Isavuconazonium capsules

What is this medication?

ISAVUCONAZONIUM (I sa vue KON a ZOE NE um) is an antifungal medicine. It is used to treat certain kinds of fungal infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): CRESEMBA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• history of irregular heartbeat
• liver disease
• an unusual or allergic reaction to isavuconazonium, isavuconazole, antifungals, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medicines:

• certain antiviral medicine for HIV or AIDS
• certain medicines for fungal infections like ketoconazole, itraconazole, and posaconazole
• certain medicines for infections like chloramphenicol, dalfopristin; quinupristin, rifampin, streptogramins, telithromycin
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• conivaptan
• dofetilide
• enzalutamide
• fosamprenavir
• grapefruit juice
• idelalisib
• lomitapide
• mitotane
• nefazodone
• St. John's Wort

This medicine may also interact with the following medications:

• atorvastatin
• bupropion
• cyclosporine
• digoxin
• female hormones, like estrogens or progestins and birth control pills
• midazolam
• mycophenolate mofetil
• sirolimus
• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your healthcare professional for regular checks on your progress. Tell your healthcare professional if your symptoms do not start to get better or if they get worse.

Women should inform their healthcare professional if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects and harm to an unborn child. Talk to your healthcare professional for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions or angioedema—skin rash, itching, hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Change in the amount of urine
• Heart palpitations—rapid, pounding, or irregular heartbeat
• Liver injury— right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Muscle pain or cramps
• Trouble breathing

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• Constipation
• Cough
• Diarrhea
• Fatigue
• Headache
• Nausea, vomiting
• Stomach pain
• Trouble sleeping
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degree C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.