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)

2/2023

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 prior to, during, and immediately after CIBINQO treatment. (5.7)

ADVERSE REACTIONS

Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis.

Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, 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 dose 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: 2/2023

Find CIBINQO medical information:

Find CIBINQO medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

CIBINQO Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

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)

2/2023

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 prior to, during, and immediately after CIBINQO treatment. (5.7)

ADVERSE REACTIONS

Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis.

Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, 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 dose 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: 2/2023
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information. 8AM-9PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.