WARNINGS AND PRECAUTIONS
 
•Calcineurin Inhibitor Toxicity: Noxafil increases concentrations of cyclosporine or tacrolimus; reduce dose of cyclosporine and tacrolimus and monitor concentrations frequently. (5.1)
•Arrhythmias and QTc Prolongation: Noxafil has been shown to prolong the QTc interval and cause cases of TdP. Administer with caution to patients with potentially proarrhythmic conditions. Do not administer with drugs known to prolong QTc interval and metabolized through CYP3A4. Correct K+, Mg++, and Ca++ before starting Noxafil. (5.2)
•Hepatic Toxicity: Elevations in LFTs may occur. Discontinuation should be considered in patients who develop abnormal LFTs or monitor LFTs during treatment. (5.3)
•Midazolam: Noxafil can prolong hypnotic/sedative effects. Monitor patients and benzodiazepine receptor antagonists should be available. (5.4, 7.5)

ADVERSE REACTIONS
 
•Common treatment-emergent adverse reactions (>25%) in prophylaxis studies with posaconazole are fever, diarrhea, and nausea. (6.2)
•Common treatment-emergent adverse reactions (>5%) in controlled OPC pool with posaconazole oral suspension are diarrhea, nausea, headache, vomiting, and fever. Common adverse reactions (>20%) in the refractory OPC pool are fever, diarrhea, nausea, vomiting, and coughing. (6.2)
 
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Interaction Drug
 
Interaction

* The drug interactions with esomeprazole and metoclopramide do not apply to posaconazole tablets. 
 
Rifabutin, phenytoin, efavirenz, cimetidine, esomeprazole* Avoid coadministration unless the benefit outweighs the risks (7.6, 7.7, 7.8, 7.9)
Other drugs metabolized by CYP3A4 Consider dosage adjustment and monitor for adverse effects and toxicity (7.1, 7.10, 7.11)
Digoxin Monitor digoxin plasma concentrations (7.12)
Fosamprenavir, metoclopramide* Monitor for breakthrough fungal infections (7.6, 7.13)

USE IN SPECIFIC POPULATIONS
 
•Pregnancy: Based on animal data, may cause fetal harm. (8.1)
•Nursing Mothers: Discontinue drug or nursing, taking in to consideration the importance of drug to the mother. (8.3)
•Severe renal impairment: Monitor closely for breakthrough fungal infections. (8.6)
 
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
 
Revised: 11/2013

FULL PRESCRIBING INFORMATION: CONTENTS*
 
1 INDICATIONS AND USAGE
 
1.1 Prophylaxis of Invasive Aspergillus and Candida Infections
 
1.2 Treatment of Oropharyngeal Candidiasis Including Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole
 
2 DOSAGE AND ADMINISTRATION
 
2.1 Instructions for use with Noxafil Delayed-Release Tablets 
 
2.2 Instructions for use with Noxafil Oral Suspension
 
2.3 Administration Information
 
3 DOSAGE FORMS AND