This medicine is an immunosuppressant used with other medicines to prevent organ rejection following kidney, liver, or heart transplants. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for taking this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE by mouth on an empty stomach at least 1 hour before or 2 hours after eating unless your doctor tells you otherwise. SWALLOW THIS MEDICINE WHOLE. Do not break, crush, chew, or open the capsule before swallowing. If capsules are opened accidentally, DO NOT INHALE OR TOUCH THE POWDER CONTAINED INSIDE THE CAPSULES. If contact occurs, wash the contact area immediately with soap and water; rinse eyes with plain water. IF YOU CANNOT SWALLOW this medicine whole, check with your doctor. You may need a different doseform of this medicine. IF YOU TAKE ANTACIDS that contain aluminum or magnesium, do not take them at the same time as this medicine. Ask your doctor or pharmacist how to take them with this medicine. IF YOU TAKE SEVELAMER, take it 2 hours after taking this medicine. DO NOT STOP taking this medicine or change the dose unless your doctor tells you to. DO NOT CHANGE BRANDS OR DOSE FORMS (eg, tablets, suspension, injection) of this medicine without talking with your doctor. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Check with your doctor if you are not sure what to do.
WARNING: This medicine weakens your immune system, which may decrease your ability to fight illness or infection. It may also increase the risk of certain types of cancer (eg, lymphoma). Use this medicine only under close medical supervision. Be sure to keep all doctor and lab appointments while taking this medicine. THIS MEDICINE MAY CAUSE BIRTH DEFECTS OR FETAL DEATH if taken during pregnancy. Women who may become pregnant must use acceptable birth control methods while they are taking this medicine. Your doctor must talk with you about acceptable birth control methods to use while you are taking this medicine. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking azathioprine, cholestyramine, colestipol, or another medicine that contains mycophenolate or mycophenolic acid. DO NOT TAKE THIS MEDICINE if you are taking norfloxacin and metronidazole together. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking acyclovir, amoxicillin plus clavulanic acid, ciprofloxacin, ganciclovir, hormonal birth control (eg, birth control pills), probenecid, proton pump inhibitors (PPIs) (eg, lansoprazole), rifamycins (eg, rifampin), sulfamethoxazole/trimethoprim, valacyclovir, or valganciclovir. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including immune system problems or if you have been taking another medicine that may suppress your immune system, stomach or bowel problems (eg, ulcers), kidney problems, phenylketonuria (PKU), allergies, pregnancy or if you are able to become pregnant, or breast-feeding. Tell your doctor if you have fair skin or if you have a personal or family history of skin cancer, blood cancer (eg, lymphoma), or other blood problems. Tell your doctor if you are scheduled for a vaccination or if you will be in close contact with a person who has shingles, another type of herpes infection, or cytomegalovirus (CMV) infection. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a rare hereditary deficiency of hypoxanthine guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include anxiety; back pain; constipation; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; tremor; trouble sleeping; upset stomach; or vomiting. If they continue or are bothersome, check with your doctor. DIARRHEA MAY OCCUR with this medicine. If you develop diarrhea, check with your doctor or pharmacist about ways to lessen this effect. Do not stop this medicine without talking with your doctor. SOME PATIENTS TREATED WITH THIS MEDICINE have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. Tell your doctor right away if you notice symptoms of PML (eg, confusion or disorientation; you do not care about things that you usually care about; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine). In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Discuss any questions or concerns with your doctor. SOME PATIENTS TREATED WITH THIS MEDICINE have developed a type of anemia called pure red cell aplasia (PRCA). Contact your doctor immediately if you experience severe or persistent tiredness or weakness, sluggishness, or unusually pale skin. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bloody or black, tarry stools; burning, numbness, or tingling; change in the size or color of a mole; chest pain or pounding in the chest; ear pain; fainting; fast, slow, or irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; severe or persistent headache or dizziness; severe or persistent diarrhea, vomiting, or stomach pain or upset; shortness of breath; swelling of the hands, ankles, or feet; swollen glands; symptoms of infection (eg, fever, chills, cough, runny nose, sore throat); symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual skin lumps or growths; unusual weight loss; vision changes; vomit that looks like blood or coffee grounds; warm, red, swollen, or painful skin; white patches in mouth or throat; or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include diarrhea; fever, chills, or sore throat; nausea; stomach pain or upset; or vomiting.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.