Basic Information
VORICONAZOLE KABI POWDER FOR SOLUTION FOR INFUSION 200MG/VIAL
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Regulatory Information
SIN16509P
June 9, 2022
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
June 3, 2025
XJ02AC03
Company Information
Active Ingredients
Strength: 200 mg/vial
Detailed Information
Contraindications
**4.3 Contraindications** Voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or to any of the excipients. Co-administration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, 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_ (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration of voriconazole and sirolimus is contraindicated, since voriconazole has been shown to significantly increase plasma concentrations of sirolimus in healthy subjects (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration of voriconazole with rifabutin, rifampicin, carbamazepine, long-acting barbiturates (e.g., phenobarbital) and St John’s Wort is contraindicated since these medicinal products are likely to decrease plasma voriconazole concentrations significantly (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration of standard doses of voriconazole with efavirenz doses of 400 mg QD or higher is contraindicated because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. Voriconazole also significantly increases efavirenz plasma concentrations (see Section 4.5, for lower doses see Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration of voriconazole with high-dose ritonavir (400 mg and above twice daily) is contraindicated because ritonavir significantly decreases plasma voriconazole concentrations in healthy subjects at this dose (see Section 4.5, for lower doses see Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration of voriconazole with naloxegol is contraindicated because voriconazole may significantly increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration of voriconazole with tolvaptan is contraindicated because voriconazole may significantly increase plasma concentrations of tolvaptan (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration of voriconazole with venetoclax at initiation and during the venetoclax dose titration phase since voriconazole is likely to significantly increase plasma concentrations of venetoclax and increase risk of tumour lysis syndrome (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration of voriconazole with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**4.1 Therapeutic indications** Voriconazole is a broad spectrum, triazole antifungal agent and is indicated as follows: Treatment of invasive aspergillosis; Treatment of candidemia in non-neutropenic patients; Treatment of fluconazole-resistant serious invasive _Candida_ infections (including _C. krusei_); Treatment of serious fungal infections caused by _Scedosporium_ spp. and _Fusarium_ spp.; Prophylaxis in patients ≥12 years old who are at high risk of developing invasive fungal infections. The indication is based on a study which includes patients ≥12 years old undergoing allogeneic haematopoietic stem cell transplantation (see Section on 'Clinical Experience' – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).