Patient Medication Information: uses, side effects, how to take - Micafungin Sodium for Injection (Hikma Canada)
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed Micafungin Sodium for Injection to treat one of several types of fungal infections described below.
Micafungin Sodium for 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 Sodium for 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 Sodium for Injection is used to help prevent fungal infections caused by Candida in patients who are undergoing a stem cell transplant.
Micafungin for injection has not been studied for the treatment of other types of fungal infections.
What it does:
Micafungin Sodium for Injection is an antifungal drug that belongs to a class of drugs called echinocandins. Micafungin Sodium for 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 Sodium for Injection have incomplete or defective cell walls, making them fragile and unable to grow.
When it should not be used:
Do not use Micafungin Sodium for Injection if you are allergic to it, another echinocandin (eg. caspofungin acetate (Cancidas) or anidulafungin (Eraxis)) or any of the
ingredients in Micafungin Sodium for Injection (see What the non-medicinal ingredients are).
Use in children:
Micafungin Sodium for 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:
Lactose monohydrate, citric acid and/or sodium hydroxide
This is a complete listing of all non-medicinal ingredients.
What dosage forms it comes in:
Micafungin Sodium for Injection (micafungin sodium) is available as a sterile powder for injection containing 50 mg or 100 mg micafungin sodium per vial.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions:
- The use of Micafungin Sodium for 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 Sodium for Injection may cause kidney problems, kidney failure, and abnormal kidney function tests.
- Micafungin Sodium for Injection may cause destruction of red blood cells called hemolysis or hemolytic anemia.
Use in pregnancy and breast-feeding:
Micafungin for injection has not been studied in pregnant women. Micafungin Sodium for 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 for Injection 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.
IMPORTANT: PLEASE READ
BEFORE you use Micafungin Sodium for 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 Sodium for Injection.
INTERACTIONS WITH THIS MEDICATION
Micafungin Sodium for 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 (Rapamune)
- nifedipine (Adalat)
- itraconazole (Sporanox)
- amphotericin B
The doses of these medicines may need to be reduced while you are receiving Micafungin Sodium for 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 Sodium for Injection should be administered once daily by slow intravenous infusion of approximately 1 hour.
Overdose:
Any medicine may have unintended or undesirable effects, so- called side effects
Common side effects of Micafungin Sodium for Injection include rash, mental confusion, nausea, vomiting, itching, facial swelling, diarrhea, fever, fatigue and relaxing of
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
blood vessels (vasodilation). Micafungin Sodium for 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 sodium.
If you think you, or a person you are caring for,
have taken too much Micafungin Sodium for
Injection, contact a healthcare professional,
hospital emergency department, or regional
poison control centre immediately, even if there are
no symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Common | |||
Swollen veins (phlebitis, thrombophlebitis) | ✓ | ||
| Liver problems (eg. yellowing of the skin and eyes, abdominal pain, nausea, vomiting and fatigue) | ✓ | ||
| Uncommon | |||
| Serious allergic reaction and symptoms such as severe rash, itching, swelling of hands and feet, trouble breathing | ✓ | ||
IMPORTANT: PLEASE READ
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 Sodium for injection contact your doctor.
HOW TO STORE IT
Store between 20-25° C. Protect from light.
MORE INFORMATION
If you want more information about Micafungin Sodium for 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 website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or by calling 1-800-656-0793
Last Approved: October 26, 2022
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 Reporting (https://www.canada.ca/en/health- canada/services/drugs-health-products/medeffect- canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice