Posaconazole Delayed-Release Suspension

What is this medication?

POSACONAZOLE (POE sa KON a zole) prevents fungal infections. It belongs to a group of medications called antifungals. It will not treat colds, the flu, or infections caused by bacteria or viruses.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Noxafil

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Hereditary fructose intolerance
• History of irregular heartbeat or rhythm
• History of low levels of calcium, magnesium, or potassium in the blood
• Kidney disease
• Liver disease
• An unusual or allergic reaction to posaconazole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Take it with or right after a full meal. For those who cannot eat a full meal, take it with a liquid nutrition supplement or an acidic carbonated beverage, such as ginger ale. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Use the supplies that come in the kit to prepare this medication. Add the powder to the mixing cup. Use the blue syringe to measure and add 9 mL of mixing liquid to the powder. Close the lid and shake the mixing cup for 45 seconds or longer until mixed. Use the correct size syringe to measure the dose. Give the dose within 1 hour of mixing.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications for cholesterol, such as atorvastatin, lovastatin, simvastatin
• Certain medications for irregular heartbeat, such as quinidine
• Ergot alkaloids, such as dihydroergotamine or ergotamine
• Other medications that cause heart rhythm changes
• Pimozide
• Sirolimus

This medication may also interact with the following:

• Alcohol
• Certain medications for blood pressure or heart disease, such as diltiazem, felodipine, nifedipine
• Certain antivirals for HIV or hepatitis
• Certain medications for cancer, such as venetoclax, vinblastine, vincristine
• Certain medications for diabetes, such as glipizide
• Cimetidine
• Cyclosporine
• Digoxin
• Esomeprazole
• Metoclopramide
• Midazolam
• Phenytoin
• Rifabutin
• Tacrolimus

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work while taking this medication.

If you get severe diarrhea or vomiting, tell your care team right away. You may not get your full dose of medication if you are sick.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fever
• Itching
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.