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NOXAFIL®
(posaconazole) Oral Suspension

Read the Patient Information that comes with NOXAFIL® (posaconazole oral suspension) Oral Suspension before you start taking it and each time you get a refill. There may be new information. This information does not replace talking with your doctor about your condition or treatment. Only your doctor can prescribe NOXAFIL (posaconazole oral suspension) and determine if it is right for you.

What is NOXAFIL® (posaconazole oral suspension) ?

• NOXAFIL (posaconazole oral suspension) is a prescription medicine that is used to prevent invasive fungal infections (infections that can spread throughout the body) caused by Aspergillus or Candida in patients with weak immune systems because of medicines or diseases [such as stem cell transplantation with graft-vs.-host disease or chemotherapy for hematologic malignancy (blood cancers)].
• NOXAFIL (posaconazole oral suspension) is also used to treat fungal infections in the mouth or throat area (known as “thrush”) caused by fungi called Candida. NOXAFIL (posaconazole oral suspension) can be used as initial treatment or as a treatment after itraconazole and/or fluconazole have failed.

NOXAFIL (posaconazole oral suspension) is for adults and children over 13 years of age.

What should I tell my doctor before taking NOXAFIL® (posaconazole oral suspension) ?

Tell your doctor about all your health conditions, including if you:

• are taking certain drugs that suppress your immune system like cyclosporine (Neoral®), or tacrolimus (Prograf®). Serious and rare fatal toxicity from cyclosporine has occurred when taken in combination with posaconazole, and, therefore, reduction of the dose of drugs like cyclosporine or tacrolimus and frequent monitoring of drug levels of these medicines is necessary when taking them in combination with NOXAFIL (posaconazole oral suspension) .
• are taking certain drugs for HIV infection, such as ritonavir, atazanavir, or efavirenz. Frequent monitoring of drug levels of ritonavir and/or atazanavir is necessary when taking them in combination with NOXAFIL (posaconazole oral suspension) . Efavirenz can cause a decrease in NOXAFIL (posaconazole oral suspension) levels in the body, and, therefore, it is recommended that efavirenz should not be administered with NOXAFIL (posaconazole oral suspension) .
• are taking midazolam, a hypnotic and sedative medication. NOXAFIL (posaconazole oral suspension) in combination with midazolam increases the midazolam plasma concentrations, which could increase and prolong sleepiness.
• have ever had an allergic reaction to other antifungal medicines such as ketoconazole, fluconazole, itraconazole, or voriconazole.
• are taking any other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements.
• have, or have had, liver problems. Your doctor may do blood tests to make sure you should take NOXAFIL (posaconazole oral suspension) .
• have, or have had, an abnormal heart rate or rhythm.
• are, or think you are, pregnant. Do not use NOXAFIL (posaconazole oral suspension) during pregnancy unless specifically advised by your doctor. You should use effective birth control while you are taking NOXAFIL (posaconazole oral suspension) if you are a woman who could become pregnant.

Contact your doctor immediately if you become pregnant while being treated with NOXAFIL (posaconazole oral suspension) .

Do not breastfeed while being treated with NOXAFIL (posaconazole oral suspension) , unless specifically advised by your doctor.

Who should not take NOXAFIL® (posaconazole oral suspension) ?

• Do NOT take NOXAFIL (posaconazole oral suspension) if you are taking any of the medicines listed below. If any of these medicines are taken together with NOXAFIL (posaconazole oral suspension) , serious or lifethreatening side effects from these medicines, or a decrease in the effect of NOXAFIL (posaconazole oral suspension) can occur. Tell your doctor right away if you are taking any of these medicines:
  • sirolimus
  • ergot alkaloids (ergotamine, dihydroergotamine, methylsergide, methylergonovine, ergonovine, or bromocriptine)
  • pimozide
  • quinidine
  • simvastatin
  • rifabutin
  • phenytoin
  • cimetidine
• If you have questions or are uncertain about your medicines, talk with your doctor or pharmacist.
• Do not take NOXAFIL (posaconazole oral suspension) if you are allergic to anything in it. There is a list of what is in NOXAFIL (posaconazole oral suspension) at the end of this leaflet.

Can I take other medicines with NOXAFIL® (posaconazole oral suspension) ?

NOXAFIL (posaconazole oral suspension) and many medicines can interact with each other, and some must not be taken together (see “Who should not take NOXAFIL (posaconazole oral suspension) ?”). The dose of other medicines may need to be adjusted when taken with NOXAFIL (posaconazole oral suspension) [for example, cyclosporine (Neoral®), tacrolimus (Prograf®), ritonavir, or atazanavir] (see “What should I tell my doctor before taking NOXAFIL (posaconazole oral suspension) ?”).

Knowing the medicines that you are taking is important. Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Keep a list of them with you to show your doctor or pharmacist. Do not take any new medicine without talking to your doctor.

What are possible side effects of NOXAFIL® (posaconazole oral suspension) ?

The most commonly reported side effects were fever, nausea, diarrhea, vomiting, and headache.

Rarely, NOXAFIL (posaconazole oral suspension) may cause serious or life-threatening side effects. It may also cause severe drug interactions as discussed above. Call your doctor right away if you have any of the symptoms listed below.

Changes in heart rate or rhythm. People who have certain heart conditions or who take certain other medicines have a higher chance for this problem.

Rarely, very serious liver problems were reported in patients with serious underlying medical conditions. Your doctor may test your liver function while you are taking NOXAFIL (posaconazole oral suspension) . Call your doctor if you have any of these symptoms, as these may be signs of liver problems: you have itching, your eyes or skin turn yellow, you feel more tired than usual or feel like you have the flu, or you have nausea or vomiting.

Rarely, an increase in blood clots may occur in patients with blood cancers or poststem cell transplantation. These events may or may not be further increased in patients also on posaconazole and primarily occurred in patients also receiving cyclosporine or tacrolimus. If you notice swelling of one leg or shortness of breath, notify your doctor immediately.

These are not all the side effects associated with NOXAFIL (posaconazole oral suspension) . For more information, ask your doctor or pharmacist. If you experience any unusual effects while taking NOXAFIL (posaconazole oral suspension) , contact your doctor immediately.

How do I take NOXAFIL® (posaconazole oral suspension) ?

• NOXAFIL (posaconazole oral suspension) comes in cherry-flavored liquid form. Shake NOXAFIL (posaconazole oral suspension) Oral Suspension well before use.
• Take NOXAFIL (posaconazole oral suspension) for as long as your doctor tells you. Take each dose of NOXAFIL (posaconazole 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 (posaconazole oral suspension) should be administered with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale).
• Follow your doctor's instructions on how much NOXAFIL (posaconazole oral suspension) you should take and when.

If you miss a dose of NOXAFIL (posaconazole oral suspension) , take it as soon as you remember.

• If you take too much NOXAFIL (posaconazole oral suspension) , call your doctor or poison control center immediately.
• Tell your doctor right away if you develop severe diarrhea or vomiting.

A measured dosing spoon is provided, marked for doses of 2.5 mL and 5 mL.

It is recommended that the spoon is rinsed with water after each administration and before storage.

How do I store NOXAFIL® (posaconazole oral suspension) ?

• Store at 25oC (77oF); excursions permitted to 15°-30oC (59°-86oF) [see USP Controlled Room Temperature]. DO NOT FREEZE. Keep all containers tightly closed.
• Keep NOXAFIL (posaconazole oral suspension) , as well as other medicines, out of the reach of children.

General information about NOXAFIL® (posaconazole oral suspension)

Doctors can prescribe medicines for conditions that are not in this leaflet. Use NOXAFIL (posaconazole oral suspension) only as directed by your doctor. Do not give it to other people, even if they have the same symptoms as you. It may harm them.

This leaflet gives the most important information about NOXAFIL (posaconazole oral suspension) . For more information, talk to your doctor. You can ask your doctor or pharmacist for information about NOXAFIL (posaconazole oral suspension) that is written for health care professionals.

What is in NOXAFIL®?

Active ingredient: posaconazole.

Inactive ingredients: polysorbate 80, simethicone, sodium benzoate, sodium citrate dihydrate, citric acid monohydrate, glycerin, xanthan gum, liquid glucose, titanium dioxide, artificial cherry flavor, and purified water.

Last reviewed on RxList: 10/12/2010
This monograph has been modified to include the generic and brand name in many instances.