Micafungin

Micafungin is used to treat infections caused by the Candida fungus. Micafungin is also used to prevent Candida fungal infections in patients who have had a stem cell transplant. Micafungin is for use in adults and children who are at least 4 months old.

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

Micafungin is typically given once daily for up to several weeks. Follow all instructions on your prescription label and read all medication guides or instruction sheets.

Micafungin is given as an infusion into a vein. A healthcare provider may give you this injection or may teach you how to properly use this medicine by yourself.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it. Ask your doctor or pharmacist if you do not understand how to use an injection.

Make sure you understand how to properly mix this medicine with a liquid (diluent) and how to store the mixture.

Do not shake the medication bottle or you may ruin the medicine.

Micafungin 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. Micafungin Sodium Chloride Injection does not require diluent.

Micafungin must be given slowly through an IV infusion, and each injection can take at least 1 hour to complete. Do not mix micafungin 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 at room temperature away from moisture, heat, and light. Mixed medicine can be stored at room temperature but must be used within 12 to 24 hours after mixing.

Store micafungin sodium chloride injection in the refrigerator, do not freeze. Micafungin Sodium Chloride Injection is stable for 30 days at room temperature and should not be placed back into a refrigerator.

Use only as directed. Inform your doctor if you are taking other medicines or if you have other medical conditions or allergies.

You should not use micafungin if you are allergic to micafungin or similar medicines.

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

• liver disease; or
• kidney disease.

May harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Micafungin may lead to serious side effects. Contact your doctor immediately if you experience:

• pale or yellow skin, dark urine, fever, confusion, or weakness;
• swelling, rapid weight gain, little or no urination;
• liver issues—loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney issues—swelling, urinating less, feeling tired or short of breath; or
• pain, bruising, swelling, or irritation at the injection site.

Common side effects of micafungin may include:

• nausea, vomiting, diarrhea, abdominal pain;
• fever, headache;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• low white blood cell counts—fever, mouth sores, skin sores, sore throat, cough;
• symptoms of sepsis—confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• low red blood cells (anemia)—pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low blood potassium—leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or a limp feeling.

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

Usual Adult Dose for Esophageal Candidiasis:

150 mg IV once a dayComments:-In patients treated successfully, the mean duration of therapy was 15 days (range: 10 to 30 days).Use: For treatment of esophageal candidiasis

Usual Adult Dose for Fungal Infection Prophylaxis:

50 mg IV once a dayComments:-In hematopoietic stem cell transplant (HSCT) recipients who had successful prophylactic therapy, the mean duration of prophylaxis was 19 days (range: 6 to 51 days).Use: For prophylaxis of Candida infections in patients undergoing HSCT

Usual Adult Dose for Candidemia:

100 mg IV once a dayComments:-In patients treated successfully, the mean duration of therapy was 15 days (range: 10 to 47 days).Uses: For treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses

Usual Pediatric Dose for Esophageal Candidiasis:

4 months or older:-Weight 30 kg or less: 3 mg/kg IV once a day-Weight greater than 30 kg: 2.5 mg/kg IV once a day---Maximum dose: 150 mg/dayUse: For treatment of esophageal candidiasis

Usual Pediatric Dose for Fungal Infection Prophylaxis:

4 months or older: 1 mg/kg IV once a dayMaximum dose: 50 mg/dayUse: For prophylaxis of Candida infections in patients undergoing HSCT

Usual Pediatric Dose for Candidemia:

Younger than 4 months: 4 mg/kg IV once a day4 months or older: 2 mg/kg IV once a day-Maximum dose: 100 mg/dayComments:-Safety and efficacy have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months as a higher dose may be needed.Uses:-Pediatric patients younger than 4 months: For treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination-Pediatric patients 4 months or older: For treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses

Call your doctor for instructions if you miss a dose.

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.

Micafungin Sodium Chloride Injection contains high sodium load. Avoid in patients with congestive heart failure who are on low salt diet.

Other drugs may affect micafungin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.