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CAMPTOSAR®Index Section (irinotecan HCl)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: DIARRHEA and MYELOSUPPRESSION

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Colorectal Cancer Combination Regimens 1 and 2

2.2 Colorectal Single Agent Regimens 1 and 2

2.3 Dosage in Patients with Reduced UGT1A1 Activity

2.4 Premedication

2.5 Preparation of Infusion Solution

2.6 Safe Handling

2.7 Extravasation

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Diarrhea and Cholinergic Reactions

5.2 Myelosuppression

5.3 Patients With Reduced UGT1A1 Activity

5.4 Hypersensitivity

5.5 Renal Impairment/Renal Failure

5.6 Pulmonary Toxicity

5.7 Toxicity of the 5 Day Regimen

5.8 Increased Toxicity in Patients with Performance Status 2

5.9 Embryo-Fetal Toxicity

5.10 Patients with Hepatic Impairment

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 5-Fluorouracil (5-FU) and Leucovorin (LV)

7.2 Strong CYP3A4 Inducers

7.3 Strong CYP3A4 or UGT1A1 Inhibitors

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

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 Metastatic Colorectal Cancer

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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