Posaconazole

Posaconazole is a prescription medication used to prevent and treat fungal infections caused by Aspergillus or Candida. Posaconazole belongs to a group of drugs called triazole antifungal agents, which work by slowing the growth of fungi.

Posaconazole is available as an oral suspension (liquid) and in a delayed-release tablet form. The delayed-release tablets should be swallowed whole and taken with food. Shake posaconazole oral suspension well before use and take during, or within 20 minutes of a meal.

Posaconazole is also available as an injection to be given directly into a vein by a healthcare provider.

Common side effects include fever, nausea, and diarrhea.

Posaconazole delayed-release tablets, posaconazole injection, and posaconazole oral suspension are prescription medicines used to help prevent and treat fungal infections that can spread throughout your body (invasive fungal infections). These infections are caused by fungi called Aspergillus or Candida. Posaconazole is used in people who have an increased chance of getting these infections due to a weak immune system. These include people who have:

• had a hematopoietic stem cell transplantation (bone marrow transplant) with graft versus host disease
• a low white blood cell count due to chemotherapy for blood cancers (hematologic malignancy)

Posaconazole oral suspension is also used to treat severe yeast infections of the mouth and throat caused by Candida called oropharyngeal candidiasis (OPC). Posaconazole oral suspension can be used as the first treatment for OPC, or as another treatment for OPC after itraconazole or fluconazole treatment has not worked.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Posaconazole may be found in some form under the following brand names:

• Noxafil

Serious side effects have been reported. See "Drug Precautions" section.

The most common side effects of posaconazole delayed-release tablets include:

• diarrhea
• fever
• nausea

The most common side effects of posaconazole oral suspension include:

• diarrhea
• nausea
• headache
• vomiting
• fever

The most common side effects of posaconazole injection include:

• anemia
• abdominal pain
• diarrhea
• nausea
• vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of posaconazole. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all of the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not take posaconazole if you are taking any of the following medicines:

• sirolimus
• pimozide
• quinidine
• certain statin medicines that lower cholesterol (atorvastatin, lovastatin, simvastatin)
• ergot alkaloids (ergotamine, dihydroergotamine)

​Also, you should tell your healthcare provider if you:

• are taking certain medicines that lower your immune system like cyclosporine or tacrolimus
• are taking certain drugs for HIV infection, such as ritonavir, atazanavir, efavirenz, or fosamprenavir. Efavirenz and fosamprenavir can cause a decrease in the posaconazole levels in your body. Efavirenz and fosamprenavir should not be taken with posaconazole.
• are taking midazolam, a hypnotic and sedative medicine

Ask your healthcare provider or pharmacist if you are not sure if you are taking any of these medicines.

Do not start taking a new medicine without talking to your healthcare provider or pharmacist.

Posaconazole may cause serious side effects, including:

• drug interactions with cyclosporine or tacrolimus. If you take posaconazole with cyclosporine or tacrolimus, your blood levels of cyclosporine or tacrolimus may increase. Serious side effects can happen in your kidney or brain if you have high levels of cyclosporine or tacrolimus in your blood. Your healthcare provider should do blood tests to check your levels of cyclosporine or tacrolimus if you are taking these medicines while taking posaconazole. Tell your healthcare provider right away if you have swelling in your arm or leg or shortness of breath.
• problems with the electrical system of your heart (arrhythmias and QTc prolongation). Certain medicines used to treat fungus called azoles, including posaconazole may cause heart rhythm problems. People who have certain heart problems or who take certain medicines have a higher chance for this problem. Tell your healthcare provider right away if your heartbeat becomes fast or irregular.
• liver problems. Some people who also have other serious medical problems may have severe liver problems that may lead to death, especially if you take certain doses of posaconazole. Your healthcare provider should do blood tests to check your liver while you are taking posaconazole. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
  • itchy skin
  • nausea or vomiting
  • yellowing of your eyes
  • feeling very tired
  • flu-like symptoms
• increased amounts of midazolam in your blood. If you take posaconazole with midazolam, posaconazole increases the amount of midazolam in your blood. This can make your sleepiness last longer. Your healthcare provider should check you closely for side effects if you take midazolam with posaconazole.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of posaconazole, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take posaconazole, tell your healthcare provider if you:

• are taking certain medicines that lower your immune system like cyclosporine or tacrolimus.
• are taking certain drugs for HIV infection, such as ritonavir, atazanavir, efavirenz, or fosamprenavir. Efavirenz and fosamprenavir can cause a decrease in the posaconazole levels in your body. Efavirenz and fosamprenavir should not be taken with posaconazole.
• are taking midazolam, a hypnotic and sedative medicine.
• have or had liver problems.
• have or had kidney problems.
• have or had an abnormal heart rate or rhythm, heart problems, or blood circulation problems.
• are pregnant or plan to become pregnant. It is not known if posaconazole will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if posaconazole passes into your breast milk. You and your healthcare provider should decide if you will take posaconazole or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. The FDA categorizes medications based on safety for use during pregnancy.

Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. 

Posaconazole falls into category C. There are no well-controlled studies in pregnant women. Posaconazole should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby

Do not breastfeed while being treated with posaconazole, unless specifically advised by your doctor.

Posaconazole is available as delayed-release tablets and as an oral suspension:

• Take posaconazole exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much posaconazole to take and when to take it.
• Take posaconazole for as long as your healthcare provider tells you to take it.
• If you take too much posaconazole , call your healthcare provider or go to the nearest hospital emergency room right away.
  • Take posaconazole delayed-release tablets with food.
  • Take posaconazole delayed-release tablets whole. Do not break, crush, dissolve or chew posaconazole delayed-release tablets before swallowing. If you cannot swallow posaconazole delayed-release tablets whole, tell your healthcare provider. You may need a different medicine.
  • If you miss a dose, take it as soon as you remember and then take your next scheduled dose at its regular time. If, however, it is within 12 hours of your next dose, do not take the missed dose. Skip the missed dose and go back to your regular schedule. Do not double your next dose or take more than your prescribed dose.
  • Shake posaconazole oral suspension well before use.
  • Take each dose of posaconazole oral suspension during or within 20 minutes after a full meal. If you cannot eat a full meal, take each dose of posaconazole oral suspension with a liquid nutritional supplement or an acidic carbonated beverage, like ginger ale.
  • A measured dosing spoon comes with your posaconazole oral suspension and is marked for doses of 2.5 mL and 5 mL.
  • Rinse the spoon with water after each dose of posaconazole oral suspension and before you store it away.

Posaconazole is also available as an injection to be given directly into a vein by a healthcare provider.

Take posaconazole exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• For prevention of fungal infections: the recommended dose is 200 mg (5 mL) three times a day of the oral suspension. Duration of therapy depends on speed of recovery of certain white blood cells (your neutrophil count) and how weak your immune system is (immunosuppression).

• For treating oropharyngeal candidiasis: the recommended dose is to start with 100 mg (2.5 mL) twice a day of the oral suspension or 300 mg of the injection on the first day, then 100 mg (2.5 mL) of the oral suspension or 300 mg of the injection once a day for 13 days.

• For treating oropharyngeal candidiasis that is not cured by itraconazole or fluconazole: the recommended dose is 400 mg (10 mL) twice a day of the oral suspension. Duration of therapy should be based on the severity of the patient's underlying disease and response to this medication.

If you take too much posaconazole, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If posaconazole is administered by a healthcare provider, an overdose is unlikely, but you should still seek emergency care if you suspect an overdose.

Keep this and all medicines out of the reach of children.

• Store posaconazole delayed release tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep posaconazole delayed-release tablets in a tightly closed container.
• Do not freeze posaconazole oral suspension.
• Posaconazole injection can be stored up to 24 hours refrigerated.
• Safely throw away medicine that is out of date or no longer needed.