Teva-Mycophenolate: Uses, Side Effects and Dosage

Serious Warnings and Precautions Box

What TEVA-MYCOPHENOLATE is used for:

• TEVA-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 TEVA-MYCOPHENOLATE works:

TEVA-MYCOPHENOLATE works by slowing down your body's defense system (immune system). When you receive an organ transplant, TEVA-MYCOPHENOLATE prevents your body from rejecting this organ.

The ingredients in TEVA-MYCOPHENOLATE are:

Medicinal ingredient(s): mycophenolate mofetil

Non-medicinal ingredients:

TEVA-MYCOPHENOLATE 250 mg capsules contain the following non-medicinal ingredients: croscarmellose sodium, magnesium stearate, povidone, pregelatinized starch, hard gelatin capsules contain gelatin, titanium dioxide, FD & C Blue 1 (cap) and FD & C Red 40, D & C Red 28, D & C Yellow 10 (body). The compositions of black ink are black iron oxide, propylene glycol and shellac.

TEVA-MYCOPHENOLATE 500 mg tablets contain the following non-medicinal ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, opadry coating (hypromellose, polyethylene glycol, talc, titanium dioxide, FD & C Red #40 Allura Red AC Aluminum Lake, FD & C Blue #2 Indigo Carmine Aluminum Lake).

TEVA-MYCOPHENOLATE comes in the following dosage forms:

As capsules containing 250 mg mycophenolate mofetil.

As tablets containing 500 mg mycophenolate mofetil.

Do not use TEVA-MYCOPHENOLATE if:

• are allergic to mycophenolate mofetil or to mycophenolic acid.
• are allergic to any other ingredients in TEVA-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 TEVA-MYCOPHENOLATE. Talk about any health conditions or problems you may have, including if you:

• 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 TEVA-MYCOPHENOLATE:

• Do not take TEVA-MYCOPHENOLATE if you are pregnant.
• TEVA-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 TEVA-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 TEVA-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 TEVA-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 TEVA-MYCOPHENOLATE,
  • During your entire treatment with TEVA-MYCOPHENOLATE and
  • For 6 weeks after stopping your treatment with TEVA-MYCOPHENOLATE.
• Talk to your doctor about the best methods of contraception for you. If you take oral contraceptives (birth control pills) while using TEVA-MYCOPHENOLATE you must also use another form of birth control method. This is because TEVA-MYCOPHENOLATE may make oral contraceptives less effective.
• Do not breastfeed your baby if you are taking TEVA-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 TEVA-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 TEVA-MYCOPHENOLATE. Effective birth control must be used for at least 90 days after you stop taking TEVA-MYCOPHENOLATE.
• Men should not donate semen during therapy and for 90 days after taking of TEVA-MYCOPHENOLATE.

Serious infections and cancers:

• TEVA-MYCOPHENOLATE suppresses your immune system. This can make you more likely to get infections and certain cancers, such as lymphoma.

• TEVA-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 TEVA-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.

• TEVA-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 TEVA-MYCOPHENOLATE:

• Tell all health professionals you see that you are taking TEVA-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 TEVA-MYCOPHENOLATE.
• During treatment with TEVA-MYCOPHENOLATE, vaccinations may be less effective. Also, you should not receive live vaccines. Talk to your doctor before receiving any vaccines.

• TEVA-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 also interact with TEVA-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 TEVA-MYCOPHENOLATE:

• Take TEVA-MYCOPHENOLATE exactly as your doctor has told you to. Ask your healthcare professional if you are not sure.
• Your initial dose of TEVA-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 capsules and tablets in blister pack until you are ready to take a dose.

• Take TEVA-MYCOPHENOLATE on an empty stomach.

• Swallow tablets or capsules whole with plenty of water. Do not crush, chew or open them up.
• Space your two doses of TEVA-MYCOPHENOLATE as evenly as you can throughout the day leaving about 12 hours between each dose.
• Take TEVA-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 TEVA-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 TEVA-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 capsules or 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 TEVA-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 TEVA-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.

Possible side effects from using TEVA-MYCOPHENOLATE:

These are not all the possible side effects you may have when taking TEVA-MYCOPHENOLATE. If you experience any side effects not listed here, tell your healthcare professional.

Serious side effects and what to do about them

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

Storage:

• Keep TEVA-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.
• TEVA-MYCOPHENOLATE capsules should be stored at 15°C - 30°C and the tablets should be stored at 15°C - 25°C. The capsules should be protected from light. The tablets should be protected from light and moisture. Remember to keep each capsule or tablet in its original package until you need to take it.
• TEVA-MYCOPHENOLATE should not be used after the expiry date (EXP) shown on the package.

If you want more information about TEVA-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 http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Last Revised: 2026-07-13