utropenic patients
1.2 Treatment of Candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections
1.3 Treatment of Esophageal Candidiasis
1.4 Treatment of Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies
2. DOSAGE AND ADMINISTRATION
2.1 Instructions for Use in All Patients
2.2 Recommended Dosing in Adult Patients [≥18 years of age]
2.3 Recommended Dosing in Pediatric Patients [3 months to 17 years of age]
2.4 Patients with Hepatic Insufficiency
2.5 Patients Receiving Concomitant Inducers of Drug Clearance
2.6 Preparation and Reconstitution for Administration
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Concomitant Use with Cyclosporine
5.2 Hepatic Effects
5.3 Duration and Dose of CANCIDAS
6. ADVERSE REACTIONS
6.1 Clinical Trials Experience in Adults
6.2 Clinical Trials Experience in Pediatric Patients (3 months to 17 years of age)
6.3 Overall Safety Experience of CANCIDAS in Clinical Trials
6.4 Postmarketing Experience
7. DRUG INTERACTIONS
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Patients with Hepatic Insufficiency
8.7 Patients with Renal Insufficiency
10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism Of Action
12.3 Pharmacokinetics
12.4 Microbiology
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility
13.2 Animal Toxicology And/Or Pharmacology
14. CLINICAL STUDIES
14.1 Empirical Therapy in Febrile, Neutropenic Patients
14.2 Candidemia and the following other Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections
14.3 Esophageal Candidiasis (and information on oropharyngeal candidiasis)
14.4 Invasive Aspergillosis
14.5 Pediatric Patients
15. REFERENCES
16. HOW SUPPLIED/STORAGE AND HANDLING
17. PATIENT COUNSELING INFORMATION
17.1 Instructions
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FULL PRESCRIBING INFORMATION
1. INDICATIONS AND USAGE
CANCIDAS1 is indicated in adults and pediatric patients (3 months and older) for:
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1.1 Empirical therapy for presumed fungal infections in febrile, neutropenic patients
1.2 Treatment of Candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections
CANCIDAS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.
1.3 Treatment of Esophageal Candidiasis
[see Clinical Studies (14.3)]
1.4 Treatment of Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies
(i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). CANCIDAS has not been studied as initial therapy for invasive aspergillosis.
2. DOSAGE AND ADMINISTRATION
2.1 Instructions for Use in All Patients
CANCIDAS should be administered by slow intravenous infusion (IV) over approximately 1 ho
