Micafungin in 0.9% Sodium Chloride Injection: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed Micafungin in 0.9% Sodium Chloride Injection to treat one of several types of fungal infections described below.

Micafungin in 0.9% Sodium Chloride Injection is used to treat certain fungal infections of the esophagus (food tube connecting the mouth to the stomach). These infections are called esophageal candidiasis and are caused by Candida (fungus). Healthy individuals usually have Candida in their mouth and throat without any ill effects. An infection occurs when the body’s resistance is lowered.

Micafungin in 0.9% Sodium Chloride Injection is used to treat patients with certain fungal infections caused by Candida including Candidemia and other Candida infections as determined by the doctor.

Micafungin in 0.9% Sodium Chloride Injection is used to help prevent fungal infections caused by Candida in patients who are undergoing a stem cell transplant.

Micafungin in 0.9% Sodium Chloride Injection has not been studied for the treatment of other types of fungal infections.

What it does:

Micafungin in 0.9% Sodium Chloride Injection is an antifungal drug that belongs to a class of drugs called echinocandins. Micafungin in 0.9% Sodium Chloride Injection interferes with the production of a component (glucan polysaccharide) of the fungal cell wall that is necessary if the fungus is to continue living and growing. Fungal cells exposed to Micafungin in 0.9% Sodium Chloride Injection have incomplete or defective cell walls, making them fragile and unable to grow.

When it should not be used:

Do not use Micafungin in 0.9% Sodium Chloride Injection if you are allergic to it, another echinocandin (eg. caspofungin acetate (Cancidas) or anidulafungin (Eraxis)) or any of the ingredients in Micafungin in 0.9% Sodium Chloride Injection (see What the non-medicinal ingredients are).

Use in children:

Micafungin in 0.9% Sodium Chloride Injection should not be used in patients under 4 months of age.

What the medicinal ingredient is:

Micafungin sodium

What the non-medicinal ingredients are:

Citric acid, sodium chloride, sodium citrate and water for injection

This is a complete listing of all non-medicinal ingredients.

What dosage forms it comes in:

Micafungin in 0.9% Sodium Chloride Injection is supplied as a refrigerated sterile solution in the following presentations:

50 mg / 50 mL: contains 50 mg micafungin (as micafungin sodium)

100 mg / 100 mL: contains 100 mg micafungin (as micafungin sodium)

150 mg / 150 mL: contains 150 mg micafungin (as micafungin sodium)

Serious Warnings and Precautions:

The use of Micafungin in 0.9% Sodium Chloride Injection may sometimes cause severe allergic reactions including shock (see Side Effects).

Serious liver problems including liver inflammation or worsening of liver failure (see Side Effects).

Micafungin in 0.9% Sodium Chloride Injection may cause kidney problems, kidney failure, and abnormal kidney function tests.

WARNINGS AND PRECAUTIONS

Micafungin in 0.9% Sodium Chloride Injection may cause destruction of red blood cells called hemolysis or hemolytic anemia.

Use in pregnancy and breast-feeding:

Micafungin in 0.9% Sodium Chloride Injection has not been studied in pregnant women. Micafungin in 0.9% Sodium Chloride Injection should not be used in pregnancy unless the doctor decides the potential benefit justifies the potential risk to the fetus.

It is not known if micafungin sodium is excreted in breast milk. You and your doctor will discuss this.

Use in patients with liver problems:

Patients with liver problems may require extra vigilance by their doctor to monitor liver function. Be sure to tell your doctor if you have had or now have liver problems.

BEFORE you use Micafungin in 0.9% Sodium Chloride Injection talk to your doctor or pharmacist if:

You are taking or plan to take other medications,

including those obtained without a prescription.

• You have liver problems
• You are pregnant
• You are breast feeding
• You are allergic to any component of Micafungin in 0.9% Sodium Chloride Injection.

INTERACTIONS WITH THIS MEDICATION

Micafungin in 0.9% Sodium Chloride Injection and other medicines may interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially, tell your healthcare professional if you take:

• Sirolimus
• nifedipine
• itraconazole
• amphotericin B

The doses of these medicines may need to be reduced while you are receiving Micafungin in 0.9% Sodium Chloride Injection.

PROPER USE OF THIS MEDICATION

Usual dose (adults and children over 4 months of age):

The treatment schedule and dosage will be set by your doctor, who will monitor your response and condition. Micafungin in 0.9% Sodium Chloride Injection should be administered once daily by slow intravenous infusion of approximately 1 hour.

Overdose

If you think you, or a person you are caring for, have taken too much Micafungin in 0.9% Sodium Chloride Injection, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

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Any medicine may have unintended or undesirable effects, so- called side effects.

Common side effects of Micafungin in 0.9% Sodium Chloride Injection include rash, mental confusion, nausea, vomiting, itching, facial swelling, diarrhea, fever, fatigue and relaxing of blood vessels (vasodilation). Micafungin in 0.9% Sodium Chloride Injection may also cause injection site reactions such as inflammation of the veins.

Other reported medication-related undesirable effects include: anemia, low white blood cells count, abdominal pain, injection site pain, itching, trouble breathing, swelling of the hands, ankles, or feet, impaired liver function, sleep problems, and alterations in some laboratory blood tests. Life-threatening allergic reactions have been reported rarely during administration of Micafungin in 0.9% Sodium Chloride Injection.

Other side effects may also occur rarely; and, as with any prescription medication, some side effects may be serious. Ask your doctor or pharmacist for more information. Tell your doctor promptly about these or any other unusual symptoms.

This is not a complete list of side effects. For any unexpected effects while taking Micafungin in 0.9% Sodium Chloride Injection contact your doctor.

HOW TO STORE IT

Store in refrigerator at 2ºC to 8ºC in the original carton. The drug is sensitive to light, keep in original container until ready to use.

The drug product should be stored under prescribed conditions in the refrigerator. In rare cases, if needed, the unopened/sterile product in the original carton may be stored at room temperature of 25 ºC up to a maximum of 10 days. Any product stored at room temperature exceeding 10 days should be discarded.

Do not freeze and do not use Micafungin in 0.9% Sodium Chloride Injection if it has been frozen.

Serious side effects and what to do about them

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

If you want more information about Micafungin in 0.9% Sodium Chloride Injection:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer's website www.baxter.ca; or by calling 1-888-719-9955.

BAXTER AND GALAXY ARE REGISTERED TRADEMARKS OF BAXTER INTERNATIONAL INC.

Date of Revision: SEP 17, 2025

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