Patient information: uses, side effects, how to take - Posaconazole Injection
What is posaconazole injection?
Posaconazole injection is a prescription medicine used in adults and children to help prevent or treat fungal infections that can spread throughout your body (invasive fungal infections). These infections are caused by fungi called Aspergillus or Candida. Posaconazole injection 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 or those with a low white blood cell count due to chemotherapy for blood cancers (hematologic malignancies).
Posaconazole injection is used for:
- prevention of fungal infections in adults and children 2 years of age and older who weigh 22 lbs (10 kg) or greater.
- treatment of fungal infections in adults and children 2 years of age and older who weigh 22 lbs (10 kg) or greater.
It is not known if posaconazole injection is safe and effective in children under 2 years of age.
Do not take posaconazole injection if you:
- are allergic to posaconazole, any of the ingredients in posaconazole injection, or other azole antifungal medicines. See the end of this Patient Information leaflet for a complete list of ingredients in posaconazole injection.
are taking any of the following medicines:
- sirolimus
- pimozide
- quinidine
- certain statin medicines that lower cholesterol (atorvastatin, lovastatin, simvastatin)
- ergot alkaloids (ergotamine, dihydroergotamine)
- have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and you have just started taking venetoclax or your venetoclax dose is being slowly increased.
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.
Before you take posaconazole, tell your healthcare provider about all of your medical conditions, including 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.
- are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).
- are taking venetoclax, a medicine used to treat cancer.
- 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. Posaconazole can affect the way other medicines work, and other medicines can affect the way posaconazole work, and can cause serious side effects.
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them with you to show your healthcare provider or pharmacist when you get a new medicine.
How should I take posaconazole?
- 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.
- Posaconazole injection is usually given over 30 to 90 minutes through a plastic tube placed in your vein.
Follow the instructions from your healthcare provider on how much posaconazole injection you should take and when to take it.
What are the possible side effects of posaconazole?
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, the active ingredient in posaconazole injection, 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.
- changes in body salt (electrolytes) levels in your blood. Your healthcare provider should check your electrolytes while you are taking posaconazole.
- new or worsening high blood pressure and low potassium levels in your blood (pseudoaldosteronism). Your healthcare provider should check your blood pressure and potassium levels.
- 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:
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- 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.
The most common side effects of posaconazole in adults include:
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The most common side effects of posaconazole injection in children include:
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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 FDA at 1-800-FDA-1088.
How should I store posaconazole?
Posaconazole injection
- Store posaconazole injection refrigerated between 36◦F to 46◦F (2◦C to 8◦C).
Safely throw away medicine that is out of date or no longer needed.
Keep posaconazole and all medicines out of the reach of children.
General information about the safe and effective use of posaconazole.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use posaconazole for a condition for which it was not prescribed. Do not give posaconazole to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about posaconazole that is written for health professionals.
What are the ingredients in posaconazole injection?
Active ingredient: posaconazole
Inactive ingredients:
Posaconazole injection: Betadex Sulfobutyl Ether Sodium (SBECD), edetate sodium dihydrate, hydrochloric acid, sodium hydroxide, and water for injection.
Brands listed are the trademarks of their respective owners.
Manufactured by:
Gland Pharma Limited
Hyderabad-500043, India
For more information, call 866-770-7144
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 05/2026