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Abrocitinib: Indications, Dosing, Side Effects and Interactions
Abrocitinib is a selective inhibitor of the Janus-associated tyrosine kinase JAK1.
MedNext Academy | 4 min read
Abrocitinib: Indications, Dosing, Side Effects and Interactions
Abrocitinib is a selective inhibitor of the Janus-associated tyrosine kinase JAK1.
Drug action
Abrocitinib is a selective inhibitor of the Janus-associated tyrosine kinase JAK1.
Indications and dose
**Moderate-to-severe atopic eczema (under expert supervision)**
- **Adult** (By Mouth): 200 mg once daily, a reduced initial dose of 100 mg once daily is recommended for patients less likely to tolerate treatment, consider discontinuation of treatment if no response after 12 weeks in all patients, for dose adjustments, interruption or discontinuation due to clinical response or side-effects-consult product literature; maximum 200 mg per day.
- **Elderly** (By Mouth): Initially 100 mg once daily, increased to 200 mg once daily if necessary and if tolerated, consider discontinuation of treatment if no response after 12 weeks, for dose adjustments, interruption or discontinuation due to clinical response or side-effects-consult product literature; maximum 200 mg per day.
**Moderate-to-severe atopic eczema (under expert supervision) for abrocitinib**
- **Child 12-17 years** (By mouth): Initially 100 mg once daily, increased to 200 mg once daily if necessary and if tolerated, consider discontinuation of treatment if no response after 12 weeks, for dose adjustments, interruption or discontinuation due to clinical response or side-effects-consult product literature; maximum 200 mg per day.
Cautions
Chronic or recurrent infection; elderly (65 years and older); history of atherosclerotic cardiovascular disease or other cardiovascular risk factors; history of serious or opportunistic infection; predisposition to infection; risk factors for deep-vein thrombosis or pulmonary embolism; risk factors for malignancy; risk of viral reactivation (consult product literature); tuberculosis exposure Cautions, further information Tuberculosis Consider anti-tuberculosis therapy prior to initiation of abrocitinib in patients with previously untreated latent tuberculosis. Use abrocitinib with caution in patients who have travelled or resided in areas of endemic tuberculosis or endemic mycoses. M Immunisation Patients should receive all recommended vaccinations before starting treatment; live vaccines are not recommended immediately before, or during, treatment. M Deep-vein thrombosis or pulmonary embolism If deep-vein thrombosis or pulmonary embolism occurs during treatment, discontinuation of abrocitinib is recommended. M
Contraindications
Absolute lymphocyte count less than 0.5 x 10 9 cells/litre (do not initiate); absolute neutrophil count less than 1 x 10 9 cells/litre (do not initiate); clinically significant active infection; haemoglobin less than 8 g/dL (do not initiate); platelet count less than 150 x 10 9 cells/litre (do not initiate)
Side effects
Common or very common Abdominal pain upper; acne; dizziness; headache; increased risk of infection; nausea; vomiting Uncommon Dyslipidaemia; embolism and thrombosis; lymphopenia; thrombocytopenia Frequency not known Cardiovascular event; malignancy; neoplasms; reactivation of infections
Interactions
**Severe interactions:**
- Co-administration with products which increase gastric pH The effect of elevating gastric pH on abrocitinib active moiety exposures is not clinically significant and dose adjustment is not needed.
- Potential for Cibinqo to affect pharmacokinetics of other medicinal products No clinically significant effects of Cibinqo were observed in drug interaction studies with oral contraceptives (e.g.
**Other interactions (18):**
- Potential for other medicines to affect pharmacokinetics of abrocitinib Abrocitinib is metabolised predominantly by CYP2C19 and CYP2C9 enzymes, and to a lesser extent by CYP3A4 and CYP2B6 enzymes,...
- Therefore, exposures of abrocitinib and/or its active metabolites may be affected by medicinal products that strongly inhibit or induce CYP2C19 or CYP2C9 or inhibit the OAT3 transporter.
- Co-administration with CYP2C19/CYP2C9 inhibitors When 100 mg Cibinqo was administered concomitantly with fluvoxamine (a strong CYP2C19 and moderate CYP3A inhibitor) or fluconazole (a strong CYP2C19,...
- Co-administration with CYP2C19/CYP2C9 inducers Administration of 200 mg Cibinqo after multiple doses with rifampicin, a strong inducer of CYP enzymes, resulted in reduction of abrocitinib active...
- Based on the results of PBPK analysis, moderate induction of CYP enzymes reduces the exposure of abrocitinib active moiety by 44%.
- Co-administration with OAT3 inhibitors When Cibinqo 200 mg was administered concomitantly with probenecid, an OAT3 inhibitor, abrocitinib active moiety exposures increased by approximately 66%.
Pregnancy
Avoid-toxicity in animal studies. M
Breast feeding
Avoid-present in milk in animal studies. M
Hepatic impairment
Avoid in severe impairment (no information available). M
Renal impairment
Caution in moderate and severe impairment. M Dose adjustments Reduce dose by half in moderate impairment. M Reduce initial dose to 50 mg once daily, and increase to maximum 100 mg once daily, in severe impairment. M
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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