SAFETY 
CIBINQO was studied in > 2850 patients with moderate-to-severe atopic dermatitis (AD)1,2
Safety Profile
The most common adverse reactions (≥2%) in study population with CIBINQO and placebo from the pivotal trials
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*Herpes simplex includes oral herpes, ophthalmic herpes, herpes dermatitis, genital herpes.
  • Nausea was most frequent in the first week of CIBINQO therapy and generally resolved within 2 weeks of continued therapy and improved by taking CIBINQO with food
  •  
Discontinuation rates due to adverse events for MONO-1, MONO-2, and COMPARE, respectively
Important Safety Considerations
Serious Infections
  • Serious infections, defined as any infection (viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials, have been reported in patients receiving CIBINQO
  • In placebo-controlled studies, for up to 16 weeks, serious infections have been reported in 2 patients (2.31 per 100 patient-years) treated with placebo, 6 patients (3.80 per100 patient-years) treated with CIBINQO 100 mg, and 2 patients (1.28 per 100 patient-years) treated with CIBINQO 200 mg
  • The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia
  • If a serious infection develops, consider interruption of CIBINQO until the infection is controlled
Malignancies
  • Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical studies with CIBINQO. Clinical data are insufficient to assess the potential relationship of exposure to CIBINQO and the development of malignancies
  • Among all patients treated with CIBINQO, including the long-term extension study, malignancies were reported in 3 patients, 2 of which were NMSC, all treated with CIBINQO 100 mg
Thrombosis
  • Venous thromboembolism, including deep venous thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients treated with CIBINQO
  • Among all patients treated with CIBINQO, including the long-term extension study, PE was reported in 3 patients (0.18 per 100 patient-years), all treated with CIBINQO 200 mg. Events of DVT were reported in 2 patients (0.09 per 100 patient-years) treated with CIBINQO 200 mg
  • If clinical features of DVT/PE occur, CIBINQO treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment
References: 1. CIBINQO™ (abrocitinib) Full Prescribing Information. April 2021. 2. Data on file. Pfizer Inc; New York, NY.
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