Pronunciation:

poe-sa-KON-a-zole

Brand Names:

• Noxafil

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antifungal

Chemical—

Triazole

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of posaconazole injection in the elderly.

Breast-feeding—

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.

Other medicines—

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
• Astemizole
• Atorvastatin
• Bedaquiline
• Bepridil
• Buprenorphine
• Cisapride
• Citalopram
• Clarithromycin
• Clozapine
• Colchicine
• Conivaptan
• Crizotinib
• Dabrafenib
• Dasatinib
• Dihydroergotamine
• Disopyramide
• Dofetilide
• Domperidone
• Donepezil
• Dronedarone
• Eletriptan
• Eliglustat
• Encorafenib
• Entrectinib
• Eplerenone
• Ergonovine
• Ergotamine
• Erythromycin
• Etrasimod
• Fexinidazole
• Finerenone
• Flibanserin
• Fluvastatin
• Fostemsavir
• Gepirone
• Glasdegib
• Halofantrine
• Haloperidol
• Iloperidone
• Isavuconazonium Sulfate
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Levoketoconazole
• Lomitapide
• Lopinavir
• Lovastatin
• Lumefantrine
• Lurasidone
• Macimorelin
• Maraviroc
• Mavacamten
• Mefloquine
• Mesoridazine
• Methadone
• Methylergonovine
• Methysergide
• Mifepristone
• Mirtazapine
• Mobocertinib
• Naloxegol
• Nelfinavir
• Nilotinib
• Nimodipine
• Ondansetron
• Osilodrostat
• Pacritinib
• Pazopanib
• Pimozide
• Piperaquine
• Propafenone
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Relugolix
• Ribociclib
• Saquinavir
• Selpercatinib
• Simvastatin
• Sirolimus
• Solifenacin
• Sorafenib
• Sparfloxacin
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telithromycin
• Terfenadine
• Thioridazine
• Tolvaptan
• Toremifene
• Trazodone
• Ubrogepant
• Vardenafil
• Vemurafenib
• Venetoclax
• Vilanterol
• Voclosporin
• Voriconazole
• Ziprasidone

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.

• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Alfentanil
• Amitriptyline
• Amprenavir
• Anagrelide
• Apalutamide
• Apixaban
• Apomorphine
• Aprepitant
• Arsenic Trioxide
• Asciminib
• Asenapine
• Atogepant
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Azithromycin
• Benzhydrocodone
• Berotralstat
• Bosutinib
• Brentuximab Vedotin
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buserelin
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Capivasertib
• Capmatinib
• Carbamazepine
• Cariprazine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Cilostazol
• Cimetidine
• Ciprofloxacin
• Clofazimine
• Clomipramine
• Clothiapine
• Cobimetinib
• Codeine
• Copanlisib
• Cyclobenzaprine
• Cyclosporine
• Daclatasvir
• Daridorexant
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dihydrocodeine
• Docetaxel
• Dolasetron
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Duvelisib
• Ebastine
• Efavirenz
• Elacestrant
• Elagolix
• Elexacaftor
• Enzalutamide
• Erdafitinib
• Eribulin
• Erlotinib
• Escitalopram
• Esomeprazole
• Eszopiclone
• Etravirine
• Everolimus
• Famotidine
• Fedratinib
• Felbamate
• Fentanyl
• Fesoterodine
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Fluticasone
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gilteritinib
• Gonadorelin
• Goserelin
• Granisetron
• Histrelin
• Hydrocodone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrexafungerp
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Imipramine
• Infigratinib
• Inotuzumab Ozogamicin
• Irinotecan
• Irinotecan Liposome
• Istradefylline
• Ivacaftor
• Ixabepilone
• Larotrectinib
• Lefamulin
• Lemborexant
• Leniolisib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Lofexidine
• Lorlatinib
• Lumacaftor
• Lumateperone
• Lurbinectedin
• Macitentan
• Manidipine
• Meperidine
• Methotrexate
• Methotrimeprazine
• Metronidazole
• Midazolam
• Midostaurin
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mizolastine
• Moricizine
• Moxifloxacin
• Nafarelin
• Neratinib
• Nifedipine
• Nirogacestat
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Oliceridine
• Omaveloxolone
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pemigatinib
• Pentamidine
• Pentazocine
• Perphenazine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pirtobrutinib
• Pitolisant
• Ponatinib
• Ponesimod
• Pralsetinib
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Protriptyline
• Quizartinib
• Reboxetine
• Regorafenib
• Repotrectinib
• Retapamulin
• Rifabutin
• Rifampin
• Rimegepant
• Risperidone
• Ritonavir
• Rivaroxaban
• Roflumilast
• Romidepsin
• Ruxolitinib
• Salmeterol
• Selumetinib
• Sertindole
• Sertraline
• Sevoflurane
• Sildenafil
• Simeprevir
• Siponimod
• Sirolimus Protein-Bound
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sonidegib
• Sotalol
• Sparsentan
• Sufentanil
• Sulpiride
• Sultopride
• Suvorexant
• Tadalafil
• Tamsulosin
• Tazemetostat
• Telaprevir
• Telavancin
• Tetrabenazine
• Tezacaftor
• Thiotepa
• Tolterodine
• Trabectedin
• Tramadol
• Triclabendazole
• Trimipramine
• Triptorelin
• Upadacitinib
• Valbenazine
• Vamorolone
• Vandetanib
• Venlafaxine
• Vilazodone
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vinorelbine
• Vorapaxar
• Vorinostat
• Warfarin
• Zanubrutinib
• Zolpidem
• Zotepine
• Zuclopenthixol
• Zuranolone

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
• Aripiprazole Lauroxil
• 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.

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
• 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 of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube 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 While Using This Medicine:

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 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.

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 of This Medicine:

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

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.