posaconazole (oral/injection)

What is the most important information I should know about posaconazole?

Tell your doctor about all your other medicines. Some drugs should not be used with posaconazole.

What is posaconazole?

Posaconazole 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.

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

To prevent infections, posaconazole 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).
• The 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 posaconazole is also used to treat oral thrush (yeast infection of the mouth).

Posaconazole may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using posaconazole?

Some drugs should not be used with posaconazole. 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 for oral suspension if you have hereditary fructose intolerance.

Tell your doctor if you have ever had:

• 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).

How should I use posaconazole?

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

Posaconazole 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.

Take posaconazole 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 posaconazole tablet whole or cannot take posaconazole liquid with food or beverages as directed.

Posaconazole 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).

You may need frequent medical tests.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while using posaconazole?

What are the possible side effects of posaconazole?

• 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 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.

What other drugs will affect posaconazole?

Tell your doctor about all your current medicines. Many drugs can affect 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 affect posaconazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about posaconazole.