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NIVESTYM™ Index Section (filgrastim-aafi)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy

1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy

1.3 Patients with Cancer Undergoing Bone Marrow Transplantation

1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy

1.5 Patients with Severe Chronic Neutropenia

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Patients with Cancer Receiving Myelosuppressive Chemotherapy or Induction and/or Consolidation Chemotherapy for AML

2.2 Dosage in Patients with Cancer Undergoing Bone Marrow Transplantation

2.3 Dosage in Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy

2.4 Dosage in Patients with Severe Chronic Neutropenia

2.5 Important Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Splenic Rupture

5.2 Acute Respiratory Distress Syndrome

5.3 Serious Allergic Reactions

5.4 Sickle Cell Disorders

5.5 Glomerulonephritis

5.6 Alveolar Hemorrhage and Hemoptysis

5.7 Capillary Leak Syndrome

5.8 Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

5.9 Thrombocytopenia

5.10 Leukocytosis

5.11 Cutaneous Vasculitis

5.12 Potential Effect on Malignant Cells

5.13 Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended

5.14 Nuclear Imaging

5.15 Aortitis

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Immunogenicity

6.3 Postmarketing Experience

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

13.2 Animal Toxicology and Pharmacology

14 CLINICAL STUDIES

14.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy

14.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy

14.3 Patients with Cancer Undergoing Bone Marrow Transplantation

14.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy

14.5 Patients with Severe Chronic Neutropenia

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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Sections or subsections omitted from the full prescribing information are not listed.
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