bDMARDs Quick Reference Guide

Infliximab IV

Infliximab IV

Active ingredient

Infliximab

Mechanism of action

Tumour necrosis factor (TNF) – alpha inhibitor

Molecule type

IgG monoclonal antibody (chimeric)

PBS listed indications

RheumatologyAnkylosing spondylitis

Severe psoriatic arthritis

Severe active rheumatoid arthritis

DermatologySevere chronic plaque psoriasis
GastroenterologyAcute 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

Reference product (brand)

Remicade

Biosimilar brands

Inflectra, Renflexis

IndicationPBS item codeBrands funded
Ankylosing spondylitis11482H

11489Q

5753T

6448J

Inflectra

Remicade

Renflexis

11486M

Public - streamlined authority (9481)

11488P

Private - streamlined authority (9621)

Inflectra

Renflexis

Severe psoriatic arthritis11497D

11498E

5756Y

6496X

Inflectra

Remicade

Renflexis

11514B

Public - streamlined authority (9188)

11515C

Private - streamlined authority (9472)

Inflectra

Renflexis

Severe active rheumatoid arthritis11481G

11487N

5757B

6397Q

Inflectra

Remicade

Renflexis

11483J

Private - streamlined authority (12067)

11490R

Public - streamlined authority (12075)

Inflectra

Renflexis

Severe chronic plaque psoriasis11590B

11606W

5758C

9617E

Inflectra

Remicade

Renflexis

11595G

Private - streamlined authority (9602)

11605T

Public - streamlined authority (8844)

Inflectra

Renflexis

Acute severe ulcerative colitis10057H

Private - streamlined authority (9632)

10067W

Public  - streamlined authority (4524)

Inflectra

Remicade

Renflexis

Moderate to severe ulcerative colitis10184B

10196P

11459D

11797X

5755X

9612X

Inflectra

Remicade

Renflexis

11461F

Public - streamlined authority (12042)

11796W

Private - streamlined authority (12074)

Inflectra

Renflexis

Moderate to severe Crohn disease11445J

11448M

 

Inflectra

Remicade

Renflexis

11449N

Public - streamlined authority (9668)

11450P

Private - streamlined authority (9775)

Inflectra

Renflexis

Severe Crohn disease11389K

11399Y

9613Y

5754W

Inflectra

Remicade

Remflexis

11396T

Private - streamlined authority (12051)

11400B

Public - streamlined authority (12069)

Inflectra

Renflexis

Complex refractory fistulising Crohn disease11412P

11424G

9654D

9674E

Inflectra

Remicade

Renflexis

11423F

Public - streamlined authority (9787)

11432Q

Private - streamlined authority (9732)

Inflectra

Renflexis

Administration information

Mode of administration

IV infusion

Administration devices and strengths

Vial containing powder for injection 100mg

Frequency of administration

Every 8 weeks (maintenance dosing)

Storage

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.

Standard dosing

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.

 

Dose variations

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.

  • Dose reduction - 50% of standard dose.
  • Dose interval increase - stepwise increase in dose interval every year (up to 3 years with complete stop at third step).

 

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.

Special notes

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.

References

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