NOXAFIL POWDERMIX for ORAL SUSP Rx

Fungal infections:

Indications for: NOXAFIL POWDERMIX for ORAL SUSP

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-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia due to chemotherapy.

Adult Dosage:

Not applicable.

Children Dosage:

<2yrs: not established; >40kg: not recommended. Take with food. Ensure delivery of correct dose using provided notched tip syringes. 2–<18yrs (10–<12kg): 90mg twice daily on Day 1, then 90mg once daily; (12–<17kg): 120mg twice daily on Day 1, then 120mg once daily; (17–<21kg): 150mg twice daily on Day 1, then 150mg once daily; (21–<26kg): 180mg twice daily on Day 1, then 180mg once daily; (26–<36kg): 210mg twice daily on Day 1, then 210mg once daily; (36–40kg): 240mg twice daily on Day 1, then 240mg once daily. Continue treatment until recovery from neutropenia or immunosuppression.

NOXAFIL POWDERMIX for ORAL SUSP 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). Concomitant venetoclax (at initiation and during the ramp-up phase) in those with leukemia or lymphoma. PowderMix: known or suspected hereditary fructose intolerance (HFI).

NOXAFIL POWDERMIX for ORAL SUSP Warnings/Precautions:

Tabs, oral susp, and PowderMix susp are not interchangeable. Proarrhythmic conditions. Correct potassium, calcium, magnesium levels before and during therapy. Evaluate and monitor LFTs before and during therapy; consider discontinuing if liver disease occurs. Patients who cannot eat a full meal or tolerate an oral nutritional supplement, or those with severe renal impairment, severe diarrhea, vomiting, or >120kg: monitor for breakthrough fungal infections. Inj: avoid in moderate or severe renal impairment (eGFR <50mL/min); if needed, monitor and consider switching to oral therapy if creatinine levels increase. PowderMix: may precipitate a metabolic crisis due to presence of sorbitol; obtain history of HFI symptoms (with sorbitol/fructose/sucrose) exposure prior to initiation. Pregnancy. Nursing mothers.

NOXAFIL POWDERMIX for ORAL SUSP Classification:

Azole antifungal.

NOXAFIL POWDERMIX for ORAL SUSP 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. May increase venetoclax toxicities with concomitant use. Susp: avoid concomitant cimetidine, esomeprazole, metoclopramide; if needed, monitor for breakthrough fungal infections. PowderMix: avoid concomitant alcohol.

Adverse Reactions:

Fever, diarrhea, nausea, vomiting, headache, hypokalemia, cough; also children: febrile neutropenia, mucosal inflammation, pruritus, hypertension, stomatitis; lab abnormalities (eg, anemia, neutropenia, thrombocytopenia, increased liver enzymes), arrhythmias, QT prolongation.

Generic Drug Availability:

NO

How Supplied:

Tabs—60; Susp—105mL (w. dosing spoon); Vials—1; Packets—1, 8, Kit (8 packets w. supplies)