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Noxafil Oral Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Posaconazole 40mg/mL; cherry flavor.
Pharmacological Class
Azole antifungal.
How Supplied
Tabs—60; Susp—105mL (w. dosing spoon); Vials—1; Packets—1, 8, Kit (8 packets w. supplies)
Manufacturer
Generic Availability
Tabs, Susp, Vials (YES); Packets (NO)
Mechanism of Action
Blocks synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane.
Noxafil Oral Suspension Indications
Indications
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. Treatment of oropharyngeal candidiasis, including refractory to itraconazole and/or fluconazole.
Noxafil Oral Suspension Dosage and Administration
Adult
Take within 20mins after a full meal; may take with liquid nutritional supplement or an acidic carbonated beverage (eg, gingerale) if cannot eat a full meal or del-rel tabs or inj are not an option. ≥13yrs: Invasive fungal prophylaxis: 200mg 3 times daily, until recovery from neutropenia or immunosuppression. Oropharyngeal candidiasis: 100mg twice daily on Day 1, then 100mg once daily thereafter for 13 days; refractory: 400mg twice daily until response.
Children
<13yrs: not established.
Administration
Shake well before use. Rinse spoon with water after each administration and before storage. Take within 20mins after a full meal; may take with liquid nutritional supplement or an acidic carbonated beverage (eg, gingerale) if cannot eat a full meal or del-rel tabs or inj are not an option.
Nursing Considerations
Shake well before use. Rinse spoon with water after each administration and before storage. Take within 20mins after a full meal; may take with liquid nutritional supplement or an acidic carbonated beverage (eg, gingerale) if cannot eat a full meal or del-rel tabs or inj are not an option. Monitor for breakthrough fungal infections in patients who cannot eat a full meal, or tolerate an oral nutritional supplement, or those with severe renal impairment, severe diarrhea, vomiting, or >120kg.
Noxafil Oral Suspension Contraindications
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 Oral Suspension Boxed Warnings
Not Applicable
Noxafil Oral Suspension Warnings/Precautions
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 Oral Suspension Pharmacokinetics
Elimination
Fecal (71%), renal (13%). Half-life: 27 hours (inj); 26–31 hours (tabs); 35 hours (oral susp).
Noxafil Oral Suspension Interactions
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.
Noxafil Oral Suspension Adverse Reactions
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.
Noxafil Oral Suspension Clinical Trials
See Literature
Noxafil Oral Suspension Note
Not Applicable
Noxafil Oral Suspension Patient Counseling
See Literature
