tacrolimus (oral and injection)

Pronunciation: ta KROE li mus

Brand: Astagraf XL, Envarsus XR, Prograf

Tacrolimus

slide 1 of 11, Tacrolimus,

0.5 mg, capsule, gray/orange, imprinted with MYLAN 2045

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Tacrolimus

slide 2 of 11, Tacrolimus,

1 mg, capsule, blue/gray, imprinted with MYLAN 2046

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Tacrolimus

slide 3 of 11, Tacrolimus,

5 mg, capsule, gray/red, imprinted with MYLAN 2047

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Prograf

slide 4 of 11, Prograf,

0.5 mg, capsule, yellow, imprinted with 0.5mg, LOGO 607

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Prograf

slide 5 of 11, Prograf,

1 mg, capsule, white, imprinted with 1 mg, f 617

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Prograf

slide 6 of 11, Prograf,

5 mg, capsule, red, imprinted with 5mg, LOGO 657

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Tacrolimus

slide 7 of 11, Tacrolimus,

0.5 mg, capsule, yellow, imprinted with TCR, 0.5

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Tacrolimus

slide 8 of 11, Tacrolimus,

1 mg, capsule, white, imprinted with TCR, 1

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Tacrolimus

slide 9 of 11, Tacrolimus,

5 mg, capsule, pink, imprinted with TCR, 5

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Tacrolimus

slide 10 of 11, Tacrolimus,

1 mg, oblong, blue/gray, imprinted with MYLAN 2046

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Prograf

slide 11 of 11, Prograf,

1 mg, capsule, white, imprinted with 1 mg, 617

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What is the most important information I should know about tacrolimus?

Tacrolimus may increase your risk of developing a serious infection, lymphoma, or other cancers. Talk with your doctor about the risks and benefits of using this medicine.

Call your doctor right away if you have any signs of infection such as fever, chills, flu symptoms, cough, skin sores, or muscle aches.

What is tacrolimus?

Tacrolimus weakens your body's immune system, to help keep it from "rejecting" a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Tacrolimus is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

Tacrolimus may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking tacrolimus?

You should not use this medicine if you are allergic to tacrolimus or hydrogenated castor oil, or if you have used cyclosporine (Neoral, Sandimmune, Gengraf) within the past 24 hours.

Using tacrolimus may increase your risk of developing serious infections or certain types of cancer, such as lymphoma or skin cancer. Your risk may be higher if you are treated over long periods of time with drugs that weaken the immune system. Ask your doctor about this risk and about symptoms to watch for.

Some people taking tacrolimus after a kidney transplant have developed diabetes. This effect has been seen most commonly in people who are Hispanic or African-American.

Tell your doctor if you have ever had:

  • kidney or liver disease;
  • heart problems; or
  • long QT syndrome (in you or a family member).

Both men and women using this medicine should use effective birth control to prevent pregnancy. Tacrolimus can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tacrolimus on the baby.

You should not breast-feed while you are using tacrolimus.

How should I take tacrolimus?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may receive an injection of tacrolimus shortly after your transplant. Tacrolimus injection is given until you are ready to take the pill form of tacrolimus.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Take this medicine at the same time each day, with a full glass of water. Swallow the capsule whole and do not crush, chew, break, or open it.

Take Astragraf XL or Envarsus XR in the morning on an empty stomach, at least 1 hour before or 2 hours after a meal.

You may take Prograf with or without food, but take it the same way each time.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. All forms of tacrolimus are not equivalent and may not have the same dose or schedule. Avoid medication errors by using only the form and strength your doctor prescribes.

You will need frequent medical tests, and your blood pressure will need to be checked often.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

For Prograf: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.

For Astragraf XL: Take the medicine as soon as you can, but skip the missed dose if you are more than 14 hours late for the dose.

For Envarsus XR: Take the medicine as soon as you can, but skip the missed dose if you are more than 15 hours late for the dose.

Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tacrolimus?

Do not receive a "live" vaccine while using tacrolimus, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Grapefruit may interact with tacrolimus and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid drinking alcohol.

Tacrolimus could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of tacrolimus?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Stop taking tacrolimus and call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, cough, sweating, painful skin sores, skin warmth or redness, or muscle aches.

Also call your doctor at once if you have:

  • general ill feeling, pain or swelling near your transplanted organ;
  • confusion, change in mental status, vision changes, seizure (convulsions);
  • numbness or tingly feeling;
  • little or no urination, swelling in your feet or ankles;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • high blood pressure --severe headache, pounding in your neck or ears;
  • high blood sugar --increased thirst, increased urination, hunger, fruity breath odor, nausea, loss of appetite, drowsiness, confusion;
  • high potassium level --nausea, weakness, chest pain, irregular heartbeats, loss of movement;
  • low magnesium or phosphate --bone pain, jerky muscle movements, muscle weakness or limp feeling, slow reflexes;
  • low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

  • infections, anemia, weakness;
  • high blood sugar, low levels of phoshate, potassium, or magnesium;
  • tremors or shaking;
  • nausea, diarrhea, constipation, stomach pain;
  • headache, general pain;
  • sleep problems (insomnia); or
  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tacrolimus?

Tacrolimus can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, bowel disorders, or pain or arthritis (including aspirin, Tylenol, Advil, and Aleve).

Tell your doctor about all your current medicines. Many drugs can affect tacrolimus, especially:

  • amiodarone;
  • cyclosporine;
  • sirolimus;
  • antibiotic, antifungal, or antiviral medicines; or
  • heart or blood pressure medication, such as a diuretic or "water pill."

This list is not complete and many other drugs may affect tacrolimus. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about tacrolimus.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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tacrolimus (oral and injection)