Description
Isavuconazonium is used to treat serious fungal or yeast infections, including invasive aspergillosis and invasive mucormycosis. This medicine works by killing the fungus or yeast and preventing its growth.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
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 isavuconazonium in children younger than 6 years of age weighing less than 16 kilograms (kg). 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 isavuconazonium 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 taking 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.
- Apalutamide
- Boceprevir
- Carbamazepine
- Ceritinib
- Clarithromycin
- Cobicistat
- Enzalutamide
- Fosphenytoin
- Idelalisib
- Indinavir
- Itraconazole
- Ivosidenib
- Ketoconazole
- Lonafarnib
- Lumacaftor
- Mephobarbital
- Mifepristone
- Mitotane
- Nefazodone
- Nelfinavir
- Paritaprevir
- Phenytoin
- Posaconazole
- Ribociclib
- Rifampin
- Rifapentine
- Ritonavir
- Saquinavir
- St John's Wort
- Telaprevir
- Telithromycin
- Troleandomycin
- Tucatinib
- Voriconazole
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.
- Adagrasib
- Atorvastatin
- Avacopan
- Colchicine
- Cyclosporine
- Digoxin
- Enasidenib
- Everolimus
- Fluconazole
- Lopinavir
- Mavacamten
- Midazolam
- Mycophenolate Mofetil
- Mycophenolic Acid
- Nirmatrelvir
- Sirolimus
- Tacrolimus
- Tazemetostat
- Tolvaptan
- Vincristine
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.
- Bupropion
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 not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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 rhythm problem (eg, familial short QT syndrome)—Should not be used in patients with this condition.
- Liver disease—Use with caution. May make this condition worse.
Proper Use
Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule whole. Do not crush, break, dissolve, or open it. You may take this medicine with or without food.
Your doctor may switch you between injection and oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For invasive aspergillosis and invasive mucormycosis:
- Adults—At first, 372 milligrams (mg) (two 186 mg capsules or five 74.5 mg capsules) every 8 hours for 6 doses (48 hours). Then, your doctor will adjust your dose to 372 mg (two 186 mg capsules or five 74.5 mg capsules) once a day.
- Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor.
- Weighing 32 kilograms (kg) or more—At first, 372 milligrams (mg) (five 74.5 mg capsules) every 8 hours for 6 doses (48 hours). Then, your doctor will adjust your dose to 372 mg (five 74.5 mg capsules) once a day.
- Weighing 25 to less than 32 kg—At first, 298 mg (four 74.5 mg capsules) every 8 hours for 6 doses (48 hours). Then, your doctor will adjust your dose to 298 mg (four 74.5 mg capsules) once a day.
- Weighing 18 to less than 25 kg—At first, 223.5 mg (three 74.5 mg capsules) every 8 hours for 6 doses (48 hours). Then, your doctor will adjust your dose to 223.5 mg (three 74.5 mg capsules) once a day.
- Weighing 16 to less than 18 kg—At first, 149 mg (two 74.5 mg capsules) every 8 hours for 6 doses (48 hours). Then, your doctor will adjust your dose to 149 mg (two 74.5 mg capsules) once a day.
- Children younger than 6 years of age weighing less than 16 kg—Use and dose must be determined by your doctor.
- For invasive aspergillosis and invasive mucormycosis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the medicine in the original container. Do not put it in pill boxes or pill organizers.
Precautions
It is important that your doctor check your or your child's progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects. Blood tests may be needed to check for unwanted effects.
If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take this medicine for several weeks or months before your infection gets better.
Do not use this medicine together with carbamazepine (Tegretol®), ketoconazole (Nizoral®), phenobarbital (Luminal®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), or St. John's wort. Using these medicines together may cause unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 28 days after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Serious skin reactions (eg, Stevens-Johnson syndrome) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, chills, cough, diarrhea, 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, or unusual tiredness or weakness while you are 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 immediately if any of the following side effects occur:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody urine
- blurred vision
- chest pain or tightness
- confusion
- decreased frequency or amount of urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast or irregular heartbeat
- loss of appetite
- lower back or side pain
- muscle pain or cramps
- muscle spasms (tetany) or twitching
- numbness or tingling in the hands, feet, or lips
- seizures
- severe nausea or vomiting
- sweating
- tingling of the hands or feet
- trembling
- trouble breathing
- unusual tiredness or weakness
Less common or rare
- Black, tarry stools
- chills
- cough or hoarseness
- dark urine
- fever with or without chills
- hives, itching, or rash
- irritation
- joint pain, stiffness, or swelling
- light-colored stools
- painful or difficult urination
- red, swollen skin
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- unusual bleeding or bruising
- upper right abdominal or stomach pain
- yellow eyes and skin
Incidence not known
- Blistering, peeling, or loosening of the skin
- diarrhea
- red skin lesions, often with a purple center
- red, irritated eyes
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
- Acid or sour stomach
- anxiety
- back pain
- headache
- heartburn or indigestion
- seeing, hearing, or feeling things that are not there
- stomach discomfort or upset
- trouble sleeping
- unusual excitement, nervousness, or restlessness
Less common or rare
- Burning, numbness, tingling, or painful sensations
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased vision
- eye pain
- feeling of constant movement of self or surroundings
- hearing loss
- loss or thinning of the hair
- sensation of spinning
- unsteadiness or awkwardness
- weakness in arms, hands, legs, or feet
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.
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