HOW SHOULD I TAKE TOLSURA?

INDICATIONS AND IMPORTANT SAFETY INFORMATION

TOLSURA is a prescription medicine used to treat the following fungal infections in adults:
blastomycosis, histoplasmosis, and aspergillosis.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TOLSURA?

TOLSURA CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

• Congestive heart failure. TOLSURA can cause congestive heart failure or make congestive heart failure that you already have worse. Stop taking TOLSURA and call your doctor right away if you have any of these symptoms of congestive heart failure:
  • shortness of breath
  • swelling of your feet, ankles, or legs
  • sudden weight gain
  • increased tiredness
  • coughing up white or pink mucus (phlegm)
  • fast heartbeat
  • waking up at night more
  • than normal
• Heart problems and other serious medical problems. Serious medical problems that affect the heart and other parts of your body can happen if you take TOLSURA with certain other medicines.
  • Do not take TOLSURA if you take any of the following medicines:
  • avanafil
  • disopyramide
  • dofetilide
  • dronedarone
  • eplerenone
  • ergot alkaloids (such as
    dihydroergotamine or ergotamine)
  • felodipine
  • irinotecan
  • isavuconazonium
  • simvastatin
  • ticagrelor
  • ivabradine
  • lomitapide
  • lovastatin
  • lurasidone
  • methadone
  • midazolam (taken by mouth)
  • naloxegol
  • nisoldipine
  • pimozide
  • quinidine
  • ranolazine
  • triazolam
  • Do not take TOLSURA if you have kidney or liver problems and take any of the following medicines:
  • colchicine
  • fesoterodine
  • solifenacin
  • Do not take TOLSURA:
  • If you have been told that enzymes in your body, called CYP2D6 or CYP3A4, break down (metabolize) certain medicines in your body too slowly.
  • If you are taking the medicine eliglustat and are also taking a medicine that slows the rate that your body breaks down (metabolizes) certain other medicines (CYP2D6 inhibitor). Ask your doctor or pharmacist if you take any of these medicines.

  These are not complete lists of medicines that can interact with TOLSURA. TOLSURA may affect the way other medicines work, and other medicines may affect how TOLSURA works. You can ask your pharmacist for a list of medicines that interact with TOLSURA.

  Before you start taking TOLSURA, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  Before you start any new medicine, ask your doctor or pharmacist if it is safe to take it with TOLSURA or within 2 weeks after stopping treatment with TOLSURA.

• Liver problems. TOLSURA can cause serious liver problems, which may be severe and lead to death. Stop taking TOLSURA and call your doctor right away if you have any of these symptoms of liver problems:
  • unusual fatigue
  • loss of appetite
  • nausea or vomiting
  • your skin or the white part of your eyes turn yellow (jaundice)
  • dark (tea-colored) urine
  • light-colored stools (bowel movement)

  Do not take TOLSURA:

  • if you are allergic to itraconazole or any of the ingredients in TOLSURA. Please see the end of the Patient Information leaflet for a complete list of ingredients in TOLSURA.

  Before taking TOLSURA, tell your doctor about all of your medical conditions, including if you:

  • have heart problems.
  • have lung problems.
  • have kidney problems.
  • have liver problems.
  • have had an allergic reaction to a medicine used to treat a fungal infection.
  • are pregnant or plan to become pregnant. It is not known if
  • TOLSURA will harm your unborn baby. Tell your doctor if you become pregnant during treatment with TOLSURA.
  • are breastfeeding or plan to breastfeed. TOLSURA can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take TOLSURA.

  Before you start taking TOLSURA, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • a medicine to treat high blood pressure or certain other heart problems called a calcium channel blocker.
  • a medicine to reduce acid in your stomach called a proton pump inhibitor, such as omeprazole.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF TOLSURA?

TOLSURA may cause serious side effects, including:

• See “What is the most important information I should know about TOLSURA?”
• Nerve problems (neuropathy). Nerve problems have happened in some people who have taken TOLSURA for longer than 3 months. Call your doctor right away if you have tingling or numbness in your hands or feet. Your doctor may stop your treatment with TOLSURA if you have nerve problems.
• Hearing loss. Hearing loss can happen in some people who take TOLSURA. Hearing loss usually improves when treatment with TOLSURA is stopped, but hearing loss has been permanent in some people. Call your doctor if you have any changes in your hearing.

The most common side effects of TOLSURA include:

• nausea
• rash
• vomiting
• swelling
• headache
• diarrhea
• fatigue
• fever
• itching
• high blood pressure
• abnormal liver blood tests

• stomach pain
• dizziness
• low blood potassium levels
• loss of appetite
• general feeling of discomfort
• decreased sex drive
• sleepiness
• elevated levels of a type of protein, called albumin, in your urine
• erectile dysfunction

These are not all the possible side effects of TOLSURA.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or call Mayne Pharma at 1-844-825-8500.