Mycophenolate Injection

Risk of birth defects:

Mycophenolate must not be taken by women who are pregnant or who may become pregnant. There is a high risk that mycophenolate will cause miscarriage (loss of the pregnancy) during the first 3 months of pregnancy or will cause the baby to be born with birth defects (problems that are present at birth).

You should not receive mycophenolate injection if you are pregnant or if you may become pregnant. You must have a negative pregnancy test before starting your treatment with mycophenolate, again 8 to 10 days later, and at routine follow-up appointments. You must use acceptable birth control during your treatment, and for 6 weeks after you stop taking mycophenolate. Your doctor will tell you which forms of birth control are acceptable for you to use. Mycophenolate may decrease the effectiveness of oral contraceptives (birth control pills), so it is especially important to use a second form of birth control along with this type of contraceptive.

If you are a male with a female partner who may become pregnant, you should use acceptable birth control during treatment and for at least 90 days after your last dose. Do not donate sperm during your treatment and for at least 90 days after your last dose.

Call your doctor right away if you think you or your partner, is pregnant or if you miss a menstrual period.

Because of the possibility that your donation may go to a female who may be or become pregnant, do not donate blood during your treatment and for at least 6 weeks after your last dose.

Risk of serious infections:

Mycophenolate injection weakens the body's immune system and may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you have any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Also tell your doctor if you have or have ever had human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B virus infection (HBV; an ongoing liver infection), hepatitis C virus infection (HCV; an ongoing liver infection), or herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past). If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, or cough; unusual bruising or bleeding; pain or burning during urination; frequent urination; wound or sore that is red, warm, or won't heal; drainage from a skin wound; general weakness, extreme tiredness, or sick feeling; symptoms of the ''flu'' or a ''cold''; pain or swelling in the neck, groin, or armpits; white patches in the mouth or throat; cold sores; blisters; headache or earache; or other signs of infection.

Mycophenolate may increase the risk that you will develop progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). Tell your doctor if you have or have ever had PML, or another condition that affects your immune system. If you experience any of the following symptoms, call your doctor immediately: weakness on one side of the body or in the legs, difficulty or inability to control your muscles, confusion or difficulty thinking clearly, or a lack of interest or concern for usual activities or things you usually care about.

Mycophenolate injection may increase your risk of developing certain types of cancer, including lymphoma (a type of cancer that develops in the lymph system) and skin cancer. Tell your doctor if you have or have ever had skin cancer or any other type of cancer. Avoid unnecessary or prolonged exposure to real and artificial sunlight (tanning beds, sunlamps) and light therapy and wear protective clothing, sunglasses, and sunscreen (with a SPF factor of 30 or above). This will help to decrease your risk of developing skin cancer. Call your doctor if you experience any of the following symptoms: pain or swelling in the neck, groin, or armpits; a new skin sore or bump; a change in the size or color of a mole; a brown or black skin lesion (sore) with uneven edges or one part of the lesion that does not look like the other; skin changes; sores that do not heal; unexplained fever; tiredness that does not go away; weight loss; or any other changes to your health.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with mycophenolate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website http://www.fda.gov/Drugs to obtain the Medication Guide.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to mycophenolate injection.

Talk to your doctor about the risks of receiving mycophenolate injection.

Mycophenolate injection is used with other medications to help prevent transplant organ rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in adults and children 3 months of age and older who have received kidney, heart, or liver transplants and who cannot take oral medication. Mycophenolate is in a class of medications called immunosuppressive agents. It works by weakening the body's immune system so it will not attack and reject the transplanted organ.

Mycophenolate injection comes as a powder to be mixed with liquid and injected intravenously (into a vein) over at least 2 hours by a doctor or nurse. It is usually given twice a day for as long as you are unable to take mycophenolate tablets, capsules, or oral suspension by mouth or for up to 14 days.

You may receive mycophenolate injection in a hospital or you may use the medication at home. If you will be receiving mycophenolate injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions.

Mycophenolate is also used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving mycophenolate injection,

• tell your doctor and pharmacist if you are allergic to mycophenolate, mycophenolic acid, any other medications, or any of the ingredients in mycophenolate injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Also be sure tell your doctor if you stop taking any of your medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome (inherited diseases that cause high levels of a certain substance in the blood, joint pain, and problems with motion and behavior); anemia (a lower than normal number of red blood cells); neutropenia (less than normal number of white blood cells); ulcers or any disease that affects your stomach, intestines, or digestive system; or kidney or liver disease.
• tell your doctor if you are breastfeeding.
• do not have any vaccinations without talking to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Mycophenolate injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• injection pain, redness, swelling, warmth, or burning
• constipation
• nausea
• vomiting
• difficulty falling asleep or staying asleep
• pain, especially in the back, muscles, or joints
• headache
• gas
• rash
• prickling, tingling, or burning feeling on the skin
• swelling of the hands, arms, feet, ankles, or lower legs
• tremor

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• sudden severe stomach pain, stomach pain that doesn't go away, or diarrhea
• dizziness, fainting, pale skin, lack of energy, shortness of breath, or fast heartbeat
• unusual bleeding or bruising; vomiting or spitting up blood or brown material that resembles coffee grounds; bloody or black, tarry stools; or blood in urine
• fever, muscle or joint stiffness or pain

Mycophenolate injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• stomach pain
• nausea
• vomiting
• heartburn
• diarrhea
• fever, sore throat, chills, cough and other signs of infection

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving mycophenolate injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• CellCept^®