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Isavuconazonium sulfate capsules

Generic Name: isavuconazonium sulfate (eye-sa-vue-na-ZOE-nee-um sul-FATE)
Brand Name: Cresemba

Isavuconazonium sulfate capsules are used for:

Treating certain fungal infections.

Isavuconazonium sulfate capsules are an azole antifungal. It works by blocking fungal cell wall growth, resulting in the death of the fungus.

Do NOT use isavuconazonium sulfate capsules if:

  • you are allergic to any ingredient in isavuconazonium sulfate capsules
  • you have a certain type of irregular heartbeat (familial short QT syndrome)
  • you are taking a barbiturate (eg, phenobarbital), carbamazepine, ketoconazole, rifampin, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using isavuconazonium sulfate capsules:

Some medical conditions may interact with isavuconazonium sulfate capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are allergic to other azole antifungals (eg, fluconazole, itraconazole)
  • if you have a history of irregular heartbeat
  • if you have liver problems (eg, cirrhosis)
  • if you are taking ritonavir. Isavuconazonium sulfate capsules should not be taken with certain doses of ritonavir

Some MEDICINES MAY INTERACT with isavuconazonium sulfate capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many other prescription and nonprescription medicines (eg, used for aches and pains, anxiety, birth control, blood flow problems, blood thinning, cancer, diabetes, drug dependence, heartburn or reflux, high blood pressure, high cholesterol, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, mental or mood problems, pain, seizures, stomach or bowel problems), multivitamin products, or herbal or dietary supplements (eg, St. John's wort) because they may interact with isavuconazonium sulfate capsules. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with isavuconazonium sulfate capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if isavuconazonium sulfate capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use isavuconazonium sulfate capsules:

Use isavuconazonium sulfate capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with isavuconazonium sulfate capsules. Talk to your pharmacist if you have questions about this information.
  • Take isavuconazonium sulfate capsules by mouth with or without food.
  • Swallow isavuconazonium sulfate capsules whole. Do not crush, chew, dissolve, or open before swallowing.
  • Take isavuconazonium sulfate capsules by mouth on an empty stomach at least 1 hour before or 1 hour after eating.
  • To clear up your infection completely, take isavuconazonium sulfate capsules for the full course of treatment. Keep taking it even if you feel better in a few days.
  • If you miss a dose of isavuconazonium sulfate capsules, take it as soon as possible. It is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use isavuconazonium sulfate capsules.

Important safety information:

  • Tell your doctor or dentist that you take isavuconazonium sulfate capsules before you receive any medical or dental care, emergency care, or surgery.
  • Serious and sometimes fatal liver problems have happened with isavuconazonium sulfate capsules. Call your doctor right away if you have symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or stomach pain; loss of appetite; itching).
  • A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause serious health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • You may need to have an electrocardiogram (ECG) checked before starting isavuconazonium sulfate capsules and while taking it. Discuss any questions or concerns with your doctor.
  • Lab tests may be performed while you use isavuconazonium sulfate capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Isavuconazonium sulfate capsules may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. Isavuconazonium sulfate capsules are found in breast milk. Do not breast-feed while taking isavuconazonium sulfate capsules.

Possible side effects of isavuconazonium sulfate capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; cough; diarrhea; headache; nausea; stomach pain; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); shortness of breath; swelling of the arms or legs; symptoms of kidney problems (eg, unable to pass urine, change in the amount of urine passed, blood in the urine, big weight gain); symptoms of low potassium levels (eg, irregular heartbeat; muscle pain, cramps, or weakness).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of isavuconazonium sulfate capsules:

Store isavuconazonium sulfate capsules in the original container at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep isavuconazonium sulfate capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about isavuconazonium sulfate capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Isavuconazonium sulfate capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take isavuconazonium sulfate capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about isavuconazonium sulfate capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to isavuconazonium sulfate capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using isavuconazonium sulfate capsules.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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