Version July 2025
Patients treated with abrocitinib may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with abrocitinib were herpes simplex, herpes zoster, and pneumonia. If a serious or opportunistic infection develops, discontinue abrocitinib and control the infection.
Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions include:
Active tuberculosis (TB), 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 abrocitinib in patients with an active, serious infection, including localized infections. The risks and benefits of treatment with abrocitinib 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 abrocitinib, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients ≥50 years of age with at least 1 cardiovascular risk factor comparing another JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Abrocitinib is not approved for use in RA patients.
Malignancies were reported in patients treated with abrocitinib. 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 nonmelanoma skin cancer) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.
Major adverse cardiovascular events were reported in patients treated with abrocitinib. In RA patients ≥50 years of age with at least 1 cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (defined as cardiovascular death, myocardial infarction [MI], and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue abrocitinib in patients that have experienced a MI or stroke.
Deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with abrocitinib. 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 with at least 1 cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid abrocitinib in patients at risk. If symptoms of thrombosis occur, discontinue abrocitinib and treat appropriately.
Dosage guidance:
Safety: Do not initiate therapy in patients with active serious infection (including localized infection, tuberculosis, hepatitis B and/or C), a platelet count <150,000/mm3, an absolute lymphocyte count <500 cells/mm3, an ANC <1,000 cells/mm3, or Hb <8 g/dL. Complete all age-appropriate immunizations before initiating therapy; avoid administering live vaccines immediately prior to, during, and immediately after therapy.
Atopic dermatitis, refractory, moderate to severe: Note: Not recommended for use with biologic immunomodulators, other Janus kinase inhibitors, or other systemic immunosuppressants (Ref). May be used with or without topical corticosteroids.
Oral:
US labeling: Initial: 100 mg once daily. For insufficient response, may increase dose to 200 mg once daily. Discontinue treatment if inadequate response is seen after dose increase.
Canadian labeling: Adults <65 years of age: Initial: 100 to 200 mg once daily; consider an initial dose of 100 mg once daily in patients at increased risk of adverse reactions (eg, cardiovascular events, malignancy, venous thromboembolism). For insufficient response, may increase dose to 200 mg once daily. In patients taking 200 mg once daily, consider decreasing dose to 100 mg once daily if symptom control is achieved; may increase dose to 200 mg once daily if symptom control cannot be maintained. Maximum dose: 200 mg/day.
Dosage recommendations for CYP2C19 poor metabolizers: Oral: Initial: 50 mg once daily. For insufficient response, may increase dose to 100 mg once daily. Discontinue treatment if inadequate response is seen after dose increase.
Missed doses: Administer missed dose as soon as possible within 12 hours of scheduled dose. If <12 hours until the next scheduled dose, skip the missed dose and resume dosing at regular scheduled time.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: Renal function estimated using the MDRD formula for dose adjustment purposes.
US labeling:
eGFR ≥60 mL/minute: No dosage adjustment necessary.
eGFR 30 to <60 mL/minute: 50 mg once daily. For insufficient response, may increase dose to 100 mg once daily. Discontinue treatment if inadequate response is seen after dose increase.
eGFR <30 mL/minute, end-stage renal disease: Use is not recommended.
Patients on renal replacement therapy: Use is not recommended (has not been studied).
Canadian labeling:
eGFR ≥60 mL/minute: No dosage adjustment necessary.
eGFR <60 mL/minute: Reduce dose by 50%.
Mild to moderate impairment (Child-Turcotte-Pugh class A and B): No dosage adjustment necessary.
Severe impairment (Child-Turcotte-Pugh class C): Avoid use (has not been studied).
Hematologic toxicity:
Platelet count <50,000/mm3: Discontinue use and monitor CBC until platelet count >100,000/mm3.
Absolute lymphocyte count <500/mm3: Interrupt therapy until absolute lymphocyte count ≥500/mm3.
ANC <1,000/mm3: Interrupt therapy until ANC ≥1,000/mm3.
Hemoglobin <8 g/dL: Interrupt therapy until hemoglobin ≥8 g/dL.
Infection (severe or opportunistic): Discontinue abrocitinib and treat infection. Consider risks and benefits of continuing abrocitinib prior to reinitiating therapy.
US labeling: Refer to adult dosing.
Canadian labeling: ≥65 years of age: Initial dose: 100 mg once daily.
(For additional information see "Abrocitinib: Pediatric drug information")
Dosage guidance:
Safety: Do not initiate therapy in patients with active serious infection (including localized infection, tuberculosis, hepatitis B and/or C), a platelet count <150,000/mm3, an absolute lymphocyte count (ALC) <500 cells/mm3, an ANC <1,000 cells/mm3, or Hb <8 g/dL. Complete all age-appropriate immunizations before initiating therapy; avoid administering live vaccines immediately prior to, during, and immediately after therapy.
Atopic dermatitis, refractory, moderate to severe:
Children ≥12 years and Adolescents: Oral: 100 mg once daily; for insufficient response, may increase dose to 200 mg once daily; use the lowest effective dose to maintain response. Maximum daily dose: 200 mg/day. If response remains inadequate after dose increase to 200 mg, discontinue therapy. Note: May be used in combination with topical steroids (Ref).
Dosage recommendations for CYP2C19 poor metabolizers: Children ≥12 years and Adolescents: Oral: Initial: 50 mg once daily; for insufficient response, may increase dose to 100 mg once daily; use the lowest effective dose to maintain response. If response remains inadequate after dose increase to 100 mg, discontinue therapy.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity:
Children ≥12 years and Adolescents: Oral:
Hematologic toxicity:
Platelet count <50,000/mm3: Discontinue use and monitor CBC until platelet count >100,000/mm3.
ALC <500/mm3: Interrupt therapy until ALC ≥500/mm3.
ANC <1,000/mm3: Interrupt therapy until ANC ≥1,000/mm3.
Hemoglobin <8 g/dL: Interrupt therapy until hemoglobin ≥8 g/dL.
Infection (severe or opportunistic): Discontinue abrocitinib and treat infection. Consider risks and benefits of continuing abrocitinib prior to reinitiating therapy.
Altered kidney function:
Children ≥12 years and Adolescents: Oral:
eGFR ≥60 mL/minute: No dosage adjustment necessary.
eGFR 30 to <60 mL/minute: Initial: 50 mg once daily. For insufficient response, may increase dose to 100 mg once daily. If response remains inadequate after dose increase, discontinue therapy.
eGFR <30 mL/minute, end-stage renal disease: Use is not recommended.
Renal replacement therapy: Use is not recommended (has not been studied).
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: Use is not recommended (has not been studied).
Major cardiovascular/thrombotic events, including acute myocardial infarction, cerebrovascular accident, deep vein thrombosis, and pulmonary embolism (PE) have been reported in patients receiving abrocitinib.
Mechanism: Dose-related; unknown. Dose-related events of venous thromboembolism occurred in patients treated with abrocitinib (Ref) though Janus kinase (JAK) inhibitors may reduce the risk for cardiovascular disease via inhibition of JAK-dependent cytokines (Ref)
Risk factors:
• Current or past smokers
• Existing cardiovascular or thrombotic risk factors (ie, previous PE, recent hospitalization) (Ref)
• Higher doses (ie, 200 mg) (Ref)
An increased incidence of infection (including serious infection [eg, pneumonia]) has been demonstrated with abrocitinib. Opportunistic infection, including herpes simplex infection and herpes zoster infection have also been reported, including herpes virus reactivation. Invasive fungal infections, tuberculosis, and other bacterial and viral infections have been reported with other nonselective Janus kinase (JAK) inhibitors, although JAK1-selective inhibitors are thought to be less likely to result in opportunistic infections (Ref).
Mechanism: Dose-related; related to the pharmacologic action. Abrocitinib inhibits activity of the JAK1 enzymes, which block signaling of type 1 and type 2 interferons and cytokines which are necessary for lymphocyte development (Ref).
Risk factors:
• Higher doses (ie, 200 mg) (Ref)
• Chronic infection, recurrent infection, or history of serious or opportunistic infection (ie, tuberculosis, hepatitis B virus, herpes virus)
• Underlying conditions that may predispose to infection
Abrocitinib is a Janus kinase inhibitor; therefore, use may result in malignancies, including lymphomas. Nonmelanoma skin cancer (NMSC) has been rarely reported with abrocitinib.
Mechanism: Dose-related; related to the pharmacologic action. Janus kinase (JAK) inhibition interferes with T and NK cells and interferon function (Ref).
Onset: Delayed; most cases of NMSC occurred in the first 3 months of abrocitinib treatment (Ref).
Risk factors:
• Known malignancy (other than successfully treated NMSC)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
>10%:
Gastrointestinal: Nausea (6% to 15%)
Infection: Infection (35%; serious infection: ≤1% [including pneumonia]) (table 1)
|
Drug (Abrocitinib) |
Placebo |
Dose |
Number of Patients (Abrocitinib) |
Number of Patients (Placebo) |
|---|---|---|---|---|
|
35% |
26% |
200 mg once daily |
590 |
342 |
|
35% |
26% |
100 mg once daily |
608 |
342 |
|
Serious infection: 1% |
0.6% |
100 mg once daily |
608 |
342 |
|
Serious infection: 0.3% |
0.6% |
200 mg once daily |
590 |
342 |
Respiratory: Nasopharyngitis (9% to 12%)
1% to 10%:
Cardiovascular: Hypertension (1%)
Dermatologic: Acne vulgaris (2% to 5%), contact dermatitis (1%), impetigo (2%)
Gastrointestinal: Abdominal distress (1%), gastroenteritis (1%), upper abdominal pain (≤2%), vomiting (2% to 3%)
Genitourinary: Urinary tract infection (2%)
Hematologic & oncologic: Thrombocytopenia (2%)
Infection: Herpes simplex infection (3% to 4%, including reactivation of disease), herpes zoster infection (≤1%, including reactivation of disease), influenza (1%)
Nervous system: Dizziness (2% to 3%), fatigue (1% to 2%), headache (6% to 8%)
Neuromuscular & skeletal: Increased creatinine phosphokinase in blood specimen (3%)
Respiratory: Oropharyngeal pain (1%)
<1%:
Cardiovascular: Acute myocardial infarction, deep vein thrombosis, pulmonary embolism
Endocrine & metabolic: Hyperlipidemia
Hematologic & oncologic: Lymphocytopenia, malignant neoplasm (including nonmelanoma skin cancer [basal cell carcinoma of skin, cutaneous T-cell lymphoma, squamous cell carcinoma]) (Simpson 2021)
Nervous system: Cerebrovascular accident
Ophthalmic: Retinal detachment
Concomitant use of antiplatelet therapy, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to abrocitinib or any component of the formulation.
Concerns related to adverse effects:
• Hematologic toxicity: Hematologic toxicity, including thrombocytopenia and lymphopenia, has been observed in patients treated with abrocitinib.
• Lipid abnormalities: Dose-dependent increases in lipid parameters (eg, total cholesterol, low-density lipoprotein cholesterol, triglycerides) have been observed in patients treated with abrocitinib.
Disease-related concerns:
• Hepatic impairment: Avoid use in patients with severe hepatic impairment or those with active hepatitis B or hepatitis C.
• Renal impairment: Avoid use in patients with severe renal impairment or end-stage renal disease.
Special populations:
• CYP2C19 poor metabolizers: Dose reduction recommended in patients who are known or suspected to be CYP2C19 poor metabolizers due to reduced metabolic clearance of abrocitinib.
Other warnings/precautions:
• Immunizations: Complete all age-appropriate immunizations before initiating therapy; avoid administration of live vaccines immediately prior to, during, and immediately after therapy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Cibinqo: 50 mg, 100 mg, 200 mg
No
Tablets (Cibinqo Oral)
50 mg (per each): $233.83
100 mg (per each): $233.83
200 mg (per each): $233.83
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Cibinqo: 50 mg, 100 mg, 200 mg
Oral: Administer with or without food. Swallow tablet whole; do not crush, split, or chew.
Oral: Administer with or without food. Swallow tablet whole; do not crush, split, or chew.
Missed doses: Administer missed dose as soon as possible within 12 hours of scheduled dose. If <12 hours until the next scheduled dose, skip the missed dose and resume dosing at regular scheduled time.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Cibinqo: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213871s004lbl.pdf#page=27
Atopic dermatitis, refractory, moderate to severe: Treatment of refractory, moderate to severe atopic dermatitis in adults and pediatric patients ≥12 years of age whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
Limitations of use: Not recommended for use in combination with other Janus kinase inhibitors, biologic immunomodulators, or other immunosuppressants.
Substrate of CYP2B6 (Minor), CYP2C19 (Major), CYP2C9 (Major with inducers), CYP2C9 (Minor with inhibitors), CYP3A4 (Minor), OAT1/3; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP1A2 (Weak), CYP2C19 (Moderate), P-glycoprotein;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Afatinib. Management: If combined, administer the P-gp inhibitor simultaneously with, or after, the dose of afatinib. Monitor closely for signs and symptoms of afatinib toxicity and if the combination is not tolerated, reduce the afatinib dose by 10 mg. Risk D: Consider Therapy Modification
Agents with Antiplatelet Effects: May increase antiplatelet effects of Abrocitinib. Risk X: Avoid
Aliskiren: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Aliskiren. Risk C: Monitor
Anifrolumab: Biologic Disease-Modifying Antirheumatic Drugs may increase immunosuppressive effects of Anifrolumab. Risk X: Avoid
Aspirin: May increase antiplatelet effects of Abrocitinib. Management: Do not use aspirin at doses greater than 81 mg/day with abrocitinib during the first 3 months of abrocitinib therapy. The abrocitinib prescribing information lists this combination as contraindicated. Risk D: Consider Therapy Modification
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Belzutifan: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Belzutifan. Risk C: Monitor
Beta-Acetyldigoxin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Beta-Acetyldigoxin. Risk C: Monitor
Bilastine: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Bilastine. Risk X: Avoid
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivaracetam: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Brivaracetam. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Carisoprodol: CYP2C19 Inhibitors (Moderate) may decrease active metabolite exposure of Carisoprodol. CYP2C19 Inhibitors (Moderate) may increase serum concentration of Carisoprodol. Risk C: Monitor
Celiprolol: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Celiprolol. Risk C: Monitor
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloBAZam: CYP2C19 Inhibitors (Moderate) may increase active metabolite exposure of CloBAZam. CYP2C19 Inhibitors (Moderate) may increase serum concentration of CloBAZam. Risk C: Monitor
CloZAPine: CYP1A2 Inhibitors (Weak) may increase serum concentration of CloZAPine. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: This combination is often contraindicated, but combined use may be permitted with dose adjustment and monitoring. Recommendations vary based on brand, indication, use of CYP3A4 inhibitors, and hepatic/renal function. See interaction monograph for details. Risk D: Consider Therapy Modification
Corticosteroids (Systemic): May increase immunosuppressive effects of Abrocitinib. Management: The use of abrocitinib in combination with other immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP2C19 Inducers (Moderate): May decrease serum concentration of Abrocitinib. Risk C: Monitor
CYP2C19 Inducers (Strong): May decrease serum concentration of Abrocitinib. Risk X: Avoid
CYP2C19 Inhibitors (Moderate): May increase serum concentration of Abrocitinib. Risk C: Monitor
CYP2C9 Inducers (Moderate): May decrease serum concentration of Abrocitinib. Risk C: Monitor
Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase active metabolite exposure of Dabigatran Etexilate. Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Dexlansoprazole: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Dexlansoprazole. Risk C: Monitor
DiazePAM: CYP2C19 Inhibitors (Moderate) may increase serum concentration of DiazePAM. Risk C: Monitor
Digitoxin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Digitoxin. Risk C: Monitor
Digoxin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Digoxin. Management: Measure digoxin serum concentrations before initiating treatment with these P-glycoprotein (P-gp) inhibitors. Reduce digoxin concentrations by either reducing the digoxin dose by 15% to 30% or by modifying the dosing frequency. Risk D: Consider Therapy Modification
DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of DOXOrubicin (Conventional). Risk X: Avoid
Edoxaban: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Edoxaban. Risk C: Monitor
Ensartinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Ensartinib. Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Etravirine: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Etravirine. Risk C: Monitor
Fezolinetant: CYP1A2 Inhibitors (Weak) may increase serum concentration of Fezolinetant. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Flibanserin: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Flibanserin. Risk C: Monitor
Fluconazole: May increase serum concentration of Abrocitinib. Risk X: Avoid
Fosphenytoin-Phenytoin: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor
Glecaprevir and Pibrentasvir: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Glecaprevir and Pibrentasvir. Risk C: Monitor
Immunosuppressants (Cytotoxic Chemotherapy): Abrocitinib may increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Immunosuppressants (Miscellaneous Oncologic Agents): Abrocitinib may increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Immunosuppressants (Therapeutic Immunosuppressant Agents): Abrocitinib may increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Lansoprazole: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Lansoprazole. Risk C: Monitor
Lapatinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Lapatinib. Risk C: Monitor
Larotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Larotrectinib. Risk C: Monitor
Lefamulin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Lefamulin. Management: Avoid concomitant use of lefamulin tablets with P-glycoprotein/ABCB1 inhibitors. If concomitant use is required, monitor for lefamulin adverse effects. Risk D: Consider Therapy Modification
Lumacaftor and Ivacaftor: May decrease serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor
Lumacaftor and Ivacaftor: May decrease serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor
Mavacamten: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Mavacamten. Management: For patients on stable therapy with a moderate CYP2C19 inhibitor initiate mavacamten at 2.5 mg daily. For patients initiating a moderate CYP2C19 inhibitor during mavacamten therapy, dose reductions are recommended. See full mono for details. Risk D: Consider Therapy Modification
Mavorixafor: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Mavorixafor. Risk C: Monitor
Methadone: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Methadone. Risk C: Monitor
Methotrexate: Abrocitinib may increase immunosuppressive effects of Methotrexate. Risk X: Avoid
Moclobemide: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Moclobemide. Risk C: Monitor
Morphine (Systemic): P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Morphine (Systemic). Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Nadolol: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Nadolol. Risk C: Monitor
Naldemedine: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Naldemedine. Risk C: Monitor
Naloxegol: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Naloxegol. Risk C: Monitor
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Omeprazole: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Omeprazole. Risk C: Monitor
PAZOPanib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of PAZOPanib. Risk X: Avoid
PHENobarbital: CYP2C19 Inhibitors (Moderate) may increase serum concentration of PHENobarbital. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Pralsetinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Pralsetinib. Management: If this combo cannot be avoided, decrease pralsetinib dose from 400 mg daily to 300 mg daily; from 300 mg daily to 200 mg daily; and from 200 mg daily to 100 mg daily. Risk D: Consider Therapy Modification
Primidone: CYP2C19 Inhibitors (Moderate) may increase active metabolite exposure of Primidone. Specifically, concentrations of phenobarbital may be increased. Risk C: Monitor
Proguanil: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Proguanil. CYP2C19 Inhibitors (Moderate) may decrease active metabolite exposure of Proguanil. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Ranolazine. Risk C: Monitor
Relugolix, Estradiol, and Norethindrone: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Relugolix, Estradiol, and Norethindrone. Management: Avoid use of relugolix/estradiol/norethindrone with P-glycoprotein (P-gp) inhibitors. If concomitant use is unavoidable, relugolix/estradiol/norethindrone should be administered at least 6 hours before the P-gp inhibitor. Risk D: Consider Therapy Modification
Relugolix: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Relugolix. Management: Avoid coadministration of relugolix with oral P-gp inhibitors whenever possible. If combined, take relugolix at least 6 hours prior to the P-gp inhibitor and monitor patients more frequently for adverse reactions. Risk D: Consider Therapy Modification
Repotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Repotrectinib. Risk X: Avoid
Rifapentine: May decrease serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor
RifAXIMin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of RifAXIMin. Risk C: Monitor
Rimegepant: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Rimegepant. Management: Avoid administration of another dose of rimegepant within 48 hours if given concomitantly with a P-glycoprotein (P-gp) inhibitor. Risk D: Consider Therapy Modification
RisperiDONE: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of RisperiDONE. Risk C: Monitor
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Saquinavir: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Saquinavir. Risk C: Monitor
Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Silodosin. Risk C: Monitor
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sirolimus (Protein Bound): P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Sirolimus (Protein Bound). Risk X: Avoid
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talazoparib: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Talazoparib. Risk C: Monitor
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tenofovir Disoproxil Fumarate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Theophylline Derivatives: CYP1A2 Inhibitors (Weak) may increase serum concentration of Theophylline Derivatives. Risk C: Monitor
Therapeutic Antiplatelets: May increase antiplatelet effects of Abrocitinib. Management: Do not use antiplatelet drugs with abrocitinib during the first 3 months of abrocitinib therapy. The abrocitinib prescribing information lists this combination as contraindicated. This does not apply to low dose aspirin (81 mg/day or less). Risk X: Avoid
Tilidine: CYP2C19 Inhibitors (Moderate) may increase serum concentration of Tilidine. CYP2C19 Inhibitors (Moderate) may increase active metabolite exposure of Tilidine. Risk C: Monitor
TiZANidine: CYP1A2 Inhibitors (Weak) may increase serum concentration of TiZANidine. Management: Avoid the use of tizanidine with weak CYP1A2 inhibitors when possible. If combined, monitor closely for increased tizanidine toxicities (eg, hypotension, bradycardia, drowsiness). Tizanidine dose reduction or discontinuation may be necessary. Risk D: Consider Therapy Modification
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid
Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Topotecan. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ubrogepant: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a P-gp inhibitor. Risk D: Consider Therapy Modification
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification
VinCRIStine: P-glycoprotein/ABCB1 Inhibitors may increase serum concentration of VinCRIStine. Risk X: Avoid
Voriconazole: May increase serum concentration of Abrocitinib. Abrocitinib may increase serum concentration of Voriconazole. Risk C: Monitor
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Adverse events were observed in some animal reproduction studies.
Agents other than abrocitinib are preferred for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019).
Data collection to monitor pregnancy and infant outcomes following exposure to abrocitinib is ongoing. Health care providers are encouraged to enroll patients exposed to abrocitinib during pregnancy in the Pregnancy Registry (877-311-3770). Patients may also enroll themselves.
It is not known if abrocitinib is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 1 day after the last abrocitinib dose.
CBC (prior to initiating therapy, 4 weeks after initiation, 4 weeks after dose increase, and periodically thereafter in patients who develop hematologic abnormalities); lipid parameters (4 weeks after initiating therapy and periodically thereafter); tuberculosis (TB) screen (baseline and annually thereafter for patients in highly endemic areas for TB); viral hepatitis screening (prior to initiating therapy and periodically thereafter); clinical signs/symptoms of infection (including TB) during and after therapy; skin examinations (periodically, in patients at increased risk for skin cancer); signs/symptoms of thrombosis.
Abrocitinib reversibly inhibits the Janus kinase 1 (JAK1) enzyme by blocking the adenosine triphosphate binding site. Inhibition of JAK1 prevents signaling of interleukin-4, interleukin-13, and other cytokines involved in the pathogenesis of atopic dermatitis (Bieber 2021).
Absorption: >91%.
Distribution: Vd: ~100 L.
Protein binding: ~64% (primarily albumin).
Metabolism: Hepatic via CYP2C19 (~53%), CYP2C9 (~30%), CYP3A4 (~11%), and CYP2B6 (~6%). Metabolized to 2 active metabolites (3-hydroxypropyl [less active than parent] and 2-hydroxypropyl [as active as parent]).
Bioavailability: ~60%.
Half-life elimination: Abrocitinib and active metabolites: 3 to 5 hours.
Time to peak: ≤1 hour.
Excretion: Urine (<1% as unchanged drug; active metabolites predominantly excreted in urine).
Altered kidney function: In patients with moderate (eGFR 30 to 59 mL/minute) and severe (eGFR <30 mL/minute) renal impairment, AUC of abrocitinib and its active metabolites was increased by 110% and 191%, respectively, compared to subjects with normal renal function (eGFR ≥90 mL/minute).
Hepatic function: In patients with mild (Child-Pugh class A) and moderate (Child-Pugh class B) hepatic impairment, AUC of abrocitinib and its active metabolites was increased by ~4% and ~15%, respectively, compared to patients with normal hepatic function.
CYP2C19 poor metabolizers: AUC of abrocitinib was 2.3-fold higher in poor metabolizers compared to normal metabolizers.
