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Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
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 reactions in
placebo-controlled
trials
Adverse events of
special interest*
Adverse events
with variable dosing
(JADE REGIMEN)
Most common adverse reactions observed in 5 placebo-controlled phase 2 and 3 trials up to 16 weeks, with CIBINQO in adults and adolescents
• The most common adverse reactions were dose-dependent2
• The majority of adverse reactions were mild or moderate in severity2
• The most frequent serious adverse reactions were infections (0.3%)3
• In clinical studies, CIBINQO was administered without regard to food3
Please refer to the CIBINQO Summary of Product Characteristics for complete safety information.
Discover the efficacy of CIBINQO
Discover the efficacy of CIBINQO
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
This analysis includes patients treated with CIBINQO, including pooled phase 2b and 3 studies and an analysis of the ongoing long-term extension study (N=2784).†
In the consistent-dose cohort, 1451 patients taking CIBINQO had at least 48 weeks of constant exposure and 554 patients had at least 96 weeks of exposure.1
These data include a safety analysis of patients who received the same dose of CIBINQO during the parent studies and JADE EXTEND (consistent dose cohort). The data cutoff was 16 April 2021.
All opportunistic infections, excluding tuberculosis, were cases of herpes zoster. Most cases were multidermatomal cutaneous herpes zoster, and the majority were mild or moderate.
Please refer to the CIBINQO Summary of Product Characteristics for complete safety information.
Long-term extension study design2,3
An ongoing long-term extension trial with a 92-week primary treatment period followed by an open-label, variable duration treatment period to evaluate the safety and efficacy of CIBINQO, with or without TCS,* in adult and adolescent patients with moderate-to-severe AD who have previously participated in a qualifying parent clinical trial.
Discover the efficacy of CIBINQO
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
Discover the efficacy of CIBINQO
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
Discover the efficacy of CIBINQO
▼ 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
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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PP-UNP-IRL-0176. January 2023