Micafungin Intravenous

In the U.S.

• Mycamine

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antifungal

Pharmacologic Class: Glucan Synthesis Inhibitor

Chemical Class: Echinocandin

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 micafungin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to micafungin 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 have not been performed on the relationship of age to the effects of micafungin injection in children younger than 4 months of age. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

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.

Interactions with 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 micafungin, 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 micafungin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Itraconazole
• Nifedipine
• Sirolimus

Interactions with Food/Tobacco/Alcohol

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 micafungin. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems (eg, hemolysis or hemolytic anemia) or
• Kidney problems—Use with caution. May make these conditions worse.

• Liver disease, moderate to severe—Higher blood levels of micafungin may result, increasing the chance of side effects.

This medication is used to treat a variety of fungal infections. It is also used to prevent fungal infections in patients who are having a stem cell transplant. Micafungin belongs to a class of drugs known as echinocandins. It works by stopping the growth of fungi.

How to use Micafungin Solution, Reconstituted (Recon Soln)

This medication is given by injection into a vein as directed by your doctor, usually once a day over 1 hour. The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Learn how to store and discard medical supplies safely.

Infusion reactions may happen while you are receiving the drug. Tell your doctor right away if you have symptoms such as flushing or dizziness.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition does not get better or if it gets worse.

Swelling/redness/irritation at the injection site, nausea/vomiting, diarrhea, headache, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellowing eyes/skin), signs of kidney problems (such as change in the amount of urine), unusual tiredness, shortness of breath, signs of infection (such as fever, chills), easy bleeding/bruising, mental/mood changes (such as anxiety), fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.