baricitinib: clinical use

Prescribing considerations

• Assess infection history and screen for tuberculosis and viral hepatitis before treatment.
• Bring vaccinations up to date where possible; avoid live attenuated vaccines during or immediately before treatment.
• Use only when no suitable alternatives exist in older patients and those with cardiovascular, smoking-related or malignancy risk factors.
• Assess venous thromboembolism risk initially and periodically, including surgery, immobility, hormonal treatment and previous thrombosis.
• Review renal and hepatic function; use is not recommended with severe hepatic impairment or creatinine clearance below 30 mL/min.
• Exercise caution with diverticular disease, recurrent infection, diabetes and previous malignancy.

Contraindications and cautions

• Hypersensitivity to baricitinib or a formulation excipient
• Pregnancy

Monitoring

• Full blood count, including neutrophils, lymphocytes and haemoglobin, before treatment and during routine care
• Liver transaminases and investigation of suspected medicine-induced liver injury
• Lipid profile after initiation and subsequently according to clinical need
• Renal function
• Clinical surveillance for infection, thrombosis, cardiovascular events and malignancy
• Periodic skin examination, especially where skin-cancer risk factors are present

Clinical pharmacology

Baricitinib is a selective, reversible JAK1/JAK2 inhibitor with rapid oral absorption. It undergoes little metabolism and is cleared mainly unchanged through the kidneys, so renal function and strong OAT3 inhibition materially affect exposure.

Formulation and product differences

• The selected products are film-coated oral tablets containing the same active ingredient.
• Current product information permits water dispersion for paediatric patients unable to swallow whole tablets.