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tacrolimus - injection, Prograf (cont.)

USES: Tacrolimus is used with other medications to prevent rejection of a kidney, heart, or liver transplant. The injection form of the medication is used when you cannot take the medication by mouth. As soon possible, your doctor will switch you to the form of this medication that is taken by mouth. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used to treat a certain type of bowel condition (severe fulminant Crohn's disease) in patients who have not been successfully treated by the usual treatment. This medication may also be used to prevent rejection of other types of transplant (such as lung).

HOW TO USE: This medication is given by injection into a vein by a health care professional.Dosage is based on your weight, medical condition, blood test results (e.g., tacrolimus trough levels), and response to treatment.Tell your doctor if your condition worsens.

SIDE EFFECTS: See also Warning section.Shaking (tremor), headache, diarrhea, nausea/vomiting, upset stomach, loss of appetite, trouble sleeping, or tingling hands/feet may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: change in the amount of urine, mental/mood changes (e.g., anxiety, agitation), extreme tiredness, swelling ankles/feet, fast/pounding heartbeat, muscle spasm/weakness, hearing problems (e.g., hearing loss, ringing in the ears), pain/redness/swelling at injection site or in the arms/legs, dizziness, easy bruising/bleeding, yellowing skin/eyes, severe stomach/abdominal pain, dark urine, shortness of breath.This medication may also increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur: clumsiness, loss of coordination, weakness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving your muscles, problems with speech, seizure, vision changes.Get medical help right away if any of these rare but very serious side effects occur: fainting, irregular heartbeat, chest pain, black stools, vomit that looks like coffee grounds, trouble breathing.Tacrolimus may cause your blood pressure to increase. You may be required to check your blood pressure periodically and/or take another medication to control your blood pressure.Tacrolimus may cause diabetes. Tell your doctor or pharmacist if you experience any of the following symptoms of high blood sugar: increased thirst/hunger, frequent urination.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.



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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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