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AboutAboutHow Cibinqo worksIntroducing CibinqoMOA OverviewAtopic DermatitisPatient ProfilesPatient Profiles OverviewPatient Profile 1Patient Profile 2Patient Profile 3Patient Profile 4EfficacyEfficacyClinical EfficacyStudy OverviewJADE COMPAREJADE MONOJADE REGIMENJADE TEENJADE EXTENDJADE DARESafety
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Information on how to access Cibinqo®▼ (abrocitinib) prescribing information and adverse event reporting can be found at the bottom of the page. 
Updated Safety Recommendation - Abrocitinib 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). (Cibinqo Summary of Product Characteristics)

Safety guidance: Summary of the safety profile of Cibinqo

Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.1

 

Cibinqo is contraindicated in patients with1:

• Hypersensitivity to the active substance or to any of the excipients.​

• Active serious systemic infections, including tuberculosis​

• Severe hepatic impairment ​

• Pregnancy and breast-feeding 

Cibinqo should only be used if no suitable treatment alternatives are available in patients 1:

  • 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)

Use in patients 65 years of age and older1:

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 another JAK inhibitor, Cibinqo should only be used in these patients if no suitable treatment alternatives are available.

Safety profile of Cibinqo: Tabulated list of adverse reactions1

A total of 3,582 patients were treated with Cibinqo in clinical studies in atopic dermatitis, among them 2,784 patients (representing 3,006 patient-years of exposure) were integrated for safety analysis, 1,451 with at least 48 weeks of exposure. The integrated safety analysis included 1,761 patients receiving a constant dose of abrocitinib 200 mg and 1,023 patients receiving abrocitinib 100 mg. Five placebo‑controlled studies were integrated (703 patients on 100 mg once daily, 684 patients on 200 mg once daily and 438 patients on placebo) to evaluate the safety of Cibinqo in comparison to placebo for up to 16 weeks.1

A total of 635 adolescents (12 to less than 18 years of age) were enrolled in Cibinqo atopic dermatitis studies representing 851.5 patient-years of exposure. The safety profile observed in adolescents in atopic dermatitis clinical studies was similar to that of the adult population.1

The most commonly reported adverse reactions occurring in ≥2% of patients treated with Cibinqo 200 mg in placebo-controlled studies are nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%).1


PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION

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  Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100)
Infections and infestations   Herpes simplex,a Herpes zosterb Pneumonia
Blood and lymphatic system disorders     Thrombocytopenia, Lymphopenia
Metabolism and nutrition disorders     Hyperlipidaemiac
Nervous system disorders   Headache, Dizziness  
Vascular disorders     Venous thromboembolismd
Gastrointestinal disorders Nausea Vomiting, Abdominal pain upper  
Skin and subcutaneous tissue disorders   Acne  
Investigations   Creatine phosphokinase increased >5 x ULNe  

Adapted from Cibinqo (abrocitinib) Summary of Product Characteristics.


a. Herpes simplex includes oral herpes, ophthalmic herpes simplex, genital herpes and herpes dermatitis.

b. Herpes zoster includes ophthalmic herpes zoster.

c. Hyperlipidaemia includes dyslipidaemia and hypercholesterolaemia.

d. Venous thromboembolism includes pulmonary embolism and deep vein thrombosis.

e. Includes changes detected during laboratory monitoring.

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION​​​​​​​.
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Description of selected adverse reactions with Cibinqo1

FOR FURTHER INFORMATION ON ADVERSE REACTIONS PLEASE SEE THE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS 

Infections1
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Infections/Serious infections1

In placebo-controlled studies, for up to 16 weeks, infections have been reported in 27.4% of patients treated with placebo and in 34.9% and 34.8% of patients treated with Cibinqo 100 mg and 200 mg, respectively. Most infections were mild or moderate. The percentage of patients reporting infection-related adverse drug reactions in the 200 mg and 100 mg groups compared to placebo were: herpes simplex (4.2% and 2.8% versus 1.4%), herpes zoster (1.2% and 0.6% versus 0%), pneumonia (0.1% and 0.1% versus 0%). Herpes simplex was more frequent in patients with a history of herpes simplex or eczema herpectium. Most of the herpes zoster events involved a single dermatome and were non-serious. Most opportunistic infections were cases of herpes zoster (0.97 per 100 patient years), most of which were non-serious, multidermatomal cutaneous infections. Among all patients treated with abrocitinib in the integrated safety analysis, including the long-term extension study, the incidence rate of herpes zoster in patients treated with abrocitinib 200 mg (4.83 per 100 patient-years) was higher than that of patients treated with 100 mg (2.39 per 100 patient-years). Incidence rates for herpes zoster were also higher for patients 65 years of age and older, patients with a medical history of herpes zoster, patients with severe atopic dermatitis at baseline, and a confirmed ALC < 1.0x103/mm3 prior to the event of herpes zoster.

In placebo‑controlled studies, for up to 16 weeks, the rate of serious infections was 1.81 per 100 patient-years in patients treated with placebo, 3.32 per 100 patient-years in patients treated with 100 mg, and 1.12 per 100 patient-years in patients treated with 200 mg. Among all patients treated with Cibinqo in the integrated safety analysis, including the long-term extension study, the rate of serious infections was 2.43 per 100 patient-years treated with 100 mg and 2.46 per 100 patient-years treated with 200 mg. The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia.
 

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.Venous thromboembolism1
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Among all patients treated with Cibinqo in the integrated safety analysis, including the long-term extension study, the rate of PE was 0.17 per 100 patient-years for 200 mg and 0.08 per 100 patient-years for 100 mg. The rate of DVT was 0.11 per 100 patient-years in the 200 mg group and 0 per 100 patient-years in the 100 mg group.

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.Nausea1
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In placebo-controlled studies, for up to 16 weeks, nausea was reported in 1.8% of patients treated with placebo and in 6.3% and 15.1% of patients treated with 100 mg and 200 mg, respectively. Discontinuation due to nausea occurred in 0.4% of patients treated with Cibinqo. Among patients with nausea, 63.5% of patients had onset of nausea in the first week of therapy. The median duration of nausea was 15 days. Most of the cases were mild to moderate in severity.1
PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.Acne1
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In placebo-controlled studies, for up to 16 weeks, acne was reported in 0.2% of patients treated with placebo and in 1.8% and 4.8% of patients treated with 100 mg and 200 mg, respectively. No subjects discontinued due to an event of acne. All events were mild to moderate in severity.1
PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.In placebo controlled studies, laboratory abnormalities in patients taking Cibinqo1Thrombocytopenia1In placebo‑controlled studies, for up to 16 weeks, treatment was associated with a dose‑related decrease in platelet count. Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned towards baseline despite continued therapy.

Confirmed platelet counts of < 50 × 103/mm3 were reported in 0.1% of patients treated with  200 mg, and in 0 patients treated with 100 mg or placebo. Among all patients treated with Cibinqo in the integrated safety analysis, including the long‑term extension study, the rate of confirmed platelet counts of< 50 × 103/mm3 was 0.17 per 100 patient-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. PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION​​​​​​​.Lymphopenia1In placebo‑controlled studies, for up to 16 weeks, confirmed ALC < 0.5 × 103/mm3 occurred in 0.3% of patients treated with 200 mg and 0% of patients treated with 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure.

Among all patients treated with Cibinqo in the integrated safety analysis, 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. There were no adolescent patients who developed an ALC <0.5 × 103/mm3.PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION​​​​​​​.Lipid elevations1In placebo-controlled studies, for up to 16 weeks, there was a dose-related increase in LDL-c, total cholesterol, and HDL-c relative to placebo at Week 4 which remained elevated through the final visit in the treatment period.1The median % change in LDL-c at Week 4 was 9.1%, 4.9% and -2.8% in patients exposed to 200 mg, 100 mg and placebo, respectively; at Month 12 the median % change was 22.8% and 13.7% in the 200 mg and 100 mg groups, respectively. The median % change in HDL-c at Week 4 was 20.0%, 12.1%, and 0% in patients exposed to 200 mg, 100 mg and placebo, respectively; at Month 12 the median % change was 17.1% and 8.9% in the 200 mg and 100 mg groups, respectively.1Events related to hyperlipidaemia occurred in 0.4% of patients exposed to Cibinqo 100 mg, 0.6% of patients exposed to 200 mg and 0% of patients exposed to placebo.​​​​​​​1PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.Creatine phosphokinase elevations1In 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 100 mg and 3.8% of patients treated with 200 mg of Cibinqo, respectively. Most elevations were transient, and none led to discontinuation.1PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

For information about monitoring patients on Cibinqo, please visit the Practical Considerations page below:

Practical Considerations | Cibinqo®▼ (abrocitinib) | PfizerPro UK

Explore moreStarting your patients on Cibinqo

Learn more about flexible dosing in patients on Cibinqo.

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Practical considerations

Learn more about monitoring patients on Cibinqo.

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AE=adverse event; ALC=absolute lymphocyte count; CI=confidence interval; CPK=creatine phosphokinase; DVT=deep vein thrombosis; HDL-c=high-density lipoprotein cholesterol; IR=incidence rate; LDL-c=low-density lipoprotein cholesterol; MACE=major adverse cardiovascular events; NMSC=non-melanoma skin cancer; PE=pulmonary embolism; PY=patient years; ULN=upper limit of normal.

Prescribing information:
Cibinqo (abrocitinib) Prescribing information (Great Britain)

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.
PP-CIB-GBR-1079. August 2023

Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc/product/12874/rmms. Patients treated with Cibinqo should be given the Patient Card.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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