Posaconazole (Intravenous)

Posaconazole injection is used to prevent certain fungal (yeast) infections (for example, invasive Aspergillus or Candida infections) in patients who have a weakened immune system (for example, hematopoietic stem cell transplant or HSCT recipients, or patients with blood cancers).

Posaconazole injection is also used to treat invasive aspergillosis.

This medicine should only be given by a doctor or under the direct supervision of a doctor.

It is very important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should continue taking 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 (for example, bromocriptine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, methysergide, Cafergot®, Ergomar®, Wigraine®). Using any of them 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, an 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.

In deciding to use a drug, the risks of taking the medication 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

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medications. Additionally 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 issues 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 issues 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 medicine during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain drugs 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 clinician may want to change the dose, or other precautions may be necessary. When you are receiving this medication, it is especially important that your healthcare professional know if you are using 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 drug with any of the following medications is not advised. Your physician may decide not to treat you with this medication or change some of the other drugs 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 drug with any of the following medicines is typically not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how frequently you use one or both of the drugs.

• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Alfentanil
• Amitriptyline
• Amprenavir
• Anagrelide
• Apalutamide
• Apixaban
• Apomorphine
• Aprepitant
• Arsenic Trioxide
• Asenapine
• Atogepant
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Azithromycin
• Benzhydrocodone
• Bosutinib
• Brentuximab Vedotin
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buserelin
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Capmatinib
• 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
• 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
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• 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
• Retapamulin
• Rifabutin
• Rifampin
• Rimegepant
• Risperidone
• Ritonavir
• Rivaroxaban
• 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 drugs may cause an increased risk of certain side effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your clinician may change the dose or how frequently you use one or both of the drugs.

• Amlodipine
• Aripiprazole Lauroxil
• Lorazepam
• Topiramate

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 Issues

The presence of other medical problems may affect the use of this medication. Make sure you inform your clinician if you have any other medical issues, especially:

• Heart disease, history of or
• Heart rhythm issues (eg, arrhythmia, QT prolongation) or
• Liver disease or
• Mineral imbalance (low potassium, magnesium, or calcium in the blood)—These conditions may cause adverse effects to become worse.

• Kidney disease, moderate to severe—Use is not advised.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your healthcare 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.

In the U.S.

• Noxafil

Available Dosage Forms:

• Solution

Therapeutic Class: Antifungal

Chemical Class: Triazole

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.