Tacrolimus Oral capsule

What is this medicine?

TACROLIMUS (ta KROE li mus) is used to decrease the immune system's response to a transplanted organ.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease or heart failure

• high blood pressure

• immune system problems

• infection

• kidney disease

• liver disease

• an unusual or allergic reaction to tacrolimus, lactose, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. If you take the medicine with food, always take it with food. Do not take the medicine with grapefruit juice. Follow the directions on the prescription label. Take your medicine at regular intervals. You must take the medicine at the same time each day. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can, and call your doctor or health care professional. Call your doctor or health care professional if you vomit after a dose.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• astemizole

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cidofovir

• cisapride

• cyclosporine

• dofetilide

• dronedarone

• droperidol

• grepafloxacin

• pimozide

• probucol

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alcohol and medicines that contain alcohol

• amiodarone

• antiviral medicines for HIV or AIDS

• bromocriptine

• certain antibiotics like aminoglycosides, chloramphenicol, clarithromycin, erythromycin, rifabutin, rifampin, troleandomycin

• certain calcium channel blockers like diltiazem, nicardipine, nifedipine, verapamil

• certain medicines for fungal infections like amphotericin B, caspofungin, clotrimazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• certain medicines for stomach problems like antacids, cimetidine, famotidine, lansoprazole, metoclopramide, omeprazole

• certain supplements that contain schisandra sphenanthera extracts

• cisplatin

• danazol

• diuretics

• ethinyl estradiol

• ganciclovir

• grapefruit juice

• nefazodone

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• sirolimus

• St. John's wort

• steroid medicines like prednisone, cortisone, methylprednisone

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need frequent blood checks.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• burning or tingling in the hands or feet

• changes in vision

• chest pain

• confusion

• difficulty breathing, wheezing

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• fever, chills or any other sign of infection

• frequent urination

• increased thirst or hunger

• loss of appetite

• pain or difficulty passing urine

• seizures

• severe headache

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• diarrhea

• nausea

• swelling of the feet or legs, unusual or sudden weight gain

• tremor

• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Tacrolimus Oral capsule, extended-release

What is this medicine?

TACROLIMUS (ta KROE li mus) is used to decrease the immune system's response to a transplanted kidney.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease

• high blood pressure

• immune system problems

• infection

• kidney disease

• liver disease

• an unusual or allergic reaction to tacrolimus, lactose, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water.Take this medicine in the morning on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Do not cut, crush or chew this medicine. Do not take the medicine with alcohol or grapefruit juice. Follow the directions on the prescription label. Take your medicine at regular intervals. You must take the medicine at the same time each day. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 10 hours, then do not take

the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• astemizole

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cidofovir

• cisapride

• cyclosporine

• dofetilide

• dronedarone

• droperidol

• grepafloxacin

• pimozide

• probucol

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alcohol and medicines that contain alcohol

• amiodarone

• antiviral medicines for HIV or AIDS

• bromocriptine

• certain antibiotics like aminoglycosides, chloramphenicol, clarithromycin, erythromycin, rifabutin, rifampin, troleandomycin

• certain calcium channel blockers like diltiazem, nicardipine, nifedipine, verapamil

• certain medicines for fungal infections like amphotericin B, caspofungin, clotrimazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• certain medicines for stomach problems like antacids, cimetidine, famotidine, lansoprazole, metoclopramide, omeprazole

• cisplatin

• danazol

• diuretics

• ethinyl estradiol

• ganciclovir

• grapefruit juice

• nefazodone

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• sirolimus

• St. John's wort

• steroid medicines like prednisone, cortisone, methylprednisone

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need frequent blood checks.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• burning or tingling in the hands or feet

• changes in vision

• confusion

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• fever, chills or any other sign of infection

• frequent urination

• increased thirst or hunger

• loss of appetite

• pain or difficulty passing urine

• seizures

• severe headache

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• diarrhea

• nausea

• swelling of the feet or legs, unusual or sudden weight gain

• tremor

• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Tacrolimus Solution for injection

What is this medicine?

TACROLIMUS (ta KROE li mus) is used to prevent organ rejection after a transplant.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease or heart failure

• high blood pressure

• infection

• kidney disease

• an unusual or allergic reaction to tacrolimus, castor oil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• astemizole

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cidofovir

• cisapride

• cyclosporine

• dofetilide

• dronedarone

• droperidol

• grepafloxacin

• pimozide

• probucol

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alcohol and medicines that contain alcohol

• amiodarone

• antiviral medicines for HIV or AIDS

• bromocriptine

• certain antibiotics like aminoglycosides, chloramphenicol, clarithromycin, erythromycin, rifabutin, rifampin, troleandomycin

• certain calcium channel blockers like diltiazem, nicardipine, nifedipine, verapamil

• certain medicines for fungal infections like amphotericin B, caspofungin, clotrimazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• certain medicines for stomach problems like antacids, cimetidine, famotidine, lansoprazole, metoclopramide, omeprazole

• certain supplements that contain schisandra sphenanthera extracts

• cisplatin

• danazol

• diuretics

• ethinyl estradiol

• ganciclovir

• grapefruit juice

• nefazodone

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• sirolimus

• St. John's wort

• steroid medicines like prednisone or cortisone

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Your blood sugar may increase while you are taking this medicine. Call your doctor or health care professional for advice if you have any of the following symptoms: increased thirst, dry mouth, pass urine frequently, notice a fruity odor on your breath, or feel tired and lose your appetite.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• burning or tingling in the hands or feet

• changes in vision

• chest pain

• fever, chills or any other sign of infection

• increased thirst or hunger

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• swelling of the feet or legs, unusual or sudden weight gain

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• confusion

• constipation

• diarrhea

• difficulty sleeping

• headache

• nausea

• tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Tacrolimus Topical ointment

What is this medicine?

TACROLIMUS (ta KROE li mus) is used on the skin to treat eczema.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cold sores or shingles

• decreased immune function

• Netherton's syndrome

• receiving any form of light therapy (phototherapy, UVA, or UVB) to your skin

• skin infection

• an unusual or allergic reaction to tacrolimus, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Wash your hands before and after use. If treating a hand infection, wash hands before use only. Before applying this medicine, be sure your skin is completely dry. Apply a thin layer to the affected areas. Rub in gently and completely. Do not bathe, shower, or swim right after applying this medicine. This could wash off the ointment. Do not cover with a bandage or dressing unless your doctor or health care professional tells you to. You can wear normal clothing. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Do not use your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

• alcoholic beverages or medicines containing high percentages of alcohol

• calcium channel blockers like diltiazem, nifedipine, nimodipine, nisoldipine

• certain medicines used to treat fungal infections like itraconazole, ketoconazole, and fluconazole

• cimetidine

• erythromycin

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Improvements to your skin may occur after the first few weeks of treatment. Even though your skin looks better, it is important to keep using the ointment as instructed by your health care provider. Tell your health care professional if your condition does not get better within the first few weeks of treatment or if it gets worse.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.While you are using this medicine, drinking alcohol may cause the skin or face to become flushed or red and feel hot. Let your health care provider know if you notice such reactions, especially if they bother you.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• chickenpox infection

• cold sores or shingles

• extreme tiredness

• skin bleeding or change in your skin's appearance (color, change in a mole or freckle, new growth)

• skin infection or infection of hair follicles

• swollen glands

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• increased sensitivity of the skin to hot or cold temperatures

• irritation at the site or sites where you apply this medicine including stinging, soreness, a burning feeling, tingling, or itching

• muscle pains

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.