Generic Name and Formulations:
Posaconazole 40mg/mL; oral susp; cherry flavor.

Company:
Merck & Co., Inc.

Indications for NOXAFIL:
Prophylaxis against invasive Aspergillus and Candida infections, in patients at high risk due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with Graft vs. Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia due to chemotherapy. Treatment of oropharyngeal candidiasis, including refractory to itraconazole and/or fluconazole.

Adult Dose for NOXAFIL:
Take within 20mins after a full meal or liquid nutritional supplement; or may take with an acidic carbonated beverage (eg, gingerale). ≥13yrs: Invasive fungal prophylaxis: 200mg 3 times daily. Oropharyngeal candidiasis: 100mg twice daily on day 1, then 100mg once daily for 13 days; refractory: 400mg twice daily.

Children's Dose for NOXAFIL:
<13yrs: not recommended.

Pharmacological Class:
Triazole.

Contraindications:
Hypersensitivity to other azole antifungal agents. Concomitant sirolimus, ergots, or HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin). Drugs that cause QT prolongation and are metabolized by CYP3A4 (eg, quinidine, pimozide).

Warnings/Precautions:
Correct potassium, calcium, magnesium levels before starting. Monitor liver function tests before starting and during therapy. Proarrhythmic conditions. Patients who cannot eat a full meal or nutritional supplement or those with severe renal impairment, severe diarrhea, or vomiting: monitor for breakthrough fungal infections. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
See Contraindications. Avoid drugs that lower posaconazole levels (eg, cimetidine, esomeprazole, rifabutin, phenytoin, efavirenz). Monitor for breakthrough fungal infections with metoclopramide, fosamprenavir. Potentiates CYP3A4 substrates (eg, cyclosporine, tacrolimus, midazolam, rifabutin, phenytoin, ritonavir, atazanavir, calcium channel blockers, vinca alkaloids, digoxin, other benzodiazepines); monitor and consider dose reduction. Monitor glucose levels with glipizide.

Adverse Reactions:
Fever, headache, rigors, GI upset, anorexia, abdominal pain, constipation, fatigue, hypokalemia, coughing, hypertension, lab abnormalities (eg, anemia, neutropenia, thrombocytopenia, bilirubinemia, increased liver enzymes), rash; arrhythmias, QT prolongation.

Metabolism:
Hepatic (CYP3A4).

Elimination:
Fecal (major), renal.

Generic Availability:
NO

How Supplied:
Susp—105mL (w. dosing spoon)