Vfend I.v. For Injection

— THERAPEUTIC CATEGORIES —
  • Fungal infections

Vfend I.v. For Injection Generic Name & Formulations

General Description

Voriconazole 200mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.

Pharmacological Class

Azole antifungal.

How Supplied

Tabs—30; Susp—75mL (w. dispenser); Vials—1

Manufacturer

Generic Availability

YES

Vfend I.v. For Injection Indications

Indications

Invasive aspergillosis. Nonneutropenic candidemia. Candida infections in abdomen, kidney, bladder wall, wounds, or skin (disseminated). Esophageal candidiasis. Serious infections caused by Scedosporium apiospermum and Fusarium species in patients intolerant of, or refractory to, other therapy.

Vfend I.v. For Injection Dosage and Administration

Adult

See full labeling. Infuse IV over 1–3hrs; max rate 3mg/kg per hour. Aspergillosis, Scedosporium and Fusarium: initially 6mg/kg IV every 12hrs for 2 doses, then 4mg/kg every 12hrs; continue for at least 7 days. Candidemia, other deep tissue candida infections: initially 6mg/kg IV every 12hrs for 2 doses, then 3–4mg/kg every 12hrs; treat for at least 14 days after symptoms resolve or following last positive culture, whichever is longer. Both: switch to oral form when tolerated; give 1hr before or after meals. Oral forms (<40kg): 100mg every 12hrs; may increase to 150mg every 12hrs if inadequate response; (≥40kg): 200mg every 12hrs; may increase to 300mg every 12hrs if inadequate response. Esophageal candidiasis: oral forms (<40kg): 100mg every 12hrs; (≥40kg): 200mg every 12hrs; treat for a minimum 14 days, and for at least 7 days after symptoms resolve. Concomitant efavirenz: increase voriconazole dose to 400mg every 12hrs and decrease efavirenz dose to 300mg every 24hrs. Concomitant phenytoin: increase voriconazole dose. Hepatic impairment (mild to moderate): reduce maintenance dose by ½; (severe): see full labeling. Renal impairment (CrCl <50mL/min): oral forms preferred. Duration of therapy, and for dose adjustments: see full labeling.

Children

<2yrs: not recommended. See full labeling. 2–14yrs (<50kg): Aspergillosis, Scedosporium and Fusarium, Candidemia, other deep tissue candida infections: initially 9mg/kg IV every 12hrs for 2 doses, then 8mg/kg IV every 12hrs. Esophageal candidiasis: 4mg/kg IV every 12hrs. Oral forms: 9mg/kg every 12hrs (at max 350mg every 12hrs). ≥12yrs (≥50kg): use adult regimen. Hepatic or renal impairment: monitor closely. Duration of therapy, and for dose adjustments: see full labeling.

Vfend I.v. For Injection Contraindications

Contraindications

Concomitant cisapride, pimozide, quinidine, ivabradine, sirolimus, rifampin, rifabutin, carbamazepine, long-acting barbiturates, ergot alkaloids, St. John's wort, lurasidone, naloxegol, tolvaptan, efavirenz ≥400mg every 24hrs (adjusted dose may be used; see Adult dose), high-dose ritonavir (400mg every 12hrs). Concomitant venetoclax at initiation and during ramp-up phase in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Vfend I.v. For Injection Boxed Warnings

Not Applicable

Vfend I.v. For Injection Warnings/Precautions

Warnings/Precautions

Correct electrolyte disturbances before and during treatment. Monitor AST/ALT levels and bilirubin at baseline, at least weekly for the first month, then monthly thereafter; discontinue if LFTs become markedly elevated. Monitor renal function. Proarrhythmic conditions (eg, QT prolongation, arrhythmias, cardiomyopathy esp. if HF is present). Monitor visual function (including acuity, field, color perception) if used >28 days. Risk factors for acute pancreatitis (eg, recent chemotherapy, HSCT); monitor. Discontinue if severe cutaneous reactions, squamous cell carcinoma, melanoma, or skeletal adverse events occur. Avoid direct sunlight. Tabs: galactose intolerance. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during therapy. Pregnancy. Nursing mothers.

Vfend I.v. For Injection Pharmacokinetics

See Literature

Vfend I.v. For Injection Interactions

Interactions

See Contraindications. Potentiates cyclosporine, tacrolimus, phenytoin, warfarin, methadone, fentanyl, alfentanil, oxycodone, other CYP3A4, CYP2C9, or CYP2C19 substrates (eg, benzodiazepines, vinca alkaloids, statins, omeprazole, ivacaftor, other NNRTIs, HIV protease inhibitors, calcium channel blockers, sulfonylureas, NSAIDs); monitor for adverse reactions; adjust dose as needed. Potentiates, and potentiated by oral contraceptives; monitor. Antagonized by phenobarbital, phenytoin, letermovir, possibly delavirdine, efavirenz 300mg every 24hrs, other CYP3A4 inducers. Concomitant everolimus, fluconazole: not recommended. Avoid concomitant low-dose ritonavir (100mg every 12hrs), lemborexant, glasdegib, tyrosine kinase inhibitors; see full labeling. Monitor for adrenal dysfunction with corticosteroids. IV: do not infuse with concomitant blood product or short-term infusion of concentrated electrolytes. Increased risk of skin toxicity with methotrexate.

Vfend I.v. For Injection Adverse Reactions

Adverse Reactions

Visual disturbances, fever, nausea, vomiting, rash, chills, headache, increased LFTs, tachycardia, hallucinations; infusion-related reactions, cutaneous reactions (eg, SJS, TEN, DRESS), photosensitivity (esp. in children), squamous cell carcinoma (during long-term use), renal toxicity, adrenal dysfunction. Children also: epistaxis, abdominal pain, diarrhea, hypertension, thrombocytopenia, hypokalemia, cough, peripheral edema, ALT abnormal, others.

Vfend I.v. For Injection Clinical Trials

See Literature

Vfend I.v. For Injection Note

Not Applicable

Vfend I.v. For Injection Patient Counseling

See Literature