Drug Action
Baricitinib selectively and reversibly inhibits the Janus-associated tyrosine kinases JAK1 and JAK2.
PDF page 1188
Loading InternPractice…
Drug reference
Baricitinib selectively and reversibly inhibits the Janus-associated tyrosine kinases JAK1 and JAK2.
PDF page 1188
Moderate-to-severe active rheumatoid arthritis in patients who have had an inadequate response to, or are intolerant to, one or more disease-modifying anti- rheumatic drugs (as monotherapy or in combination with methotrexate) (initiated by a specialist) ▶BY MOUTH ▶Adult 18–74 years: 4 mg once daily, for dose adjustments Musculoskeletal system due to side-effects or dose reduction due to history of infection or sustained control of disease activity, consult product literature ▶Adult 75 years and over: 2 mg once daily, for dose adjustments due to side-effects, consult product literature
PDF page 1188
Absolute lymphocyte count less than 0.5 6 109 cells /litre (do not initiate). absolute neutrophil count less than 1 6 109 cells/litre (do not initiate). haemoglobin less than 8 g/dL (do not initiate). tuberculosis (active)
PDF page 1188
Active, chronic or recurrent infection (interrupt treatment if no response to standard therapy). risk of viral reactivation (consult product literature) CAUTIONS, FURTHER INFORMATION ▶Tuberculosis Manufacturer advises consider anti- tuberculosis therapy prior to initiation of baricitinib in patients with previously untreated latent tuberculosis.
PDF page 1188
Manufacturer advises patients should be evaluated for tuberculosis and viral hepatitis before treatment.
PDF page 1188
NICE decisions ▶Baricitinib for moderate to severe rheumatoid arthritis (August 2017) NICE TA466 Baricitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in patients whose disease has responded inadequately to intensive therapy with a combination of conventional disease- modifying antirheumatic drugs (DMARDs), only if: . disease is severe (a disease activity score [DAS28] of more than 5.1), and . the company provides baricitinib with the discount agreed in the patient access scheme (PAS). Baricitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in patients whose disease has responded inadequately to or who cannot have other DMARDs, including at least one biological DMARD, only if: . disease is severe (a DAS28 of more than 5.1), and . they cannot have rituximab, and . the company provides baricitinib with the discount agreed in the PAS. Baricitinib can be used as monotherapy for people who cannot take methotrexate because it is contra-indicated or because of intolerance, when the above two sets of criteria are met. Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained. Patients currently receiving baricitinib whose disease does not meet the above criteria should be able to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/TA466 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (September 2017) that baricitinib (Olumiant ®) is accepted for restricted use within NHS Scotland for the treatment of active rheumatoid arthritis only if the following criteria are met: . disease is severe, that is, a disease activity score (DAS28) greater than 5.1, and . disease has not responded to intensive therapy with a combination of conventional disease-modifying anti- rheumatic drugs, or . disease inadequately controlled by a tumour necrosis factor antagonist and patients are ineligible to receive rituximab. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent of lower.
PDF pages 1188, 1189
MHRA/CHM ADVICE: BARICITINIB (OLUMIANT ®): RISK OF VENOUS THROMBOEMBOLISM (MARCH 2020) Clinical trial data have shown that baricitinib is associated with an increased frequency of venous thromboembolism (VTE) compared with placebo. Healthcare professionals are advised to use baricitinib with caution in patients with additional risk factors for VTE. Patients should be informed of the signs and symptoms of VTE before starting treatment and advised to seek urgent medical attention if these develop. Baricitinib should be permanently discontinued if clinical features of VTE occur.
PDF page 1188
→Appendix 1: baricitinib
PDF page 1188
▶Common or very common Dyslipidaemia. herpes zoster (interrupt treatment). increased risk of infection. nausea. oropharyngeal pain. thrombocytosis ▶Uncommon Acne. deep vein thrombosis (discontinue permanently). neutropenia. pulmonary embolism (discontinue permanently). weight increased ▶Frequency not known Venous thromboembolism (discontinue permanently)
PDF page 1188
Manufacturer advises effective contraception during and for at least 1 week after treatment in women of child-bearing potential.
PDF page 1188
Manufacturer advises avoid—toxicity in animal studies.
PDF page 1188
Manufacturer advises avoid—present in milk in animal studies.
PDF page 1188
Manufacturer advises avoid in severe impairment (no information available).
PDF page 1188
Manufacturer advises avoid if creatinine clearance less than 30 mL/minute. Dose adjustments Manufacturer advises reduce dose to 2 mg once daily if creatinine clearance 30–60 mL/minute.
PDF page 1188
▶Manufacturer advises monitor patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, for expression of hepatitis B virus (HBV) DNA—if HBV DNA detected, consult liver specialist for advice. ▶Manufacturer advises monitor lipid profile 12 weeks after treatment initiation—hyperlipidaemia should be managed according to international clinical guidelines; monitor hepatic transaminases routinely—interrupt treatment if drug-induced liver injury suspected. ▶Manufacturer advises monitor for haematological abnormalities; interrupt treatment if absolute neutrophil count less than 1 6 109 cells/litre, absolute lymphocyte count less than 0.5 6 109 cells/litre, or haemoglobin less than 8 g/dL—treatment may be restarted when levels return above these values.
PDF page 1188
There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Olumiant (Eli Lilly and Company Ltd) A Baricitinib 2 mg Olumiant 2mg tablets | 28 tablet P £805.56 DT = £805.56 Baricitinib 4 mg Olumiant 4mg tablets | 28 tablet P £805.56 DT = £805.56
PDF page 1189
4 mg once daily, for dose adjustments
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1188
2 mg once daily, for dose
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1188