Patient Medication Information: uses, side effects, how to take - Apo-Mycophenolate (Apotex, 500 mg)
Serious Warnings and Precautions
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What is APO-MYCOPHENOLATE used for?
- APO-MYCOPHENOLATE is used after kidney, heart and liver transplantation to help prevent organ rejection.
- It is used along with other medicines including cyclosporine and medicines called corticosteroids.
How does APO-MYCOPHENOLATE work?
APO-MYCOPHENOLATE works by slowing down your body's defense system (immune system). When you receive an organ transplant, APO-MYCOPHENOLATE prevents your body from rejecting this organ.
What are the ingredients in APO-MYCOPHENOLATE?
Medicinal ingredients: mycophenolate mofetil
Non-medicinal ingredients: croscarmellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified talc, and titanium dioxide.
APO-MYCOPHENOLATE comes in the following dosage forms:
As tablets containing 500 mg mycophenolate mofetil
Do not use APO-MYCOPHENOLATE if you:
- Are allergic to mycophenolate mofetil or to mycophenolic acid
- Are allergic to any other ingredients in APO-MYCOPHENOLATE.
Are pregnant
- Are breastfeeding
- Are of childbearing age and not using highly effective birth control
- Do not have results from a pregnancy test showing that you are not pregnant
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-MYCOPHENOLATE. Talk about any health conditions or problems you may have, including if you:
- are already on any immune suppressant treatment.
- have rare diseases called Lesch-Nyhan and Kelley-Seegmiller syndrome.
- have digestive problems, including ones with your stomach or bowels.
- have severe renal problems.
Other warnings you should know about:
Important warnings for women taking APO-MYCOPHENOLATE:
- Do not take APO-MYCOPHENOLATE if you are pregnant.
- APO-MYCOPHENOLATE can cause first trimester pregnancy loss (miscarriage) and birth defects when used along with other medicines used to prevent organ rejection.
- These birth defects can affect the development of a baby’s ears, limbs, face, heart and brain.
- You can only take APO-MYCOPHENOLATE if you are not pregnant and if you are using highly effective birth control.
- If you think you may be pregnant, tell your doctor right away. Keep taking APO-MYCOPHENOLATE until you see your doctor. They will talk to you about other medicines you can take to prevent rejection of your transplanted organ.
- Women who can get pregnant must have two negative blood or urine pregnancy tests. The second test should be performed 8 to 10 days later after the first. You can only start APO-MYCOPHENOLATE if the tests are negative. You will be given repeat pregnancy tests during follow-up visits.
You must always use two reliable methods of birth control:
- Before you start taking APO-MYCOPHENOLATE
- During your entire treatment with APO-MYCOPHENOLATE and
- For 6 weeks after stopping your treatment with APO-MYCOPHENOLATE
Talk to your doctor about the most suitable methods of contraception for you. If you take oral contraceptives (birth control pills) while using APO-MYCOPHENOLATE you must also use another form of birth control method. This is because APO-MYCOPHENOLATE may make oral contraceptives less effective.
- Do not breastfeed your baby if you are taking APO-MYCOPHENOLATE. It may pass into breast milk and may harm your baby.
- Be sure to keep all appointments at your transplant clinic. During visits, pregnancy tests may be administered by your doctor.
Important warnings for men taking APO-MYCOPHENOLATE
- If you are a sexually active male, you must use effective birth control or your female partner must use effective birth control while you are taking APO-MYCOPHENOLATE. Effective birth control must be used for at least 90 days after you stop taking APO-MYCOPHENOLATE.
- Men should not donate semen during therapy and for 90 days after taking of APO-MYCOPHENOLATE.
Serious infections and cancers
- APO-MYCOPHENOLATE suppresses your immune system. This can make you more likely to get infections and certain cancers, such as lymphoma and skin cancer.
- APO-MYCOPHENOLATE slows down your immune system. This can affect your body’s ability to fight infections. You are more likely to get infections when you take APO-MYCOPHENOLATE. Some of these infections can be serious and fatal. Infections include: viral infections, a brain infection called progressive multifocal leukoencephalopathy, sepsis and other infections. It can also cause other infections to emerge in your body like hepatitis B or C or infections caused by polyomaviruses. See “Serious side effects and what to do about them” table for more information.
APO-MYCOPHENOLATE increases your chances of getting certain cancers, especially skin cancers. See “Serious side effects and what to do about them” table for more information. You must limit the amount of sunlight and UV light you get. Do this by:
- wearing protective clothing which also covers your head, neck, arms and legs.
- using a sunscreen with a high sun protection factor (SPF).
Additional important warnings for all patients taking APO-MYCOPHENOLATE:
- Tell all health professionals you see that you are taking APO-MYCOPHENOLATE.
- Be sure to keep all appointments at your transplant clinic. During these visits, complete blood counts will need to be measured weekly in the first month, twice monthly for the second and third months of treatment and then monthly for the remainder of the first year. Your doctor may sometimes order additional blood tests.
- You should not donate blood during therapy and for at least 6 weeks after taking APO-MYCOPHENOLATE.
- During treatment with APO-MYCOPHENOLATE, vaccinations may be less effective. Also, you should not receive live vaccines. Talk to your doctor before receiving any vaccines.
APO-MYCOPHENOLATE may affect your ability to drive and use machines. Before driving or using machines, wait until you are feeling well again.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-MYCOPHENOLATE:
- Acyclovir, an antiviral medication;
- Ganciclovir or valganciclovir, antiviral medications’
- Isavuconazole, an antiviral medication;
- Tacrolimus, used to suppress the body’s immune system;
- Telmisartan, used to treat high blood pressure;
- Rifampicin, an antibiotic;
- Azathioprine, used to suppress the body’s immune system;
- Antacids, which neutralize stomach acidity;
- Proton pump inhibitors, such as lansoprazole and pantoprazole;
- Renagel® (sevelamer), or other calcium free phosphate binders;
- Cholestyramine, which is used to treat high blood cholesterol.
- Combinations of antibiotics taken at the same time.
How to take APO-MYCOPHENOLATE:
- Take APO-MYCOPHENOLATE exactly as your doctor has told you to. Ask your healthcare professional if you are not sure.
- Your initial dose of APO-MYCOPHENOLATE should be taken as soon as possible following transplantation. If you are not sure of your dose, or when to take it, ask your doctor, pharmacist or nurse.
Take APO-MYCOPHENOLATE on an empty stomach.
- Space your two doses of APO-MYCOPHENOLATE as evenly as you can throughout the day leaving about 12 hours between each dose.
- Take APO-MYCOPHENOLATE along with other medicines prescribed to you, including cyclosporine and medicines called corticosteroids. These are also medicines used to prevent rejection of your transplanted organ. It is important to take all of these medicines properly. Talk to your doctor if you are not sure.
- Try to take your doses at the same times each day. Taking your medicine at the same time each day will also help you remember each dose.
- Vomiting or diarrhea may prevent APO-MYCOPHENOLATE from being taken up into your body. Always call your doctor if you have either of these episodes.
- Do not change the dose on your own, no matter how you are feeling. Call your doctor.
- Do not stop taking APO-MYCOPHENOLATE on your own even if you have been taking it for several years.
- Leave tablets in blister pack until you are ready to take a dose.
- Swallow tablets whole with plenty of water. Do not crush or chew them.
- Avoid contact with any powder, including accidentally breathing it in, from damaged tablets. Wash any powder from your skin with soap and water. If you get any in your eyes, rinse eyes with plain water.
Usual Dose:
Kidney Transplant Patients
Adults
- A dose of 1 g taken twice a day (daily dose of 2 g) is recommended after kidney transplantation.
Heart Transplants Patients
Adults
- A dose of 1.5 g twice a day (daily dose of 3 g) is recommended after heart transplantation in adults.
Liver Transplant Patients
Adults
- A dose of 1.5 g taken twice a day (daily dose of 3 g) is recommended after liver transplantation in adults.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-MYCOPHENOLATE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
- If you ever do miss a dose of APO-MYCOPHENOLATE, do not catch up on your own. Instead call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses. Do not double dose.
What are possible side effects from using APO-MYCOPHENOLATE?
These are not all the possible side effects you may have when taking APO-MYCOPHENOLATE. If you experience any side effects not listed here, tell your healthcare professional.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
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| Only if severe | In all cases | ||
| VERY COMMON | |||
| Abdominal pain |
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| Blood in urine |
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| Constipation |
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| Increased cough |
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| Diarrhea |
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| Fever |
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| Laboured breathing |
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| Headache |
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| High blood pressure |
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| Swelling of parts of your body |
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| Vomiting |
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| Weakness |
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| COMMON | |||
| Chest or back pain |
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| Dizziness |
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| Heart burn |
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| Involuntary trembling |
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| Muscle weakness |
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| Nausea |
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| Nosebleed |
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| Sleeplessness |
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| Stomach pain |
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| Sepsis (severe infection): fever and chills, low body temperature, fast heartbeat, nausea and vomiting |
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| Gastrointestinal perforation (a hole in your stomach or bowels): chills or fever, nausea, severe abdominal pain, vomiting |
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| UNCOMMON | |||
| Blood or black tarry stools |
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Serious side effects 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 | ||
| Joint pain: painful inflammation and stiffness of the joints |
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| Muscle pain |
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| UNKNOWN | |||
| Progressive multifocal leukoencephalopathy (infection of the brain): loss of coordination, difficulty walking, facial drooping, loss of vision, trouble speaking |
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| Infections: body aches and pains, boils on your skin, chills, cold symptoms, earache, flu-like symptoms, headache, pain when you urinate, sore throat, cuts and scrapes that are red, have pus or don’t heal. |
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| Pure red cell aplasia (bone marrow stops producing red cells): dizziness, fainting, fatigue, feeling unwell, pale skin, pale stools, rapid heartbeat, shortness of breath, weakness |
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| Neutropenia (decreased white blood cells): infections, fatigue, fever, aches, pains and flu-like symptoms. |
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| Bone marrow suppression (a large decrease in the production of blood cells and platelets by the bone marrow): fatigue, increased heart rate, unexpected bruising, bleeding; paleness of the skin, lips, and bail beds; dizziness |
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| BK virus-associated nephropathy (kidney disease due to an infection): changes in vision, like blurred vision; changes in the color of your urine (urine that is brown or red in color); difficulty urinating; needing to urinate more than is normal for you; a cough, cold, or trouble breathing; fever, muscle pain, or weakness |
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| Certain types of cancers (such as lymphoma and skin cancer): new moles, skin lesions or bumps; change in the size or colour of a mole, moles with uneven borders or that are asymmetric, fever, prolonged tiredness, weight loss, lymph node swelling, a change in your bowel or bladder habits, unusual bleeding or discharge, the appearance of a lump or |
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Serious side effects 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 | |
| thickened areas in your breast or anywhere else on your body, unexplained stomach upset or any trouble with swallowing, a nagging cough or hoarseness, night sweats | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
- Keep APO-MYCOPHENOLATE out of reach and sight of children. A child who accidentally takes the drug may be seriously harmed. A locked drawer or cupboard is best if you have small children in the house.
- APO-MYCOPHENOLATE should be stored at room temperature (15°C to 30°C). The tablets should be protected from light. Remember to keep each tablet in its original package until you need to take it.
- APO-MYCOPHENOLATE should not be used after the expiry date (EXP) shown on the package.
If you want more information about APO-MYCOPHENOLATE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html). Find the Patient Medication Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.
Renagel® (sevelamer) is a registered Trade-Mark of Genzyme Corporation