Short prescribing information NOXAFIL^® (posaconazole)

NOXAFIL^®: AI: Posaconazole. I: Prophylaxis of invasive fungal infection, incl. yeasts and molds, in patients 13 years and older (tablets/oral suspension) and 2 years and older (infusion) who are at high risk of these infections; (adults or as of 2 years for IV) fusariosis: patients refractory to or intolerant of amphotericin B; chromoblastomycosis/mycetoma: patients refractory to or intolerant of itraconazole; coccidioidomycosis: patients refractory to or intolerant of amphotericin B, itraconazole, fluconazole. D: Tablet: Prophylaxis of invasive fungal infections/treatment of refractory invasive fungal infections: initial dose 300 mg (3×100 mg) twice daily on the first day, then 300 mg (3x 100 mg) once daily; regardless of food intake. Oral suspension: prophylaxis: 200 mg (5 ml) three times a day; taken with meals or food supplements. Refractory invasive fungal infections (IFI)/IFI and intolerability: 400 mg (10 ml) twice daily. 200 mg (5 ml) four times a day in patients who cannot take any meals or dietary supplements. Solution for infusion: adults: 1. day 300 mg twice daily, then 300 mg once daily administered via a central venous access over min. 90 minutes. Children from 2 to <12 years: 1st day 2x daily 6mg/kg, from 2nd day 1x daily 6mg/kg up to a maximum single dose of 300mg. Adolescents from 12 to <18 years: 1st day 2x daily 4.5mg/kg, from 2nd day 1x daily 4.5mg/kg up to a maximum single dose of 300mg. If necessary increase up to 6mg/kg. Caution in patients under 60 kg: raised plasma levels and toxicity possible. Special caution is required in patients over 120 kg: reduced posaconazole exposure possible. Duration of prophylaxis: depending on recovery after neutropenia or immunosuppression. In patients with acute myeloid leukaemia or myelodysplastic syndromes, prophylaxis should start several days before the expected onset of neutropenia and continue for 7 days after the number of neutrophils has risen to >500 cells per mm3. The duration of treatment depends on the severity of the underlying disease, recovery from immunosuppression, and clinical response. Control of the therapeutic agent is recommended. CI: Co-administration with ergot alkaloids, CYP3A4 substrates, HMG-CoA reductase inhibitors. Hypersensitivity to the active substance/excipients. Pr: Tablets and oral suspension are not interchangeable. In patients with hypersensitivity to other azoles, severe hepatic impairment, arrhythmic disorders, electrolyte imbalances, glucose-galactose malabsorption. Co-administration with medicines metabolised by CYP3A4, rifabutin, rifamycin antibiotics, certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz, cimetidine, sirolimus, medicines known to prolong QTc interval. Use together with vinca allkaloids should be avoided (benefit-risk assessment, if necessary dose reduction of the vinca alkaloid). Pseudoaldosteronism: Monitor blood pressure and potassium levels. DDI: rifabutin, efavirenz, phenytoin, fosamprenavir, flucloxacillin, CYP3A4 substrates, ergot alkaloids, CYP3A4-metabolised HMG-COA reductase inhibitors, vinca alkaloids, ciclosporin, tacrolimus, sirolimus, antiretroviral agents, midazolam/other CYP3A4-metabolised benzodiazepines, CYP3A4-metabolised calcium channel blockers, digoxin, sulfonylurea, macrolide antibiotics. P/L: Not recommended, contraception. Wean prior to therapy. UDE: Very common: Nausea. P: Tablets: 24 (2×12) and 96 (8×12) tablets of 100 mg; Suspension: 40 mg/ml Fl 105 ml; vial: 16.7 ml at 18 mg/ml concentrate. DC: B. MAH: MSD Merck Sharp & Dohme AG, Werftestrasse 4, 6005 Lucerne; (V5.0); CH-POS-00007.

Before prescribing, please consult the full prescribing information, published on the website of Swissmedic (www.swissmedicinfo-pro.ch).