Classes
DEA Class; Rx
Common Brand Names; Vfend
- Antifungals, Systemic;
Description
IV and oral azole antifungal drug
Indicated for aspergillosis, candidiasis, candidemia, and as salvage therapy for Scedosporium and Fusarium sp. infections
Associated with visual disturbances, QT prolongation, and phototoxicity
Indications
In clinical trials, the majority of isolates recovered were Aspergillus fumigatus
Indicated for candidemia in non-neutropenic patients with other deep tissue Candida infections (eg, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis)
Candida albicans, Candida glabrata, Candida krusei
Caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in patients intolerant of or refractory to other therapy
Contraindications
Hypersensitivity
Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Coadministration with cisapride, astemizole, cisapride, lurasidone, pimozide, quinidine, ivabradine, efavirenz (doses ≥400 mg/day), ritonavir (high dose – 400 mg q12hr), ergot alkaloids (ergotamine, dihydroergotamine), rifabutin, sirolimus, St. John’s wort, rifampin, carbamazepine, barbiturates, naloxegol, or tolvaptan
Coadministration with venetoclax at initiation and during ramp-up phase in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
Cautions
Hypersensitivity to other azoles
Do not give IV bolus
Review patient’s concomitant medications
Caution with renal impairment; patients should be monitored for development of abnormal renal function; this should include laboratory evaluation of serum creatinine
Serious hepatic reactions reported; evaluate liver function tests at start of and during therapy; hepatic function should be monitored in both adult and pediatric patients; a higher frequency of liver enzyme elevations was observed in the pediatric patients
Discontinue for exfoliative cutaneous reactions or phototoxicity; avoid sunlight due to risk of photosensitivity
Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, reported; if patient develops a severe cutaneous adverse reaction, therapy should be discontinued
No activity against Zygomycetes; some evidence suggests expanded use associated with increase incidence of zygomycosis
Visual disturbances, including optic neuritis and papilledema, reported; monitor visual function if treatment lasts >28 days
Adverse Effects
- Visual changes (photophobia, color changes, increased or decreased visual acuity, or blurred vision occur in 21%)
- Tachycardia
- Hypertension
- Hypotension
- Vasodilation
- Peripheral edema
- Fever
- Chills
- Headache
- Hallucinations
- Dizziness
- Rash
- Pruritus
- Photosensitizing skin reactions
- Hypokalemia
- Hypomagnesemia
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Xerostomia
- Thrombocytopenia
- Alkaline phosphatase increased
- Serum transaminases increased, ALT/AST increased
- Cholestatic jaundice
- ARF
Pregnancy and Lactation
Therapy can cause fetal harm when administered to a pregnant woman; there are no available data on pregnant women
Advise females of reproductive potential to use effective contraception during treatment
No data are available regarding presence of drug in human milk, the effects of voriconazole on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child or from underlying maternal condition
Maximum Dosage
weighing 40 kg or more: 12 mg/kg/day IV; 600 mg/day PO is FDA-approved maximum; however, doses up to 800 mg/day PO have been used off-label.
weighing less than 40 kg: 12 mg/kg/day IV; 300 mg/day PO is FDA-approved maximum; however, doses up to 800 mg/day PO have been used off-label.
weighing 40 kg or more: 12 mg/kg/day IV; 600 mg/day PO is FDA-approved maximum; however, doses up to 800 mg/day PO have been used off-label.
weighing less than 40 kg: 12 mg/kg/day IV; 300 mg/day PO is FDA-approved maximum; however, doses up to 800 mg/day PO have been used off-label.
15 to 17 years weighing 40 kg or more: 12 mg/kg/day IV; 600 mg/day PO is FDA-approved maximum; however, doses up to 800 mg/day PO have been used off-label.
15 to 17 years weighing less than 40 kg: 12 mg/kg/day IV; 300 mg/day PO is FDA-approved maximum; however, doses up to 800 mg/day PO have been used off-label.
13 to 14 years weighing 50 kg or more: 12 mg/kg/day IV; 600 mg/day PO is FDA-approved maximum; however, doses up to 800 mg/day PO have been used off-label.
13 to 14 years weighing less than 50 kg: 18 mg/kg/day IV; 18 mg/kg/day PO (Max: 700 mg/day) is FDA-approved maximum; however, doses up to 800 mg/day PO have been used off-label.
12 years weighing 50 kg or more: 12 mg/kg/day IV; 600 mg/day PO.
12 years weighing less than 50 kg: 18 mg/kg/day IV; 18 mg/kg/day PO (Max: 700 mg/day).
2 to 11 years: 18 mg/kg/day IV; 18 mg/kg/day PO (Max: 700 mg/day).
younger than 2 years: Safety and efficacy have not been established; however, doses up to 18 mg/kg/day IV/PO have been used off-label.
Safety and efficacy have not been established; however, doses up to 18 mg/kg/day IV/PO have been used off-label.
Safety and efficacy have not been established; however, doses up to 18 mg/kg/day IV and 8 mg/kg/day PO have been used off-label.
How supplied
Voriconazole
oral suspension
- 200mg/5mL
injection, powder for reconstitution
- 200mg
tablets
- 50mg
- 200mg
