Adult: For the treatment of moderate to severe active cases in patients with inadequate response to or are intolerant of 1 or more disease-modifying anti-rheumatic drugs (DMARDs): As monotherapy or in combination with methotrexate or other conventional DMARDs: 4 mg once daily, may be decreased to 2 mg once daily once sustained control of disease activity is achieved. Do not initiate treatment in patients with absolute lymphocyte count (ALC) <500 cells/mm3, absolute neutrophil count (ANC) <1,000 cells/mm3, or Hb level <8 g/dL. Dosing interruption or discontinuation may be required if serious infections or other serious adverse reactions (e.g. MI, DVT) occur, or according to the severity of the patient's laboratory abnormalities. Dosage recommendations may vary among countries. Refer to specific product guidelines. Elderly: ≥75 years 2 mg once daily. Dosage recommendations may vary among countries. Refer to specific product guidelines.
Oral Atopic dermatitis
Adult: For the treatment of moderate to severe cases in patients who are candidates for systemic therapy: 4 mg once daily, may be decreased to 2 mg once daily once sustained control of disease activity is achieved. Consider discontinuation of treatment if no response is evident after 8 weeks. Do not initiate treatment in patients with ALC <500 cells/mm3, ANC <1,000 cells/mm3, or Hb level <8 g/dL. Dosing interruption or discontinuation may be required if serious infections or other serious adverse reactions (e.g. MI, DVT) occur, or according to the severity of the patient's laboratory abnormalities. Dosage or treatment recommendations may vary among countries. Refer to specific product guidelines. Elderly: ≥75 years 2 mg once daily. Dosage or treatment recommendations may vary among countries and individual products. Refer to specific product guidelines.
Oral Coronavirus disease 2019 (COVID-19)
Adult: In hospitalised patients requiring supplemental oxygen, invasive or non-invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO): As part of appropriate combination therapy: 4 mg once daily for 14 days or until hospital discharge, whichever occurs 1st. Dosing interruption or discontinuation may be required if serious infections or other serious adverse reactions (e.g. MI, DVT) occur, or according to the severity of the patient's laboratory abnormalities. Dosage recommendation is based on currently available data from clinical studies and may vary among countries. Refer to local treatment or specific product guidelines for further information, including alternative administration in patients who are unable to swallow the whole tab. Child: In hospitalised patients requiring supplemental oxygen, invasive or non-invasive mechanical ventilation, or ECMO: 2-<9 years 2 mg once daily; ≥9 years 4 mg once daily. Recommended treatment duration: 14 days or until hospital discharge, whichever occurs 1st. Dosing interruption or discontinuation may be required if serious infections or other serious adverse reactions (e.g. MI, DVT) occur, or according to the severity of the patient's laboratory abnormalities. Dosage recommendation is based on limited data from clinical studies and may vary among countries. Refer to local treatment or specific product guidelines for further information, including alternative administration in patients who are unable to swallow the whole tab. Elderly: Same as adult dose.
Special Patient Group
Rheumatoid arthritis; Atopic dermatitis:
Patients with history of chronic or recurrent infections: 2 mg once daily.
Rheumatoid arthritis; Atopic dermatitis; COVID-19:
Patients taking potent organic anion transporter 3 (OAT3) inhibitors (e.g. probenecid): Reduce the recommended dose from 4 mg once daily to 2 mg once daily or from 2 mg once daily to 1 mg once daily. If the recommended dose is 1 mg once daily, consider discontinuing probenecid.
Renal Impairment
Rheumatoid arthritis; Atopic dermatitis:
Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
CrCl (mL/min)
Dosage
<30
Not recommended.
30-60
2 mg once daily.
COVID-19:
Adult: Patients on dialysis, with ESRD or eGFR <15 mL/min/1.73 m2: Not recommended. eGFR 15-<30 mL/min/1.73 m2: 1 mg once daily. eGFR 30-<60 mL/min/1.73 m2: 2 mg once daily.
Child: 2-<9 years eGFR <30 mL/min/1.73 m2: Not recommended; eGFR 30-<60 mL/min/1.73 m2: 1 mg once daily. ≥9 years eGFR <15 mL/min/1.73 m2: Not recommended; eGFR 15-<30 mL/min/1.73 m2: 1 mg once daily; eGFR 30-<60 mL/min/1.73 m2: 2 mg once daily.
Hepatic Impairment
Rheumatoid arthritis; Atopic dermatitis:
Severe: Not recommended.
COVID-19:
Severe: Use only if the potential benefit outweighs the potential risks.
Administration
film-coated tab: May be taken with or without food. For patients w/ difficulty swallowing, tab may be dispersed/crushed in approx 10 mL of water. Drink the dispersion liqd & then the glass rinse immediately. The mixt may also be administered via nasogastric, orogastric, & gastronomy tubes followed by the container rinse. Consult product literature for specific instructions.
Contraindications
Active, serious infections other than COVID-19, including localised infections and active TB. Pregnancy and lactation. Concomitant use with other biological DMARDs, strong immunosuppressants (e.g. azathioprine, ciclosporin, tacrolimus), and live vaccines.
Special Precautions
Patient with CV risk factors, known malignancy (apart from successfully treated non-melanoma skin cancer), risk factors for gastrointestinal perforation (e.g. history of diverticulitis); chronic or recurrent infection, underlying condition predisposing to infection; risk factors for DVT or pulmonary embolism (e.g. obesity, history of DVT or pulmonary embolism, undergoing major surgery, immobilisation). Current or past smokers. Patient who has been exposed to TB or who travelled or resided in areas where mycoses or TB are endemic. Patient taking potent organic anion transporter 3 (OAT3) inhibitors (e.g. probenecid). Moderate renal impairment. Children (when used for COVID-19) and elderly.
It should be noted that:
- Use of baricitinib for the treatment of COVID-19 has not been fully established, some data are available from several initial clinical trials in the US and other countries.
- Baricitinib may be available for use in some countries under emergency use authorisation (EUA) or conditional approval for the treatment of COVID-19. Registration status and/or availability may vary between countries.
- The safety and efficacy of baricitinib for the treatment of COVID-19 continue to be evaluated. Preliminary clinical trial results have shown that patients treated with baricitinib have reduced mortality and disease severity.
- There is limited information regarding the use of baricitinib in patients with ALC <200 cells/mm3, ANC <1,000 cells/mm3, and Hb <8 g/dL. It is currently recommended to avoid initiation or to interrupt treatment in patients who have COVID-19 with ALC <200 cells/mm3 or ANC <500 cells/mm3.
- The role of baricitinib in COVID-19 treatment is evolving and may vary among available guidelines. Current guidelines recommend its use in combination with systemic corticosteroids and/or remdesivir. Treatment decisions should be made based on local guidelines, drug availability, and patient comorbidities.
For healthcare professionals:
- Refer to the local health authority for the most up-to-date information when prescribing baricitinib for COVID-19.
- Administration of prophylaxis for venous thromboembolism in patients with COVID-19 is recommended unless contraindicated.
- To alleviate the risks of this unapproved drug during pandemic use, local regulatory agencies may require healthcare facilities and healthcare providers to comply with certain regulations for the administration of baricitinib. Please refer to respective local regulatory agencies for further information.
Adverse Reactions
Significant: Malignancies (e.g. lymphoma, non-melanoma skin cancer), reactivation of virus (e.g. herpes zoster, herpes simplex) or latent infections (e.g. TB), diverticulitis, gastrointestinal perforation, lymphocytopenia, anaemia, neutropenia, increased AST and ALT, lipid elevations (e.g. dose-related increases in total cholesterol, triglycerides, LDL and HDL cholesterol levels), hypersensitivity reactions (e.g. angioedema, urticaria, rash). Rarely, lymphoproliferative disorders. Blood and lymphatic system disorders: Thrombocytosis. Gastrointestinal disorders: Gastroenteritis, nausea, abdominal pain. Investigations: Increased creatine phosphokinase, serum creatinine, and weight. Nervous system disorders: Headache. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infections. Skin and subcutaneous tissue disorders: Acne. Potentially Fatal: Serious bacterial, fungal, viral and opportunistic infections (e.g. pneumonia, UTI, herpes zoster, active pulmonary or extrapulmonary TB, oesophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus disease, BK virus); increased risk of major adverse CV events (e.g. sudden CV death, MI, stroke); thrombosis (e.g. DVT, pulmonary embolism, arterial thrombosis).
Monitoring Parameters
Monitor lymphocyte, neutrophil, platelet counts, Hb, and LFTs (at baseline and periodically thereafter); lipid parameters (approx 12 weeks after treatment initiation and periodically thereafter); eGFR (at baseline, particularly in COVID-19 patients). Screen for latent or active TB infection and viral hepatitis before starting treatment. Assess for signs and symptoms of infections, including TB (during and after treatment), thrombosis, and abdominal symptoms. Perform skin examinations periodically in patients at increased risk for skin cancer.
Drug Interactions
Increased serum concentration with potent organic anion transporter 3 (OAT3) inhibitors (e.g. probenecid). Potentially Fatal: May increase the risk of additive immunosuppression when used concomitantly with other biologic DMARDs and potent immunosuppressive agents (e.g. azathioprine, ciclosporin, tacrolimus). May increase the risk of vaccine-associated infection with live vaccines.
Action
Description: Baricitinib is a reversible Janus kinase (JAK) inhibitor that is selective for JAK1 and JAK2, which are intracellular enzymes involved in the stimulation of haematopoiesis and immune cell function via a signalling pathway. JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which regulate intracellular activity, including gene expression. Inhibition of JAKs leads to reduced phosphorylation and activation of STATs and decreases in serum IgG, IgM, IgA, and C-reactive protein. Pharmacokinetics: Absorption: Rapidly absorbed. Bioavailability: Approx 80%. Time to peak plasma concentration: Approx 1 hour (range: 0.5-3 hours). Distribution: Plasma protein binding: Approx 50%. Metabolism: Metabolised in the liver by CYP3A4 isoenzyme. Excretion: Mainly via urine (approx 75%; 69% as unchanged drug); faeces (approx 20%; 15% as unchanged drug). Elimination half-life: Approx 12 hours.
Chemical Structure
Baricitinib Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 44205240, Baricitinib. https://pubchem.ncbi.nlm.nih.gov/compound/Baricitinib. Accessed May 26, 2022.
L04AA37 - baricitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
References
Anon. Baricitinib. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 17/05/2022.Anon. Baricitinib. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/05/2022.Buckingham R (ed). Baricitinib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/05/2022.Fact Sheet for Healthcare Providers Emergency Use Authorization (EUA) of Baricitinib. U.S. FDA. https://www.fda.gov. Accessed 18/05/2022.Interim Clinical Commissioning Policy: Baricitinib for Patients Hospitalised Due to COVID-19 (Adults and Children Aged 2 Years and Over). NHS England. https://www.england.nhs.uk. Accessed 18/05/2022.Joint Formulary Committee. Baricitinib. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/05/2022.Olumiant 2 mg Film-coated Tablets; Olumiant 4 mg Film-coated Tablets (Eli Lilly Nederland B.V.). European Medicines Agency [online]. Accessed 04/05/2022.Olumiant 2 mg Film-coated Tablets; Olumiant 4 mg Film-coated Tablets (Zuellig Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/05/2022.Olumiant Tablet, Film-coated (Eli Lilly and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/05/2022.Olumiant Tablets (Lily USA, LLC). U.S. FDA. https://www.fda.gov. Accessed 18/05/2022.Preston CL (ed). Baricitinib Drug Interaction. Stockley’s Drug Interactions [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/05/2022.Therapeutic Management of Hospitalized Adults with COVID-19. National Institutes of Health. http://www.covid19treatmentguidelines.nih.gov. Accessed 04/05/2022.Therapeutics and COVID-19: Living Guideline. World Health Organization. https://www.who.int. Accessed 04/05/2022.
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