Description
Posaconazole injection is used to prevent certain fungus (yeast) infections (eg, invasive Aspergillus or Candida infections) in patients who have a weakened immune system (eg, hematopoietic stem cell transplant or HSCT recipients, or patients with blood cancers).
Posaconazole injection is also used to treat invasive aspergillosis.
This medicine is to be given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of posaconazole injection in children younger than 2 years of age to prevent fungus infections. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of posaconazole injection in children 13 years of age and older to treat invasive aspergillosis. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of posaconazole injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alfuzosin
- Alprazolam
- Amiodarone
- Aripiprazole
- Aripiprazole Lauroxil
- Astemizole
- Atazanavir
- Atorvastatin
- Bedaquiline
- Bepridil
- Bromocriptine
- Buprenorphine
- Ceritinib
- Cisapride
- Citalopram
- Clarithromycin
- Clozapine
- Colchicine
- Conivaptan
- Crizotinib
- Dabrafenib
- Dasatinib
- Dihydroergotamine
- Dofetilide
- Domperidone
- Dronedarone
- Efavirenz
- Eletriptan
- Encorafenib
- Entrectinib
- Eplerenone
- Ergotamine
- Erythromycin
- Finerenone
- Flibanserin
- Fluconazole
- Fluvastatin
- Gepirone
- Glasdegib
- Halofantrine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abrocitinib
- Acalabrutinib
- Adagrasib
- Ado-Trastuzumab Emtansine
- Alfentanil
- Alogliptin
- Amisulpride
- Amitriptyline
- Amprenavir
- Anagrelide
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Arsenic Trioxide
- Asciminib
- Asenapine
- Asunaprevir
- Atogepant
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Azathioprine
- Azithromycin
- Benzhydrocodone
- Berotralstat
- Bictegravir
- Boceprevir
- Bosutinib
- Brentuximab Vedotin
- Brexpiprazole
- Brigatinib
- Budesonide
- Buserelin
- Cabazitaxel
- Cabozantinib
- Calcifediol
- Canagliflozin
- Capivasertib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
- Lorazepam
- Topiramate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Green Tea
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart disease, history of or
- Heart rhythm problems (eg, arrhythmia, QT prolongation) or
- High blood pressure or
- Liver disease or
- Mineral imbalance (low potassium, magnesium, or calcium in the blood)—These conditions may cause side effects to become worse.
- Kidney disease, moderate to severe—Use is not recommended.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through an IV placed in one of your veins. The medicine must be injected slowly, so your IV will need to stay in place for 30 to 90 minutes.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.
You should not use atorvastatin (Lipitor®), lovastatin (Mevacor®), pimozide (Orap®), quinidine (Quinaglute®), simvastatin (Zocor®), sirolimus (Rapamune®), venetoclax (Venclexta®), or ergotamine medicines (eg, bromocriptine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, methysergide, Cafergot®, Ergomar®, Wigraine®). Using any of them together with this medicine may increase the chance of unwanted effects.
This medicine can cause changes in heart rhythms, including QT prolongation and torsades de pointes. Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing.
This medicine may cause pseudoaldosteronism, including new or worsening high blood pressure and hypokalemia (low potassium in the blood). Check with your doctor right away if you have blurred vision, decrease urine output, dizziness, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood change, muscle pain or cramps, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, pounding in the ears, seizures, slow or fast heartbeat, trouble breathing, or unusual tiredness or weakness.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow skin or eyes. These could be symptoms of a serious liver problem.
Check with your doctor right away if you have severe diarrhea or vomiting while using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- decreased urine
- dizziness
- fever or chills
- headache
- increased thirst
- irregular heartbeat
- loss of appetite
- mood or mental changes
- muscle pain, cramps, spasms, or twitching
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- slow or fast heartbeat
- swelling of the hands, ankles, feet, or lower legs
- trembling
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Dry mouth
- seizures
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Cough
- diarrhea
- difficulty having a bowel movement (stool)
- rash
- small red or purple spots on the skin
- upper stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20095189
