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Baricitinib oral


Oral formulations containing baricitinib.

Drugs List

  • baricitinib 2mg tablets
  • baricitinib 4mg tablets
  • OLUMIANT 2mg tablets
  • OLUMIANT 4mg tablets
  • Therapeutic Indications


    Dermatitis - atopic
    Severe active rheumatoid arthritis-other regimens unsuitable/ineffective

    Rheumatoid arthritis
    For the treatment of moderate to severe active rheumatoid arthritis in patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Baricitinib can be used as monotherapy or in combination with methotrexate.

    Atopic dermatitis
    For the treatment of moderate to severe atopic dermatitis.



    Rheumatoid arthritis
    4mg once daily. If patients achieve sustained control of the disease with 4mg once a day, consider tapering dose to 2mg once a day.

    Atopic dermatitis
    4mg once daily. If patients achieve sustained control of the disease with 4mg once a day, consider tapering dose to 2mg once a day.

    Baricitinib can be used with or without topical corticosteroids.


    A dose of 2mg once daily may be more appropriate for patients aged 75 years or older.

    Patients with Renal Impairment

    2mg once daily is recommended in patients with creatinine clearance between 30 and 60 ml/minute.


    Absolute lymphocyte count below 0.5 x 10 to the power of 9/L
    Children under 18 years
    Haemoglobin concentration below 8g / dL
    Neutrophil count below 1.0 x 10 to the power of 9 / L
    Acute untreated tuberculosis
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    History of recurrent infection
    Predisposition to pulmonary embolism
    Predisposition to venous thromboembolism
    Risk factors for diverticulitis
    Latent or healed tuberculosis
    Pulmonary embolism
    Renal impairment - creatinine clearance 30-60ml/minute
    Venous thromboembolism

    Administration of live vaccines is not recommended
    Before initiating screen all patients for viral hepatitis
    Consider anti-TB therapy in patients with latent TB
    HBV DNA: Refer to liver specialist to consider interruption
    Interrupt therapy if herpes zoster occurs
    Before starting therapy ensure immunisations are up to date
    Prior to starting therapy rule out active tuberculosis
    Advise patient to report signs of gastrointestinal perforation immediately
    Monitor lymphocyte count before and regularly during treatment
    Monitor haemoglobin levels
    Monitor hepatic function regularly
    Monitor neutrophil count
    Monitor serum lipids 3 months after initiation
    Advise patient to report symptoms of infection immediately
    Advise patient to report unexplained nausea,vomiting,abdominal pain
    Immunosuppressive drugs may increase risk of malignancy
    Reactivation of herpes simplex may occur
    Reactivation of herpes zoster may occur
    Risk of developing opportunistic infections
    Advise patient to seek advice at first indications of pregnancy
    Atopic dermatitis: Consider discontinuing if no response after 8 weeks
    Discontinue if pulmonary embolism occurs
    Discontinue if serious allergic or anaphylactic reaction occurs
    Discontinue if there is a rise in liver enzymes
    Discontinue if venous thromboembolism develops
    Interrupt if haemoglobin falls below 8 g/dL
    Interrupt if lymphocyte count less than 0.5 x 10 to the power of 9/L
    Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
    Suspend if drug induced liver injury is suspected
    Consider interrupting treatment if infection occurs
    Female: May cause infertility
    Female: Contraception required during and for 1 week after treatment
    Advise patient to report symptoms of herpes zoster urgently
    Give patient package leaflet and patient reminder card
    Remind patient of importance of carrying Alert Card with them at all times

    It should be noted that there is an increased risk of lymphocytosis in elderly patients with rheumatoid arthritis. Rare cases of lymphoproliferative disorders have been reported. Before starting treatment with baricitinib, all patients should be screened for viral hepatitis in accordance with clinical guidelines. If hepatitis B DNA is detected, a hepatic specialist should be consulted to establish whether treatment interruption is necessary.

    Prior to initiating baricitinib, it is recommended all patients are up to date with all immunisations in line with current immunisation guidelines.
    Dose dependent increases in blood lipid parameters have been reported in patients treated with baricitinib. LDL cholesterol levels are expected to decrease to baseline levels in response to statin therapy. Lipid parameters should be assessed 12 weeks following initiation of baricitinib therapy.

    In the event that increased alanine transaminase (ALT) and aspartate transaminase (AST) are observed during routine patient observations, consider if this may be due to drug-induced liver injury. If drug induced liver injury is suspected, baricitinib should be temporarily interrupted until this diagnosis is eliminated.

    Venous thromboembolism (VTE) and pulmonary embolism (PE) has been reported during baricitinib therapy. If clinical signs of VTE or PE occur, temporarily interrupt baricitinib whilst confirming the diagnosis and initiating any necessary treatment.

    Pregnancy and Lactation


    Baricitinib is contraindicated during pregnancy.

    The manufacturer states that baricitinib is contraindicated during pregnancy.

    The pathways on which baricitinib act are involved in the cell adhesion and cell polarity which affects early embryonic development. Animal studies have indicated that the use of baricitinib during pregnancy is related to reproductive toxicity, including adverse effects on bone development in utero at higher doses. Baricitinib is teratogenic in animals.


    Baricitinib is contraindicated during breastfeeding.

    The manufacturer states that baricitinib should not be used during breastfeeding.

    It is unknown whether baricitinib or its metabolites are excreted in human milk. Available animal data has shown baricitinib is excreted in milk. Consequently, a risk to infants cannot be excluded.

    Side Effects

    Abdominal pain
    Creatine phosphokinase increased
    Deep vein thrombosis (DVT)
    Eczema herpeticum
    Facial swelling
    Gastro-intestinal perforation
    Herpes simplex
    Herpes zoster
    Increase in serum ALT/AST
    Lymphoproliferative disorders
    Ophthalmic herpes simplex
    Oral herpes
    Oropharyngeal pain
    Pulmonary embolism
    Upper respiratory tract infection
    Urinary tract infections
    Weight gain


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: December 2020

    Reference Sources

    Summary of Product Characteristics: Olumiant 2mg and 4mg Film-Coated Tablets. Eli Lilly and Company Limited. Revised November 2020.

    MHRA Drug Safety Update August 2020
    Available at:
    Last accessed: 23 October 2020

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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