Consumer Information for: MICAFUNGIN FOR INJECTION

Serious Warnings and Precautions:

• The use of Micafungin for Injection may sometimes severe cause allergic reactions including shock (see Side Effects).

• Serious liver problems including liver inflammation or worsening of liver failure (see Side Effects).

• Micafungin for Injection may cause kidney problems, kidney failure, and abnormal kidney function tests.

• Micafungin for Injection may cause destruction of red blood cells called hemolysis or hemolytic anemia.

Use in pregnancy and breast-feeding: Micafungin for Injection has not been studied in pregnant women. Micafungin for Injection should not be used in pregnancy unless the doctor decides the potential benefit justifies the potential risk to the fetus.

It is not known if Micafungin for Injection is excreted in breast milk. You and your doctor will discuss this.

Use in patients with liver problems:

Patients with liver problems may require extra vigilance by their doctor to monitor liver function. Be sure to tell your doctor if you have had or now have liver problems.

BEFORE you use Micafungin for Injection talk to your doctor or pharmacist if:

• You are taking or plan to take other medications, including those obtained without a prescription.

• You have liver problems

• You are pregnant

• You are breast feeding

• You are allergic to any component of Micafungin for Injection.

Micafungin for Injection and other medicines may interact with each other. Tell your healthcare professional about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially, tell your healthcare professional if you take:

• sirolimus (Rapamune)

• nifedipine (Adalat)

• itraconazole (Sporanox)

• amphotericin B

The doses of these medicines may need to be reduced while you are receiving Micafungin for Injection.

Usual dose (adults and children over 4 months of age): The treatment schedule and dosage will be set by your doctor, who will monitor your response and condition. Micafungin for Injection should be administered once daily by slow intravenous infusion of approximately 1 hour.

Overdose

Any medicine may have unintended or undesirable effects, so- called side effects.

Common side effects of Micafungin for Injection include rash, mental confusion, nausea, vomiting, itching, facial swelling, diarrhea, fever, fatigue and relaxing of blood vessels (vasodilation). Micafungin for Injection may also cause injection site reactions such as inflammation of the veins.

Other reported medication-related undesirable effects include: anemia, low white blood cells count, abdominal pain, injection site pain, itching, trouble breathing, swelling of the hands, ankles, or feet, impaired liver function, sleep problems, and alterations in some laboratory blood tests. Life-threatening allergic reactions have been reported rarely during administration of micafungin sodium.

Other side effects may also occur rarely; and, as with any prescription medication, some side effects may be serious. Ask your doctor or pharmacist for more information. Tell your doctor promptly about these or any other unusual symptoms.

This is not a complete list of side effects. For any unexpected effects while taking Micafungin for Injection contact your doctor.

Store between 15-30° C. Protect from light.