Cresemba (Oral)

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 stopping its growth.

This medicine is available only with your doctor's prescription.

It is important for your doctor to check your progress after treatment. This is to ensure that the infection is completely cleared up and to allow your doctor to monitor any unwanted effects. Blood tests may be required to check for unwanted effects.

If your symptoms do not improve, or if they worsen, consult your doctor. You may need to take this medicine for several weeks or months before your infection improves.

Do not use this medicine with carbamazepine (Tegretol®), ketoconazole (Nizoral®), phenobarbital (Luminal®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), or St. John's wort. Taking these medicines together may cause unwanted effects.

Using this medicine during pregnancy can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment and for at least 28 days after your last dose of this medicine. If you think you might be pregnant while using this medicine, inform your doctor immediately.

Contact your doctor right away if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver issue.

This medicine may cause severe allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical help. Notify your doctor immediately if you develop a rash, itching, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Severe skin reactions (e.g., Stevens-Johnson syndrome) can occur with this medicine. Contact your doctor right away if you experience 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 using this medicine.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Appropriate studies have not been done to understand how isavuconazonium affects children. Safety and effectiveness have not been established for this age group.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the use of isavuconazonium.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

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.

• Atazanavir
• Boceprevir
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Delavirdine
• Enzalutamide
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lumacaftor
• Mephobarbital
• Mitotane
• Nefazodone
• Nelfinavir
• Phenytoin
• Posaconazole
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Atorvastatin
• Cyclosporine
• Digoxin
• Fluconazole
• Lopinavir
• Mavacamten
• Midazolam
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nirmatrelvir
• Quinidine
• Sirolimus
• Tacrolimus
• Tocilizumab

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

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 provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Heart rhythm problem (e.g., familial short QT syndrome)—Should not be used in patients with this condition.

• Liver disease—Use with caution. May worsen this condition.

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. 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.

In the U.S.

• Cresemba

Available Dosage Forms:

• Capsule

Therapeutic Class: Antifungal

Chemical Class: Isavuconazonium

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.

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 (tablets):For invasive aspergillosis and invasive mucormycosis: Adults—At first, 372 milligrams (mg) (2 capsules) every 8 hours for 6 doses (48 hours). Then, your doctor will adjust your dose to 372 mg (2 capsules) per day. Children—Use and dose must be determined by your doctor.

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.