Pronunciation:

mye-ka-FUN-jin

Brand Names:

• Mycamine

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antifungal

Pharmacologic—

Glucan Synthesis Inhibitor

Chemical—

Echinocandin

Uses of This Medicine:

Micafungin injection is used to treat fungal infections, including candidemia, acute disseminated candidiasis (fungal infection in the blood), candida peritonitis and abscess (fungal infection in the stomach), and esophageal candidiasis (fungal infection in the esophagus). This medicine is also used to prevent candida infections in patients who have a weakened immune system (eg, hematopoietic stem cell transplant). It is also used to treat candida peritonitis and abscess (fungal infection in the stomach) without meningoencephalitis or ocular dissemination.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of micafungin injection to treat candidemia, acute disseminated candidiasis, candida peritonitis and abscess, esophageal candidiasis, and to prevent candida infections with stem cell treatment in children 4 months of age and older and to treat candidemia, acute disseminated candidiasis, and candida peritonitis and abscess without meningoencephalitis or ocular dissemination in children younger than 4 months of age. However, safety and efficacy of micafungin injection have not been established for the treatment of candidemia with meningoencephalitis or ocular dissemination, esophageal candidiasis, and to prevent candida infections with stem cell treatment in children younger than 4 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of micafungin injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Itraconazole
• Levoketoconazole
• Methotrexate
• Nifedipine
• Sirolimus

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems (eg, hemolysis or hemolytic anemia) or
• Congestive heart failure or
• Kidney problems or
• Liver problems or
• Patients who are on a salt-restricted diet—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through an IV catheter placed in one of your veins. This medicine must be injected slowly, so the needle will have to remain in place for at least 1 hour.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have blurred vision, chest tightness, confusion, cough, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, hoarseness, redness of the skin, skin rash, itching, hives or welts, sweating, swelling of your hands, face, or mouth, trouble breathing or swallowing, or unusual tiredness or weakness after you receive this medicine.

This medicine may cause blood problems (eg, hemolysis, hemolytic anemia). Check with your doctor right away if you have back, leg, or stomach pain, bleeding gums, chills, dark urine, decreased urination, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, tiredness, trouble breathing, or yellow eyes or skin.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious kidney problems. Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

This medicine may cause infusion and injection site reactions (eg, phlebitis, thrombophlebitis), which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have changes in skin color, difficulty with swallowing, dizziness, fast heartbeat, chest tightness, flushing, sweating, swelling in your face, hands, foot, or leg, lightheadedness or faintness while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Anxiety

black, tarry, stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

cold sweats

coma

confusion

cool, pale skin

cough

decreased frequency or amount of urine

depression

dizziness

fast, pounding, or irregular heartbeat or pulse

fever or chills

headache

increased hunger

increased thirst

loss of appetite

lower back or side pain

nausea or vomiting

nervousness

nightmares

numbness or tingling in the hands, feet, or lips

painful or difficult urination

pinpoint red spots on the skin

rapid weight gain

seizures

shakiness

slurred speech

swelling of the face, fingers, or lower legs

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

weakness or heaviness of the legs

weight gain

Less common

Agitation

back pain

bone pain

changes in skin color, pain, tenderness, or swelling of the foot or leg

chest pain, discomfort, or tightness

dark urine

drowsiness

fainting

hallucinations

light-colored stools

mood or mental changes

muscle pain, cramps, spasms, or twitching

numbness or tingling in the hands, feet, or lips

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

right upper abdominal or stomach pain and fullness

stiff neck

sweating

swollen glands

trembling

vomiting

Rare

Dizziness

headache

nervousness

pounding in the ears

slow or fast heartbeat

stomach cramps

weakness or heaviness of the legs

Incidence not known

Back, leg, or stomach pain

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blistering, peeling, or loosening of the skin

bloody urine

bruising

diarrhea

fast, weak pulse

feeling faint, dizzy, or lightheaded

flushing or redness of the skin, especially on the face and neck

general body swelling

hives or itching

joint pain

persistent bleeding or oozing from puncture sites, mouth, or nose

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

skin rash or redness

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Trouble sleeping

Less common

Feeling unusually cold or shivering

Rare

Belching

change in taste

confusion as to time, place, or person

difficulty having a bowel movement (stool)

heartburn

hiccups

sleepiness or unusual drowsiness

stomach discomfort or upset

unusual excitement, nervousness, or restlessness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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