Details for: MYCAMINE
Company: ASTELLAS PHARMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02294222 | MYCAMINE | MICAFUNGIN SODIUM | 50 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02311054 | MYCAMINE | MICAFUNGIN SODIUM | 100 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your doctor has prescribed Mycamine to treat one of several types of fungal infections described below.
- Mycamine 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.
- Mycamine is used to treat patients with certain fungal infections caused by Candida including Candidemia and other Candida infections as determined by the doctor.
- Mycamine is used to help prevent fungal infections caused by Candida in patients who are undergoing a stem cell transplant.
Mycamine has not been studied for the treatment of other types of fungal infections.
What it does
Mycamine is an antifungal drug that belongs to a class of drugs called echinocandins. Mycamine 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 Mycamine have incomplete or defective cell walls, making them fragile and unable to grow.
When it should not be used
Do not use Mycamine if you are allergic to it, another echinocandin (eg. caspofungin acetate (Cancidas) or anidulafungin (Eraxis)) or any of the ingredients in Mycamine (see What the non-medicinal ingredients are).
Use in children:
- Mycamine 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, citric acid and/or sodium hydroxide
This is a complete listing of all non-medicinal ingredients
What dosage form it comes in
Mycamine 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 Mycamine 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).
- Mycamine may cause kidney problems, kidney failure, and abnormal kidney function tests.
- Mycamine may cause destruction of red blood cells called hemolysis or hemolytic anemia.
Use in pregnancy and breast-feeding:
Mycamine has not been studied in pregnant women. Mycamine
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 Mycamine 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 Mycamine 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 Mycamine.
Interactions with this medication
Mycamine 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 Mycamine.
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. Mycamine should be administered once daily by slow intravenous infusion of approximately 1 hour.
Overdose
Side effects and what to do about them
| Symptom / effect | Talk with your doctor Only if severe | Talk with your doctor In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| 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 | ✔ | ||
Any medicine may have unintended or undesirable effects, so-called side effects.
Common side effects of Mycamine include rash, mental confusion, nausea, vomiting, itching, facial swelling, diarrhea, fever, fatigue and relaxing of blood vessels (vasodilation). Mycamine 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 Mycamine.
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 Mycamine contact your doctor.
How to store
Store between 15-30° C. Protect from light.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
www.astellas.caor by contacting the sponsor, Astellas Pharma Canada, Inc., at:
1-888-338-1824
This leaflet was prepared by Astellas Pharma Canada, Inc.
Last revised: March 24, 2014
Mycamine is a Registered Trademark of Astellas Pharma, Inc.
12K074-MYC-CA