This medicine is an immunosuppressant used to prevent the rejection of organ transplants (kidney, liver, and heart). It is used in combination with adrenal corticosteroids. It may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. TAKE THIS MEDICINE ON A REGULAR SCHEDULE with regard to food and time(s) of day. 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. DO not eat grapefruit or drink grapefruit juice while you use this medicine. STORE THIS MEDICINE at 77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. 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 should be used with adrenal corticosteroids (eg, hydrocortisone). It should not be used with other medicines that suppress the immune system. Suppressing the immune system may increase the risk of developing an infection or a certain type of cancer (lymphoma). THIS MEDICINE CANNOT BE SWITCHED with other forms of cyclosporine (eg, Neoral) without your doctor's approval. IF YOU ARE TAKING THIS MEDICINE FOR A LONG PERIOD OF TIME, lab tests should be performed to monitor your progress or to check for side effects. This is especially important for liver transplant patients. 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 also taking aliskiren, bosentan, disulfiram, dronedarone, enzalutamide, lovastatin, metronidazole, mifepristone, orlistat, pitavastatin, a potassium-sparing diuretic (eg, spironolactone), simvastatin, or another medicine used to suppress the immune system (eg, azathioprine, sirolimus). DO NOT TAKE THIS MEDICINE if you have taken or will be taking tacrolimus within 24 hours before or after using this medicine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other prescription or nonprescription medicines (eg, used for infections, inflammation, allergic reactions, asthma, aches and pains, high blood pressure, cancer, gout, diabetes, heartburn or reflux, high cholesterol, irregular heartbeat or other heart problems, birth control, Parkinson disease, stomach or bowel problems, endometriosis, HIV, seizures, blood thinning, weight loss, arthritis, psoriasis, depression or other mental or mood problems, sleep, fibrocystic breast disease, hepatitis C, high blood prolactin levels, immune system suppression, pulmonary arterial hypertension / PAH), multivitamin products, or herbal or dietary supplements (eg, St. John's wort). Tell your doctor if you are taking medicines that may harm the kidney (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; nonsteroidal anti-inflammatory drugs / NSAIDs, such as ibuprofen; tacrolimus; vancomycin) or the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection). Ask your doctor or pharmacist if you are unsure if any of your medicines might harm the kidney or liver, 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 liver, kidney, brain, or nerve problems; gout or high blood uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; an infection; a weakened immune system; problems absorbing food or medicine; high blood potassium levels; allergies; pregnancy; or breast-feeding. Tell your doctor if you have recently had or will be having a vaccine, if your diet contains a lot of potassium, or if you have a history of seizures. Tell your doctor if you are having phototherapy for psoriasis, or are having radiation treatment. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are having radiation therapy, including PUVA or UVB therapy, for psoriasis. Contact your doctor or pharmacist if you have any questions about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include acne; dizziness; flushing; headache; increased hair growth; mild diarrhea; nausea; runny nose; sleeplessness; stomach discomfort; or vomiting. If they continue or are bothersome, check 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. In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. 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 kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine). CONTACT YOUR DOCTOR IMMEDIATELY if you experience black, tarry stool; burning, numbness, or tingling; change in the appearance of a mole; chest, jaw, or arm pain; confusion; decreased coordination; fast or irregular heartbeat; gum disease or overgrowth; mental or mood changes (eg, depression); mouth sores or swelling; muscle aches, cramps, pain, or weakness; ringing in the ears or hearing loss; seizures; severe or persistent diarrhea; severe or persistent headache or dizziness; shortness of breath; stomach pain; sudden unusual sweating; symptoms of infection (eg, fever, chills, sore throat, severe or persistent cough, increased or painful urination, warm or painful skin); symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite); tremors; unusual bleeding or bruising; unusual lumps; unusual swelling; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes (eg, blindness); vomit that looks like coffee grounds; wheezing; 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 drowsiness, fast or irregular heartbeat, headache, symptoms of kidney problems (eg, change in the amount of urine produced), 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.