Abrocitinib is an active pharmaceutical ingredient in the Agents For Dermatitis, Excluding Corticosteroids group (D11AH). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 17, 2026[1]
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.
How to take
GB
CACanada· Health Canada
3 products
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 18, 2026[2]
). If a patient develops herpes zoster, temporary interruption of treatment may be considered until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy with CIBINQO.
Patients with evidence of active hepatitis B or hepatitis C (positive hepatitis C PCR) infection were excluded from clinical studies. Patients who were hepatitis B surface antigen negative, hepatitis B core antibody positive, and hepatitis B surface antibody positive had testing for hepatitis B virus (HBV) DNA.
Patients who had HBV DNA above the lower limit of quantification (LLQ) were excluded. Patients who had HBV DNA negative or below LLQ could initiate CIBINQO (abrocitinib) Page 13 of 45 Unclassified / Non classifié treatment with CIBINQO; such patients had HBV DNA monitored.
If HBV DNA is detected, a liver specialist should be consulted. Monitoring and Laboratory Tests Table 3. Laboratory monitoring guidance Laboratory measure Monitoring guidance Action Complete blood count including Platelet Count, Absolute Lymphocyte Count (ALC), Absolute Neutrophil Count (ANC), and Hemoglobin (Hb) Before treatment initiation, 4 weeks after initiation and thereafter according to routine patient management.
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised March 20, 2025[3]
1 INDICATIONS AND USAGE CIBINQO 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.
CIBINQO is a Janus kinase (JAK) inhibitor 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.
( 1 ) Limitation of Use : CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised February 6, 2026[4]
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]MHRA (UK) · PLGB000571704 · revised April 17, 2026
[2]Health Canada (DPD) · 02528363 · revised March 18, 2026
[3]FDA DailyMed · 16c12a56-4550-41… · revised March 20, 2025 [PDF]
[4]European Medicines Agency · EMEA/H/C/005452 · revised February 6, 2026
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. 4). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily (see below).
• A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily.
If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered. The lowest effective dose for maintenance should be considered. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.
Cibinqo can be used with or without medicated topical therapies for atopic dermatitis. 4). 4). 4). Missed doses If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose.
Thereafter, dosing should be resumed at the regular scheduled time. g. fluvoxamine, fluconazole, fluoxetine and ticlopidine), the recommended starting dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. g. 5). e. estimated glomerular filtration rate (eGFR) of 60 to < 90 mL/min.
2). In patients with severe (eGFR < 30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose. 2). Cibinqo has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy. Hepatic impairment No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
3). 4). Paediatric population The recommended starting dose for adolescents (12 to 17 years old) is 100 mg once daily. The safety and efficacy of Cibinqo in children under 12 years of age have not yet been established. No data are available.
Method of administration This medicinal product is to be taken orally once daily with or without food at approximately the same time each day. In patients who experience nausea, taking Cibinqo with food may improve nausea. Tablets should be swallowed whole with water and should not be split, crushed or chewed because these methods have not been studied in clinical trials.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[1]
2%). 4). Tabulated list of adverse reactions A total of 3848 patients were treated with Cibinqo in clinical studies in atopic dermatitis, among them 3050 patients (representing 5166 patient-years of exposure) were integrated for safety analysis, 2013 with at least 48 weeks of exposure.
The integrated safety analysis included 1997 patients receiving a constant dose of abrocitinib 200 mg and 1053 patients receiving a constant dose of 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.
Listed in Table 2 are adverse reactions observed in atopic dermatitis clinical studies presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 2. Adverse reactions System organ class Very common Common Uncommon Infections and infestations Herpes simplexa Herpes zosterb Pneumonia Blood and lymphatic system disorders Thrombocytopenia Lymphopenia Neutropeniac Metabolism and nutrition disorders Hyperlipidaemiad Nervous system disorders Headache Dizziness Vascular disorders Venous thromboembolisme Gastrointestinal disorders Nausea Vomiting Abdominal pain upper Skin and subcutaneous tissue disorders Acne Investigations Creatine phosphokinase increased > 5 × ULNf a.
Herpes simplex includes oral herpes, ophthalmic herpes simplex, genital herpes, and herpes dermatitis. b. Herpes zoster includes ophthalmic herpes zoster. c. Neutropenia includes neutrophil count decreased and granulocytopenia. d. Hyperlipidaemia includes dyslipidaemia and hypercholesterolaemia.
e. Venous thromboembolism includes pulmonary embolism and deep vein thrombosis. f. Includes changes detected during laboratory monitoring (see text below). 8% of patients treated with Cibinqo 100 mg and 200 mg, respectively. Most infections were mild or moderate.
1% versus 0%). Herpes simplex was more frequent in patients with a history of herpes simplex or eczema herpeticum. Most of the herpes zoster events involved a single dermatome and were non-serious. 61 per 100 patient-years). 4). 12 per 100 patient-years in patients treated with 200 mg.
48 per 100 patient-years treated with 200 mg. 4). Opportunistic infections were observed. 96 per 100 patient-years in the abrocitinib 200 mg group) and were non-serious multidermatomal cutaneous infections. 06 per 100 patient-years). 21 per 100 patient-years for 200 mg group.
4). Thrombocytopenia In 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.
1% of patients treated with 200 mg, and in 0 patients treated with 100 mg or placebo. 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 […]
GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[1]
g. current malignancy or a history of malignancy) Infections/serious infections Serious infections have been reported in patients receiving Cibinqo. 8). 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.
2). 3). Risks and benefits of treatment prior to initiating Cibinqo should be considered for patients: • with chronic or recurrent infection • who have been exposed to TB • with a history of a serious or an opportunistic infection • who have resided or travelled in areas of endemic TB or endemic mycoses; or • with underlying conditions that may predispose them to infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated.
The patient should be closely monitored and Cibinqo therapy should be temporarily interrupted if the patient is not responding to standard therapy. Tuberculosis Tuberculosis was observed in clinical studies with abrocitinib. Patients should be screened for TB before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered.
3). For patients with a new diagnosis of latent TB or prior untreated latent TB, preventive therapy for latent TB should be started prior to initiation of Cibinqo. g. 8). 8). If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves.
Eczema herpeticum (disseminated viral infection mostly due to herpes simplex virus) was also reported in clinical studies with abrocitinib. The condition is characterised by rapid spread of vesicular and erosive lesions, fever and malaise in patients with atopic dermatitis and requires prompt treatment with antiviral agents.
Discontinuation or interruption of abrocitinib therapy until the resolution of an eczema herpeticum infection should be considered, depending on the seriousness of the event. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy with Cibinqo.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 17, 2026[1]
1. 4). 2). 6).
This is not medical advice. Consult a qualified healthcare professional.
Platelets:
Treatment should be discontinued if platelet counts are < 50 × 103/mm3. 5 × 103/mm3 and may be restarted once ALC returns above this value. Treatment should be discontinued if confirmed.
ANC:
Treatment should be interrupted if ANC is < 1 × 103/mm3 and may be restarted once ANC returns above this value. Hb: Treatment should be interrupted if Hb < 8 g/dL and may be restarted once Hb returns above this value. Lipid parameters Before treatment initiation, 4 weeks after initiation and thereafter according to clinical guidelines for hyperlipidemia.
Patients should be monitored according to clinical guidelines for hyperlipidemia. Reproductive Health • Fertility Based on findings in rats, oral administration of CIBINQO may impair female fertility. Impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration (see 16 Non-Clinical Toxicology, Reproductive and developmental toxicity).
1. 1.
Pregnancy Women of childbearing potential:
Women of reproductive potential should be advised to use effective contraception during treatment with CIBINQO and for at least 1 month after the last dose. Consider pregnancy planning and prevention for females of reproductive potential.
CIBINQO (abrocitinib) Page 14 of 45 Unclassified / Non classifié Pregnancy:
The limited human data on use of CIBINQO in pregnant women are not sufficient to evaluate a drug- associated risk for major birth defects or miscarriage. In animal embryo-fetal development studies, oral administration of CIBINQO to pregnant rats during organogenesis resulted in fetotoxicity at exposures equal to approximately 17 times the unbound human AUC at the maximum recommended clinical dose of 200 mg once daily.
No fetal malformations were observed. CIBINQO increased the incidence of skeletal variations at equal to or greater than 11 times the unbound human AUC at the maximum recommended clinical dose of 200 mg once daily (see 16 Non-Clinical Toxicology, Reproductive and developmental toxicity).
In a pre- and postnatal development study in pregnant rats, CIBINQO oral administration during gestation and through lactation resulted in lower postnatal survival, lower offspring body weights and/or dystocia with prolonged parturition at exposures equal to or greater than approximately 11 times the unbound human AUC at the maximum recommended clinical dose of 200 mg once daily (see 16 Non-Clinical Toxicology, Reproductive and developmental toxicity).
CIBINQO should not be used during pregnancy unless clearly necessary. 2. Breastfeeding There are no data on the presence of CIBINQO in human milk, the effects on the breast-fed infant, or the effects on milk production. CIBINQO was secreted in milk of lactating rats.
Women should not breast-feed while treated with CIBINQO. A risk to newborns and infants cannot be excluded and CIBINQO should not be used during breast-feeding. 3.
Pediatrics Pediatrics (12-17 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of CIBINQO in pediatric patients 12-17 years of age has been established for treatment of moderate to severe atopic dermatitis. Of the 3848 patients with atopic dermatitis exposed to CIBINQO, a total of 635 adolescents (12 to less than 18 years of age) were enrolled in CIBINQO studies.
The safety profile observed in adolescents in atopic dermatitis clinical studies was similar to that of the adult population. 5 × 103/mm3.
Pediatrics under 12 years of age:
The safety and efficacy of CIBINQO in pediatric patients under 12 years of age have not yet been established. Therefore, Health Canada has not authorized an indication for pediatric use in pediatric patients under 12 years of age. 4.
Geriatrics A total of 176 patients 65 years of age and older were treated with abrocitinib in clinical studies in atopic dermatitis. The safety profile observed in elderly patients was generally similar to that of the adult population overall with the following exceptions: a higher proportion of patients 65 years of age and older discontinued from clinical studies and were more likely to have serious adverse events compared to younger patients.
5 × 103/mm3 occurred only in patients 65 years of age and older. A higher proportion of patients 65 years of age and older had platelet counts <75 × 103/mm3. The incidence rate of herpes zoster in […]
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised March 20, 2025[3]
2 DOSAGE AND ADMINISTRATION • For recommended testing, evaluations, and procedures prior to CIBINQO initiation, see Full Prescribing Information. 1 ) • Recommended dosage is 100 mg orally once daily. 2 ) • 200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily.
2 ) • Moderate renal impairment: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. 3 ) • CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily.
4 ) • For dosage modifications for certain adverse reactions, see Full Prescribing Information. 1 Recommended Testing, Evaluations, and Procedures Prior to Treatment Initiation Perform the following tests and evaluations prior to CIBINQO initiation: • Tuberculosis (TB) infection evaluation – CIBINQO initiation is not recommended in patients with active TB.
1) ] . 1) ] . 6) ] . 7) ] . 2 Recommended Dosage The recommended dose is 100 mg once daily. If an adequate response is not achieved with CIBINQO 100 mg once daily, consider increasing the dosage to 200 mg once daily. Discontinue CIBINQO if an adequate response is not achieved with 200 mg once daily.
Use the lowest efficacious dose to maintain response. CIBINQO can be used with or without topical corticosteroids. If a dose is missed, administer the dose as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose.
Thereafter, resume dosing at the regular scheduled time. 3) ] . 2) ] . Table 1. Dosage Recommendations in Patients with Renal Impairment Renal Impairment Stage Estimated Glomerular Filtration (eGFR) Glomerular filtration rate was estimated by the Modification of Diet in Renal Disease (MDRD) formula.
Dosage Mild 60 – 89 mL/minute CIBINQO 100 mg once daily Moderate 30 – 59 mL/minute CIBINQO 50 mg once daily Severe Severe Renal Impairment and End-Stage Renal Disease include patients on renal replacement therapy. 3) ]. 5) ]. If an adequate response is not achieved with CIBINQO 50 mg once daily, consider increasing the dosage to 100 mg once daily.
Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily . 3) ] . If an adequate response is not achieved with CIBINQO 50 mg daily, consider increasing the dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.
6 Treatment Discontinuation due to Serious Infections or Hematologic Adverse Reactions Serious or Opportunistic Infections If a patient develops a serious or opportunistic infection, discontinue CIBINQO and control the infection. 1) ] .
Hematologic Abnormalities Recommendations for CIBINQO discontinuation for laboratory abnormalities are summarized in Table 2. Table 2. Recommendations for CIBINQO Discontinuation for Hematologic Abnormalities Abbreviations: ALC=absolute lymphocyte count; ANC=absolute neutrophil count; CBC=complete blood count; Hb=hemoglobin Laboratory Measure Recommendation Platelet Count <50,000/mm 3 Discontinue CIBINQO and follow with CBC until >100,000/mm 3 ALC <500/mm 3 Treatment should be temporarily discontinued if ALC is less than 500 cells/mm 3 and may be restarted once ALC return above this value ANC <1,000/mm 3 Treatment should be temporarily discontinued if ANC is less than 1,000 cells/mm 3 and may be restarted once ANC return above this value Hb value <8 g/dL Treatment should be temporarily discontinued if Hb is less than 8 g/dL and may be restarted once Hb return above this value CBC evaluations are recommended at baseline, 4 weeks after treatment initiation and 4 weeks after dosage increase of CIBINQO.
6) ] . 7 Administration Instructions Administer CIBINQO with or without food at approximately the same time each day. Swallow CIBINQO tablets whole with water. Do not crush, split, or chew CIBINQO tablets.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 608 reports total. [5]
Drug Ineffective 92
Condition Aggravated 71
Off Label Use 40
Pruritus 35
Therapeutic Product Effect Incomplete 29
Nausea 26
Dermatitis Atopic 19
Rash 19
Headache 17
Acne 15
Abdominal Discomfort 14
Fatigue 13
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised March 20, 2025[3]
6) ] Most common adverse events (≥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.
1 ) 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.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the 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 practice.
The safety of CIBINQO was evaluated in four randomized, placebo-controlled clinical trials (2 monotherapy, 1 combination therapy with topical corticosteroid, and 1 dose-ranging) and one long-term extension trial in subjects with moderate to severe atopic dermatitis (AD).
A total of 1623 subjects with moderate to severe atopic dermatitis were treated with CIBINQO in these clinical trials representing 1428 patient-years of exposure. There were 634 subjects with at least 1 year of exposure to CIBINQO. In the placebo-controlled clinical trials, a total of 1198 subjects were exposed to CIBINQO with 608 subjects receiving CIBINQO 100 mg once daily and 590 subjects receiving CIBINQO 200 mg once daily for up to 16 weeks.
1%) were 65 years of age or older. 9%). Adverse reactions occurring at ≥1% in any of the treated groups and at a higher rate than in the placebo group are presented in Table 3. 1%) subjects treated with CIBINQO were discontinued from the trials due to adverse reactions.
The safety profile of CIBINQO in the monotherapy and the combination trial(s) were similar. Table 3. 5) Herpes simplex Herpes simplex also includes oral herpes, ophthalmic herpes, herpes dermatitis, genital herpes. 0) Specific Adverse Reactions Exposure adjusted incidence rates were adjusted by trial size for all the adverse reactions reported in this section.
5 per 100 patient-years) treated with CIBINQO 200 mg. 2 per 100 patient-years) treated with CIBINQO 200 mg. 3 per 100 patient-years) treated with CIBINQO 200 mg. 3 per 100 patient-years) treated with CIBINQO 200 mg. The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia.
Herpes Zoster In the placebo-controlled trials, for up to 16 weeks, opportunistic infections were generally cases of multidermatomal cutaneous herpes zoster. 1 per 100 patient-years) treated with CIBINQO 200 mg. 2 per 100 patient-years) treated with CIBINQO 200 mg.
65 per 100 patient-years) treated with CIBINQO 200 mg. 3 per 100 patient-years) treated with CIBINQO 200 mg. 4 per 100 patient-years), who were treated with CIBINQO 200 mg. 3 per 100 patient-years) who were treated with CIBINQO 200 mg.
No thrombosis occurred in subjects treated with CIBINQO 100 mg. 6 per 100 patient-years) treated with CIBINQO 100 mg. 3 per 100 patient-years) treated with CIBINQO 200 mg. Thrombocytopenia In the placebo-controlled trials, for up to 16 weeks, treatment with CIBINQO 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. 9 per 100 patient-years) treated with CIBINQO 200 mg had adverse reactions of thrombocytopenia; no subjects treated with CIBINQO 100 mg had an adverse reaction of thrombocytopenia.
2 per 100 patient-years) treated with CIBINQO 200 mg and 0 subjects treated with CIBINQO 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure. Lipid Elevations In the placebo-controlled trials, for up to 16 weeks, there was a dose-related percent 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.
0 per 100 patient-years) exposed to CIBINQO 200 mg. 6 per 100 patient-years) treated with CIBINQO 100 mg. 3 per 100 patient-years) treated with CIBINQO 100 mg. 3 per 100 patient-years) treated with 200 mg of CIBINQO. Most elevations were transient, there were no reported adverse reactions of rhabdomyolysis.
Pediatric Subjects (12 to less than 18 years of age) The safety of CIBINQO was assessed in a trial of 284 subjects 12 to less than 18 years of age with moderate-to-severe atopic dermatitis (Trial-AD-4). The safety profile of CIBINQO in these subjects, assessed through the initial treatment period of 12 weeks and the long-term period (213 with at least 52 weeks of abrocitinib exposure), was comparable to the safety profile from trials in adults with atopic dermatitis.
USOfficial regulatory label· Warnings and precautions· revised March 20, 2025[3]
5 WARNINGS AND PRECAUTIONS • Laboratory Abnormalities : Laboratory monitoring is recommended due to potential changes in platelets, lymphocytes, and lipids. 6 ) • Immunizations : Avoid use of live vaccines immediately prior to, during and immediately after CIBINQO treatment.
1) ] . Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions.
Avoid use of CIBINQO in patients with active, serious infection including localized infections. Consider the risks and benefits of treatment prior to initiating CIBINQO in patients: • with chronic or recurrent infection • who have been exposed to tuberculosis • with a history of a serious or an opportunistic infection • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses • with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with CIBINQO.
If a patient develops a serious or opportunistic infection, discontinue CIBINQO. Initiate complete diagnostic testing and appropriate antimicrobial therapy. The risks and benefits of treatment with CIBINQO should be carefully considered prior to reinitiating therapy with CIBINQO.
Tuberculosis Evaluate and test patients for TB before starting CIBINQO therapy and 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.
Monitor patients for the development of signs and symptoms of TB, including patients who were tested negative for latent TB infection prior to initiating therapy. 1) ] . If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves.
Hepatitis B virus (HBV) 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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised March 20, 2025[3]
2) ]. Antiplatelet therapies except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment. ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. 4). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily.
• A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily.
If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered. In adolescents (12 years to 17 years of age), weighing 25 kg to < 59 kg, a starting dose of 100 mg once a day is recommended.
If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily. In adolescents weighing at least 59 kg, a starting dose of 100 mg or 200 mg once daily may be appropriate. The lowest effective dose for maintenance should be considered.
Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks. Cibinqo can be used with or without medicated topical therapies for atopic dermatitis. 4 Laboratory monitoring Table 1.
Laboratory measures and monitoring guidance Laboratory measures Monitoring guidance Action Complete blood count including Platelet Count, Absolute Lymphocyte Count (ALC), Absolute Neutrophil Count (ANC) and Haemoglobin (Hb) Before treatment initiation, 4 weeks after initiation and thereafter according to routine patient management.
Platelets:
Treatment should be discontinued if platelet counts are < 50 × 103/mm3. 5 × 103/mm3 and may be restarted once ALC returns above this value. Treatment should be discontinued if confirmed.
ANC:
Treatment should be interrupted if ANC is < 1 × 103/mm3 and may be restarted once ANC returns above this value. Hb: Treatment should be interrupted if Hb is < 8 g/dL and may be restarted once Hb returns above this value. Lipid parameters Before treatment initiation, 4 weeks after initiation and thereafter according to the patient’s risk for cardiovascular disease and clinical guidelines for hyperlipidaemia.
Patients should be monitored according to clinical guidelines for hyperlipidaemia. 4). 4). Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1. Missed doses If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose.
Thereafter, dosing should be resumed at the regular scheduled time. g. 5). g. 5). g. 5). e. estimated glomerular filtration rate (eGFR) of 60 to < 90 mL/min. 2). In patients with severe (eGFR < 30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose.
2). Abrocitinib has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy. Hepatic impairment No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
3). 4). Paediatric population The safety and efficacy of Cibinqo in children under 12 years of age have not yet been established. No data are available. Method of administration This medicinal product is to be taken orally once daily with or without food at approximately the same time each day.
In patients who experience nausea, taking tablets with food may improve nausea. Tablets should be swallowed whole with water and should not be split, crushed or chewed because these methods have not been studied in clinical trials.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised February 6, 2026[4]
2%). 4). Tabulated list of adverse reactions A total of 3 848 patients were treated with abrocitinib in clinical studies in atopic dermatitis. Among them 3 050 patients (representing 5 166 patient-years of exposure) were integrated for safety analysis.
The integrated safety analysis included 1 997 patients receiving a constant dose of abrocitinib 200 mg and 1 053 patients receiving a constant dose of 100 mg. There were 2 013 patients with at least 48 weeks of exposure. 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 abrocitinib in comparison to placebo for up to 16 weeks.
Listed in Table 2 are adverse reactions observed in atopic dermatitis clinical studies presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 12 Table 2. Adverse reactions System organ class Very common Common Uncommon Infections and infestations Herpes simplexa Herpes zosterb Pneumonia Blood and lymphatic system disorders Thrombocytopenia Lymphopenia Neutropeniac Metabolism and nutrition disorders Hyperlipidaemiad Nervous system disorders Headache Dizziness Vascular disorders Venous thromboembolisme Gastrointestinal disorders Nausea Vomiting Abdominal pain upper Skin and subcutaneous tissue disorders Acne Investigations Creatine phosphokinase increased ˃ 5 × ULNf a.
Herpes simplex includes oral herpes, ophthalmic herpes simplex, genital herpes, and herpes dermatitis. b. Herpes zoster includes ophthalmic herpes zoster. c. Neutropenia includes neutrophil count decreased and granulocytopenia. d. Hyperlipidaemia includes dyslipidaemia and hypercholesterolaemia.
e. Venous thromboembolism includes pulmonary embolism and deep vein thrombosis. f. Includes changes detected during laboratory monitoring (see text below). 8% of patients treated with abrocitinib 100 mg and 200 mg, respectively. Most infections were mild or moderate.
1% versus 0%). Herpes simplex was more frequent in patients with a history of herpes simplex or eczema herpeticum. Most of the herpes zoster events involved a single dermatome and were non-serious. 96 per 100 patient-years in the abrocitinib 200 mg group), most of which were non-serious multidermatomal cutaneous infections.
61 per 100 patient-years). 4). 12 per 100 patient-years in patients treated with 200 mg. 48 per 100 patient-years treated with 200 mg. 4). 05 per 100 patient-years for 100 mg. 4). Thrombocytopenia In 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. 1% of patients exposed to 200 mg, and in 0 patients treated with 100 mg or placebo. 15 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 […]
EUOfficial regulatory label· Warnings and precautions· revised February 6, 2026[4]
g. current malignancy or history of malignancy) Infections/serious infections Serious infections have been reported in patients receiving abrocitinib. 8). 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.
2). 3). Risks and benefits of treatment prior to initiating abrocitinib should be considered for patients: • with chronic or recurrent infection • who have been exposed to TB • with a history of a serious or an opportunistic infection • who have resided or travelled in areas of endemic TB or endemic mycoses; or • with underlying conditions that may predispose them to infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated.
The patient should be closely monitored and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Tuberculosis Tuberculosis was observed in clinical studies with abrocitinib. Patients should be screened for TB before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered.
3). For patients with a new diagnosis of latent TB or prior untreated latent TB, preventive therapy for latent TB should be started prior to initiation of treatment. g. 8). 8). If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves.
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy. 2). Patients who were hepatitis B surface antigen negative, hepatitis B core antibody positive, and hepatitis B surface antibody positive had testing for hepatitis B virus (HBV) DNA.
Patients who had HBV DNA above the lower limit of quantification (LLQ) were excluded. Patients who had HBV DNA negative or below 7 LLQ could initiate treatment; such patients had HBV DNA monitored. If HBV DNA is detected, a liver specialist should be consulted.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised February 6, 2026[4]
1. 4). 2). 6). 6
This is not medical advice. Consult a qualified healthcare professional.
2). Patients who were hepatitis B surface antigen negative, hepatitis B core antibody positive, and hepatitis B surface antibody positive had testing for hepatitis B virus (HBV) DNA. Patients who had HBV DNA above the lower limit of quantification (LLQ) were excluded.
Patients who had HBV DNA negative or below LLQ could initiate treatment; such patients had HBV DNA monitored. If HBV DNA is detected, a liver specialist should be consulted. Vaccination No data are available on the response to vaccination in patients receiving Cibinqo.
Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating treatment with this medicinal product, it is recommended that patients be brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines.
8). In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.
A higher rate of VTE was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. 4 “Major adverse cardiovascular events (MACE)” and “Malignancy”) abrocitinib should only be used if no suitable treatment alternatives are available.
In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, abrocitinib should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder.
Patients should be re-evaluated periodically during abrocitinib treatment to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue abrocitinib in patients with suspected VTE, […]
3) ] . Monitor patients with inactive HBV for expression of HBV DNA during therapy with CIBINQO. If HBV DNA is detected during therapy with CIBINQO, consult a liver specialist. 2 Mortality In a large, randomized, postmarketing safety trial of another JAK inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in subjects treated with the JAK inhibitor compared with TNF blockers.
CIBINQO is not approved for use in RA. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO. 1) ] . 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. Malignancies, including lymphomas, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions.
In a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in subjects treated with the JAK inhibitor compared to those treated with TNF blockers.
CIBINQO is not approved for use in RA. A higher rate of lymphomas was observed in subjects 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.
In this trial, current or past smokers had an additional increased risk of overall malignancies. 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.
1) ]. In a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers.
CIBINQO is not approved for use in RA. 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 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. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke. 1) ] . Thrombosis, including DVT, PE, 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 a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers.
CIBINQO is not approved for use in RA. Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and evaluate and treat patients appropriately. 1) ] . 1) ] . CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO.
6) ]. 1) ] . 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.
7 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.
Vaccination No data are available on the response to vaccination in patients receiving abrocitinib. Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating treatment with this medicinal product, it is recommended that patients be brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines.
8). In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.
A higher rate of VTE was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. 4 “Major adverse cardiovascular events (MACE)” and “Malignancy”) abrocitinib should only be used if no suitable treatment alternatives are available.
In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, abrocitinib should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder.
Patients should be re-evaluated periodically during abrocitinib treatment to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue abrocitinib in patients with suspected VTE, regardless of dose.
Major adverse cardiovascular events (MACE) Events of MACE have been observed in patients taking abrocitinib. In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke, was observed with tofacitinib compared to […]