Vivori 50

Indications

Vivori, an advanced azole antifungal medication, is recommended for individuals aged 12 and older to effectively treat various fungal infections, including:

• Invasive Aspergillosis
• Candidemia (non-neutropenic) and disseminated candidiasis affecting skin, abdomen, kidneys, bladder wall, and wounds
• Esophageal Candidiasis
• Severe Infections caused by Scedosporium apiospermum and Fusarium species, including Fusarium solani
• Intolerance or Resistance to alternative antifungal therapies

Pharmacology

Vivori contains Voriconazole, a potent triazole antifungal used to address serious fungal infections. It functions by inhibiting ergosterol synthesis through the suppression of CYP450-dependent 14-alpha sterol demethylase. This action leads to a reduction in ergosterol within fungal cell membranes, disrupting their integrity.

Dosage & Administration

Oral Dosage:

• For Patients Weighing 40 kg or More: Begin with a loading dose of 400 mg (or 10 ml) every 12 hours for the first 24 hours, followed by a maintenance dose of 200 mg (or 5 ml) twice daily.
• For Patients Weighing Less Than 40 kg: Start with a loading dose of 200 mg (or 5 ml) every 12 hours for the first 24 hours, then maintain with 100 mg (or 2.5 ml) twice daily. Dosage adjustments should be made based on physician recommendations.

Injection Dosage:

• Invasive Aspergillosis: Initial loading dose of 6 mg/kg every 12 hours for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours.
• Candidemia and Deep Tissue Candida Infections: Start with a loading dose of 6 mg/kg every 12 hours for 24 hours, then continue with a maintenance dose of 3-4 mg/kg every 12 hours.
• Scedosporiosis and Fusariosis: Begin with 6 mg/kg every 12 hours for 24 hours, then maintain with 4 mg/kg every 12 hours.

Always use Vivori as directed by your healthcare provider.

Drug Interactions

• CYP3A4, CYP2C9, and CYP2C19 Inhibitors and Inducers: Monitor and adjust Vivori dosage as necessary to avoid adverse effects or reduced efficacy.
• Substrates of CYP3A4, CYP2C9, and CYP2C19: Vivori may elevate the levels and effects of these drugs; consider dose reductions and watch for potential side effects.
• Phenytoin and Efavirenz Co-administration: May require increased doses of Vivori.

Contraindications

Do not use Vivori if you have a known hypersensitivity to Voriconazole or its components, or if co-administering with the following:

• Medications: Terfenadine, astemizole, cisapride, pimozide, quinidine, sirolimus, rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids, or St. John’s Wort due to serious adverse reactions or reduced efficacy.

Side Effects

Common side effects include abdominal pain, anemia, blurred vision, headache, chest pain, nausea, and diarrhea.

Pregnancy & Lactation

The safety of Vivori during pregnancy has not been fully established. It should be used only if the benefits outweigh the potential risks to the fetus.

Precautions & Warnings

Prolonged use of Vivori (more than 180 days) may require careful benefit-risk evaluation, as long-term treatment has been associated with an increased risk of skin squamous cell carcinoma (SCC).

Use in Special Populations

The effectiveness of Vivori in children under 12 years of age has not been established.

Overdose

Information regarding Vivori overdose is currently not available.

Therapeutic Class

Vivori is categorized under Other Antifungal Preparations.

Reconstitution Instructions

For oral suspension, shake the bottle well before adding 25 ml of boiled and cooled water (approximately 5 spoonfuls from the provided spoon). Mix thoroughly until the powder is fully dissolved. Store the reconstituted suspension at 15°-30°C and discard after 14 days.

Storage Conditions

Keep Vivori out of the reach of children. Store in a dry place, away from light, below 25°C. The powder for suspension should be stored between 2° and 8°C.