Description
Voriconazole injection is used to treat certain serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esophageal candidiasis (candida esophagitis), or other fungal infections (including infections in the skin, stomach, kidney, bladder, and wounds). It may also be used to treat patients with serious fungal or yeast infections who cannot tolerate or do not respond to other types of medicine.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for 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 voriconazole injection in children younger than 2 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of voriconazole 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.
- Alprazolam
- Astemizole
- Atazanavir
- Bepridil
- Carbamazepine
- Cisapride
- Colchicine
- Conivaptan
- Dihydroergotamine
- Dronedarone
- Efavirenz
- Eletriptan
- Eplerenone
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Finerenone
- Flibanserin
- Fluconazole
- Gepirone
- Isavuconazonium Sulfate
- Ivabradine
- Levoketoconazole
- Lisuride
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Mavacamten
- Mephobarbital
- Mesoridazine
- Metergoline
- Methylergonovine
- Methysergide
- Naloxegol
- Nicergoline
- Nimodipine
- Nirmatrelvir
- Pacritinib
- Phenobarbital
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
- Acenocoumarol
- Adagrasib
- Ado-Trastuzumab Emtansine
- Afatinib
- Alectinib
- Alfentanil
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asciminib
- Asenapine
- Atogepant
- Atorvastatin
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Azathioprine
- Azithromycin
- Baricitinib
- Bedaquiline
- Belzutifan
- Benzhydrocodone
- Bictegravir
- Boceprevir
- Bosutinib
- Brentuximab Vedotin
- Bretylium
- Brexpiprazole
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
- Amprenavir
- Cerivastatin
- Clopidogrel
- Desogestrel
- Dienogest
- Drospirenone
- Esomeprazole
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etravirine
- Fosamprenavir
- Gestodene
- Glipizide
- Glyburide
- Levonorgestrel
- Meloxicam
- Mestranol
- Midazolam
- Nomegestrol
- Norethindrone
- Norgestimate
- Norgestrel
- Tolbutamide
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Cancer treatment (eg, chemotherapy), recent or history of or
- Electrolyte imbalance (eg, low potassium, magnesium, calcium) or
- Heart disease, history of or
- Stem cell transplant—Use with caution. These conditions may increase your risk of having serious side effects.
- Heart rhythm problems (eg, arrhythmia, QT prolongation) or
- Liver disease (including cirrhosis) or
- Kidney disease or
- Pancreas problems—Use with caution. May make these conditions worse.
- Hypocalcemia (low calcium in the blood), uncorrected or
- Hypokalemia (low potassium in the blood), uncorrected or
- Hypomagnesemia (low magnesium in the blood)—Use with caution. These should be corrected first before starting treatment and during treatment with voriconazole.
Proper Use
A nurse or other trained health professional will give you or your child this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so your IV tube should stay in place for up to 2 hours.
Your doctor will give you or your child a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Precautions
It is very important that your doctor check you or your child closely while you are receiving this medicine. This is to make sure that this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.
If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.
Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
You or your child should not use astemizole (Hismanal®), barbiturates (eg, phenobarbital, Luminal®), carbamazepine (Tegretol®), efavirenz (Sustiva®), ergot medicines (eg, dihydroergotamine, ergotamine, Cafergot®, Ergomar®, Wigraine®), finerenone (Kerendia®), ivabradine (Corlanor®, Procoralan®), lemborexant (Dayvigo®), lurasidone (Latuda®), naloxegol (Movantik®), pimozide (Orap®), quinidine (Quinaglute®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), sirolimus (Rapamune®), St. John's wort, terfenadine (Seldane®), tolvaptan (Jynarque®, Samsca®), or venetoclax (Venclexta®). Using any of them together with this medicine may increase the chance of unwanted effects.
This medicine may cause some people to have changes in vision, including blurred vision and seeing bright spots or wavy lines. Do not drive (especially at night) or do anything else that could be dangerous until you know how this medicine affects you.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Contact your doctor right away if you or your child have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem, including QT prolongation.
This medicine may cause a serious type of allergic reaction, called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have a fever, chills, flushing, itching or skin rash, sweating, trouble breathing, lightheadedness, fainting, or chest tightness within a few hours after you receive it.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, painful or difficult urination, swollen glands. trouble breathing, unusual bleeding, bruising, tiredness, or weakness.
Voriconazole may increase your or your child's risk of having kidney problems, including acute kidney failure. Check with your doctor right away if you have blood in the urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, decreased awareness or responsiveness, severe sleepiness, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
Pancreatitis (swelling of the pancreas) may occur while you or your child are receiving this medicine. Check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
This medicine may make your skin more sensitive to sunlight when used together with methotrexate (Reditrex®). Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
This medicine may cause adrenal gland problems. Check with your doctor right away if you or your child have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
This medicine may cause bone pain when used for a long period of time. Check with your doctor right away if you or your child have bone pain while receiving 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
- blistering, peeling, loosening of the skin
- chest pain
- chills
- cough
- diarrhea
- difficulty seeing at night
- fever
- increased sensitivity of the eyes to sunlight
- itching, rash
- joint or muscle pain
- painful or difficult urination
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision changes
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chills
- clay-colored stools
- confusion
- dark urine
- decreased urine
- dizziness
- dry mouth
- faintness or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- increased thirst
- irregular or pounding heartbeat
- loss of appetite
- muscle pain or cramps
- muscle spasms or twitching
- nausea
- nervousness
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- rapid weight gain
- rash with flat lesions or small raised lesions on the skin
- redness of the face, neck, arms, and occasionally, the upper chest
- seizures
- slow or fast heartbeat
- stomach pain
- sweating
- trembling
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Rare
- Black, bloody, or tarry stools
- bleeding gums
- blood in the eye
- blood in the urine or stools
- eye pain
- pale skin
- pinpoint red spots on the skin
- redness in the white part of the eyes
- seeing things that are not there
Incidence not known
- Backache
- blindness
- blue-yellow color blindness
- bone pain
- chapped, red, or swollen lips
- darkening of the skin
- decreased vision
- diarrhea
- facial hair growth in females
- fainting
- fractures
- full or round face, neck, or trunk
- increased urination
- irritability
- loss of sexual desire or ability
- menstrual irregularities
- mental depression
- muscle wasting
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- vomiting
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:
Less common
- Headache
- pain or swelling at the injection site
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.
CON-XXXXXXXX
