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INFLECTRA®Index Section (infliximab-dyyb)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SERIOUS INFECTIONS and MALIGNANCY

1 INDICATIONS AND USAGE

1.1 Crohn's Disease

1.2 Pediatric Crohn's Disease

1.3 Ulcerative Colitis

1.4 Pediatric Ulcerative Colitis

1.5 Rheumatoid Arthritis

1.6 Ankylosing Spondylitis

1.7 Psoriatic Arthritis

1.8 Plaque Psoriasis

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Crohn's Disease

2.2 Dosage in Pediatric Crohn's Disease

2.3 Dosage in Adult Ulcerative Colitis

2.4 Dosage in Pediatric Ulcerative Colitis

2.5 Dosage in Rheumatoid Arthritis

2.6 Dosage in Ankylosing Spondylitis

2.7 Dosage in Psoriatic Arthritis

2.8 Dosage in Plaque Psoriasis

2.9 Assessment for Latent and Active Tuberculosis

2.10 Administration Instructions Regarding Infusion Reactions

2.11 Reconstitution, Dilution, and Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

5.2 Malignancies

5.3 Hepatitis B Virus Reactivation

5.4 Hepatotoxicity

5.5 Heart Failure

5.6 Hematologic Reactions

5.7 Hypersensitivity

5.8 Cardiovascular and Cerebrovascular Reactions During and After Infusion

5.9 Neurologic Reactions

5.10 Concurrent Administration with Other Biological Products

5.11 Switching Between Biological Disease-Modifying Antirheumatic Drugs (DMARDs)

5.12 Autoimmunity

5.13 Vaccinations and Use of Live Vaccines/Therapeutic Infectious Agents

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Immunogenicity

6.3 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Other Biological Products

7.2 Methotrexate and Other Concomitant Medications

7.3 Immunosuppressants

7.4 Cytochrome P450 Substrates

7.5 Live Vaccines/Therapeutic Infectious Agents

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

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 Adult Crohn's Disease

14.2 Pediatric Crohn's Disease

14.3 Adult Ulcerative Colitis

14.4 Pediatric Ulcerative Colitis

14.5 Rheumatoid Arthritis

14.6 Ankylosing Spondylitis

14.7 Psoriatic Arthritis

14.8 Plaque Psoriasis

15 REFERENCES

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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