Noxafil Adverse Reactions

Clinical Trials Experience: Posaconazole Tablets Safety: The safety of posaconazole tablets has been assessed in 230 patients enrolled in the pivotal clinical study. Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole tablets when given as antifungal prophylaxis. Patients were immunocompromised with underlying conditions including hematological malignancy, neutropenia post-chemotherapy, Graft versus Host Disease (GVHD), and post HSCT. 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).
The most frequently reported treatment-related adverse reactions (≥ 5%) with posaconazole tablets (300 mg once daily) were nausea and diarrhoea.
The most frequently reported adverse reaction leading to discontinuation of posaconazole tablets 300 mg once daily was nausea.
Posaconazole Oral Suspension Safety: The safety of posaconazole oral suspension has been assessed in 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience. One hundred seventy two patients received posaconazole therapy for ≥ 6 months; 58 of these received posaconazole therapy for ≥ 12 months.
Treatment related serious adverse events reported in 428 patients treated with posaconazole oral suspension with invasive fungal infections (1% each) included altered concentration of other medicinal products, increased hepatic enzymes, nausea, rash, and vomiting. Treatment-related serious adverse events reported in 605 patients treated with posaconazole oral suspension for prophylaxis (1% each) included bilirubinemia, increased hepatic enzymes, hepatocellular damage, nausea, and vomiting.
Uncommon and rare treatment related medically significant adverse events reported during clinical trials with posaconazole oral suspension have included adrenal insufficiency, pancreatitis, allergic and/or hypersensitivity reactions.
In addition, rare cases of torsade de pointes have been reported in patients taking posaconazole oral suspension.
In addition, rare cases of hemolytic uremic syndrome and thrombotic thrombocytopenic purpura have been reported primarily among patients who had been receiving concomitant cyclosporine or tacrolimus with posaconazole oral suspension for management of transplant rejection or graft vs. host disease.
Treatment-related adverse reactions (TRAEs) reported in posaconazole tablets and oral suspension studies: The most common treatment-related adverse reactions reported in posaconazole tablets and oral suspension studies across the whole population of healthy volunteers and patients are shown in Table 2. (See Table 2.)

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Post-marketing Experience: The following post-marketing adverse experience has been reported: Endocrine Disorders: pseudoaldosteronism.