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About CIBINQOEfficacyEfficacyOverviewEfficacy of CIBINQO + Medicated TopicalsEfficacy of CIBINQO Without Medicated TopicalsReduction in Risk of FlaresLong-term Efficacy ResultsBefore and After PhotosGlossarySafetySafetySafety ProfileSafety ConsiderationsLab AbnormalitiesDosing & MonitoringDosing &
MonitoringDosingLab Monitoring

Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
Safety Considerations

CIBINQO▼ should only be used if no suitable treatment alternatives are available in patients:
-65 years of age and older;
-patients with 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 history of malignancy)
Adverse events of special interest with CIBINQO1-3

SERIOUS INFECTIONS*

  • Serious infections† have been reported in patients receiving CIBINQO
  • If a serious infection develops, dose interruption should be considered until the infection is controlled 
  • Risks and benefits of treatment prior to initiating CIBINQO should be considered for patients. As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients 65 years of age and older CIBINQO should only be used if no suitable treatment alternatives are available. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO. 
  • In placebo-controlled studies, for up to 16 weeks, the rate of serious infections was:

1.12 per 100 patient-years

3.32 per 100 patient-years

1.81 per 100 patient-years

  • The most frequent serious infections were herpes simplex, herpes zoster, and  pneumonia
  • Among all patients treated with consistent dosing regimens of CIBINQO in the integrated safety analysis ‡, including the long-term extension study, the rate of serious infections was: 
 ​​​​​​​ 0.33 malignancies (excluding NMSC) per 100 patient-years

0.08 malignancies (excluding NMSC) per 100 patient-years

 0.17 NMSC per 100 patient-years

0.38 NMSC per 100 patient-years


​​​​​​​As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients 65 years of age and older CIBINQO should only be used if no suitable treatment alternatives are available. 

​​​​​​​MALIGNANCY‡ 

  • Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including CIBINQO.
  • In a large randomised active controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and non-melanoma skin cancer (NMSC) was observed with tofacitinib compared to TNF inhibitors.
  • A higher rate of malignancies (excluding non-melanoma skin cancer, NMSC) was observed with CIBINQO 200 mg compared to CIBINQO 100 mg.
  • In patients 65 years of age and older, patients who are current or past long-time smokers, or with other malignancy risk factors (e.g. current malignancy or history of malignancy), CIBINQO should only be used if no suitable treatment alternatives are available. 
  • NMSCs have been reported in patients receiving CIBINQO. Periodic skin examination is recommended for all patients, particularly those who are at increased risk for skin cancer
  • Among all patients treated with consistent dosing regimens of CIBINQO in the integrated safety analysis, including the long-term extension study, the rate of VTE was:

0.08 Malignancies (excluding NMSC) per 100 patient-years

0.17 NMSC per 100 patient-years

VENOUS THROMBOEMBOLISM (VTE)‡    
  • Venous thromboembolism, including deep venous thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients treated with CIBINQO
  • Among all patients treated with consistent dosing regimens of CIBINQO in the integrated safety analysis, including the long-term extension study, the rate of VTE was: 

0.28 (DVT 0.11 and PE 0.17) per 100 patient-years

0.08 (DVT 0.00 and PE 0.08) per 100 patient-years

  • A higher rate of VTE was observed with CIBINQO 200 mg compared to CIBINQO 100 mg.
    In patients with cardiovascular or malignancy risk factors CIBINQO should only be used if no suitable treatment alternatives are available.In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, CIBINQO should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder. Patients should be re-evaluated periodically during CIBINQO treatment to assess for changes in VTE risk.

  • If clinical features of DVT/PE occur, CIBINQO treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment 
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)
  • Events of MACE have been observed in patients taking CIBINQO. In patients 65 years of age and older, patients who are current or past long-time smokers, and patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, CIBINQO should only be used if no suitable treatment alternatives are available.

0.22 per 100 patient-years

0.15 per 100 patient-years

 
  • The safety profile observed in elderly patients was similar to that of the adult population with the following exceptions: a higher proportion of patients 65 years of age and older discontinued from clinical studies and were more likely to have serious adverse reactions compared to younger patients; patients 65 years and older were more likely to develop low platelet and ALC values; the incidence rate of herpes zoster in patients 65 years of age and older was higher than that of younger patients. Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of tofacitinib (another JAK inhibitor), CIBINQO should only be used in these patients if no suitable treatment alternatives are available.

Please refer to the CIBINQO Summary of Product Characteristics for complete safety information.Combination with biologic immunomodulators, potent immunosuppressants such as ciclosporin or other Janus kinase (JAK) inhibitors has not been studied. Their concomitant use with CIBINQO is not recommended as a risk of additive immunosuppression cannot be excluded.
In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of major adverse cardiovascular events, VTE, malignancies and increased mortality was observed with tofacitinib (another JAKi) compared to TNF inhibitors.Includes pooled results from a phase 2b, placebo-controlled, dose-ranging study and phase 3, placebo-controlled trials, including JADE MONO-1, JADE MONO-2, JADE COMPARE, and JADE TEEN.1,3Serious infections included viral, bacterial, and fungal infections and were defined per protocol as events resulting in death, life-threatening (immediate risk of death), require inpatient hospitalisation or prolongation of existing hospitalisation, result in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), result in congenital anomaly/birth defect, or are important medical events based on investigator’s judgment.3,4Includes pooled results from a phase 2b, dose-ranging study and phase 3 trials, including JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE TEEN, non-responders in the open-label period of JADE REGIMEN, JADE DARE, and interim safety analysis of JADE EXTEND, with data cutoff date of 16 April 20212
Explore moreLearn more about flexible dosing in patients on CIBINQOGo to Dosing Loading See patient results with CIBINQO in the JADE clinical program Before and After PhotosLoading
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Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.

References:CIBINQO Summary of Product CharacteristicsSimpson EL, Silverberg JI, Nosbaum A, et al. Safety of abrocitinib in 3582 patients with moderate-to-severe atopic dermatitis with over 900 patients exposed for almost 2 years. Poster P0362. Presented at: European Academy of Dermatology and Venereology Hybrid Congress; 7–10 September 2022.Data on file. Pfizer Inc.; New York, NY.Simpson EL, Silverberg JI, Nosbaum A, et al. Supplementary appendix to: Integrated safety analysis of abrocitinib for the treatment of moderate-to-severe atopic dermatitis from the phase II and phase III clinical trial program. Am J Clin Dermatol. 2021;22(5):693-707.Safety
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▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions. 

Legal Category: S1A
Further information is available upon request

PP-CIB-IRL-0093 June 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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