Medication Guide — Sporanox

This Patient Information has been approved by the U.S. Food and Drug Administration

Read this Patient Information that comes with SPORANOX before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

1. Heart failure. Do not take SPORANOX if you have had heart failure, including congestive heart failure.
   Stop taking SPORANOX and call your healthcare provider 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 for you

1. 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 SPORANOX with certain other medicines. Do not take SPORANOX if you also take the following medicines:

• methadone
• disopyramide
• dofetilide
• dronedarone
• quinidine
• isavuconazole
• ergot alkaloids (such as dihydroergotamine, ergometrine ergonovine)
• ergotamine
• methylergometrine (methylergonovine)

• irinotecan
• lurasidone
• oral midazolam
• pimozide
• triazolam
• felodipine
• nisoldipine
• ivabradine
• ranolazine
• eplerenone
• cisapride

• naloxegol
• lomitapide
• lovastatin
• simvastatin
• avanafil
• ticagrelor
• venetoclax (see below)
• finerenone
• voclosporin

take SPORANOX with venetoclax for chronic lymphocytic leukemia/small lymphocytic lymphoma when you first start treatment with venetoclax or with increasing doses of venetoclax.

This is not a complete list of medicines that can interact with SPORANOX. SPORANOX may affect the way other medicines work, and other medicines may affect how SPORANOX works. You can ask your pharmacist for a list of medicines that interact with SPORANOX.

Before you start taking SPORANOX, tell your healthcare provider 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 healthcare provider or pharmacist if it is safe to take it with SPORANOX.

1. Liver problems. SPORANOX can cause serious liver problems which may be severe and lead to death. Stop taking SPORANOX and call your healthcare provider right away if you have any of these symptoms of liver problems:

• tiredness
• loss of appetite for several days or longer
• nausea or vomiting
• dark or "tea-colored" urine

• your skin or the white part of your eyes turn yellow (jaundice)
• light-colored stools (bowel movement)

For more information about side effects, see "

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• SPORANOX is a prescription medicine used to treat the following fungal infections of the toenails, fingernails and other parts of the body: blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.
• It is not known if SPORANOX is safe and effective in children.

• have or have had heart failure, including congestive heart failure.
• take certain medicines. See " What is the most important information I should know about SPORANOX? "
• are pregnant or plan to become pregnant. SPORANOX can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking SPORANOX. Females who are able to become pregnant must use effective forms of birth control during treatment and for 2 months after stopping treatment with SPORANOX.
• are allergic to itraconazole or any of the ingredients in SPORANOX. See the end of this Patient Information leaflet for a complete list of ingredients in SPORANOX.

• have heart problems.
• have liver problems.
• have kidney problems.
• have a weakened immune system (immunocompromised).
• have lung problems including cystic fibrosis.
• are breastfeeding or plan to breastfeed. SPORANOX can pass into your breast milk. You and your healthcare provider should decide if you will take SPORANOX or breastfeed.

Taking SPORANOX with certain medicines may affect each other. Taking SPORANOX with other medicines can cause serious side effects.

• Take SPORANOX exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much SPORANOX to take and when to take it.
• You will receive SPORANOX capsules in a blister pack or bottle. Your healthcare provider will decide the type of SPORANOX that is right for you.
• Take SPORANOX with a full meal.
• Swallow SPORANOX capsules whole.
• You should not take SPORANOX oral solution instead of SPORANOX capsules, because they will not work the same way.
• If you take too much SPORANOX, call your healthcare provider or go to the nearest hospital emergency room right away.

SPORANOX can cause dizziness and vision problems. Do not drive or operate machinery until you know how SPORANOX affects you.

• See What is the most important information I should know about SPORANOX?"
• New or worsening high blood pressure and low potassium levels in your blood (pseudoaldosteronism).Your healthcare provider should check your blood pressure and potassium levels.
• Nerve problems (neuropathy).Call your healthcare provider right away if you have tingling or numbness in your hands or feet. Your healthcare provider may stop your treatment with SPORANOX if you have nerve problems.
• Hearing loss.Hearing loss can happen for a short time or permanently in some people who take SPORANOX. Stop taking SPORANOX and call your healthcare provider right away if you have any changes in your hearing.

: headache, rash, digestive system problems (such as nausea and vomiting), and edema.

Additional possible side effects include upset stomach, constipation, fever, inflammation of the pancreas, increase in blood pressure, menstrual disorder, erectile dysfunction, dizziness, muscle pain, painful joints, unpleasant taste, or hair loss.

These are not all the possible side effects of SPORANOX.

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

• Store SPORANOX at room temperature between 59°F to 77°F (15°C to 25°C).
• Keep SPORANOX dry and away from light.

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Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SPORANOX for a condition for which it was not prescribed. Do not give SPORANOX to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about SPORANOX that is written for health professionals.

: itraconazole

: hard gelatin capsule, hypromellose, polyethylene glycol (PEG) 20,000, titanium dioxide, FD&C Blue No. 1, FD&C Blue No. 2, D&C Red No. 22 and D&C Red No. 28.

Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560, USA

For patent information: www.janssenpatents.com

© 2024 Janssen Pharmaceutical Companies

For more information or call 1-800-526-7736.