Tacrolimus-injection

• Prograf^®

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.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Do not switch between different forms of tacrolimus injection without first talking with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Many other drugs affect how much of this medicine is in your body. This may raise the chance of organ rejection or raise the chance of side effects. If you take other drugs, check with your doctor to see if you need to have your blood work checked more closely while taking them with tacrolimus injection.
• High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
• This medicine may raise the chance of high blood sugar (diabetes). The chance may be raised in people who are black or Hispanic. Talk with the doctor.
• Check your blood sugar as you have been told by your doctor.
• Avoid grapefruit and grapefruit juice.
• Avoid drinking alcohol while taking tacrolimus injection.
• If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• There is a chance of skin cancer. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Very bad and sometimes deadly holes in the GI (gastrointestinal) tract have happened with tacrolimus injection. Talk with the doctor.
• A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this medicine. Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
• This medicine may cause a type of abnormal heartbeat (prolonged QT interval). If this happens, the chance of other unsafe and sometimes deadly abnormal heartbeats may be raised. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tacrolimus injection while you are pregnant.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• A heartbeat that does not feel normal.
• Chest pain or pressure.
• Shortness of breath.
• Very bad dizziness or passing out.
• Shakiness.
• Trouble moving around.
• Any unexplained bruising or bleeding.
• Swelling in the arms or legs.
• A burning, numbness, or tingling feeling that is not normal.
• Change in color or size of a mole.
• A skin lump or growth.
• Any skin change.
• Swollen gland.
• Night sweats.
• Weight gain or loss.
• Pale skin.
• Feeling very tired or weak.
• Very bad belly pain.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with tacrolimus injection. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Belly pain or heartburn.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Hard stools (constipation).
• Not hungry.
• Not able to sleep.
• Back pain.
• Joint pain.
• Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• The shot will be given to you in a hospital or doctor's office. You will not store it at home.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take tacrolimus injection or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tacrolimus injection. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017