bDMARDs Quick Reference Guide

Infliximab SC

Infliximab SC

Active ingredient

Infliximab

Mechanism of action

Tumour necrosis factor (TNF) – alpha inhibitor

Molecule type

IgG monoclonal antibody (chimeric)

PBS listed indications

Severe active rheumatoid arthritis

Moderate to severe ulcerative colitis

Severe Crohn disease

 

Reference product (brand)

Remicade (subcutaneous Remicade is not available in Australia)

Biosimilar brands

Remsima SC

NOTE: This is the only subcutaneous infliximab product available on the PBS in Australia

Administration information

Mode of administration

Subcutaneous injection

Administration devices and strengths

Pre-filled syringe 120mg/mL

Pre-filled pen 120mg/mL

 

Instructions for patient self-administration are outlined in the CMI.

Frequency of administration

Every two weeks (maintenance therapy only)

Storage

Store at 2o – 8oC (refrigerate do not freeze)

Keep pre-filled syringes and pens in the outer carton until time of use to protect from light.

Remsima may be stored at temperatures up to a maximum of 25°C for a single period of up to 28 days. Once removed from the refrigerator, Remsima must not be returned to refrigerated storage.

The product must be discarded if not used within the 14-day period.

Standard dosing

Rheumatoid arthritis, ulcerative colitis and Crohn disease: 120mg every 2 weeks

Subcutaneous therapy should be initiated as maintenance therapy 4 weeks after the last administration of two infliximab infusions (week 0 and 2).

Treatment with methotrexate should be continued with infliximab (unless contraindicated).

Dose variations

When switching from maintenance therapy with infliximab intravenous formulations to the subcutaneous formulation, the subcutaneous formulation may be administered 8 weeks after the last administration of the intravenous infusions of infliximab.

Special notes

If patients miss an injection and are within 7 days of the scheduled dose, they should be instructed to take the missed dose immediately and then remain on their original bi-weekly dosing schedule.

If the dose is delayed by 8 days or more, patients should be instructed to skip the missed dose, wait until their next scheduled dose, and then remain on their original bi-weekly dosing schedule.

 

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-2020-PI-02540-1 [accessed 8/10/21]