NOXAFIL Rx

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NOXAFIL

Fungal infections
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Generic Name and Formulations:

Posaconazole 100mg; del-rel tabs.

Select therapeutic use:

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.

Adult:

Swallow whole. Take with food. ≥13yrs: 300mg twice a day on Day 1, then 300mg once daily starting on Day 2 until recovery from neutropenia or immunosuppression.

Children:

<13yrs: 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 <50mL/min); if needed, monitor and consider switching to oral therapy if creatinine levels increase. Proarrhythmic conditions. Correct potassium, calcium, magnesium levels before starting. Evaluate and monitor liver function tests 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. Pregnancy (Cat.C). Nursing mothers: not recommended.

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. 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.

See Also:

NOXAFIL ORAL SUSPENSION

NOXAFIL INJECTION

Pharmacological Class:

Azole antifungal.

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

NOXAFIL 100mg tablets (Qty:90)

appx. price $5499.00