IV) and left ventricular ejection fraction <50%; use cautiously in mild disease as TNF-alpha antagonists may worsen heart failure.
Rare cases of serious blood dyscrasias (some fatal) have been reported in patients taking infliximab. Monitor full blood count regularly.
A drug-induced lupus is rarely seen following administration of any TNF-alpha inhibitor. Patients presenting with a new rash or joint pain should be referred to their prescriber. This does not represent a class effect, and patients may be successfully rechallenged with a different TNF-alpha inhibitor without recurrence of a drug-induced lupus.
Live vaccines should not be given concurrently with infliximab.
Pharmaceutical benefits Scheme (PBS) listing. Available from https://www.pbs.gov.au/pbs/search?term=infliximab [accessed 8/10/21]
Product information. Available from https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-05235-3&d=202105101016933 [accessed 8/10/21]
Australian Medicines Handbook 2020 (online). Adelaide: Australian Medicines Handbook Pty Ltd; 2020 July. Available from: https://amhonline.amh.net.au/
NPS Medicinewise. Down-titration strategies. Available from https://www.nps.org.au/bdmards/rheumatology-conditions/titration-strategies [accessed 11/5/21]
Ma D, Wong W, Aviado J, Rodriguez C, Wu H. Safety and Tolerability of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease, The American Journal of Gastroenterology: February 2019 - Volume 114 - Issue 2 - p 352-354 doi: 10.1038/s41395-018-0368-1
Moore C, Corbett G, Moss AC. Systematic Review and Meta-Analysis: Serum Infliximab Levels During Maintenance Therapy and Outcomes in Inflammatory Bowel Disease. Journal of Crohn's & colitis. 2016;10:619-625