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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 &
Monitoring
DosingLab Monitoring

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

Lab Abnormalities

Laboratory abnormalities observed across clinical studies in moderate-to-severe AD patients treated with CIBINQO 200 mg or CIBINQO 100 mg¹

Thrombocytopenia 

  • In placebo-controlled studies, for up to 16 weeks, treatment with CIBINQO was associated with a dose-related decrease in platelet count*
    • Confirmed platelet counts of <50 x 103/mm³ were reported in 0.1% of patients exposed to CIBINQO 200 mg, and in 0 patients treated with CIBINQO 100 mg or placebo
  • Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned toward baseline despite continued therapy
  • Among all patients treated in clinical studies with consistent dosing regimens of either CIBINQO 100 mg or 200 mg, including the long-term extension study, the rate of confirmed platelet counts of <50 × 103/mm3 was 0.17 per 100 patients-years for 200 mg and 0 per 100 patient-years for 100 mg, most occurring at Week 4
  • Patients 65 years of age and older had a higher rate of platelet counts <75 × 103/mm3

Lymphopenia

  • In placebo-controlled studies, for up to 16 weeks, confirmed absolute lymphocyte count (ALC) <0.5 x 10³/mm³ occurred in 0.3% of patients treated with CIBINQO 200 mg and 0% of patients treated with CIBINQO 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure*
  • Among all patients treated in clinical studies with consistent dosing regimens of either CIBINQO 100 mg or 200 mg, including the long-term extension, the rate of confirmed ALC <0.5 × 103/mm3 was 0.56 per 100 patient-years for 200 mg and 0 per 100 patient-years for 100 mg, the highest rate was observed in patients 65 years of age and older
Lipid elevations
  • In placebo-controlled studies, for up to 16 weeks, there was a dose-related increase in low-density lipoprotein cholesterol (LDL-c), total cholesterol, and high-density lipoprotein cholesterol (HDL-c) relative to placebo at week 4, which remained elevated through the final visit in the treatment period* 
  • There was no meaningful change in the LDL/HDL ratio in patients treated with CIBINQO relative to patients treated with placebo    
  • Events related to hyperlipidaemia occurred in 0.4% of patients exposed to CIBINQO 100 mg, 0.6% of patients exposed to CIBINQO 200 mg, and 0% of patients exposed to placebo
  • The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Patients with abnormal lipid parameters should be further monitored and managed according to clinical guidelines, due to the known cardiovascular risks associated with hyperlipidaemia
Creatine phosphokinase (CPK) elevations
  • In placebo-controlled studies, for up to 16 weeks, significant increases in CPK values (>5 × ULN) occurred in 1.8% of patients treated with placebo, 1.8% of patients treated with CIBINQO 100 mg, and 3.8% of patients treated with CIBINQO 200 mg, respectively. Most elevations were transient and none led to discontinuation*
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.1,2Includes 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 2021See Lab Monitoring >Loading
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Take On Moderate-to-Severe AD With CIBINQO

Discover the efficacy of CIBINQO

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Safety Across Clinical Trials

Consistent safety profile with patients with moderate-to-severe AD studied across JADE clinical trials

See Safety Profile Loading
The Convenience of a Once-daily Oral Option Go to Dosing Loading

Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.

References:CIBINQO Summary of Product CharacteristicsData on file. Pfizer Inc.; New York, NY.
Simpson 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
Safety
Take On Moderate-to-Severe AD With CIBINQO

Discover the efficacy of CIBINQO

See Efficacy OverviewLoading

▼ 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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