Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of micafungin injection in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Azathioprine
- Itraconazole
- Levoketoconazole
- Mercaptopurine
- 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
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
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
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.
DRG-20064798
