Noxafil is an antifungal medicine that is used to treat or prevent fungal infections that can spread throughout your body. This medicine is sometimes used in people with weak immune systems caused by certain treatments such as chemotherapy or stem cell transplantation.

Noxafil injection or delayed-release tablets are used to treat infections in adults and children at least 13 years old.

To prevent infections, Noxafil is given in the following ways:

• The injection is used in adults and children at least 2 years old.

• Delayed-release tablets are used in adults and children 2 years and older who weigh more than 88 pounds (40 kg).

• Noxafil PowderMix oral suspension is used people at least 13 years old.

• The PowderMix is used in adults and children 2 years and older who weigh 88 pounds (40 kg) or less.

The oral suspension liquid form of Noxafil is also used to treat oral thrush (yeast infection of the mouth).

You should not use Noxafil together with: atorvastatin, lovastatin, simvastatin, pimozide, quinidine, sirolimus, or an ergot medicine (dihydroergotamine, ergotamine, ergonovine, or methylergonovine).

Take Noxafil for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Posaconazole will not treat a viral infection such as the common cold or flu.

The liquid and tablet forms of Noxafil are not equivalent and may not have the same dose or schedule.

Use Noxafil exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Noxafil oral is taken by mouth. The liquid and tablet forms are not equivalent and may not have the same dose or schedule. Ask your pharmacist if you have questions about the medicine you receive at the pharmacy.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

You may take the delayed-release tablet with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Prepare the PowderMix oral suspension when it is time for the dose. Shake well for 45 seconds and measure a dose with the supplied dosing spoon. Rinse the spoon with water and wash the mixing cup after each use. Throw away the medicine if not used within 1 hour after mixing.

Take prepared PowderMix with food.

Take Noxafil oral suspension during or within 20 minutes after eating a full meal. If you cannot eat a full meal, take the medicine with a nutritional supplement or acidic carbonated drink such as ginger ale.

Tell your doctor if you cannot swallow a Noxafil tablet whole or cannot take Noxafil liquid with food or beverages as directed.

Noxafil injection is given in a vein and must be given slowly over 30 to 90 minutes.

Prepare an injection only when you are ready to give it. Be sure you understand how to properly mix this medicine with a liquid (diluent) and how to store the mixture. Call your pharmacist if the medicine has particles in it.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Posaconazole will not treat a viral infection (flu or a common cold).

Call your doctor if you have ongoing vomiting or diarrhea. Noxafil may not work as well while during this time.

You may need frequent medical tests.

Store the oral tablets at room temperature away from moisture and heat. Do not freeze the liquid medicine. Do not open a packet of PowderMix until you are ready to prepare a dose.

Store the injection in the refrigerator. Take the vial out of the refrigerator and let it reach room temperature before mixing with a diluent. If you cannot give the injection right away, place the mixed medicine in the refrigerator and use it within 24 hours.

Throw away a vial, bottle, or IV bag after one use even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

You should not use Noxafil if you are allergic to posaconazole or similar antifungals such as fluconazole, itraconazole, ketoconazole, or voriconazole.

Some drugs should not be used with Noxafil. Your treatment plan may change if you also use:

• midazolam;
• pimozide;
• quinidine;
• sirolimus;
• cholesterol lowering medicines atorvastatin, lovastatin, simvastatin, and others; or
• ergot medicine - dihydroergotamine, ergotamine, ergonovine, or methylergonovine.

You should not use PowderMix oral suspension if you have hereditary fructose intolerance.

To make sure Noxafil is safe for you, tell your doctor if you have:

• heart problems;
• blood circulation problems;
• liver or kidney disease; or
• an electrolyte imbalance (such as high or low blood levels of calcium, potassium, magnesium, or sodium).

Posaconazole may harm an unborn baby. Tell your doctor if you are pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

For delayed-release tablets: Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

For all other forms: Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol while you are taking Noxafil PowderMix for oral suspension.

Get emergency medical help if you have signs of an allergic reaction to Noxafil: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• swelling in an arm or leg;

• shortness of breath;

• liver problems - nausea, vomiting, itching, feeling tired, jaundice (yellowing of the skin or eyes); or

• signs of an electrolyte imbalance - increased thirst or urination, constipation, muscle pain or weakness, numbness or tingling, confusion, feeling jittery, irregular heartbeats.

Common Noxafil side effects may include:

• diarrhea, nausea, vomiting;

• low potassium (an electrolyte);

• headache;

• fever; or

• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Noxafil can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can interact with posaconazole, especially:

• cimetidine;

• cyclosporine;

• esomeprazole;

• rifabutin;

• phenytoin;

• tacrolimus;

• certain cancer medicines - vinblastine, vincristine, vinorelbine; or

• medicine to treat HIV - atazanavir, efavirenz, fosamprenavir, ritonavir.

This list is not complete and many other drugs may interact with posaconazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.