Posatif Adverse Reactions

Posaconazole Delayed Release Tablets: In clinical trials, the type and frequency of adverse effects reported for posaconazole modified release tablets were generally similar to that reported in trials of posaconazole oral suspension.
The safety of posaconazole 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 posaconazole 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. 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 delayed release tablets (300 mg once daily) were nausea and diarrhea.
The most frequently reported adverse reaction leading to discontinuation of posaconazole delayed release tablets 300 mg once daily was nausea.
Table 4 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 4.)

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Postmarketing Experience: The following adverse reaction has been identified during the post-approval use of posaconazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Endocrine Disorders: Pseudoaldosteronism.