STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Use with Sirolimus
4.3 QT Prolongation with Concomitant Use with CYP3A4 Substrates
4.4 HMG-CoA Reductase Inhibitors Primarily Metabolized Through CYP3A4
4.5 Use with Ergot Alkaloids
5 WARNINGS AND PRECAUTIONS
5.1 Calcineurin-Inhibitor Drug Interactions
5.2 Arrhythmias and QT Prolongation
5.3 Hepatic Toxicity
5.4 Use with Midazolam
6 ADVERSE REACTIONS
6.1 Serious and Otherwise Important Adverse Reactions
6.2 Clinical Trials Experience
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Immunosuppressants Metabolized by CYP3A4
7.2 CYP3A4 Substrates
7.3 HMG-CoA Reductase Inhibitors (Statins) Primarily Metabolized Through CYP3A4
7.4 Ergot Alkaloids
7.5 Benzodiazepines Metabolized by CYP3A4
7.6 Anti-HIV Drugs
7.7 Rifabutin
7.8 Phenytoin
7.9 Gastric Acid Suppressors/Neutralizers
7.10 Vinca Alkaloids
7.11 Calcium Channel Blockers Metabolized by CYP3A4
7.12 Digoxin
7.13 Gastrointestinal Motility Agents
7.14 Glipizide
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.8 Gender
8.9 Race
8.10 Weight
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Prophylaxis of Aspergillus and Candida Infections with Posaconazole Oral Suspension
14.2 Treatment of Oropharyngeal Candidiasis with Posaconazole Oral Suspension
14.3 Posaconazole Oral Suspension Treatment of Oropharyngeal Candidiasis Refractory to Treatment with Fluconazole or Itraconazole
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Administration
17.2 Drug Interactions
17.3 Serious and Potentially Serious Adverse Reactions
* Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Prophylaxis of Invasive Aspergillus and Candida Infections
Noxafil® delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
1.2 Treatment of Oropharyngeal Candidiasis Including Oropharyngeal C
