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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) |
SERIOUS INFECTIONS*
1.12 per 100 patient-years
3.32 per 100 patient-years
1.81 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‡
0.08 Malignancies (excluding NMSC) per 100 patient-years
0.17 NMSC per 100 patient-years
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
0.22 per 100 patient-years
0.15 per 100 patient-years
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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