GENERIC NAME: TACROLIMUS - INJECTION (tack-row-LEE-muss)
BRAND NAME(S): Prograf
WARNING: Tacrolimus lowers the body's ability to fight an infection/disease (immunosuppression). This effect may increase your risk of developing an infection or certain types of cancer (e.g., skin cancer, lymphoma). To reduce the risk of these serious side effects, your doctor will direct you to receive this medication at the lowest effective dose and monitor you closely. Keep all medical and laboratory appointments.
Tell your doctor immediately if you develop any of the following signs: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, swollen glands, night sweats, unexplained weight loss, signs of infection (e.g., fever, persistent sore throat).
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.
PRECAUTIONS: Before receiving tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (such as sirolimus, erythromycin); or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyl 60 hydrogenated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood pressure, diabetes, mineral imbalances (such as high potassium), any recent/current infections, cancer.Tacrolimus may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using tacrolimus, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using tacrolimus safely.This medication may increase your risk of developing skin cancer. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen with a high sun protection factor (SPF) and wear protective clothing when outdoors.Tacrolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).This drug may increase your potassium levels. Before using potassium supplements or salt substitutes containing potassium, consult your doctor or pharmacist.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: cyclosporine, sirolimus, temsirolimus, ziprasidone, other drugs that may increase the level of potassium in the blood (such as "water pills" including amiloride, spironolactone), other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).Many drugs besides tacrolimus may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.Other medications can affect the removal of tacrolimus from your body, which may affect how tacrolimus works. Examples include caspofungin, cimetidine, danazol, bromocriptine, nefazodone, ethinyl estradiol, methylprednisolone, St. John's wort, azole antifungals (such as itraconazole, voriconazole), calcium channel blockers (such as nifedipine, verapamil), proton pump inhibitors (such as omeprazole, lansoprazole), HIV protease inhibitors (such as nelfinavir, ritonavir), other protease inhibitors (such as boceprevir, telaprevir), rifamycins (such as rifampin, rifabutin), certain anti-seizure drugs (such as carbamazepine, phenobarbital, phenytoin), among others.
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OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Laboratory and/or medical tests (e.g., potassium levels, blood sugar, tacrolimus blood level, kidney/liver function) will be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the signs of organ rejection such as tenderness/pain around the transplanted organ, a feeling of being ill, or fever. Tell your doctor immediately if you notice any of these signs.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.
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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.