ty of posaconazole oral suspension has been assessed in 1844 patients. This includes 605 patients in the active-controlled prophylaxis studies, 557 patients in the active-controlled OPC studies, 239 patients in refractory OPC studies, and 443 patients from other indications. This represents a heterogeneous population, including immunocompromised patients, e.g., patients with hematological malignancy, neutropenia post-chemotherapy, GVHD post HSCT, and HIV infection, as well as non-neutropenic patients. This patient population was 71% male, had a mean age of 42 years (range 8-84 years, 6% of patients were ≥65 years of age and 1% was <18 years of age), and were 64% white, 16% Hispanic, and 36% non-white (including 14% black). Posaconazole therapy was given to 171 patients for ≥6 months, with 58 patients receiving posaconazole therapy for ≥12 months. Table 4 presents treatment-emergent adverse reactions observed at an incidence of >10% in posaconazole prophylaxis studies. Table 5 presents treatment-emergent adverse reactions observed at an incidence of at least 10% in the OPC/rOPC studies.
Prophylaxis of Aspergillus and Candida: In the 2 randomized, comparative prophylaxis studies (Oral Suspension Studies 1 and 2), the safety of posaconazole oral suspension 200 mg three times a day was compared to fluconazole 400 mg once daily or itraconazole 200 mg twice a day in severely immunocompromised patients.
The most frequently reported adverse reactions (>30%) in the prophylaxis clinical trials were fever, diarrhea, and nausea.
The most common adverse reactions leading to discontinuation of posaconazole in the prophylaxis studies were associated with GI disorders, specifically, nausea (2%), vomiting (2%), and hepatic enzymes increased (2%).
Table 4: Posaconazole Oral Suspension Study 1 and Study 2. Number (%) of Randomized Subjects Reporting Treatment-Emergent Adverse Reactions: Frequency of at Least 10% in the Posaconazole Oral Suspension or Fluconazole Treatment Groups (Pooled Prophylaxis Safety Analysis)
Body System
Preferred Term
Posaconazole
(n=605)
Fluconazole
(n=539)
Itraconazole
(n=58)
* Percentages of sex-specific adverse reactions are based on the number of males/females.
Subjects Reporting any Adverse Reaction 595 (98) 531 (99) 58 (100)
Body as a Whole - General Disorders
Fever 274 (45) 254 (47) 32 (55)
Headache 171 (28) 141 (26) 23 (40)
Rigors 122 (20) 87 (16) 17 (29)
Fatigue 101 (17) 98 (18) 5 (9)
Edema Legs 93 (15) 67 (12) 11 (19)
Anorexia 92 (15) 94 (17) 16 (28)
Dizziness 64 (11) 56 (10) 5 (9)
Edema 54 (9) 68 (13) 8 (14)
Weakness 51 (8) 52 (10) 2 (3)
Cardiovascular Disorders, General
Hypertension 106 (18) 88 (16) 3 (5)
Hypotension 83 (14) 79 (15) 10 (17)
Disorders of Blood and Lymphatic System
Anemia 149 (25) 124 (23) 16 (28)
Neutropenia 141 (23) 122 (23) 23 (40)
Disorders of the Reproductive System and Breast
Vaginal Hemorrhage* 24 (10) 20 (9) 3 (12)
Gastrointestinal System Disorders
Diarrhea 256 (42) 212 (39) 35 (60)
Nausea 232 (38) 198 (37) 30 (52)
Vomiting 174 (29) 173 (32) 24 (41)
Abdominal Pain 161 (27) 147 (27) 21 (36)
Constipation 126 (21) 94 (17) 10 (17)
Dyspepsia 61 (10) 50 (9) 6 (10)
Heart Rate and Rhythm Disorders
Tachycardia 72 (12) 75 (14) 3 (5)
Infection and Infestations
Pharyngitis 71 (12) 60 (11) 12 (21)
Liver and Biliary Syst
