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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
Safety - Important Safety Considerations

Well-Studied SAFETY PROFILE

Boxed Warning

Pooled Safety Ages 12+

Pooled Safety
Ages 12 to <18

Pooled Pivotal Trial Safety to Week 16

Tab Number 5

CIBINQO BOXED WARNING SUMMARY1

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

To review the full CIBINQO BOXED WARNING below, click the plus sign to expand each box.

SERIOUS INFECTIONS1

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.

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.MORTALITY1

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.

MALIGNANCIES1

Malignancies were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)1

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. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

THROMBOSIS1

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 thrombosis was observed when compared with TNF blockers. Avoid CIBINQO in patients at risk. If symptoms of thrombosis occur, discontinue CIBINQO and treat appropriately.

LABORATORY ABNORMALITIES1
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.

See Lab Abnormalities information.
Avoid use of live vaccines immediately prior to, during, and immediately after CIBINQO treatment.1
TB=tuberculosis, TNF=tumor necrosis factor

JADE EXTEND is a phase 3, long-term extension safety study for eligible subjects receiving CIBINQO who have completed a qualifying JADE parent study. The primary endpoints in JADE EXTEND are the incidence of safety events and clinical abnormalities. Efficacy analyses were descriptive in nature. No patients received placebo in JADE EXTEND.3,6-10

See full trial design >

Well-studied safety profile in ~3850 patients with up to 4.5 years of exposure in some patients11*

AEs of special interest

These data are from an integrated safety analysis consistent-dose cohort (n=3050) of JADE EXTEND; there was also a variable-dose cohort that included safety data from an additional 798 patients. 2013 patients treated with CIBINQO had at least 48 weeks of exposure, and 803 patients had at least 144 weeks of exposure.3,11†


Mortality10,11,13§
Three deaths were reported in the CIBINQO 100 mg group (suspected suicide, n=1; sudden death, n=1; COVID-19, n=1), and 7 in the CIBINQO 200 mg group (COVID-19, n=3; septic shock, n=1; myocardial infarction, n=1; cardiac failure, n=1; cardiorespiratory arrest, n=1).

Overall infections3
CIBINQO 100 mg: n=613 (IR: 61.1/100 PY); CIBINQO 200 mg: n=1185 (IR: 74.84/100 PY)

Retinal detachment3
CIBINQO 100 mg: n=3 (IR: 0.15/100 PY); CIBINQO 200 mg: n=2 (IR: 0.06/100 PY)

Limitations and Biases
  • Adverse reactions rates observed in CIBINQO clinical trials cannot be directly compared to rates in the clinical trials of another drug and may not fully characterize the risks
  • ​​No patients received placebo in JADE EXTEND. Treatment and dose were known to both investigator and patient; therefore, data should be interpreted with caution

Pooled safety analyses over time may provide useful data on long-latency adverse events, but adverse rates may differ in specific populations and may change over time.

AEs of special interest
Serious infections in clinical trials3,11,13,14

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration the number of patients and their length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 Herpes zoster in clinical trials3,11,13,14

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 Malignancy (excluding NMSC) in clinical trials3,11,13,14

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 NMSC in clinical trials3,11,13,14

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 MACE in clinical trials3,11,13,14

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 Pulmonary embolism in clinical trials3,11,13,14

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 Deep vein thrombosis in clinical trials3,11,13,14

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 *Based on the range of abrocitinib exposure, 1-1714 days in the consistent-dose cohort and 89-1537 days in the variable-dose cohort.11
†Pooled safety from two phase 2 trials, six phase 3 trials, and one ongoing LTE trial.11
‡This included 1 event in the abrocitinib 200 mg group, gastric adenocarcinoma, which occurred early in the treatment period, and symptoms were present prior to taking study treatment. The IR in the 200 mg group, excluding that subject, was 0.31/100 PY (95% CI, 0.15-0.56).11
§One additional death (lung cancer) was reported in the variable-dose cohort.13
AE=adverse event; CI=confidence interval; COVID‑19=coronavirus disease 2019; IR=incidence rate; LTE=long-term extension; MACE=major adverse cardiovascular event; NMSC=non-melanoma skin cancer; PY=patient-years.

JADE EXTEND is a phase 3, long-term extension safety study for eligible subjects receiving CIBINQO who have completed a qualifying JADE parent study. The primary endpoints in JADE EXTEND are the incidence of safety events and clinical abnormalities. Efficacy analyses were descriptive in nature. No patients received placebo in JADE EXTEND.3,6-10

See full trial design >

AEs of special interest for pediatric patients 12 to <18, with some having exposure up to 4.5 years11,12

AEs of special interest

These data are from an integrated safety analysis evaluating pediatric patients aged 12 to <18 (n=490) in JADE EXTEND. 345 patients treated with CIBINQO had at least 48 weeks of exposure, and 162 patients had at least 144 weeks of exposure.3,12*
Limitations and Biases
  • Adverse reactions rates observed in CIBINQO clinical trials cannot be directly compared to rates in the clinical trials of another drug and may not fully characterize the risks
  • No patients received placebo in JADE EXTEND. Treatment and dose were known to both investigator and patient; therefore, data should be interpreted with caution
​​​​​​​​​​​​​​Pooled safety analyses over time may provide useful data on long-latency adverse events, but adverse rates may differ in specific populations and may change over time.*Pooled safety from two phase 2 trials, six phase 3 trials, and one ongoing LTE trial.3,11
†Exposure-adjusted IRs were adjusted by trial for all of the adverse reactions reported in this section. Patient-year is defined as the aggregate total follow-up time calculated for each event, censored at the time of first event for any given patient, subject to a risk period of up to 28 days beyond the last dose or to the data cutoff date.1,3
‡Confidence intervals (Cls) reflect the uncertainty around an estimated number; therefore, the upper limit (UL) is nonzero. For adverse events with no instances reported, IR could be greater than zero with a 2.5% chance (due to 95% Cl) to be >2.33 in the CIBINQO 100 mg group and >1.33 in the 200 mg group. The depiction above is not intended to imply zero risk.
§1 event of MACE was reported in a 16-year-old Asian male patient with ongoing AD, gout, and hyperuricaemia (treated with febuxostat) in the abrocitinib 100 mg group.11
1 nonfatal pulmonary embolism occurred in a 16-year-old Black/African American male patient with morbid obesity in the abrocitinib 200 mg group.11
AE=adverse event; CI=confidence interval; IR=incidence rate; MACE=major adverse cardiovascular event; NMSC=non-melanoma skin cancer; PY=patient-years.

Evaluated in placebo-controlled pivotal trials for up to Week 161,3
Limitations and Biases
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The size of the control groups and duration of treatment do not permit precise comparative assessments for AEs with low frequency or long latency. In the chart where certain AEs have a zero, indicating no cases were observed in the reporting period, this should not be interpreted as no risk for a specified event. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.Data shown include one phase 2b and three phase 3 trials.3

*Exposure-adjusted IRs were adjusted by trial for all of the adverse reactions reported in this section. Patient-year is defined as the aggregate total follow-up time calculated for each event, censored at the time of first event for any given patient, subject to a risk period of up to 28 days beyond the last dose or to the data cutoff date.1
†Opportunistic infections were generally cases of multidermatomal cutaneous herpes zoster.1
‡Patients with a history of malignancy, except for treated NMSC and cervical carcinoma in situ, were excluded from enrolling in the trials.1,15,16
§MACE was defined as cardiovascular death, myocardial infarction, and stroke.1
AE=adverse event; IR=incidence rate; MACE=major adverse cardiovascular event; NMSC=non-melanoma skin cancer; PY=patient-years.

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 Safety & Tolerability

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 Data Representing More Than 7000 Patient-Years of Exposure

Review the CIBINQO long-term extension safety study

 Go to Study Designs LoadingReferences:CIBINQO Package insert. Pfizer Inc; 2023.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.Data on file. Pfizer Inc; New York, NY. 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. 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.Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-Severe Atopic Dermatitis (JADE MOA). ClinicalTrials.gov identifier: NCT03915496. Updated February 8, 2023. Accessed April 2, 2025. https://clinicaltrials.gov/study/NCT03915496Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy. ClinicalTrials.gov identifier: NCT04345367. Updated July 8, 2022. Accessed April 2, 2025. https://clinicaltrials.gov/study/NCT04345367Reich K, Silverberg JI, de Bruin-Weller M, et al. Abrocitinib long-term efficacy for up to 2 years in patients with moderate-to-severe atopic dermatitis: an interim analysis of JADE EXTEND, a long-term extension study. Presented at: European Academy of Dermatology and Venereology (EADV) Annual Congress; October 11-14, 2023; Berlin, Germany.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(2):351-358. 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 (EADV) Hybrid Congress; September 7-10, 2022; Milan, Italy.Simpson EL, Gutermuth J, Maurer M, et al. Integrated safety analysis of abrocitinib in 3848 patients with moderate-to-severe atopic dermatitis: data from more than 7000 patient-years with up to ~4.5 years of exposure. Presented at: European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024; May 31-June 3, 2024; Valencia, Spain.Paller AS, Eichenfield LF, Flohr C, et al. Integrated analysis examining safety of abrocitinib in adolescents with moderate-to-severe atopic dermatitis with up to 4.6 years of exposure and efficacy at 112 weeks of treatment. Poster 9595. Presented at: European Academy of Dermatology and Venereology (EADV) Annual Congress; September 25-28, 2024; Amsterdam, the Netherlands.Simpson EL, Gutermuth J, Maurer M, et al. Supplement to: Integrated safety analysis of abrocitinib in 3848 patients with moderate-to-severe atopic dermatitis: data from more than 7000 patient-years with up to ~4.5 years of exposure. Presented at: European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024; May 31-June 3, 2024; Valencia, Spain.Simpson EL, Silverberg JI, Nosbaum A, et al. Integrated safety analysis of abrocitinib for the treatment of moderate-to-severe atopic dermatitis from the phase II and phase III clinical trial program. Am J Clin Dermatol. 2021;22(5):693-707.Silverberg JI, Simpson EL, Thyssen JP, et al. Supplement 1 to: 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.Safety
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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.