Patient Medication Information: uses, side effects, how to take - AG-Mycophenolate
What is AG-Mycophenolate used for?
- AG-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 AG-Mycophenolate work?
AG-Mycophenolate works by slowing down your body's defence system (immune system). When you receive an organ transplant, AG-Mycophenolate prevents your body from rejecting this organ.
What are the ingredients in AG-Mycophenolate?
Medicinal ingredients: mycophenolate mofetil
Non-medicinal ingredients:
AG-Mycophenolate 500 mg film-coated tablets contain the following non-medicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, FD&C blue #2 aluminum lake, iron oxide black, iron oxide red, magnesium stearate, purified talc, microcrystalline
Serious Warnings and Precautions
AG-Mycophenolate can cause first trimester pregnancy loss (miscarriage) and birth defects when used along with other medicines used to prevent organ rejection. You must not take AG-Mycophenolate if you are pregnant. Taking AG-Mycophenolate while pregnant can harm your unborn baby. Women must have two negative pregnancy tests before starting treatment with AG-Mycophenolate. Women must use two reliable forms of contraception at the same time while taking AG-Mycophenolate. See “Other warnings you should know about, Female Patients” for more information.
- AG-Mycophenolate suppresses your immune system. This can make you more likely to get infections and certain cancers, such as lymphoma.
- AG-Mycophenolate will be prescribed to you by a doctor with experience in medicines used to prevent organ rejection.
cellulose, polyethylene glycol, povidone, titanium dioxide.
AG-Mycophenolate comes in the following dosage forms:
As tablets containing 500 mg mycophenolate mofetil.
Do not use AG-Mycophenolate if you:
- Are allergic to mycophenolate mofetil or to mycophenolic acid
- Are allergic to any other ingredients in AG-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 AG-Mycophenolate. Talk about any health conditions or problems:
- If you are already on any immune suppressant treatment
- Rare diseases called Lesch-Nyhan and Kelley-Seegmiller syndrome
- Digestive problems, including ones with your stomach or bowels
- Severe renal problems.
Other warnings you should know about:
Important warnings for women taking AG-Mycophenolate:
- Do not take AG-Mycophenolate if you are pregnant.
- AG-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 AG-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 AG-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 8-10 days after the first. You can only start AG-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 AG-Mycophenolate
- During your entire treatment with AG-Mycophenolate and
- For 6 weeks after stopping your treatment with AG-Mycophenolate.
Talk to your doctor about the best methods of contraception for you. If you take oral contraceptives (birth control pills) while using AG-Mycophenolate you must also use another form of birth control method. This is because AG-Mycophenolate may make oral contraceptives less effective.
- Do not breastfeed your baby if you are taking AG-Mycophenolate. It may pass into your breast milk and may harm your baby.
- Be sure to keep all appointments at your transplant clinic. During these visits, pregnancy tests may be administered by your doctor.
Important warnings for men taking AG-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 AG-Mycophenolate. Effective birth control must be used for at least 90 days after you stop taking AG-Mycophenolate.
- Men should not donate semen during therapy and for 90 days after taking AG-Mycophenolate.
Serious infections and cancers:
- AG-Mycophenolate suppresses your immune system. This can make you more likely to get infections and certain cancers, such as lymphoma.
- AG-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 AG-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.
AG-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 AG-Mycophenolate:
- Tell all health professionals you see that you are taking AG-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 AG-Mycophenolate.
- During treatment with AG-Mycophenolate, vaccinations may be less effective. Also, you should not receive live vaccines. Talk to your doctor before receiving any vaccines.
AG-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 AG-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 AG-Mycophenolate:
- Take AG-Mycophenolate exactly as your doctor has told you to. Ask your healthcare professional if you are not sure.
- Your initial dose of AG-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.
- Leave tablets in blister pack until you are ready to take a dose.
Take AG-Mycophenolate on an empty stomach.
- Swallow tablets whole with plenty of water. Do not crush, chew or open them up.
- Space your two doses of AG-Mycophenolate as evenly as you can throughout the day leaving about 12 hours between each dose.
- Take AG-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 AG-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 AG-Mycophenolate on your own even if you have been taking it for several years.
- 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.
Pediatric Patients:
- Your doctor will decide how much AG-Mycophenolate you will receive. The dose will depend on your body surface area.
Heart Transplant 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:
Missed Dose:
- If you ever do miss a dose of AG-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 AG-Mycophenolate?
These are not all the possible side effects you may have when taking AG-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 |
|---|---|---|
| Only if severe | In all cases | |
| VERY COMMON | ||
If you think you, or a person you are caring for, have taken too much AG-Mycophenolate, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
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 | ||
| Abdominal pain | ✓ | ||
| Blood in urine | ✓ | ||
| Constipation | ✓ | ||
| Increased cough | ✓ | ||
| Diarrhea | ✓ | ||
| Fever | ✓ | ||
| Laboured breathing | ✓ | ||
| Headache | ✓ | ||
| High blood pressure | ✓ | ||
| Swelling of parts of your body | ✓ | ||
| Vomiting | ✓ | ||
| Weakness | ✓ | ||
| COMMON | |||
| Chest or back pain | ✓ | ||
| Dizziness | ✓ | ||
| Heartburn | ✓ | ||
| Involuntary trembling | ✓ | ||
| Muscle weakness | ✓ | ||
| Nausea | ✓ | ||
| Nosebleed | ✓ | ||
| Sleeplessness | ✓ | ||
| Stomach pain | ✓ | ||
| Sepsis (severe infection): fever and chills, low body temperature, fast heartbeat, nausea and vomiting | ✓ | ||
Gastrointestinal perforation (a hole in your stomach or bowels): chills or fever, nausea, severe abdominal pain, vomiting | ✓ | ||
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 | ||
| UNCOMMON | |||
| Bloody or black tarry stools | ✓ | ||
| Joint pain: painful inflammation and stiffness of the joints | ✓ | ||
| Muscle pain | ✓ | ||
| UNKNOWN | |||
Progressive multifocal leukoencephalopathy (infection of the brain): loss of coordination, difficulty walking, facial drooping, loss of vision, trouble speaking | ✓ | ||
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. | ✓ | ||
| 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 | ✓ | ||
| Neutropenia (decreased white blood cells): infections, fatigue, fever, aches, pains and flu-like symptoms. | ✓ | ||
| 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 nail beds; dizziness | ✓ | ||
BK virus-associated nephropathy (kidney disease due to an infection): changes in vision, like blurred vision; changes in the colour of your urine (urine that is brown or red in colour); difficulty urinating; needing to urinate more than is normal for you; a cough, cold, or trouble breathing; fever, muscle pain, or weakness | ✓ | ||
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 | |
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 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.
Storage:
- Keep AG-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.
- AG-Mycophenolate should be stored at room temperature (15-30ºC). The tablets should be protected from light. Remember to keep each tablet in its original package until you need to take it.
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
- 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.
- AG-Mycophenolate should not be used after the expiry date (EXP) shown on the package.
If you want more information about AG-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); the manufacturer’s website (www.angitapharma.ca), or by calling at 450-449-9272.
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada