Isavuconazonium injection

What is this medicine?

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

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting. If you get this medicine at home, you will be taught how to prepare and give this medicine. use exactly as directed. 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.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• dark yellow or brown urine

• irregular heartbeat

• muscle cramps or pain

• pain, redness, or irritation at site where injected

• trouble passing urine or change in the amount of urine

• yellowing of the eyes or skin

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

• constipation

• diarrhea

• headache

• nausea, vomiting

• stomach pain

• tiredness

• trouble sleeping

What may interact with this medicine?

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

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment. If you give yourself the medicine and 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.

Where should I keep my medicine?

Keep out of the reach of children.

This drug is usually given in a hospital or clinic and will not be stored at home.

In rare cases, this medicine may be given at home. If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

What should I tell my health care provider before I take this medicine?

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

What should I watch for while using this medicine?

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.