TAM (Treatments and Medicines) NHS Highland- Patients aged 2 years and over.
- COVID-19 infection confirmed or suspected using clinical and/or radiological information.
- Admitted for treatment of viral pneumonia syndrome.
- Receiving supplemental oxygen or additional respiratory support.
- Receiving steroid as per current recommendations (dexamethasone or equivalent) unless contra-indicated.
- Have no evidence of infection (other than SARS-CoV-2) that might be worsened by baricitinib.
Baricitinib for adults and children aged 2 years and older admitted to hospital with confirmed SARS-CoV-2 infection (Guidelines)
Warning
What's new / Latest updates
24/07/2024
- Text added: Baricitinib may be considered in people who meet the above criteria, and who cannot have tocilizumab. When there is clinical deterioration despite treatment with tocilizumab, it may be appropriate to add baricitinib.
- Text added under Criteria:
Have no evidence of infection (other than SARS-CoV-2) that might be worsened by baricitinib.
20.07.2022
- Please note: Due to concerns over the efficacy of sotrovimab against the current circulating Omicron variants of SARS-CoV-2 (BA.2 and others), sotrovimab is not currently being offered routinely. Please discuss any individual patient requirements with one of the Infectious Diseases consultants.
Based on CEM/CMO/2022/007 interim clinical commissioning policy published 5th May 2022.
NOTE: this is an unlicensed indication for baricitinib.
Prescribing is restricted to the consultant caring for patient that day who takes full responsibility for use
Background
Baricitinib is a selective, reversible Janus kinase (JAK) 1 and 2 inhibitor, thought to control high levels of cytokines and inflammation seen in severe SARS-CoV-2 infection.
Clinical trials results show a 28 day mortality reduction from 14% to 12%, in addition to other treatments for SARS-CoV-2 (COVID-19) infection (corticosteroid, IL-6 inhibitor or remdesivir).
Baricitinib may be considered in people who meet the above criteria, and who cannot have tocilizumab. When there is clinical deterioration despite treatment with tocilizumab, it may be appropriate to add baricitinib.
Baricitinib is licensed for use in moderate to severe rheumatoid arthritis and moderate to severe atopic dermatitis.
- Known hypersensitivity to baricitinib
- eGFR below 15ml/min if aged 9 years and over
- eGFR below 30ml/min if aged between 2 and 8 years
- Receiving renal dialysis or haemofiltration
- Absolute neutrophil count less than 0.5 x 109/L
- Active tuberculosis
- Pregnancy or breast feeding
Central Alerting System (CAS) clinical pathway flowchart for eligible patients detailing all possible treatments:
https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=104008
The recommended dose is 4mg once a day for 10 days.
The treatment should be stopped on discharge, if this is before 10 days.
A longer duration of therapy is not recommended.
The manufacturer’s patient information leaflet is available here but only covers the licensed indications.
| Age category / drug interaction | Renal Function | Dose |
| Adults and children aged 9 years and older | eGFR 60mL/min or above | 4 mg* orally once a day |
| eGFR 30 to less than 60mL/min | 2 mg orally once a day | |
| Children aged 2 years to 8 years | eGFR 60mL/min or above | |
| Co-administration with a strong Organic Anion Transporter 3 (OAT3) inhibitor (e.g. probenecid) | ||
| Adults and children aged 9 years and older | eGFR 15 to less than 30mL/min | 2mg orally on alternate days |
| Children aged 2 years to 8 years | eGFR 30 to less than 60mL/min | |
* Each tablet (4mg or 2mg) costs the same (~£16) so avoid using 2 x 2mg to make 4mg if at all possible.
Dissolve the tablet in a quantity of room temperature water. Suggest 10mL for oral administration, 15mL for gastrostomy feeding tube and 30mL for nasogastric tube.
It may take up to 5 minutes for the tablet to disperse.
Do not crush the tablet as this is likely to expose the administering staff to the drug powder, which may be harmful.
Once dispersed, administer the dose immediately. Rinse the container with the same volume of water to ensure the full dose is given.
To avoid clogging small diameter tubes, the syringe can be held horizontally and shaken during administration.
Baricitinib is contra-indicated in pregnancy as there is no adequate data on use in pregnancy and animal studies have shown reproductive toxicity (teratogenicity in rats and rabbits). Animal data shows excretion of baricitinib in milk so the risk to newborn human infants cannot be excluded. Therefore, use of baricitinib during breast feeding is a clinical decision.
Women of child-bearing potential should be advised to use effective contraception during treatment and for 1 week after the treatment has stopped. See manufacturer’s summary of product characteristics for more information, section 4.6.
Baricitinib should be considered an additive therapy to an IL-6 inhibitor (tocilizumab or sarilumab). A patient may be given an IL-6 inhibitor after baricitinib has been commenced or vice versa, according to clinical judgement. If a patient is already on baricitinib and becomes eligible for treatment with an IL-6 inhibitor, the baricitinib should stop as co-administration is not routinely recommended. Where a patient has deteriorated despite treatment or is critically ill, clinical judgement may deem co-administration appropriate.
There is no interaction expected between baricitinib and tocilizumab or sarilumab, dexamethasone, prednisolone, hydrocortisone or remdesivir. For further information, please visit the University of Liverpool COVID-19 Drug Interactions website: https://www.covid19-druginteractions.org/checker.
As baricitinib is unlicensed for treating COVID-19 infection, any suspected adverse drug reactions (ADRs) for patients receiving baricitinib for this indication should be reported directly to the MHRA via the dedicated COVID-19 Yellow Card reporting site at: https://coronavirus-yellowcard.mhra.gov.uk/
Baricitinib can cause immunosuppression that renders patients at risk of bacterial and fungal infections during treatment and for up to 3 days after the treatment course has been completed. During this time, a low clinical threshold for identification and management of infection must be used. CRP level may be a less reliable marker of active infection and procalcitonin may be negative. All handovers of clinical care (including between hospitals if patients are transferred, between levels of care and clinical teams within hospitals, and between hospitals and primary care) must explicitly mention that baricitinib has been given and the date of administration. If discharged before the course is complete or within 3 days of completing the treatment course, clinicians must ensure that the GP is aware that the patient has received baricitinib and provide information to the patient to that effect.
The Deputy Chief Medical Officer recommends that data on all patients with COVID-19 should be captured through the ISARIC 4C Clinical Characterisation Protocol (CCP) case report forms (CRFs), as coordinated by the COVID-19 Clinical Information Network (CO-CIN).