Anidulafungin, Injection

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KEY POINTS

• This medicine is given by IV to treat certain kinds of fungal infections.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious liver problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antifungal

Generic and brand names: anidulafungin, injection; Eraxis

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein). It is used to treat certain kinds of fungal infections.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver disease

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is given by IV infusion by your healthcare provider over 45 minutes to 3 hours, depending on your dose. The total number of treatments you need depends on how your infection responds to the medicine.

You will be monitored closely while you are receiving this medicine to watch for infusion-related reactions.

What should I watch out for?

You will need to have lab tests regularly to see how this medicine affects you. Talk with your healthcare provider about this.

This medicine may cause serious liver problems. If you develop nausea, vomiting, a fever, stomach pain, yellowing of your eyes or skin, light-colored bowel movements, dark urine, or severe tiredness or weakness, contact your healthcare provider right away. These may be signs of liver damage. Avoid alcohol while taking this medicine. Alcohol may increase the risk of liver problems.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe stomach pain; yellowing of your skin or eyes; severe nausea or vomiting; unexplained tiredness or weakness; dark urine; light-colored bowel movements; muscle pain, cramps, or weakness; irregular heartbeat; chest pain; unusual mood changes; tremors; seizures; swelling, pain, warmth, or redness in lower legs; trouble urinating or pain with urination; dizziness or fainting; fever; chills; rash; flushing; sore throat; severe headache; trouble breathing; unexplained swelling; confusion; pain, burning, or swelling at infusion site.

Other: Mild nausea or vomiting, mild diarrhea, trouble sleeping, mild headache.

What products might interact with this medicine?

No significant drug interactions have been reported. Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.