Patient Medication Information: uses, side effects, how to take - Mycophenolate Mofetil for Injection, USP
Serious Warnings and Precautions
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What is Mycophenolate Mofetil for Injection, USP used for?
- Mycophenolate Mofetil for Injection, USP is used after kidney, heart and liver transplantation to help prevent organ rejection.
- It is used along with other drugs including cyclosporine and medicines called corticosteroids.
How does Mycophenolate Mofetil for Injection, USP work?
Mycophenolate Mofetil for Injection, USP works by slowing down your body's defense system (immune system). When you receive an organ transplant, Mycophenolate Mofetil for Injection, USP prevents your body from rejecting this organ.
What are the ingredients in Mycophenolate Mofetil for Injection, USP?
Medicinal ingredients: mycophenolate mofetil
Non-medicinal ingredients: 5 mg citric acid, 103.4 mg hydrochloric acid concentrate, 25 mg polysorbate 80, 7.5 mg sodium chloride and sodium hydroxide and/or hydrochloric acid to adjust pH.
Mycophenolate Mofetil for Injection, USP comes in the following dosage forms:
Mycophenolate Mofetil for Injection, USP is available for patients who are unable to take oral medications. It comes as a powder for solution containing 500 mg mycophenolate mofetil.
Do not use Mycophenolate Mofetil for Injection, USP if you:
- are allergic to mycophenolate mofetil or to mycophenolic acid.
- are allergic to any other ingredients in Mycophenolate Mofetil for Injection, USP.
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.
- are allergic to Polysorbate 80 (also known as TWEEN).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Mycophenolate Mofetil for Injection, USP. Talk about any health conditions or problems you may have, including if you:
- are already on any immune suppressant treatment.
- have a 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 Mycophenolate Mofetil for Injection, USP
- Do not take Mycophenolate Mofetil for Injection, USP if you are pregnant.
- Mycophenolate Mofetil for Injection, USP 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 Mycophenolate Mofetil for Injection, USP 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 Mycophenolate Mofetil for Injection, USP 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 Mycophenolate Mofetil for Injection, USP 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 Mycophenolate Mofetil for Injection, USP,
- During your entire treatment with Mycophenolate Mofetil for Injection, USP and
- For 6 weeks after stopping your treatment with Mycophenolate Mofetil for Injection, USP.
Talk to your doctor about the best methods of contraception for you. If you take oral contraceptives (birth control pills) while using Mycophenolate Mofetil for Injection, USP, you must also use another form of birth control method. This is because Mycophenolate Mofetil for Injection, USP may make oral contraceptives less effective.
- Do not breastfeed your baby if you are taking mycophenolate mofetil. 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 Mycophenolate Mofetil for Injection, USP:
- 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 Mycophenolate Mofetil for Injection, USP. Effective birth control must be used for at least 90 days after you stop taking Mycophenolate Mofetil for Injection, USP.
- Men should not donate semen during therapy and for 90 days after taking of Mycophenolate Mofetil for Injection, USP.
Serious infections and cancers:
- Mycophenolate mofetil suppresses your immune system. This can make you more likely to get infections and certain cancers, such as lymphoma and skin cancer.
Mycophenolate mofetil 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 Mycophenolate Mofetil for Injection, USP. 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.
Mycophenolate mofetil 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 Mycophenolate Mofetil for Injection, USP:
- Tell all health professionals you see that you are taking Mycophenolate Mofetil for Injection, USP.
- 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 Mycophenolate Mofetil for Injection, USP.
- During treatment with Mycophenolate Mofetil for Injection, USP, vaccinations may be less effective. Also, you should not receive live vaccines. Talk to your doctor before receiving any vaccines.
Mycophenolate Mofetil for Injection, USP 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 Mycophenolate Mofetil for Injection, USP:
- 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 Mycophenolate Mofetil for Injection, USP:
- Mycophenolate Mofetil for Injection, USP will be given to you by a healthcare professional.
- It will be infused directly into your vein.
- Mycophenolate Mofetil for Injection, USP will be given to you as soon as possible after transplantation.
- Mycophenolate Mofetil for Injection, USP must be taken with other immunosuppressive medicines (such as cyclosporine and corticosteroids). Discuss with your doctor if you are to stop, or to continue, the other immunosuppressant drugs you had been taking.
Usual Dose:
Your doctor will decide what dose of Mycophenolate Mofetil for Injection, USP you will get and when you will get it.
Kidney Transplant Patients
Adults:
- A dose of 1 g administered intravenously (over 2 hours) twice a day (daily dose of 2 g) is recommended after kidney transplantation.
*Pediatric Patients:
- In pediatrics (2 years and older), the recommended dose of mycophenolate mofetil oral suspension following kidney transplantation is 600 mg/m2 body surface area** twice a day (up to a maximum daily dose of 2 g).
- Pediatric patients with a body surface area** of 1.25 to 1.5 m2 may be dosed with mycophenolate mofetil capsules at a dose of 750 mg twice a day (1.5 g daily dose). Pediatric patients with a body surface area** greater than 1.5 m2 may be dosed with mycophenolate mofetil capsules or tablets at a dose of 1 g twice a day (2 g daily dose).
*There is no data for the mycophenolate mofetil intravenous infusion (IV infusion) in children.
**Body surface area is the total surface area of the body, and is represented as square meters (m2). It is calculated from your weight and height. Body surface area is used in many measurements in medicine, such as determining the amount of drug you need to take.
Heart Transplant Patients
Adults:
- A dose of 1.5 g twice daily (daily dose of 3 g) administered intravenously (over no less than 2 hours) is recommended after heart transplantation in adults.
Liver Transplant Patients
Adults:
- A dose of 1 g twice daily administered intravenously (over no less than 2 hours) is recommended after liver transplantation in adults.
Overdose:
| If you think you, or a person you are caring for, have taken too much Mycophenolate Mofetil for Injection, USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
- If you miss a dose of Mycophenolate Mofetil for Injection, USP, your doctor will decide when you should receive your next dose.
What are the possible side effects from using Mycophenolate Mofetil for Injection, USP?
These are not all the possible side effects you may have when taking Mycophenolate Mofetil for Injection, USP. 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 | |||
| 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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| Joint pain: painful inflammation and stiffness of the joints |
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| Muscle pain |
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| UNKNOWN | |||
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 | ||
|---|---|---|---|
| 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 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 |
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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. |
Storage:
- Keep Mycophenolate Mofetil for Injection, USP 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.
- Mycophenolate Mofetil for Injection, USP should be stored at room temperature (15°C-30°C) and be protected from light. The healthcare professional will store the reconstituted/infusion solutions at room temperature (15°C-30°C).
- Reconstituted/Infusion solutions: Store at 15°C to 30°C. Commence treatment within 4 hours from reconstitution/dilution.
- Mycophenolate Mofetil for Injection, USP should not be used after the expiry date (EXP) shown on the package.
If you want more information about Mycophenolate Mofetil for Injection, USP:
- 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); or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.
Neoral® (cyclosporine) is a registered trade-mark of Novartis Syntex Pharm AG, used under license.
Sandimmune® (cyclosporine) is a registered Trade-Mark of Novartis AG
Renagel® (sevelamar) is a registered Trade-Mark of Genzyme Corporation
Accord Healthcare Inc.
3535 Boul. St. Charles, Suite 704
Kirkland, QC H9H 5B9
Canada