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Adverse event reporting can be found at the bottom of the page
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Click here for ▼Cibinqo® (abrocitinib) Prescribing Information
Updated Safety Recommendation - 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), patients with malignancy risk factors (e.g. current malignancy or a history of malignancy). (Cibinqo Summary of Product Characteristics)
Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. (Cibinqo Summary of Product Characteristics)
CONTRAINDICATIONS
Cbinqo should only be used if no suitable treatment alternative are available in:
Considering the increased risk of MACE, malignancies, serious infections and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study (another JAK inhibitor), CIBINQO should only be used in these patients if no suitable treatment alternatives are available.
MOST COMMONLY REPORTED ADVERSE REACTIONS OCCURRING IN ≥2% OF PATIENTS WITH CIBINQO 200 mg IN PLACEBO-CONTROLLED STUDIES:
The most frequent serious adverse reactions are infections (0.3%)
Considering the increased risk of MACE, malignancies, serious infections and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study (another JAK inhibitor), CIBINQO should only be used in these patients if no suitable treatment alternatives are available.
| System organ class | Very common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1000 to <1/100) |
|---|---|---|---|
| Infections and infestations | Herpes simplex* Herpes zoster† |
Pneumonia | |
| Blood and lymphatic system disorders |
Thrombocytopenia Lymphopenia Neutropenia‡ |
||
| Metabolism and nutrition disorders |
Hyperlipidaemia§ | ||
| Nervous system disorders | Headache Dizziness |
||
| Vascular disorders | Venous thromboembolism¶ | ||
| Gastrointestinal disorders | Nausea | Vomiting Upper abdominal pain |
|
| Skin and subcutaneous tissue disorders |
Acne | ||
| Investigations | CPK increased >5×ULN# |
The safety data for CIBINQO includes data in 3848 patients evaluated up to ~4.5 years1,2|
Read the long term safety profile of Cibinqo
Log in to download the Safety Contextualisation Guide
Profiles of fictional patients with different experiences with AD
References
1. CIBINQO Summary of Product Characteristics
2. Simpson EL, et al. Poster presented at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Meeting 2024; 31 May–3 June 2024; Valencia, Spain.
Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc/product/12874/rmms. Patients treated with Cibinqo should be given the Patient Card.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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PP-UNP-GBR-13971. December 2025