Mycophenolate mofetil oral / injection

Mycophenolate mofetil is an immunosuppressant. Your body may "reject" an organ transplant when the immune system treats the new organ as an invader. An immunosuppressant helps to prevent this rejection.

Mycophenolate mofetil is used to prevent your body from rejecting a kidney, liver, or heart transplant. This medicine is usually given with cyclosporine and a steroid medicine.

Mycophenolate mofetil may also be used for purposes not listed in this medication guide.

This medicine can cause a miscarriage or birth defects, especially if used during the first 3 months of pregnancy. If you are a woman of child-bearing potential, you must use specific types of birth control to prevent pregnancy before, during, and shortly after treatment with mycophenolate mofetil.

Mycophenolate mofetil is sometimes given to pregnant women. Although this medicine can affect pregnancy or fertility, it is sometimes given to women who are unable to use other needed transplant medications.

Using mycophenolate mofetil may increase your risk of developing serious infections or other types of cancer, such as lymphoma or skin cancer. You must remain under the care of a doctor while you are using mycophenolate mofetil.

You should not use this medicine if you are allergic to mycophenolate mofetil, mycophenolic acid (Myfortic), or to an ingredient called Polysorbate 80.

Using mycophenolate mofetil may increase your risk of developing serious infections or other types of cancer, such as lymphoma or skin cancer. Ask your doctor about your specific risk.

To make sure mycophenolate mofetil is safe for you, tell your doctor if you have:

• a stomach ulcer or other disorder of your stomach or intestines;

• a viral, bacterial, or fungal infection; or

• a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

This medicine can cause a miscarriage or birth defects, especially during the first 3 months of pregnancy. You will need to have a negative pregnancy test before and during treatment with mycophenolate mofetil. You must prevent pregnancy before and during your treatment with mycophenolate mofetil, and for at least 6 weeks after your treatment ends.

If you are a woman of child-bearing potential, you will be required to use birth control. You have child-bearing potential (even if you are not sexually active) from the age of puberty until you have been in menopause for at least 12 months in a row.

Mycophenolate mofetil can make hormonal birth control (pills, injections, implants, skin patches, or vaginal rings) less effective. If you use hormonal birth control, you must also use a back-up barrier method (such as a cervical sponge, a male or female condom, or a diaphragm or cervical cap used together with spermicide).

You do not need to use additional birth control if you use an intrauterine device (IUD), if you have had a tubal ligation, or if your sexual partner has had a vasectomy.

This medicine comes with patient instructions about the most effective non-hormonal forms of birth control to use. Follow these directions carefully. Ask your doctor if you have any questions.

If a pregnancy occurs during treatment, do not stop using mycophenolate mofetil. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).

Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are pregnant or planning to become pregnant. Although this medicine can affect pregnancy or fertility, it is sometimes given to women who are unable to use other needed transplant medications.

It is not known whether mycophenolate mofetil passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

The liquid form may contain phenylalanine. Talk to your doctor before using this form of mycophenolate mofetil if you have phenylketonuria (PKU).

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using mycophenolate mofetil. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid taking an antacid together with mycophenolate mofetil. If you also take sevelamer, take it at least 2 hours after you take oral mycophenolate mofetil.

Avoid exposure to sunlight or tanning beds. Mycophenolate mofetil can increase your risk of developing skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day); [in clinical trials, 1.5 g orally or IV 2 times a day (3 gm per day) was used effectively, however, the safety profile for 3 gm a day was lower]
-CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day)
-HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.
-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Geriatric Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day)
-CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day)
-HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.
-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

-RENAL TRANSPLANTATION:
3 months to 18 years of age:
Oral Suspension: 600 mg/m2 orally 2 times a day up to a maximum of 2 grams per day
-Pediatric patients with a body surface area of 1.25 to 1.5 m2 may be dosed with the oral capsules at 750 mg orally 2 times a day (1.5 g per day)
-Pediatric patients with a body surface area greater than 1.5 m2 may be dosed with the oral capsules at 1 g orally 2 times a day (2 g per day)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.