Mycamine is an antifungal medication that fights infections caused by fungus.

Mycamine is used to treat infections caused by the Candida fungus. It is also used to prevent Candida fungal infections in stem cell transplant patients. Mycamine is for use in adults and pediatric patients.

Mycamine may also be used for purposes not listed in this medication guide.

You should not use Mycamine if you are allergic to micafungin or similar medicines such as caspofungin (Cancidas) or anidulafungin (Eraxis).

Before using Mycamine, tell your doctor if you are allergic to any drugs, if you have liver or kidney disease, or if you are also using sirolimus (Rapamune), itraconazole (Sporanox), or nifedipine (Adalat, Procardia).

Mycamine is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Before using Mycamine

You should not use Mycamine if you are allergic to micafungin or similar medicines such as caspofungin (Cancidas) or anidulafungin (Eraxis).

To make sure you can safely use Mycamine, tell your doctor if you have any of these other conditions:

• liver disease; or

• kidney disease.

FDA pregnancy category C. It is not known whether Mycamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether micafungin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Mycamine is usually given once daily for up to several weeks. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Mycamine is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Mycamine must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing this medicine, do not expose it to light. Cover the IV bag during your infusion to protect the medicine from light. Use the medicine within 24 hours after mixing.

Mycamine must be given slowly through an IV infusion, and each injection can take at least 1 hour to complete. Do not mix Mycamine with any other medicines, or give other medicines through the same IV line.

If a child is using this medication, tell your doctor if the child has any changes in weight. Micafungin doses are based on weight in children.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store Mycamine at room temperature away from moisture, heat, and light. Mixed medicine can be stored at room temperature but must be used within 24 hours after mixing.

Usual Adult Dose for Esophageal Candidiasis:

150 mg via IV infusion once a day
Duration of therapy: Has ranged from 10 to 30 days (mean duration: 15 days)

Usual Adult Dose for Fungal Infection Prophylaxis:

50 mg via IV infusion once a day
Duration of therapy: Has ranged from 6 to 51 days (mean duration: 19 days)

Comments:
-Efficacy against infections due to fungi other than Candida has not been established.

Approved indication: Prophylaxis of Candida infections in hematopoietic stem cell transplant recipients

Usual Adult Dose for Candidemia:

100 mg via IV infusion once a day
Duration of therapy: Has ranged from 10 to 47 days (mean duration: 15 days)

Comments:
-Not adequately studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida infections.

Approved indications: Treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses

Usual Pediatric Dose for Esophageal Candidiasis:

4 months or older:
30 kg or less: 3 mg/kg via IV infusion once a day
Greater than 30 kg: 2.5 mg/kg via IV infusion once a day
Maximum dose: 150 mg per day

Usual Pediatric Dose for Fungal Infection Prophylaxis:

4 months or older: 1 mg/kg via IV infusion once a day
Maximum dose: 50 mg per day

Comments:
-Efficacy against infections due to fungi other than Candida has not been established.

Approved indication: Prophylaxis of Candida infections in hematopoietic stem cell transplant recipients

Usual Pediatric Dose for Candidemia:

4 months or older: 2 mg/kg via IV infusion once a day
Maximum dose: 100 mg per day

Comments:
-Not adequately studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida infections.

Approved indications: Treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses

You should not use Mycamine if you are allergic to micafungin or similar medicines such as caspofungin (Cancidas) or anidulafungin (Eraxis).

To make sure you can safely use Mycamine, tell your doctor if you have any of these other conditions:

• liver disease; or

• kidney disease.

FDA pregnancy category C. It is not known whether Mycamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether micafungin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Call your doctor for instructions if you miss a dose of Mycamine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction to Mycamine: hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• swelling, rapid weight gain, little or no urinating; or

• upper stomach pain, itching, loss of appetite, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Mycamine side effects may include:

• nausea, vomiting, diarrhea;

• flushing (warmth, redness, or tingly feeling); or

• mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with Mycamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.