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ABRONIB

ABROCITINIB · by HORIZON

IMMUNOSUPPRESSANTS Immunosuppressant/Janus-associated Tyrosine Kinases JAK1 selective inhibitor HORIZON

Composition

Tab 100mg: Abrocitinib 100 mg

Indications & Dosage

Moderate to severe atopic eczema (specialist use only): Adult: initial dose of 100 mg once daily increased to 200 mg once daily, consider discontinuation of treatment if no response after 12 weeks, maximum 200 mg per day, for dose adjustments, interruption or discontinuation due to clinical response or side-effects; consult product literature.

Contraindications

Absolute lymphocyte count less than 0.5 x 109 cells/litre, absolute neutrophil count less than 1 x 109 cells/litre, clinically significant active infection, haemoglobin less than 8 g/dL, platelet count less than 150 x 109 cells/litre.

Precautions

Chronic or recurrent infection, known malignancy, risk factors for deep-vein thrombosis or pulmonary embolism (discontinue treatment if occurs during treatment). Females of childbearing potential should use effective contraception during treatment and for 1 month after last treatment. Patients should be evaluated and receive all recommended vaccinations before starting treatment; live vaccines are not recommended immediately before, or during, treatment. Consider anti-tuberculosis therapy prior to initiation of treatment in patients with previously untreated latent tuberculosis. Avoid in severe hepatic impairment, caution in moderate and severe impairment, reduce dose by half in moderate impairment. Monitor lipid profile at baseline, 4 weeks after treatment initiation and then periodically. Monitor for haematological abnormalities at baseline, 4 weeks after treatment initiation, and then periodically. Monitor for viral hepatitis during treatment. Reduce initial dose by half with concurrent use of potent CYP2C19 inhibitors.

Interactions

CYP3A4 inhibitors, CYP2C19 inhibitor, BCG, Natalizumab, Tacrolimus, Leflunomide, Pimecrolimus, Roflumilast, Denosumab, Dasatinib, Ivacaftor, Sitaxsentan, Mifepristone, Fluconazole.

Pregnancy

Avoid

Lactation

Avoid

Side Effects

Abdominal pain upper, acne, dizziness, headache, increased risk of infection, nausea, vomiting, dyslipidaemia, embolism and thrombosis, lymphopenia, thrombocytopenia, herpes virus reactivation.