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TORISEL®Index Section (temsirolimus)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Advanced Renal Cell Carcinoma

2.2 Premedication

2.3 Dosage Interruption/Adjustment

2.4 Dose Modification Guidelines

2.5 Instructions for Preparation

2.6 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity/Infusion Reactions

5.2 Hepatic Impairment

5.3 Hyperglycemia/Glucose Intolerance

5.4 Infections

5.5 Interstitial Lung Disease

5.6 Hyperlipidemia

5.7 Bowel Perforation

5.8 Renal Failure

5.9 Wound Healing Complications

5.10 Intracerebral Hemorrhage

5.11 Proteinuria and Nephrotic syndrome

5.12 Co-administration with Inducers or Inhibitors of CYP3A Metabolism

5.13 Concomitant use of TORISEL with sunitinib

5.14 Vaccinations

5.15 Embryo-Fetal Toxicity

5.16 Elderly Patients

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-marketing and Other Clinical Experience

7 DRUG INTERACTIONS

7.1 Agents Inducing CYP3A Metabolism

7.2 Agents Inhibiting CYP3A Metabolism

7.3 Angioedema with ACE inhibitors and Calcium Channel Blockers

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

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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