Rofend inj^®

Rofend® is a broad-spectrum antifungal medicine from the triazole class. It reduces ergosterol production and causes fungal cell death by inhibiting formation of the fungal cell membrane.

• Treatment of infections caused by fungi such as Aspergillus, Blastomyces, and others
• Treatment of infections caused by Candida, including disseminated skin and abdominal infections, bloodstream infection, cardiac involvement, esophageal candidiasis, and ocular candidiasis
• Treatment of severe fungal infections caused by Scedosporium and Fusarium species in patients who cannot use other medicines or are resistant to them
• Prevention of invasive fungal infections

200 mg lyophilized powder for preparation of injectable solution.

Add 19 mL of sterile water for injection to the contents of the Rofend® Injection vial until the powder is completely dissolved. Each milliliter of the resulting solution contains 10 mg Voriconazole.

Never inject the prepared solution before dilution. The resulting solution must be diluted in compatible diluents to a concentration of 0.5 to 5 mg/mL.

The prepared solution may be diluted in the following diluents:

• 0.9% or 0.45% sodium chloride
• Lactated Ringer’s solution
• 5% dextrose in Lactated Ringer’s solution
• 5% dextrose with 0.45% or 0.9% sodium chloride
• 5% dextrose

Rofend® Injection is for intravenous infusion only; do not administer it as an intravenous bolus injection.

The final solution should be infused over 1 to 2 hours, at a maximum rate of 3 mg/kg/hour.

This product is for single use only. Discard any remaining medicine after use.

• Serum electrolyte levels, especially potassium, magnesium, and calcium, should be corrected before administration and monitored during treatment.
• Kidney function, especially serum creatinine, and liver function should be monitored before starting and during treatment with Voriconazole.
• Pancreatic function
• Full-body skin examination
• Blood concentration monitoring immediately before the next dose may be required.
• Vision status, especially visual field and color perception, during treatments longer than 28 days
• Photosensitivity, especially in children

• Hypersensitivity to Voriconazole or to any component of the formulation
• Concomitant use with medicines such as long-acting barbiturates, alprazolam, amiodarone, aprepitant, doxorubicin, domperidone, carbamazepine, cisapride, efavirenz or ritonavir, ergotamine, ivabradine, lurasidone, pimozide, quinidine, rifampin, rifabutin, sirolimus, St. John’s wort, tolvaptan, phenobarbital, lovastatin, midazolam, simvastatin, and triazolam

• Concomitant use of Voriconazole with corticosteroids, such as prednisolone and dexamethasone, may increase the risk of Cushing’s syndrome. Contact your physician if symptoms occur, such as abnormal weight gain, fat accumulation on both sides of the face or lower neck, thinning of the skin, excessive sweating, or easy bruising.
• During treatment, patients should avoid direct sunlight and use protective clothing and high-SPF sunscreen.
• Electrolyte imbalances, such as low calcium, magnesium, or potassium, should be corrected before starting and during treatment.
• This medicine should be used with caution in liver or kidney impairment, and dose adjustment may be needed.
• Seek medical care immediately if widespread hypersensitivity reactions occur, with symptoms such as redness, swelling, blistering or peeling of the skin, eye redness, sores in the mouth, throat, nose, or eyes, fever, chills, or shortness of breath.
• This medicine should be used with caution in patients with structural heart disease or long-QT syndrome. Contact your physician if you experience fast or abnormal heartbeat or fainting.
• Contact your physician if you experience bone pain or changes in vision.
• Voriconazole has nonlinear pharmacokinetics; therefore, patients should be monitored for signs of toxicity.

Use of Voriconazole during pregnancy and breastfeeding is not recommended.

Like all medicines, Voriconazole may cause unwanted side effects along with its desired therapeutic effects, although not everyone experiences them. More common possible side effects include:

• Headache or dizziness
• Nausea, vomiting, constipation, diarrhea, and abdominal pain
• Flu-like symptoms
• Skin reactions
• Increased liver enzyme levels
• Acute kidney injury
• Cardiovascular effects
• Eye and nervous-system adverse effects

Consult your physician or pharmacist about using Voriconazole together with other medicines or supplements.

Each package contains 1 vial of Rofend® Injection.

• Store below 30°C, protected from light and moisture.
• The medicine may be used until the end of the month stated in the expiry date on the package. Do not use or store expired medicines.
• Keep the medicine out of the reach of children.
• Keep the medicine in its original packaging until use.

1. Voriconazole: Drug information, UpToDate 2025
2. Medicines.org.uk product information for Voriconazole.