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JAK1 Inhibitor — Atopic Eczema Pregnancy: Contraindicated in pregnancy and breast-feeding. There are no or limited amount of data on the use of abrocitinib in pregnant women; studies in animals have shown reproductive toxicity, with skeletal variations in the foetuses of pregnant rats and rabbits and effects on parturition and peri/postnatal development in rats. Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose of Cibinqo, and pregnancy planning and prevention for females of reproductive potential should be encouraged. Breast-feeding: there are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production; abrocitinib was secreted in the milk of lactating animals.

Abrocitinib

Brand names: Cibinqo

Abrocitinib is an oral selective Janus kinase 1 (JAK1) inhibitor used to treat moderate-to-severe atopic dermatitis (eczema) in adults when other systemic therapies are inadequate or unsuitable.

Adult dose

Dose: Moderate-to-severe atopic dermatitis: 100 mg or 200 mg once daily, chosen on individual patient characteristics. A starting dose of 100 mg once daily is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy; if the patient does not respond adequately to 100 mg once daily the dose can be increased to 200 mg once daily. A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden, or for patients with an inadequate response to 100 mg once daily. Upon disease control, the dose should be decreased to 100 mg once daily
Route: Oral - taken once daily with or without food at approximately the same time each day. Tablets should be swallowed whole with water and should not be split, crushed or chewed, because these methods have not been studied in clinical trials. In patients who experience nausea, taking Cibinqo with food may improve nausea
Frequency: Once daily
Max: 200 mg once daily - the highest dose in the SPC's atopic dermatitis posology. Lower ceilings apply in defined groups: in severe renal impairment (eGFR < 30 mL/min) the SPC states 'The maximum daily dose is 100 mg'; for patients 65 years of age and older the recommended dose is 100 mg once daily
Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. If disease control is not maintained after dose reduction to 100 mg, re-treatment with 200 mg once daily can be considered; the lowest effective dose for maintenance should be considered. DISCONTINUATION: 'Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.' Cibinqo can be used with or without medicated topical therapies for atopic dermatitis. TREATMENT INITIATION THRESHOLDS, verbatim: 'Treatment should not be initiated in patients with a platelet count < 150 x 10^3/mm3, an absolute lymphocyte count (ALC) < 0.5 x 10^3/mm3, an absolute neutrophil count (ANC) < 1 x 10^3/mm3 or who have a haemoglobin value < 8 g/dL.' DOSE INTERRUPTION: if a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled. MISSED DOSE: take as soon as possible unless it is less than 12 hours before the next dose, in which case the missed dose should not be taken; thereafter resume the regular schedule. INTERACTIONS AFFECTING DOSE: in patients receiving strong inhibitors of CYP2C19 (e.g. fluvoxamine, fluconazole, fluoxetine, ticlopidine) the recommended starting dose should be reduced by half, to 100 mg or 50 mg once daily; concomitant use with moderate or strong inducers of CYP2C19/CYP2C9 (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin) is not recommended. RENAL: no adjustment in mild impairment (eGFR 60 to < 90 mL/min); in moderate impairment (eGFR 30 to < 60 mL/min) reduce the recommended dose by half to 100 mg or 50 mg once daily; in severe impairment (eGFR < 30 mL/min) 50 mg once daily is the recommended starting dose and the maximum daily dose is 100 mg; not studied in end-stage renal disease on renal replacement therapy. HEPATIC: no adjustment in mild (Child Pugh A) or moderate (Child Pugh B) impairment; must not be used in severe (Child Pugh C) impairment.

Paediatric dose

Route: Oral - swallowed whole with water, with or without food, at approximately the same time each day
Frequency: Once daily
Max: The SPC's adolescent starting dose is 100 mg once daily; where response to 100 mg once daily is inadequate the posology permits an increase to 200 mg once daily, and 200 mg once daily is the highest dose stated anywhere in this SPC's atopic dermatitis posology
FIXED DOSE, NOT WEIGHT-BASED - dosePerKg is deliberately null because this SPC expresses the paediatric dose as a flat milligram dose, not per kilogram. Do not derive a per-kg figure. ADOLESCENTS 12 TO 17 YEARS, verbatim: 'The recommended starting dose for adolescents (12 to 17 years old) is 100 mg once daily.' The same 100 mg once daily starting dose is listed in the main posology for adolescents alongside patients at higher risk of VTE, MACE and malignancy. UNDER 12 YEARS, verbatim: 'The safety and efficacy of Cibinqo in children under 12 years of age have not yet been established. No data are available.' No dose is available for that age group from this source.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Active serious systemic infections, including tuberculosis (TB)
  • Severe hepatic impairment
  • Pregnancy and breast-feeding

Side effects

  • Nausea (15.1% with Cibinqo 200 mg in placebo-controlled studies)
  • Headache (7.9%)
  • Acne (4.8%)
  • Herpes simplex (4.2%)
  • Blood creatine phosphokinase increased (3.8%)
  • Vomiting (3.5%)
  • Dizziness (3.4%)
  • Abdominal pain upper (2.2%)
  • Infections - the most frequent serious adverse reactions (0.3%); the most frequent serious infections in clinical studies were herpes simplex, herpes zoster and pneumonia
  • Herpes zoster (common)
  • Pneumonia (uncommon)
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Full blood count before initiation - do not initiate if platelet count < 150 x 10^3/mm3, absolute lymphocyte count < 0.5 x 10^3/mm3, absolute neutrophil count < 1 x 10^3/mm3, or haemoglobin < 8 g/dL
  • Interruption of dosing may be needed for management of laboratory abnormalities as described in SPC Table 1 (section 4.4)
  • Monitor closely for the development of signs and symptoms of infection during and after treatment; treatment must not be initiated in patients with an active, serious systemic infection
  • Assess tuberculosis risk before starting - consider risks and benefits in patients who have been exposed to TB, who have resided or travelled in areas of endemic TB or endemic mycoses, with chronic or recurrent infection, with a history of a serious or opportunistic infection, or with underlying conditions predisposing to infection
  • Restricted use - abrocitinib should only be used if no suitable treatment alternatives are available in patients 65 years of age and older, patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers), and patients with malignancy risk factors
  • Review response at 24 weeks - consider discontinuation in patients who show no evidence of therapeutic benefit
  • Women of reproductive potential should use effective contraception during treatment and for 1 month following the final dose
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

It selectively inhibits JAK1, dampening signalling of cytokines such as interleukin-4, interleukin-13, interleukin-31 and interferons that drive atopic inflammation and itch.

Prescribing in practice

  • As a JAK inhibitor it carries MHRA-highlighted class risks of serious infection, venous thromboembolism, major adverse cardiovascular events and malignancy, so it is used with particular caution in those aged 65 and over, current or past smokers, and patients with cardiovascular or thrombotic risk factors.
  • Screen for and treat active or latent infection (including tuberculosis and viral hepatitis) before starting, avoid live vaccines during treatment, and consider varicella-zoster status given the herpes zoster risk.
  • It should be avoided in pregnancy, and effective contraception is advised during treatment and for a period afterwards as per the SPC.

Monitoring

Check a full blood count, lipids and liver function before and during treatment, and remain vigilant for infection and thromboembolic symptoms.

Counselling the patient

  • Report fever, persistent cough or other signs of infection promptly.
  • Seek urgent help for leg swelling, chest pain or breathlessness suggesting a clot.
  • Avoid live vaccines and discuss any planned pregnancy with your clinician.

Evidence & guidelines

The JADE phase 3 programme established abrocitinib's efficacy in moderate-to-severe atopic dermatitis, and NICE has appraised it as an option within that indication.

Reference: JADE COMPARE Trial (Bieber et al. NEJM 2021); NICE TA877; MHRA Drug Safety Update (2023) JAK Inhibitors; SPC Cibinqo; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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