This medicine is an immunosuppressant used for preventing organ rejection in certain patients following liver, kidney, or heart transplant. It may be used along with other medicines. It may also be used for other conditions as determined by your doctor.
Follow the directions for taking this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. TAKE THIS MEDICINE by mouth with or without food. It is important to take it consistently with regard to food. If you take it with food, try to always take it with food. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach. GRAPEFRUIT AND GRAPEFRUIT JUICE may increase the risk of side effects from this medicine. DO NOT EAT GRAPEFRUIT OR DRINK GRAPEFRUIT JUICE while you are taking this medicine. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), 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. Take this medicine 12 hours apart at the same times each day. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. 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.
WARNING: This medicine decreases the action of the immune system. This may increase your risk of infection. It may also increase your risk for developing certain types of cancer (eg, lymphoma, skin cancer). Tell your doctor right away if you notice signs of infection (eg, fever, chills, persistent sore throat) or any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness. 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 have taken cyclosporine within the last 24 hours. DO NOT TAKE THIS MEDICINE if you are taking asenapine, cisapride, citalopram, a potassium-sparing diuretic (eg, spironolactone), mifepristone, streptogramins (eg, dalfopristin, quinupristin), or ziprasidone. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other medicine to suppress your immune system, a medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation), or other prescription or nonprescription medicines (eg, used for birth control, cancer, infections, inflammation, aches and pains, heartburn or reflux, hepatitis, high blood pressure, high cholesterol, HIV infection, hormone replacement therapy, Huntington disease, immune system suppression, irregular heartbeat or other heart problems, mental or mood problems, nausea or vomiting, pain, Parkinson disease, seizures, stomach or bowel problems, ulcers), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort). Ask your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of QT prolongation or might interact with this medicine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including diabetes or high blood sugar, high blood potassium levels, high blood pressure, a weakened immune system, any type of infection, allergies, pregnancy, or breast-feeding. TELL YOUR DOCTOR if you have a history of chronic (long-term) infection; a certain type of anemia (pure red cell aplasia); heart, kidney, or liver problems; or skin cancer . TELL YOUR DOCTOR if you have recently received or will be receiving a live vaccine (eg, measles, mumps), if you will be in close contact with anyone who has received a live vaccine, or if a member of your family has had skin cancer. 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 back pain, constipation, diarrhea, dizziness, headache, heartburn, joint pain, loss of appetite, mild stomach pain or upset, nausea, trouble sleeping, vomiting, or weakness. If they continue or are bothersome, check with your doctor. SOME PATIENTS TREATED WITH THIS MEDICINE have developed a type of anemia called pure red cell aplasia (PRCA). Contact your doctor right away if you experience severe or persistent tiredness or weakness, sluggishness, or unusually pale skin. Discuss any questions or concerns with your doctor. THIS MEDICINE MAY INCREASE THE RISK of severe and sometimes fatal viral infections (eg, JC virus or BK virus infection). JC virus infection may lead to a serious effect called PML. BK virus may cause kidney problems or loss of a transplanted kidney in kidney transplant patients. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blurred vision or other vision changes; burning, numbness, or tingling; changes in the appearance or size of a mole; chest pain; confusion; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; memory problems; mental or mood changes (eg, agitation, anxiety, depression); muscle cramps, pain, or weakness; night sweats; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, lightheadedness, or headache; shortness of breath; swelling of the hands, ankles, feet, or legs; swollen lymph nodes; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; loss of appetite; unusual drowsiness); symptoms of kidney or urinary problems (eg, change in the amount of urine produced; difficult or painful urination; dark or bloody urine; pain in the groin, side, or lower back); tremor; trouble speaking; unusual bruising or bleeding; unusual growths or lumps; or yellowing of 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 decreased urination; hives; severe dizziness or headache; sluggishness; swelling of the hands, ankles, feet, or legs; or tremors.
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.