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XELJANZ / XELJANZ XR Index Section (tofacitinib)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY AND THROMBOSIS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 Recommended Dosage in Rheumatoid Arthritis and Psoriatic Arthritis

2.3 Recommended Dosage in Ulcerative Colitis

2.4 Recommended Dosage in Polyarticular Course Juvenile Idiopathic Arthritis

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 Thrombosis

5.5 Gastrointestinal Perforations

5.6 Hypersensitivity

5.7 Laboratory Abnormalities

5.8 Vaccinations

5.9 Risk of Gastrointestinal Obstruction with a Non-Deformable Extended-Release Formulation such as XELJANZ XR

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

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 Use in Diabetics

8.7 Renal Impairment

8.8 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Rheumatoid Arthritis

14.2 Psoriatic Arthritis

14.3 Ulcerative Colitis

14.4 Polyarticular Course Juvenile Idiopathic Arthritis

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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