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CIBINQO Index Section (abrocitinib)

FULL PRESCRIBING INFORMATION: CONTENTS*

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

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Testing, Evaluations, and Procedures Prior to Treatment Initiation

2.2 Recommended Dosage

2.3 Recommended Dosage in Patients with Renal Impairment or Hepatic Impairment

2.4 Recommended Dosage in CYP2C19 Poor Metabolizers

2.5 Dosage Modifications due to Strong Inhibitors

2.6 Treatment Discontinuation due to Serious Infections or Hematologic Adverse Reactions

2.7 Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

5.2 Mortality

5.3 Malignancy and Lymphoproliferative Disorders

5.4 Major Adverse Cardiovascular Events

5.5 Thrombosis

5.6 Laboratory Abnormalities

5.7 Immunizations

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on CIBINQO

7.2 Effects of CIBINQO on Other Drugs

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 CYP2C19 Poor Metabolizers

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.5 Pharmacogenomics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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