Isavuconazonium Sulfate (eye-sa-vue-koe-na-ZOE-nee-um SUL-fate)

Treats fungal infections.

Brand Name(s):

Cresemba

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• This medicine can also be given through a nasogastric tube by a nurse or other trained health professional.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with carbamazepine, ketoconazole, phenobarbital, rifampin, ritonavir, or St John's wort.
• Some medicines can affect how isavuconazonium works. Tell your doctor if you are using atorvastatin, bupropion, cyclosporine, digoxin, lopinavir/ritonavir, midazolam, mycophenolate mofetil, sirolimus, tacrolimus, or vincristine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use effective birth control during treatment and for at least 28 days after the last dose.
• Tell your doctor if you are breastfeeding, or if you have liver disease or heart rhythm problems (including familial short QT syndrome). Tell your doctor if you had an allergic reaction to similar medicines (including itraconazole, ketoconazole, voriconazole).
• This medicine may cause the following problems:
  • Liver problems
  • Infusion-related reactions
  • Serious skin reactions, including Stevens-Johnson syndrome
• This medicine may cause liver problems.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Chills, dizziness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Decrease in how much or how often you urinate, difficult or painful urination
• Dry mouth, increased thirst, muscle cramps, uneven heartbeat
• Lightheadedness, dizziness, fainting
• Numbness or tingling, change in sense of touch

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Constipation, diarrhea, stomach upset
• Headache, trouble sleeping
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088