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The safety of NOXAFIL delayed release 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 NOXAFIL delayed release 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. NOXAFIL 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 NOXAFIL delayed release tablets (300 mg once daily) were nausea and diarrhea.
The most frequently reported adverse reaction leading to discontinuation of NOXAFIL delayed release tablets 300 mg once daily was nausea.
Table 5 presents treatment-emergent adverse reactions observed in patients treated with 300 mg daily dose at an incidence of ≥ 10% in posaconazole modified release tablet study. (See Table 5.)
Click on icon to see table/diagram/imageNOXAFIL Oral Suspension: Drug-related adverse reactions observed in 2,400 subjects dosed with posaconazole oral suspension are shown in Table 6. 172 patients received posaconazole oral suspension therapy for ≥ 6 months; 58 of these received posaconazole oral suspension therapy for ≥ 12 months.
The most frequently reported adverse reactions reported across the whole population of healthy volunteers and patients were nausea (6%) and headache (6%). (See Table 6.)
Click on icon to see table/diagram/imagePost-marketing Experience: The following post-marketing adverse experience has been reported: Endocrine Disorders: pseudoaldosteronism.
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