Noxafil

Noxafil

posaconazole

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Posaconazole
Indications/Uses
Refractory invasive fungal infections (IFI) or intolerant patients w/ IFI. Prophylaxis of invasive Aspergillus & Candida infections including both yeasts & molds in patients who are at high risk of developing these infections (eg, patients w/ prolonged neutropenia or hematopoietic stem cell transplant recipients). Oral susp: Oropharyngeal candidiasis in patients who have severe disease or who are immunocompromised including patients w/ disease that is refractory to itraconazole & fluconazole.
Dosage/Direction for Use
DR tab Patient ≥13 yr Prophylaxis of IFI Loading dose: 300 mg bd on the 1st day then 300 mg once daily thereafter. Start for several days before anticipated neutropenia onset & continue for 7 days after the neutrophil count is >500 cells/mm3, for patients w/ acute myelogenous leukemia or myelodysplastic syndromes. Refractory IFI or IFI intolerant to 1st line therapy Loading dose: 300 mg bd on the 1st day then 300 mg once daily thereafter. Oral susp Patient ≥13 yr Prophylaxis of IFI 5 mL tds. Refractory IFI or intolerant patient w/ IFI 10 mL bd or 5 mL qds. Oropharyngeal candidiasis Loading dose: 5 mL once daily on the 1st day, then 2.5 mL once daily for 13 days. Refractory oropharyngeal candidiasis 10 mL bd.
Administration
DR tab: May be taken with or without food: Swallow whole, do not divide/crush/chew. Oral susp: Should be taken with food: Take w/ a full meal or w/ 240 mL of liqd nutritional supplement in patients who cannot eat a full meal.
Contraindications
Hypersensitivity. Co-administration w/ terfenadine, astemizole, cisapride, pimozide, quinidine, ergot alkaloids or HMG-CoA reductase inhibitors primarily metabolized through CYP3A4.
Special Precautions
Hypersensitivity to other azoles. Patients w/ potentially proarrhythmic conditions. Not to be administered w/ known QTc interval-prolonging medicines & are metabolized through CYP3A4. Risk of electrolyte disturbances; monitor K, Mg & Ca levels. Concomitant administration w/ vincristine. Patient w/ severe GI dysfunction. Closely monitor for breakthrough fungal infections in patients who have severe diarrhoea or vomiting. Posaconazole plasma conc following administration of DR tab is generally higher than w/ oral susp. Closely monitor patients w/ severe renal impairment for potential breakthrough fungal infections. Patient w/ severe hepatic impairment. Evaluate liver function tests at the start & during the course of therapy. Discontinue treatment if clinical signs & symptoms consistent w/ liver disease develop. Advise women of childbearing potential to always use effective contraceptive measure during treatment & for at least 2 wk after completing therapy. Pregnancy & lactation. Childn <13 yr.
Adverse Reactions
Neutropenia; anorexia, electrolyte imbalance; dizziness, headache, paresthesia, somnolence; abdominal pain, diarrhoea, dyspepsia, flatulence, dry mouth, nausea, vomiting; elevated liver function tests (including AST, ALT, alkaline phosphatase, GGT, bilirubin); asterixis, cholestasis, hepatic failure, cholestatic hepatitis, hepatosplenomegaly, liver tenderness, splenomegaly, rash; asthenia, fatigue, fever.
Drug Interactions
Plasma conc may be affected by inhibitors or inducers of UDP glucuronidation (phase 2 enzymes) & P-gp efflux. Decreased Cmax & AUC w/ rifabutin, efavirenz & phenytoin. May increase plasma levels of cytochrome P450 metabolized drugs. May increase plasma conc of terfenadine, astemizole, cisapride, pimozide & quinidine; ergot & vinca alkaloids, & digoxin. Increased Cmax & AUC of tacrolimus; rifabutin; midazolam IV; atazanavir; simvastatin. Frequently monitor for adverse effects & toxicity related to Ca channel blockers. Decreased glucose conc w/ sulfonylureas (eg, glipizide). Oral susp: Decreased Cmax & AUC w/ cimetidine, esomeprazole; if possible, avoid co-administration w/ H2 receptor antagonists, proton pump inhibitors & antacids. Decreased plasma conc w/ metoclopramide. Increased Cmax & AUC of sirolimus. May decrease plasma conc w/ fosamprenavir. Increased cyclosporine conc (in heart transplant patients on stable doses of cyclosporine).
MIMS Class
Antifungals
ATC Classification
J02AC04 - posaconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Noxafil DR tab 100 mg
Packing/Price
24's;96's
Form
Noxafil oral susp 40 mg/mL
Packing/Price
105 mL x 1's
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