Cresemba

Cresemba is a prescription medication used to treat adults with invasive aspergillosis and invasive mucormycosis, which are rare but serious fungal infections. Cresemba belongs to a group of drugs called azole antifungal agents, which stop the synthesis of a key component of the fungal cell wall and, ultimately, kill the fungus.

Cresemba is available in an oral capsule formulations and is usually taken once a day. It can be taken with or without food. Do not crush, chew, dissolve, or open the Cresemba capsules. Swallow the capsules whole.

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include nausea, vomiting, diarrhea, and headache.

Cresemba can also cause dizziness. Do not drive or operate heavy machinery until you know how Cresemba affects you.

Cresemba is a prescription medication used to treat adults with invasive aspergillosis and invasive mucormycosis, which are rare but serious fungal infections.

This medication may be presecribed for other uses. Ask your doctor or pharmacist for more information.

• Astellas Pharma US, Inc.

Serious side effects have been reported with Cresemba. See the "Cresemba Precautions" section.

Common side effects of Crsemba include:

• nausea
• vomiting
• diarrhea
• headache
• changes in liver function decreased levels of potassium in the blood
• shortness of breath
• cough
• swelling of the extremities
• back pain

This is not a complete list of Cresemba side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ketoconazole (Nizoral)
• ritonavir (Norvir)
• rifampin (Rifadin)
• carbampazepine (Tegretol, Carbatrol)
• phenobarbital
• St. John's Wort

This is not a complete list of Cresemba drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cresemba including the following:

• liver problems
• infusion-related reactions, including decreased blood pressure, chills, dizziness, and a sensation of tingling or burning of the skin
• hypersensitivity reactions, including severe skin reactions or difficulty breathing

Cresemba can cause dizziness. Do not drive or operate heavy machinery until you know how Cresemba affects you.

Do not take Cresemba if you:

• are allergic to Cresemba or to any of its ingredients
• are taking drugs that interact with Cresemba, such as ketoconazole, high-dose ritonavir, rifampin, carbamazepine, St. John's Wort, or phenobarbital

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cresemba, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Cresemba, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cresemba or to any of its ingredients
• are allergic to any other antifungal medications
• have or have had heart problems, including an abnormal heart rate or rhythm
• have liver problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cresemba falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Cresemba crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Cresemba.

Take Cresemba exactly as prescribed.

Cresemba is available in an oral capsule formulations and is usually taken once a day. It can be taken with or without food. Do not crush, chew, dissolve, or open the Cresemba capsules. Swallow the capsules whole.

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Cresemba at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have

The recommended starting dose of oral and intravenous Cresemba for treating fungal infections is 372 mg every 8 hours for 6 doses. After the first 6 doses, the recommended dose of Cresemba is 372 mg once daily.

If you take too much Cresemba, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Cresemba is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Cresemba capsules in the original package at room temperature.
• Keep this and all medications out of the reach of children.