Single Vial Docetaxel Injection - ION Solutions
Single Vial Docetaxel Injection - ION Solutions
Single Vial Docetaxel Injection - ION Solutions
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FULL PRESCRIBING INFORMAT<strong>ION</strong>: CONTENTS*<br />
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA,<br />
HYPERSENSITIVITY REACT<strong>ION</strong>S, AND FLUID RETENT<strong>ION</strong><br />
1 INDICAT<strong>ION</strong>S AND USAGE<br />
1.1 Breast Cancer<br />
1.2 Non-Small Cell Lung Cancer<br />
1.3 Prostate Cancer<br />
2 DOSAGE AND ADMINISTRAT<strong>ION</strong><br />
2.1 Breast Cancer<br />
2.2 Non-Small Cell Lung Cancer<br />
2.3 Prostate Cancer<br />
2.6 Premedication Regimen<br />
2.7 Dosage Adjustments During Treatment<br />
2.8 Administration Precautions<br />
2.9 Preparation and Administration<br />
2.10 Stability<br />
3 DOSAGE FORMS AND STRENGTHS<br />
4 CONTRAINDICAT<strong>ION</strong>S<br />
5 WARNINGS AND PRECAUT<strong>ION</strong>S<br />
5.1 Toxic Deaths<br />
5.2 Hepatic Impairment<br />
5.3 Hematologic Effects<br />
5.4 Hypersensitivity Reactions<br />
5.5 Fluid Retention<br />
5.6 Acute Myeloid Leukemia<br />
5.7 Cutaneous Reactions<br />
5.8 Neurologic Reactions<br />
5.9 Asthenia<br />
5.10 Use in Pregnancy<br />
6 ADVERSE REACT<strong>ION</strong>S<br />
6.1 Clinical Trial Experience<br />
6.2 Post-Marketing Experiences<br />
7 DRUG INTERACT<strong>ION</strong>S<br />
8 USE IN SPECIFIC POPULAT<strong>ION</strong>S<br />
8.1 Pregnancy<br />
8.3 Nursing Mothers<br />
8.4 Pediatric Use<br />
8.5 Geriatric Use<br />
8.6 Hepatic Impairment<br />
10 OVERDOSAGE<br />
11 DESCRIPT<strong>ION</strong><br />
12 CLINICAL PHARMACOLOGY<br />
12.1 Mechanism of Action<br />
12.3 Human Pharmacokinetics<br />
13 NONCLINICAL TOXICOLOGY<br />
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility<br />
14 CLINICAL STUDIES<br />
14.1 Locally Advanced or Metastatic Breast Cancer<br />
14.2 Adjuvant Treatment of Breast Cancer<br />
14.3 Non-Small Cell Lung Cancer (NSCLC)<br />
14.4 Hormone Refractory Prostate Cancer<br />
15 REFERENCES<br />
16 HOW SUPPLIED/STORAGE AND HANDLING<br />
16.1 How Supplied<br />
16.2 Storage<br />
16.3 Handling and Disposal<br />
17 PATIENT COUNSELING INFORMAT<strong>ION</strong><br />
* Sections or subsections omitted from the full prescribing information<br />
are not listed<br />
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