Fungal infections:

Indications for NOXAFIL INJECTION:

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.

Adult:

Give by slow IV infusion over ~90 mins via central venous line (including central venous catheter or PICC); if unavailable, may give via peripheral venous catheter over ~30 mins only as a single dose in advance of central line placement. ≥18yrs: 300mg twice daily on Day 1, then 300mg once daily starting on Day 2 until recovery from neutropenia or immunosuppression.

Children:

<18yrs: not established.

Contraindications:

Concomitant sirolimus, ergot alkaloids, or HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin). Drugs that cause QT prolongation and are metabolized by CYP3A4 (eg, quinidine, pimozide).

Warnings/Precautions:

Tabs and oral susp are not interchangeable. Inj: avoid in moderate or severe renal impairment (eGFR 120kg: monitor for breakthrough fungal infections. Pregnancy. Nursing mothers: not recommended.

Pharmacologic Class:

Azole antifungal.

Interactions:

See Contraindications. Avoid drugs that lower posaconazole levels (eg, rifabutin, phenytoin, efavirenz, fosamprenavir); monitor for breakthrough fungal infections. Potentiates calcineurin-inhibitors (eg, cyclosporine, tacrolimus); monitor trough levels frequently during and at discontinuation of posaconazole; adjust tacrolimus or cyclosporine doses. Potentiates CYP3A4 substrates (eg, ritonavir, atazanavir, calcium channel blockers, vinca alkaloids, rifabutin, phenytoin), digoxin; monitor and consider dose reduction. Neurotoxicity with concomitant vincristine; reserve azole antifungals for those who have no alternative treatment options. Prolonged hypnotic and sedative effects with concomitant midazolam or other benzodiazepines (eg, alprazolam, triazolam). Monitor glucose levels with glipizide. Susp: avoid concomitant cimetidine, esomeprazole, metoclopramide; if needed, monitor for breakthrough fungal infections.

Adverse Reactions:

Fever, diarrhea, nausea, vomiting, headache, hypokalemia, cough, rigors, fatigue, anorexia, hypertension, abdominal pain, constipation, rash; lab abnormalities (eg, anemia, neutropenia, thrombocytopenia, increased liver enzymes), arrhythmias, QT prolongation.

Metabolism:

Hepatic (CYP3A4).

Elimination:

Fecal (major), renal.

Generic Availability:

NO

How Supplied:

Tabs—60; Susp—105mL (w. dosing spoon); Vials—1