When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to isavuconazonium.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole. Do not crush, break, dissolve, or open it.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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 foods and medicines can affect how isavuconazonium works. Tell your doctor if you are using any of the following:
  
  • Atorvastatin
  • Bupropion
  • Cyclosporine
  • Digoxin
  • Lopinavir/ritonavir
  • Midazolam
  • Mycophenolate mofetil
  • Sirolimus
  • Tacrolimus

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or heart rhythm problems (such as familial short QT syndrome). Tell your doctor if you had an allergic reaction to similar medicines (including itraconazole, ketoconazole, voriconazole).
• 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.
• Call your doctor if your symptoms do not improve or if they get worse.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• 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, or fainting

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

• Headache, trouble sleeping
• Nausea, vomiting, constipation, diarrhea
• 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