VTTACK

What it is

VTTACK is voriconazole 200 mg powder for injection, a white lyophilised powder supplied in a 25 mL Type I clear glass vial. It is intended for administration by intravenous infusion. It is a single dose, unpreserved product.

Approved indications

— Invasive aspergillosis. — Serious Candida infections (including C. krusei), including systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). — Serious fungal infections caused by Scedosporium spp and Fusarium spp. — Other serious fungal infections, in patients intolerant of, or refractory to, other therapy. — Prophylaxis in patients who are at high risk of developing invasive fungal infections.

Dosing overview

VTTACK is administered at a maximum rate of 3 mg/kg per hour over 1 to 2 hours. It is not recommended for bolus injection.

Key safety warnings

Some azoles, including voriconazole, have been associated with QT interval prolongation. There have been rare cases of torsades de pointes in patients taking voriconazole who had risk factors, such as history of cardiotoxic chemotherapy, cardiomyopathy, hypokalemia and concomitant medications that may have been contributory. Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be corrected prior to initiation of voriconazole therapy and monitored during treatment. Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported with the use of voriconazole. If a patient develops a suspected SCAR, voriconazole should be discontinued immediately and an alternative treatment should be considered. Voriconazole has been associated with photosensitivity skin reaction. It is recommended that patients avoid exposure to direct sunlight during voriconazole treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF). In clinical trials, there have been cases of serious hepatic reactions during treatment with voriconazole (including clinical hepatitis, cholestasis and fulminant hepatic failure including fatalities). Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy). Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. Liver dysfunction has usually been reversible on discontinuation of therapy. Patients receiving voriconazole must be carefully monitored for hepatic toxicity. Anaphylactoid-type reactions, including flushing, fever, sweating, tachycardia, chest tightness, dyspnoea, faintness, nausea, pruritus and rash have occurred during the administration of the intravenous formulation of voriconazole.

Contraindications

VTTACK is contraindicated in patients with known hypersensitivity to voriconazole or to any of the excipients. Co-administration of the CYP3A4 substrates, terfenadine, pimozide, quinidine or ivabradine with voriconazole is contraindicated since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes. Co-administration of voriconazole with rifabutin, rifampicin, carbamazepine and long-acting barbiturates (e.g. phenobarbitone) is contraindicated. Co-administration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, is contraindicated since increased plasma concentrations of these medicinal products can lead to ergotism. Co-administration of voriconazole and sirolimus is contraindicated, since voriconazole is likely to increase plasma concentrations of sirolimus significantly. Co-administration of voriconazole with St John's Wort is contraindicated.

Regulatory history

VTTACK voriconazole 200 mg film coated tablet was first listed on the Australian Register of Therapeutic Goods (ARTG 206985) on 9 September 2015 under licence category RE.