Oral Suspension
 
Noxafil oral suspension is available in 4-ounce (123 mL) amber glass bottles with child-resistant closures (NDC 0085-1328-01) containing 105 mL of suspension (40 mg of posaconazole per mL).
Supplied with each oral suspension bottle is a plastic dosing spoon calibrated for measuring 2.5-mL and 5-mL doses. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

17 PATIENT COUNSELING INFORMATION
 
Advise the patient to read the FDA-approved patient labeling (Patient Information).

17.1 Administration

Noxafil Delayed-Release Tablets
 
Advise patients to take Noxafil delayed-release tablets with food.
 
Physicians should instruct their patients that if they miss a dose, they should take it as soon as they remember. If they do not remember until it is within 12 hours of the next dose, they should be instructed to skip the missed dose and go back to the regular schedule. Patients should not double their next dose or take more than the prescribed dose.

Noxafil Oral Suspension
 
Advise patients to take each dose of Noxafil oral suspension during or immediately (i.e., within 20 minutes) following a full meal. In patients who cannot eat a full meal, each dose of Noxafil oral suspension should be administered with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale) in order to enhance absorption.

17.2 Drug Interactions
 
Patients should be advised to inform their physician immediately if they:
•develop severe diarrhea or vomiting.
•are currently taking drugs that are known to prolong the QTc interval and are metabolized through CYP3A4.
•are currently taking a cyclosporine or tacrolimus, or they notice swelling in an arm or leg or shortness of breath.
•are taking other drugs or before they begin taking other drugs as certain drugs can decrease or increase the plasma concentrations of posaconazole.

17.3 Serious and Potentially Serious Adverse Reactions
 
Patients should be advised to inform their physician immediately if they:
•notice a change in heart rate or heart rhythm, or have a heart condition or circulatory disease. Posaconazole can be administered with caution to patients with potentially proarrhythmic conditions.
•are pregnant, plan to become pregnant, or are nursing.
•have liver disease or develop itching, nausea or vomiting, their eyes or skin turn yellow, they feel more tired than usual or feel like they have the flu.
•have ever had an allergic reaction to other antifungal medicines such as ketoconazole, fluconazole, itraconazole, or voriconazole.

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
 
Delayed-Release Tablets: Manuf. by: N. V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands
 
Oral Suspension: Manuf. by: Patheon Inc., Whitby, Ontario, Canada L1N 5Z5
 
For patent information: www.merck.com/product/patent/home.html