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
​​​​​​​
*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.
Start Guide
Ready to get a patient started?
DOWNLOAD start guide
Any questions about Safety?
To learn more about CIBINQO, schedule a call with your product representative.
Request a Call
Access
See the savings annd support progams
go to Access

​​​​​​​To report any Adverse Events related to Pfizer pharmaceutical products,
please contact us via the following [email protected]
If you have any medical inquiries about Pfizer pharmaceutical products,
please contact our medical information services: [email protected]

© 2021 Pfizer Pte Ltd. All rights reserved.


The information provided in this site is intended only for Healthcare Professionals in Singapore. The products discussed herein may have different product labelling in different countries. Pfizer Pte Ltd, Singapore is a subsidiary of Pfizer Inc, a pharmaceutical company committed to helping people improve their health by discovering and developing medicines.