Mycophenolate mofetil

What it is used for

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants

The most important thing to know

Mycophenolate mofetil capsules and tablets can cause serious side effects, including: Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects.

If you are a female who can become pregnant, your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking mycophenolate mofetil. You should have 1 pregnancy test immediately before starting mycophenolate mofetil capsules and tablets and another pregnancy test 8 to 10 days later.

Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests. You must use acceptable birth control during your entire mycophenolate mofetil treatment and for 6 weeks after stopping mycophenolate mofetil capsules and tablets, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely.

Mycophenolate mofetil decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take mycophenolate mofetil, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil you must also use another form of birth control.

Talk to your doctor about other birth control methods that you can use while taking mycophenolate mofetil capsules and tablets. If you are a sexually active male whose female partner can become pregnant while you are taking mycophenolate mofetil capsules and tablets, use effective contraception during treatment and for at least 90 days after stopping mycophenolate mofetil capsules and tablets.

If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you. If you become pregnant while taking mycophenolate mofetil capsules and tablets, do not stop taking mycophenolate mofetil capsules and tablets. Call your doctor right away. You and your doctor may decide that other medicines to prevent rejection may be right for you.

You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either: By phone at 1-800-617-8191 or By visiting the REMS website at www.mycophenolateREMS.com The purpose of this registry is to gather information about the health of you and your baby. Increased risk of getting certain cancers. People who take mycophenolate mofetil capsules and tablets have a higher risk of getting lymphoma, and other cancers, especially skin cancer.

Tell your doctor if you have: unexplained fever, prolonged tiredness, weight loss or lymph node swelling a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other a change in the size and color of a mole a new skin lesion or bump any other changes to your health Increased risk of getting certain cancers.

People who take mycophenolate mofetil capsules and tablets have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have: unexplained fever, prolonged tiredness, weight loss or lymph node swelling a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other a change in the size and color of a mole a new skin lesion or bump any other changes to your health Increased risk of getting serious infections.

Mycophenolate mofetil capsules and tablets weakens the body's immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil capsules and tablets and can lead to hospitalizations and death. These serious infections can include: Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak.

Viral infections that can

How to take it

Take mycophenolate mofetil capsules and tablets exactly as prescribed. Do not stop taking mycophenolate mofetil capsules and tablets or change the dose unless your doctor tells you to. If you miss a dose of mycophenolate mofetil capsules and tablets, or you are not sure when you took your last dose, take your prescribed dose of mycophenolate mofetil capsules and tablets as soon as you remember.

If your next dose is less than 2 hours away, skip the missed dose and take your next dose at your normal scheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do. Take mycophenolate mofetil capsules and tablets on an empty stomach, unless your doctor tells you otherwise. Do not crush mycophenolate mofetil tablets.

Do not open or crush mycophenolate mofetil capsules. If you are not able to swallow mycophenolate mofetil tablets or capsules, your doctor may prescribe mycophenolate mofetil oral suspension. This is a liquid form of mycophenolate mofetil. Your pharmacist will mix the medicine before you pick it up from a pharmacy. Do not mix mycophenolate mofetil oral suspension with any other medicine.

Mycophenolate mofetil oral suspension should not be mixed with any type of liquids before taking the dose. See the Instructions for Use at the end of this Medication Guide for detailed instructions about how to take mycophenolate mofetil oral suspension the right way. Do not breathe in (inhale) or let Mycophenolate mofetil powder or oral suspension come in contact with your skin or mucous membranes.

If you accidentally get the powder or oral suspension on the skin, wash the area well with soap and water. If you accidentally get the powder or oral suspension in your eyes or other mucous membranes, flush with plain water. If you take too much mycophenolate mofetil, call your doctor or the poison control center right away.

Side effects, and when to stop

" ). See " What are the possible side effects of mycophenolate mofetil capsules and tablets? " for information about other serious side effects. What is Mycophenolate mofetil capsules and tablets? Mycophenolate mofetil capsules and tablets are a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant.

Rejection is when the body's immune system perceives the new organ as a "foreign" threat and attacks it. Mycophenolate mofetil capsules and tablets is used with other medicines containing cyclosporine and corticosteroids.

Who should not take it

Do not take mycophenolate mofetil capsules and tablets if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil capsules and tablets. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil capsules and tablets.

What to say before you start

Tell your doctor about all of your medical conditions, including if you: have any digestive problems, such as ulcers. have Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolate mofetil capsules and tablets if you have one of these disorders.

plan to receive any vaccines. People taking mycophenolate mofetil capsules and tablets should not receive live vaccines. Some vaccines may not work as well during treatment with mycophenolate mofetil capsules and tablets. are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if mycophenolate mofetil passes into breast milk.

You and your doctor will decide if you will take mycophenolate mofetil capsules and tablets or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines may affect the way mycophenolate mofetil capsules and tablets works, and mycophenolate mofetil capsules and tablets may affect how some medicines work.

Especially tell your doctor if you take: birth control pills (oral contraceptives). sevelamer (Renagel ®, Renvela™). These products should be taken at least 2 hours after taking mycophenolate mofetil capsules and tablets. acyclovir (Zovirax ® ), valacyclovir (Valtrex ® ), ganciclovir (CYTOVENE ® -IV, Vitrasert ® ), valganciclovir (VALCYTE ® ).

rifampin (Rifater ®, Rifamate ®, Rimactane ®, Rifadin ® ). antacids that contain magnesium and aluminum (mycophenolate mofetil capsules and tablets and the antacid should not be taken at the same time). proton pump inhibitors (PPIs) (Prevacid ®, Protonix ® ). sulfamethoxazole/trimethoprim (BACTRIM™, BACTRIM DS™). norfloxacin (Noroxin ® ) and metronidazole (Flagyl ®, Flagyl ® ER, Flagyl ® IV, Metro IV, Helidac ®, Pylera™).

ciprofloxacin (Cipro ®, Cipro ® XR, Ciloxan ®, Proquin ® XR) and amoxicillin plus clavulanic acid (Augmentin ®, Augmentin XR™). azathioprine (Azasan ®, Imuran ® ). cholestyramine (Questran Light ®, Questran ®, Locholest Light, Locholest, Prevalite ® ). Know the medicines you take. Keep a list of them to show to your doctor or nurse and pharmacist when you get a new medicine.

Do not take any new medicine without talking with your doctor.

What to avoid

Avoid becoming pregnant. Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take mycophenolate mofetil capsules and tablets have a higher risk of getting skin cancer. ( ) Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high protection factor.

This is especially important if your skin is very fair or if you have a family history of skin cancer. You should not donate blood while taking mycophenolate mofetil capsules and tablets and for at least 6 weeks after stopping mycophenolate mofetil capsules and tablets. You should not donate sperm while taking mycophenolate mofetil capsules and tablets and for 90 days after stopping mycophenolate mofetil capsules and tablets.

Mycophenolate mofetil capsules and tablets may influence your ability to drive and use machines (See " What are the possible side effects of mycophenolate mofetil capsules and tablets? "). If you experience drowsiness, confusion, dizziness, tremor, or low blood pressure during treatment with mycophenolate mofetil capsules and tablets, you should be cautious about driving or using heavy machines.

What are the possible side effects of mycophenolate mofetil capsules and tablets? Mycophenolate mofetil capsules and tablets may cause serious side effects, including: Low blood cell counts. People taking high doses of mycophenolate mofetil capsules and tablets each day may have a decrease in blood counts, including: white blood cells, especially neutrophils.

Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 1 month to 6 months after your transplant. red blood cells. Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low.

platelets. Platelets help with blood clotting. Your doctor will do blood tests before you start taking mycophenolate mofetil and during treatment with mycophenolate mofetil capsules and tablets to check your blood cell counts.Tell your doctor right away if you have any signs of infection ( ), including any unexpected bruising or bleeding.

Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting. Stomach problems. Stomach problems including intestinal bleeding, a tear in your intestinal wall (perforation) or stomach ulcers can happen in people who take mycophenolate mofetil capsules and tablets. Bleeding can be severe and you may have to be hospitalized for treatment.

Call your doctor right away if you have sudden or severe stomach-area pain or stomach-area pain that does not go away, or if you have diarrhea. Inflammatory reactions. Some people taking mycophenolate mofetil may have an inflammatory reaction with fever, joint stiffness, joint pain, and muscle pain. Some of these reactions may require hospitalization.

This reaction could happen within weeks to months after your treatment with mycophenolate mofetil starts or if your dose is increased. Call your doctor right away if you experience these symptoms. The most common side effects of mycophenolate mofetil capsules and tablets include: diarrhea blood problems including low white and red blood cell counts infections blood pressure problems fast heartbeat swelling of the lower legs, ankles and feet changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) stomach problems including diarrhea, constipation, nausea and vomiting ra

Storing it

Store mycophenolate mofetil capsules and tablets at room temperature, between 59°F to 86°F (15°C to 30°C). Keep mycophenolate mofetil tablets in the light-resistant container that it comes in. Keep mycophenolate mofetil capsules and tablets and all medicines out of the reach of children.