6 ADVERSE REACTIONS

6.1 Serious and Otherwise Important Adverse Reactions
 
The following serious and otherwise important adverse reactions are discussed in detail in another section of the labeling:
•Hypersensitivity [see Contraindications (4.1)]
•Arrhythmias and QT Prolongation [see Warnings and Precautions (5.2)]
•Hepatic Toxicity [see Warnings and Precautions (5.3)]

6.2 Clinical Trials Experience
 
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of Noxafil cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, the type of adverse reactions reported for posaconazole delayed-release tablets were generally similar to that reported in trials of posaconazole oral suspension.

Clinical Trial Experience with Posaconazole Delayed-Release Tablets
 
The safety of posaconazole delayed-release tablets has been assessed in 230 patients in clinical trials. Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole delayed-release tablets when given as antifungal prophylaxis (Delayed-Release Tablet Study 1). Patients were immunocompromised with underlying conditions including hematological malignancy, neutropenia post-chemotherapy, GVHD, and post HSCT. This patient population was 62% male, had a mean age of 51 years (range 19-78 years, 17% of patients were ≥65 years of age), and were 93% white and 16% Hispanic. Posaconazole therapy was given for a median duration of 28 days. Twenty patients received 200 mg daily dose and 210 patients received 300 mg daily dose (following BID dosing on Day 1 in each cohort). Table 3 presents treatment-emergent adverse reactions observed in patients treated with 300 mg daily dose at an incidence of ≥10% in posaconazole delayed-release tablet study.
 
Table 3: Posaconazole Delayed-Release Tablet Study 1: Number (%) of Subjects Treated with 300 mg Daily Dose Reporting Treatment-Emergent Adverse Reactions: Frequency of at Least 10%
Body System
Preferred Term
 
Posaconazole delayed-release tablet (300 mg)
(n=210)
 
Subjects Reporting any Adverse Reaction 201 (99)
Blood and Lymphatic System Disorder
Anemia 22 (10)
Thrombocytopenia 29 (14)
Gastrointestinal Disorder
Abdominal Pain 23 (11)
Constipation 20 (10)
Diarrhea 61 (29)
Nausea 56 (27)
Vomiting 28 (13)
General Disorders and Administration Site Conditions
Asthenia 20 (10)
Chills 22 (10)
Mucosal Inflammation 29 (14)
Edema Peripheral 33 (16)
Pyrexia 59 (28)
Metabolism and Nutrition Disorders
Hypokalemia 46 (22)
Hypomagnesemia 20 (10)
Nervous System Disorders
Headache 30 (14)
Respiratory, Thoracic and Mediastinal Disorders
Cough 35 (17)
Epistaxis 30 (14)
Skin and Subcutaneous Tissue Disorders
Rash 34 (16)
Vascular Disorders
Hypertension 23 (11)
 
The most frequently reported adverse reactions (>25%) w