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HomeAboutAboutPfizer JAK InnovationMechanism of DiseaseMechanism of ActionReal CIBINQO Patient StoryAAD 2023 GuidelinesEfficacyEfficacyStudy DesignsJADE COMPAREJADE MONOJADE TEENJADE EXTENDSkin Clearance: Pivotal Trial DataEASI-75IGA 0/1Skin Clearance: Supportive DataHigher Threshold Skin Clearance EndpointAd Hoc Long-Term Skin Clearance AnalysisBefore & After ImagesBefore & After ImagesItch Reduction: Pivotal Trial DataPP-NRS4Itch: Supportive DataDaily Itch ResponseHigher Threshold Itch Reduction EndpointAd Hoc Long-Term Itch Reduction AnalysisData From Post Hoc AnalysesEASI-90 + PP-NRS 0/1 Endpoints With CIBINQO 100 mgData in Dupilumab Inadequate RespondersSafetySafetyImportant Safety ConsiderationsBoxed WarningPooled Safety Ages 12+Pooled Safety Ages 12 to <18Pooled Pivotal Trial Safety to Week 16Safety & TolerabilityAdverse Reactions in Placebo-Controlled TrialsAdverse Reactions in the Pediatric PopulationDosing & MonitoringDosing & MonitoringDosingDosing ConsiderationsDose AdjustmentsStarting & MonitoringBefore and During TreatmentLab AbnormalitiesSavings & SupportSavings & SupportPatient SupportCost & CoverageCopay Savings CardRequest an eRepEventsMaterialsVideosGeneral FAQs
Prescribing Information, including BOXED WARNINGMedication GuideIndicationPatient SiteInformación de Prescripción Completa
Savings & Support - General FAQs
CIBINQO FAQs for Healthcare Professionals
What are the pivotal trials for CIBINQO?

CIBINQO was evaluated in pivotal studies such as JADE MONO-1 and MONO-2, JADE COMPARE, and JADE TEEN, involving patients with moderate-to-severe atopic dermatitis. These trials assessed skin clearance, itch reduction, and safety over time. CIBINQO was also evaluated in JADE EXTEND, which was a long-term extension safety study.1,2

Click here to see the full study designs for the CIBINQO pivotal trials.

What is the mechanism of action (MOA) for CIBINQO?

CIBINQO (abrocitinib) is an oral, small molecule JAK inhibitor, not a biologic, that reversibly inhibits JAK1 inside the cell by blocking the adenosine triphosphate (ATP) binding site.1

Click here to see the MOD and MOA.

What were the primary endpoints in the pivotal trials for CIBINQO?

In JADE COMPARE, JADE TEEN, and JADE MONO-1 and JADE MONO-2, the co-primary endpoints were EASI-75 response at Week 12 vs placebo and IGA 0/1 response with a ≥2-point improvement at Week 12 vs placebo.1

Click here to see EASI-75 and IGA-0/1 response in patients taking CIBINQO.

Were any additional endpoints studied in the pivotal trials?
In JADE COMPARE, key secondary endpoints included PP-NRS4 response at Week 2 vs dupilumab and vs placebo, EASI-75 response at Week 16 vs placebo, and IGA 0/1 response with ≥2-point improvement at Week 16 vs placebo. PP-NRS response at Week 2 versus placebo was also a key secondary endpoint in JADE TEEN, JADE MONO-1 and MONO-2.3-6

Click here to see Supportive Trial Data for Skin Clearance.
Click here to see Supportive Trial Data for Itch Reduction.
What serious safety events should I know about before starting patients on CIBINQO?

CIBINQO has a BOXED WARNING for serious infections, mortality, malignancies, MACE, and thrombosis.1

To review the full CIBINQO BOXED WARNING, click here.
To review important safety considerations, click here.

What were the most common adverse reactions for CIBINQO?

The most common side effects occurring in ≥1% of patients taking CIBINQO in the placebo-controlled trials for up to 16 weeks included: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, dermatitis contact, abdominal pain upper, abdominal discomfort, herpes zoster, and thrombocytopenia.1

The safety profile for CIBINQO was consistent between adult and pediatric patients, but to see the safety profile from the JADE TEEN clinical trial, click here.1

What are the contraindications for treatment with CIBINQO?

CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.1

Please see the full Prescribing Information for complete list of contraindications.

How do patients take CIBINQO?

Patients take CIBINQO as a once-daily oral tablet, with or without food. The tablets should be swallowed whole and not crushed, split, or chewed.1

Click here to read more about administration considerations for CIBINQO.

What are the available dosing options for CIBINQO?

The recommended dose of CIBINQO is 100 mg once daily. If an adequate response is not achieved, the dose can be increased to 200 mg once daily. Discontinue CIBINQO if an adequate response is not achieved with 200 mg once daily.1

There is also a 50 mg dose available for specific populations. It is important to use the lowest efficacious dose to maintain response.1

CIBINQO can be taken with or without food. The tablets should be swallowed whole and not crushed, split, or chewed.1

To find more information about dosing, including starting and monitoring information, click here.

What should patients do if they incorrectly take or forget to take CIBINQO?

If a patient misses a dose, they should administer the dose as soon as possible. If it is less than 12 hours before the next dose, they should skip the missed dose and resume dosing at the regular time. There is no experience regarding human overdosage with CIBINQO. There is no specific antidote for overdose with CIBINQO. In case of an overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.1

To read more about dosing considerations, consult the full Prescribing Information.

How much will my patients pay for CIBINQO?

Pfizer provides patient support programs, including copay assistance, for eligible commercially insured patients. Specific costs will vary depending on insurance coverage and eligibility for assistance programs.

Click here to see if your patients qualify for financial assistance.

Who can I contact with questions about CIBINQO?

For medical inquiries, healthcare professionals can contact Pfizer Medical at 1-800-505-4426. To report an adverse event, please call 1-800-438-1985.

CPK=creatine phosphokinase; EASI-75=≥75% improvement in lesion extent and severity from baseline on the Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; JAK=Janus kinase; MACE=major adverse cardiovascular event; PP-NRS4=≥4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale; PP-NRS=Peak Pruritus Numerical Rating Scale. References:CIBINQO Package insert. Pfizer Inc; 2023.Shi VY, Bhutani T, Fonacier L, et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol. 2022;87:351-358.Bieber T, Simpson EL, Silverberg JI, et al; JADE COMPARE Investigators. Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Silverberg JI, Simpson EL, Thyssen JP, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863-873.Simpson EL, Sinclair R, Forman S, et al. Supplementary appendix to: Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised,
placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266.Eichenfield LF, Flohr C, Sidbury R, et al. Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial. JAMA Dermatol. 2021;157(10):1165-1173.
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INDICATION CIBINQO® (abrocitinib) is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.



Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
Important Safety Information WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia. If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection. Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:
  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens.
Avoid use of CIBINQO in patients with an active, serious infection, including localized infections. The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections or those who have resided or traveled in areas of endemic tuberculosis or endemic mycoses. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO. Viral reactivation, including herpes virus reactivation (eg, herpes zoster, herpes simplex), was reported in clinical studies with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves. Hepatitis B virus reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening in accordance with clinical guidelines before starting therapy and monitor for reactivation during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C.MORTALITY
In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality (including sudden cardiovascular death) was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.MALIGNANCIES

Malignancies, including non-melanoma skin cancer (NMSC), were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA patients. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) 

Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.THROMBOSIS
Deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis, have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of overall thrombosis, DVT, and PE were observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients.Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and treat patients appropriately.CONTRAINDICATION

CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.LABORATORY ABNORMALITIES
Hematologic Abnormalities: Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation, perform a complete blood count (CBC). CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities.Lipid Elevations: Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO. Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy, and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.IMMUNIZATIONS

Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations. Avoid vaccination with live vaccines immediately prior to, during, and immediately after CIBINQO therapy.RENAL IMPAIRMENT

Avoid use in patients with severe renal impairment or end stage renal disease, including those on renal replacement therapy.HEPATIC IMPAIRMENT

Avoid use in patients with severe hepatic impairment.ADVERSE REACTIONS

Most common adverse reactions (≥1% with CIBINQO 100 mg) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, and dermatitis contact.Most common adverse reactions (≥1% with CIBINQO 200 mg and greater than CIBINQO 100 mg) are nausea, headache, herpes simplex, increased blood creatine kinase, dizziness, urinary tract infection, acne, vomiting, gastroenteritis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.Inform patients that retinal detachment has been reported in CIBINQO clinical trials. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision.DRUG INTERACTIONS

Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO. See Prescribing Information for clinically relevant drug interactions.USE IN PREGNANCY

Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Advise patients who can become pregnant that CIBINQO may impair fertility.There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1‑877‑311‑3770 or visit CIBINQOPregnancyRegistry.com.LACTATION

Advise patients not to breastfeed during treatment with CIBINQO and for one day after the last dose.Please see full Prescribing Information, including BOXED WARNING, and Medication Guide.IndicationCIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.