Voriconazole drug data and news

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Fungal prosthetic mitral valve endocarditis caused by ...  May 9, 2006
...as S brevicaulis and demonstrated mean inhibitory concentrations of 4 µg/mL to amphotericin B, 1 µg/mL to terbinafine, 8 µg/mL to voriconazole, and greater ... - The Journal of Thoracic and Cardiovascular Surgery

Bristol-Myers Squibb and Gilead Sciences Submit New Drug ...  Apr 27, 2006
Propulsid(R) (cisapride), Versed(R) (midazolam), Halcion(R) (triazolam), ergot medicines (for example, Wigraine(R) and Cafergot(R)), or Vfend(R) (voriconazole ... - International News Service,

Bristol-Myers Squibb  Apr 27, 2006
Propulsid® (cisapride), Versed® (midazolam), Halcion® (triazolam), ergot medicines (for example, Wigraine® and Cafergot®), or Vfend® (voriconazole). ... - WebWire (press release),

Tables 9 and 10 provide a summary of significant drug interactions with voriconazole that either have been studied in vivo (clinically) or that may be expected to occur based on results of in vitro metabolism studies with human liver microsomes. For more details, see CLINICAL PHARMACOLOGY - Drug Interactions.

Table 9
Effect of Other Drugs on Voriconazole Pharmacokinetics

*Results based on in vivo clinical studies generally following repeat oral dosing with 200 mg Q12h voriconazole to healthy subjects

**Results based on in vivo clinical study following repeat oral dosing with 400 mg Q12h for 1 day, then 200 mg Q12h for 8 days voriconazole to healthy subjects

*** Non-Nucleoside Reverse Transcriptase Inhibitors

Table 10
Effect of Voriconazole on Pharmacokinetics of Other Drugs

*Results based on in vivo clinical studies generally following repeat oral dosing with 200 mg BID voriconazole to healthy subjects

**Results based on in vivo clinical study following repeat oral dosing with 400 mg Q12h for 1 day, then 200 mg Q12h for 8 days voriconazole to healthy subjects

*** Results based on in vivo clinical study following repeat oral dosing with 400 mg Q12h for 1 day, then 200 mg Q12h for 4 days voriconazole to subjects receiving a methadone maintenance dose (30-100 mg QD)

**** Non-Nucleoside Reverse Transcriptase Inhibitors

Patients with Hepatic Insufficiency

It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B) receiving VFEND.

VFEND has not been studied in patients with severe cirrhosis (Child-Pugh Class C). VFEND has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and should only be used in patients with severe hepatic insufficiency if the benefit outweighs the potential risk. Patients with hepatic insufficiency must be carefully monitored for drug toxicity.

Patients with Renal Insufficiency

In patients with moderate to severe renal dysfunction (creatinine clearance <50 mL/min), accumulation of the intravenous vehicle, SBECD, occurs. Oral voriconazole should be administered to these patients, unless an assessment of the benefit/risk to the patient justifies the use of intravenous voriconazole. Serum creatinine levels should be closely monitored in these patients, and if increases occur, consideration should be given to changing to oral voriconazole therapy.

Renal Adverse Events

Acute renal failure has been observed in severely ill patients undergoing treatment with VFEND. Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medications and have concurrent conditions that may result in decreased renal function.

Monitoring of Renal Function

Patients should be monitored for the development of abnormal renal function. This should include laboratory evaluation, particularly serum creatinine.

Dermatological Reactions

Patients have rarely developed serious cutaneous reactions, such as Stevens-Johnson syndrome, during treatment with VFEND. If patients develop a rash, they should be monitored closely and consideration given to discontinuation of VFEND. VFEND has been infrequently associated with photosensitivity skin reaction, especially during long-term therapy. It is recommended that patients avoid strong, direct sunlight during VFEND therapy.