CIBINQO® Highlights

(abrocitinib)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CIBINQO safely and effectively. See full prescribing information for CIBINQO.

CIBINQO® (abrocitinib) tablets, for oral use
Initial U.S. Approval: 2022

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

See full prescribing information for complete boxed warning.

•
Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with CIBINQO if serious or opportunistic infection occurs. 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. (5.1)
•
Higher rate of all-cause mortality, including sudden cardiovascular death, with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. CIBINQO is not approved for use in RA patients. (5.2)
•
Malignancies have occurred with CIBINQO. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. (5.3)
•
MACE has occurred with CIBINQO. Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. (5.4)
•
Thrombosis has occurred with CIBINQO. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. (5.5)

RECENT MAJOR CHANGES

Indications and Usage (1)

02/2023

Dosage and Administration (2.2, 2.3, 2.4, 2.5)

12/2023

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

•
For recommended testing, evaluations, and procedures prior to CIBINQO initiation, see Full Prescribing Information. (2.1)
•
Recommended dosage is 100 mg orally once daily. (2.2)
•
200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily. (2.2)
•
Moderate renal impairment: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. (2.3)
•
CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. (2.4)
•
For dosage modifications for certain adverse reactions, see Full Prescribing Information. (2.6)

DOSAGE FORMS AND STRENGTHS

CIBINQO Tablets: 50 mg, 100 mg, and 200 mg (3)

CONTRAINDICATIONS

Antiplatelet therapies except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment. (4)

WARNINGS AND PRECAUTIONS

•
Laboratory Abnormalities: Laboratory monitoring is recommended due to potential changes in platelets, lymphocytes, and lipids. (5.6)
•
Immunizations: Avoid use of live vaccines immediately prior to, during and immediately after CIBINQO treatment. (5.7)

ADVERSE REACTIONS

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. (6.1)

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. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Strong inhibitors of CYP2C19: The recommended dosage is 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. (2.5, 7.1)
•
Moderate to strong inhibitors of both CYP2C19 and CYP2C9, or strong CYP2C19 or CYP2C9 inducers: Avoid concomitant use. (7.1)
•
P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities: Monitor or titrate dosage of P-gp substrate. (7.2)

USE IN SPECIFIC POPULATIONS

•
Lactation: Breastfeeding not recommended. (8.2)
•
Renal Impairment: Avoid use in patients with severe renal impairment or end-stage renal disease. (8.6)
•
Hepatic Impairment: Avoid use in patients with severe hepatic impairment. (8.7)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CIBINQO safely and effectively. See full prescribing information for CIBINQO.

CIBINQO® (abrocitinib) tablets, for oral use
Initial U.S. Approval: 2022

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

See full prescribing information for complete boxed warning.

•
Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with CIBINQO if serious or opportunistic infection occurs. 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. (5.1)
•
Higher rate of all-cause mortality, including sudden cardiovascular death, with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. CIBINQO is not approved for use in RA patients. (5.2)
•
Malignancies have occurred with CIBINQO. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. (5.3)
•
MACE has occurred with CIBINQO. Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. (5.4)
•
Thrombosis has occurred with CIBINQO. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. (5.5)

RECENT MAJOR CHANGES

Indications and Usage (1)

02/2023

Dosage and Administration (2.2, 2.3, 2.4, 2.5)

12/2023

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

•
For recommended testing, evaluations, and procedures prior to CIBINQO initiation, see Full Prescribing Information. (2.1)
•
Recommended dosage is 100 mg orally once daily. (2.2)
•
200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily. (2.2)
•
Moderate renal impairment: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. (2.3)
•
CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. (2.4)
•
For dosage modifications for certain adverse reactions, see Full Prescribing Information. (2.6)

DOSAGE FORMS AND STRENGTHS

CIBINQO Tablets: 50 mg, 100 mg, and 200 mg (3)

CONTRAINDICATIONS

Antiplatelet therapies except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment. (4)

WARNINGS AND PRECAUTIONS

•
Laboratory Abnormalities: Laboratory monitoring is recommended due to potential changes in platelets, lymphocytes, and lipids. (5.6)
•
Immunizations: Avoid use of live vaccines immediately prior to, during and immediately after CIBINQO treatment. (5.7)

ADVERSE REACTIONS

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. (6.1)

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. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Strong inhibitors of CYP2C19: The recommended dosage is 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. (2.5, 7.1)
•
Moderate to strong inhibitors of both CYP2C19 and CYP2C9, or strong CYP2C19 or CYP2C9 inducers: Avoid concomitant use. (7.1)
•
P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities: Monitor or titrate dosage of P-gp substrate. (7.2)

USE IN SPECIFIC POPULATIONS

•
Lactation: Breastfeeding not recommended. (8.2)
•
Renal Impairment: Avoid use in patients with severe renal impairment or end-stage renal disease. (8.6)
•
Hepatic Impairment: Avoid use in patients with severe hepatic impairment. (8.7)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2023
Medication Guide

Health Professional Information

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