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PDR® PHYSICIANS DESK REFERENCE ADDENDUM Healthcare Professional Pfizer Inc is pleased to announce that VFEND (voriconazole) is now indicated for the treatment of esophageal candidiasis, and is also available as a 40 mg/mL powder for oral suspension. The recommended dosing regimen for the treatment of esophageal cnadidiasis is an oral dose of 200mg every 12 hours for patients weighing 40kg or more. Adult patients who weigh less than 40Kg should receive an oral dose of 100 mg every 12 hours. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms. VFEND is also indicated for the primary treatment of invasive asperfillosis and additionally for serious fungal infections caused by Scedosporium apiospermum and Fusarium spp incliding Fusarium solani, in patients intolerant of, or refractory to, other therapy, VFEND is also available in tablet (50 mg and 200 mg strengths) and IV (200 mg) dosage forms. The efficacy of VFEND in the primary treatment of esophageal candidiasis was demonstrated in a double-blind, double-dummy randomized study in immunocompromised patients with endoscopically proven esohageal candidiasis. Patients were treated for a median of 15 days (range 1 to 49 days) with either oral voriconazole 200 mg fluconazole were 98.2% vs 95%, respectively, in the per protocol population, as well as 87.5% vs 89.5% respectively, in the intent-to-treat population. Results with voriconazole showed comparable efficacy rates against esophageal candidiasis. VFEND is contraindicated in patients with a known hypersensitivity to voriconazole or its excipients, and in patients receiving terfenadine, astemizole, cisapride, quinidine, sirolimus, rifampin, carbamazepine, long-acting barbiturates, ritonavir (400 mg every 12 hours), efravirenz, rifabutin, and ergot alkaloids. The most frequently reported adverse events (all casualties) in the therapeutic trials were visuals disturbances, fever, rash, vomitting, nausea, diarrhea, headache, sepsis, peripheral edema, abdominal paon, and respiratory disorder. Voriconazole treatment-related visual disturbances are common. The effect of VFEND on visual function is not known if treatment continues beyond 28 days. If treatement continues beyond 28 days, visual function, including visual field and color perception, should be monitored. Patients should be advised not to drive at night while taking VFEND. If they perceive any change in vision, they should avoid potentially hazardous tasks, such as driving or operating machinery. In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with VFEND (clinical hepatitis, choletasis, and fulminanat hepatic failure, including fatalities). Therefore, liver function tests should be evaluated at the start of and during the course of VFEND therapy. VFEND should only be used in patients with sever hepatic insufficiency if the benefit outweighs the potential risk. Thomas Fleming, PharmD Manager, Professional Services & Chief Clinical Consultant |
