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Noxafil Injection Generic Name & Formulations
Legal Class
Rx
General Description
Posaconazole 18mg/mL; preservative-free.
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 Injection Indications
Indications
Treatment of invasive aspergillosis in patients aged ≥13yrs. 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.
Noxafil Injection Dosage and Administration
Adult
Give by slow IV infusion over ~90mins via central venous line (including central venous catheter or PICC); if unavailable, may give via peripheral venous catheter over ~30mins only as a single dose in advance of central line placement. Invasive aspergillosis treatment: ≥13yrs: 300mg twice a day on Day 1, then 300mg once daily starting on Day 2; total duration: 6–12 weeks. Invasive fungal prophylaxis: 300mg twice a day on Day 1, then 300mg once daily thereafter until recovery from neutropenia or immunosuppression.
Children
Give by slow IV infusion over ~90mins via central venous line (including central venous catheter or PICC); if unavailable, may give via peripheral venous catheter over ~30mins only as a single dose in advance of central line placement. Invasive aspergillosis treatment: <13yrs: not established. Invasive fungal prophylaxis: <2yrs (≤40kg): not established; 2–<18yrs (>40kg): 6mg/kg (max 300mg) twice a day on Day 1, then 6mg/kg (max 300mg) once daily thereafter until recovery from neutropenia or immunosuppression.
Administration
Give by slow IV infusion over ~90mins via central venous line (including central venous catheter or PICC); if unavailable, may give via peripheral venous catheter over ~30mins only as a single dose in advance of central line placement.
Nursing Considerations
Give by slow IV infusion over ~90mins via central venous line (including central venous catheter or PICC); if unavailable, may give via peripheral venous catheter over ~30mins only as a single dose in advance of central line placement. 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 Injection 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 Injection Boxed Warnings
Not Applicable
Noxafil Injection 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 Injection Pharmacokinetics
Elimination
Fecal (71%), renal (13%). Half-life: 27 hours (inj); 26–31 hours (tabs); 35 hours (oral susp).
Noxafil Injection 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 Injection 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 Injection Clinical Trials
See Literature
Noxafil Injection Note
Not Applicable
Noxafil Injection Patient Counseling
See Literature
