Baricitinib for in-patients

Baricitinib is a selective and reversible inhibitor of Janus kinase 1 and 2 (JAK 1 and 2).

Restricted: Recommendation by Micro/ID only. The decision to initiate treatment with baricitinib MUST be made with Micro/ID.

See Patients in hospital with COVID-19 requiring oxygen

It is good practice to screen for blood borne virus including HIV, hepatitis B and C prior to starting baricitinib. Doses can be given whilst result are pending. In case of positive result discuss with Micro/ID

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Baricitinib may be used alone or in combination with an interleukin-6 inhibitor (e.g. tocilizumab).

Cautions

Summary of product characteristics (SPC) states when Absolute Neutrophil Count (ANC) less than 1 x 10⁹ cells/L do not initiate. Use clinical discretion for ANC between 0.5 and 1 x 10⁹ cells/L.
The SPC lists where Absolute Lymphocyte Count (ALC) less than 0.5 x 10⁹cells/L treatment should not be intiated or temporarily interupted but this was not used in the RECOVERY trial. Use clinical judgement as appropriate.
When haemoglobin less than 8 g/dL, treatment should not be intiated or temporarily interupted.

If increases in ALT or AST are observed and drug-induced liver injury is suspected, treatment should be temporarily interrupted until this diagnosis is excluded.
Baricitinib should not be given to patients with active or latent TB.

The following cautions primarily refer to long term use of baricitinib therefore consider risk benefit for the short term use in COVID-19.

Combination with biological DMARDs, biological immunomodulators or other Janus kinase (JAK) inhibitors has a risk of additive immunosuppression. Clinician should take this into consideration before starting baricitinib.
Cases of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib. Baricitinib should be used with caution in patients with risk factors for DVT/PE. Clinician should assess the risk versus benefit of prescribing baricitinib in these patients. If clinical features of DVT/PE occur, treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

Teatment course is for 10 days or until discharge (if sooner)

	Baricitinib dose
eGFR 60 ml/min/1.73m² or more	4mg once daily
eGFR 30 upto 60 ml/min/1.73m²	2mg once daily
eGFR 15 upto 30ml/min/1.73m²	2mg on alternate days
eGFR less than 15 ml/min/1.73m²	Should not receive baricitinib
Co-administration of an Organic Anion Transporter 3 (OAT3) inhibitor with a STRONG inhibition potential e.g. probenecid (Discuss with pharmacy)	2mg once daily
Patients who are already taking baricitinib for a licenced indication at the dose of 4mg per day	Should not receive additional baricitinib doses
Patients who are already taking baricitinib at a dose of 2mg per day	Dose may be increased for duration of COVID-19 treatment provided the increased dose is deemed clinically appropriate Consider renal function and interactions

Prescribers should use clinical judgement and exercise caution with regards to dosing in those with unstable renal function in the context of acute kidney injury.

This use of baricitinib is off-label. A routine use unlicensed medicine form has been completed for this use of baricitinib.

Speak to pharmacy. A useful resource is University of Liverpool COVID-19 Drug Interactions website

Avoid concurrent use with live vaccines. Live vaccines should also be avoided for 3 months after use of baricitinib.

Baricitinib should NOT be used during pregnancy or whilst breastfeeding.

Record that baricitinib has been given, together with the dose and date of administration.

National Institute for Health and Care Excellence. Technology appraisal guidance 878: Casirivimab plus imdevimab, nirmatrelvir plus ritonavir, sotrovimab and tocilizumab for treating COVID-19. Last updated: 2023 Jun 22. Accessed via: www.nice.org.uk. [Accessed 22/9/23]
Baricitinib [online]. Manufacturer-Eli Lilly and Company Ltd. Last updated 10/3/23. Accessed via https://www.medicines.org.uk/emc/product/7486/smpc [Accessed 22/9/23]
Department of Health and Social Care. Rapid Policy statement. Interim Clinical Commissioning Policy:Baricitinib for patients hospitalised due to COVID-19 (adults and children aged 2 years and over) 28th November 2022. Accessed 22/9/23 at

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103221

Prescribing baricitinib

Dosage (for adults)

Unlicensed Use

Interactions

Baricitinib in pregnancy or breastfeeding

Discharge letter

References