sea 48 (9) 30 (11) 70 (29)
Vomiting 37 (7) 18 (7) 67 (28)
Abdominal Pain 27 (5) 17 (6) 43 (18)
Infection and Infestations
Candidiasis, Oral 3 (1) 1 (<1) 28 (12)
Herpes Simplex 16 (3) 8 (3) 26 (11)
Pneumonia 17 (3) 6 (2) 25 (10)
Metabolic and Nutritional Disorders
Weight Decrease 4 (1) 2 (1) 33 (14)
Dehydration 4 (1) 7 (3) 27 (11)
Psychiatric Disorders
Insomnia 8 (1) 3 (1) 39 (16)
Respiratory System Disorders
Coughing 18 (3) 11 (4) 60 (25)
Dyspnea 8 (1) 8 (3) 28 (12)
Skin and Subcutaneous Tissue Disorders
Rash 15 (3) 10 (4) 36 (15)
Sweating Increased 13 (2) 5 (2) 23 (10)
Adverse reactions were reported more frequently in the pool of patients with refractory OPC. Among these highly immunocompromised patients with advanced HIV disease, serious adverse reactions (SARs) were reported in 55% (132/239). The most commonly reported SARs were fever (13%) and neutropenia (10%).
Less Common Adverse Reactions: Clinically significant adverse reactions reported during clinical trials in prophylaxis, OPC/rOPC or other trials with posaconazole which occurred in less than 5% of patients are listed below:
• Blood and lymphatic system disorders: hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, neutropenia aggravated
• Endocrine disorders: adrenal insufficiency
• Nervous system disorders: paresthesia
• Immune system disorders: allergic reaction [see Contraindications (4.1)]
• Cardiac disorders: Torsades de pointes [see Warnings and Precautions (5.2)]
• Vascular disorders: pulmonary embolism
• Liver and Biliary System Disorders: bilirubinemia, hepatic enzymes increased, hepatic function abnormal, hepatitis, hepatomegaly, jaundice, AST Increased, ALT Increased
• Metabolic and Nutritional Disorders: hypokalemia
• Platelet, Bleeding, and Clotting Disorders: thrombocytopenia
• Renal & Urinary System Disorders: renal failure acute
Clinical Laboratory Values: In healthy volunteers and patients, elevation of liver function test values did not appear to be associated with higher plasma concentrations of posaconazole.
For the prophylaxis studies, the number of patients with changes in liver function tests from Common Toxicity Criteria (CTC) Grade 0, 1, or 2 at baseline to Grade 3 or 4 during the study is presented in Table 6.
Table 6: Posaconazole Oral Suspension Study 1 and Study 2. Changes in Liver Function Test Results from CTC Grade 0, 1, or 2 at Baseline to Grade 3 or 4
Number (%) of Patients With Change*
CTC = Common Toxicity Criteria; AST= Aspartate Aminotransferase;
ALT= Alanine Aminotransferase.
* Change from Grade 0 to 2 at baseline to Grade 3 or 4 during the study. These data are presented in the form X/Y, where X represents the number of patients who met the criterion as indicated, and Y represents the number of patients who had a baseline observation and at least one post-baseline observation.
Oral Suspension Study 1
Laboratory Parameter Posaconazole
n=301 Fluconazole
n=299
AST 11/266 (4) 13/266 (5)
ALT 47/271 (17) 39/272 (14)
Bilirubin 24/271 (9) 20/275 (7)
Alkaline Phosphatase 9/271 (3) 8/271 (3)
Oral Suspension Study 2
Laboratory Parameter Posaconazole
(n=304) Fluconazole/
