Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
January 18, 2016
Health Canada has issued new restrictions concerning the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolate sodium). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Bronchiectasis: When mycophenolate mofetil is used in combination with other immunosuppressants, there have been rare reports of bronchiectasis. Bronchiectasis is a condition where there is injury to the walls of the airways, resulting in a decreased ability to clear mucus and an increased risk of infection. If you develop symptoms such as coughing, shortness of breath, or recurrent respiratory infections, let your doctor know as soon as possible.
Infection: This medication reduces the number of cells that fight infection in the body. Take extra measures to prevent infection, and avoid people with infections if at all possible. Report any signs of infection (e.g., fever, chills, sore throat, painful or difficult urination) to your doctor immediately.
Kidney function: If you have poor kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Lymphoma and other malignancies: People taking immunosuppressant medications, such as mycophenolate mofetil, are at increased risk of developing a type of cancer known as lymphoma. This risk is related to the intensity and duration of treatment with immunosuppressant medications rather than one specific medication.
Possible warning signs of cancer include a change in bowel or bladder habits, sores that don’t heal, unusual bleeding, change in appearance of a wart or mole, night sweats, a nagging cough or persistent and severe headaches. If you experience any of these, let your doctor know right away. This may help to detect any cancers early in their development.
People with phenylketonuria: Mycophenolate mofetil oral suspension (liquid) contains aspartame (0.56 mg of phenylalanine per mL of suspension).
Pure red cell aplasia (PRCA): This medication may cause PRCA, a condition where the bone marrow does not make red blood cells. If you have symptoms of PRCA, such as sudden tiredness or shortness of breath, get immediate medical attention.
Stomach and intestinal problems: Since some people receiving this medication have experienced stomach bleeding, people with existing stomach and intestinal problems should be monitored closely by their doctor while taking this medication. If you notice symptoms of stomach bleeding (e.g., black, tarry stools; vomiting or spitting up blood or material that looks like coffee grounds; blood in the stools), seek immediate medical attention.
Pregnancy: Mycophenolate mofetil should not be used during pregnancy unless the benefits outweigh the risks. Women who may become pregnant should have a negative urine or blood pregnancy test within one week before starting this medication.
2 methods of effective birth control (unless abstinence is the chosen method) should be used before the start of treatment with mycophenolate mofetil, during treatment, and for 6 weeks after the medication has been stopped. Consult your doctor immediately if you become pregnant while taking this medication.
If you are a sexually active man, you should use condoms during and for 13 weeks after stopping treatment. Your partner should also use effective birth control during this time period.
Breast-feeding: It is not known if mycophenolate mofetil passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this medication for children with heart or liver transplants have not been established.
Seniors: Seniors may have a higher risk of side effects from this medication.