bDMARDs Quick Reference Guide

Baricitinib

Baricitinib

Active ingredient

Baricitinib

Mechanism of action

Janus Kinase [JAK] 1 & 2 inhibitor

Molecule type

Small molecule

PBS listed indications

Severe active rheumatoid arthritis

Reference product (brand)

Olumiant

Administration information

Mode of administration

Oral

Administration devices and strengths

2mg and 4 mg tablet

Frequency of administration

Daily

Storage

Store in the original packaging.

Standard dosing

2mg or 4mg daily

Baricitinib can be taken as monotherapy or in combination with csDMARDs.

Dose variations

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

  • 4mg for ≥15months reducing to 2mg

 

Use in renal impairment: in patients with moderate, stage 3 renal impairment (eGFR 30 - ≤60mL/min/1.73m2) the recommended dose of baricitinib is 2mg daily.

Use is not recommended if eGRF <30mL/min/1.73m2

Special notes

Baricitinib should not be used in combination with other cytokine modulators (e.g. TNF-alpha inhibitors, rituximab, tocilizumab). Such combinations increase the risk of infection.

Baricitinib increases the risk of infection, use cautiously in patients already at increased risk and interrupt treatment if a serious or opportunistic infection develops.
Screen for hepatitis B or C and active or latent TB (begin TB treatment before starting baricitinib). Viral reactivation of herpes zoster has been reported in patients taking baricitinib. If a patient develops herpes zoster, baricitinib treatment should be interrupted until the episode resolves.

 

Events of DVT, PE and arterial thrombosis have been reported in patients receiving baricitinib. Use with caution in patients with risk factors for DVT or PE such as older age, obesity, history of DVT / PE or patients undergoing surgery and immobilisation.

 

Live vaccines should not be given concurrently with baricitinib.

 

Laboratory measureActionMonitoring guideline
Lipid parametersPatients should be managed according to local clinical guidelines for hyperlipidaemiaWeek 0 and 12 weeks after initiation of treatment and thereafter according to local clinical guidelines
Absolute neutrophil count (ANC)Treatment should be interrupted if ANC <1x109 cells/L and may be restarted once ANC returns above this valueBefore treatment initiation and thereafter according to routine patient management
Absolute lymphocyte count (ALC)Treatment should be interrupted if ALC <0.5x109 cells/L and may be restarted once ALC returns above this value
Haemoglobin (Hb)Treatment should be interrupted if Hb  < 8g/dL and may be restarted once Hb returns above this value
Hepatic transaminasesTreatment should be interrupted if drug-induced liver injury is suspected

References

Pharmaceutical benefits Scheme (PBS) listing. Available from https://www.pbs.gov.au/medicine/item/11437Y-11442F-11443G-11447L [accessed 8/10/21]

Product information. Available from https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-PI-01225-1 [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]