Isavuconazonium Capsules

What is this medication?

ISAVUCONAZONIUM (I sa vue KON a ZOE NE um) treats fungal infections. It belongs to a group of medications called antifungals. It will not treat colds, the flu, or infections caused by bacteria or viruses.

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
• Irregular heartbeat or rhythm
• Liver disease
• An unusual or allergic reaction to isavuconazonium, isavuconazole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

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 medication with any of the following:

• Adagrasib
• Certain antibiotics, such as chloramphenicol, dalfopristin; quinupristin, rifampin, streptogramins, telithromycin
• Certain antivirals for HIV
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Conivaptan
• Dofetilide
• Enzalutamide
• Fosamprenavir
• Grapefruit juice
• Idelalisib
• Lomitapide
• Mitotane
• Nefazodone
• St. John's wort

This medication may also interact with the following:

• Atorvastatin
• Bupropion
• Cyclosporine
• Digoxin
• Estrogen or progestin hormones
• 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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Some products come in blister cards. Some of the blisters may have desiccants in them. A desiccant helps protect your medication from moisture. Do not eat the desiccant. Talk to your pharmacist if you have questions.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team if you may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 28 days after the last dose. Contraception is recommended while taking this medication and for 28 days after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• 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

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

• Constipation
• Cough
• Diarrhea
• Headache
• Nausea
• Shortness of breath
• Swelling of the ankles, hands, or feet

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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.