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bortezomib injection 1 MG and 2.5 MG VIAL Index Section (bortezomib for injection)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Multiple Myeloma

1.2 Mantle Cell Lymphoma in Adult Patients Who Have Received at Least 1 Prior Therapy

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Guidelines

2.2 Dosage in Previously Untreated Multiple Myeloma

2.3 Dose Modification Guidelines for Bortezomib for Injection When Given in Combination with Melphalan and Prednisone

2.4 Dosage and Dose Modifications for Relapsed Multiple Myeloma and Relapsed Mantle Cell Lymphoma

2.5 Dose Modifications for Peripheral Neuropathy

2.6 Dosage in Patients with Hepatic Impairment

2.7 Administration Precautions

2.8 Reconstitution/Preparation for Intravenous and Subcutaneous Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Peripheral Neuropathy

5.2 Hypotension

5.3 Cardiac Toxicity

5.4 Pulmonary Toxicity

5.5 Posterior Reversible Encephalopathy Syndrome (PRES)

5.6 Gastrointestinal Toxicity

5.7 Thrombocytopenia/Neutropenia

5.8 Tumor Lysis Syndrome

5.9 Hepatic Toxicity

5.10 Thrombotic Microangiopathy

5.11 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Bortezomib

7.2 Drugs Without Clinically Significant Interactions with Bortezomib

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 Patients with Diabetes

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

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Multiple Myeloma

14.2 Mantle Cell Lymphoma in Adult Patients Who Have Received at Least 1 Prior Therapy

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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