Tacrolimus extended-release capsules

Pronunciation

Generic Name: tacrolimus (ta-KROE-li-mus)
Brand Name: Astagraf XL

Tacrolimus extended-release capsules decreases the action of the immune system. This may increase your risk of infection. It may also increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Tell your doctor right away if you notice signs of infection (eg, fever; chills; persistent cough or sore throat; or warm, red, or painful skin) or any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness.

An increased number of deaths in female patients was observed in a study of patients receiving tacrolimus extended-release capsules after a liver transplant. Use of tacrolimus extended-release capsules following a liver transplant is not recommended.


Tacrolimus extended-release capsules is used for:

Preventing organ rejection in certain patients following a kidney transplant. It may be used along with other medicines. It may also be used for other conditions as determined by your doctor.

Tacrolimus extended-release capsules is an immunosuppressant. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.

Do NOT use tacrolimus extended-release capsules if:

  • you are allergic to any ingredient in tacrolimus extended-release capsules
  • you have had a liver transplant
  • you are taking asenapine, cisapride, citalopram, cyclosporine, dalfopristin, a potassium-sparing diuretic (eg, spironolactone), mifepristone, quinupristin, sirolimus, tofacitinib, or ziprasidone

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using tacrolimus extended-release capsules:

Some medical conditions may interact with tacrolimus extended-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have any type of infection or a history of chronic (long-term) infection
  • if you have diabetes or high blood sugar, high blood potassium levels, high blood pressure, or a weakened immune system
  • if you have a history of a certain type of anemia (pure red cell aplasia [PRCA]); heart, kidney, or liver problems; or skin cancer; or if a member of your family has had skin cancer
  • if you have recently received or will be receiving a live vaccine (eg, measles, mumps), or if you will be in close contact with anyone who has received a live vaccine
  • if you are taking other medicines to suppress your immune system
  • if you are taking a medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation) or kidney problems. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat or kidney problems

Some MEDICINES MAY INTERACT with tacrolimus extended-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for birth control, cancer, infections, inflammation, aches and pains, heartburn or reflux, hepatitis, high blood pressure, high cholesterol, HIV infection, hormone replacement therapy, Huntington disease, immune system suppression, irregular heartbeat or other heart problems, mental or mood problems, nausea and vomiting, pain, Parkinson disease, seizures, stomach or bowel problems, ulcers), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with tacrolimus extended-release capsules. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with tacrolimus extended-release capsules.

This may not be a complete list of all interactions that may occur. Ask your health care provider if tacrolimus extended-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use tacrolimus extended-release capsules:

Use tacrolimus extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Tacrolimus extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get tacrolimus extended-release capsules refilled.
  • Take tacrolimus extended-release capsules by mouth at the same time each morning on an empty stomach at least 1 hour before or 2 hours after a meal.
  • Swallow tacrolimus extended-release capsules whole. Do not break, crush, chew, or dissolve before swallowing. If you cannot swallow tacrolimus extended-release capsules whole, tell your doctor.
  • Do not eat grapefruit or drink grapefruit juice while taking tacrolimus extended-release capsules.
  • Tacrolimus extended-release capsules works best if it is taken at the same time each day.
  • Continue to take tacrolimus extended-release capsules even if you feel well. Do not miss any doses.
  • If you miss a dose of tacrolimus extended-release capsules, take it as soon as possible. If it is more than 14 hours after you normally take your dose, skip the missed dose and go back to your regular dosing schedule the next morning. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use tacrolimus extended-release capsules.

Important safety information:

  • Tacrolimus extended-release capsules may cause drowsiness and dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use tacrolimus extended-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT stop taking tacrolimus extended-release capsules or change your dose without checking with your doctor.
  • Tacrolimus extended-release capsules comes in different forms (eg, extended-release, immediate-release). Do not switch between different forms of tacrolimus extended-release capsules unless your doctor tells you to. Talk with your doctor if you have any questions.
  • Tacrolimus extended-release capsules may increase your risk of developing skin cancer or certain other types of cancer (eg, lymphoma). To decrease your risk of skin cancer, avoid using sunlamps or tanning booths. Limit your exposure to the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Tell your doctor right away if you notice a change in the appearance or size of a mole, unusual itching, fever, night sweats, unexplained weight loss, swollen lymph nodes, or unusual skin growths or lumps.
  • Tell your doctor or dentist that you take tacrolimus extended-release capsules before you receive any medical or dental care, emergency care, or surgery.
  • Do not drink alcohol when you take tacrolimus extended-release capsules. Alcohol may increase the chance of serious side effects.
  • Check with your doctor before you use a salt substitute or a product that has potassium in it.
  • Tacrolimus extended-release capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever; sweats or chills; severe or persistent sore throat; cough or flu-like symptoms; muscle aches; or warm, red, or painful areas on your skin.
  • Tacrolimus extended-release capsules may increase the risk of severe and sometimes fatal viral infections (eg, JC virus or BK virus infection). JC virus infection may lead to a serious effect called progressive multifocal leukoencephalopathy (PML). BK virus may cause kidney problems or loss of a transplanted kidney in kidney transplant patients. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine).
  • Some patients treated with tacrolimus extended-release capsules have developed a type of anemia called PRCA. Contact your doctor right away if you experience severe or persistent tiredness or weakness, sluggishness, or unusually pale skin. Discuss any questions or concerns with your doctor.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking tacrolimus extended-release capsules. Talk with your doctor before you receive any vaccine.
  • Patients who take tacrolimus extended-release capsules after an organ transplant may have an increased risk of developing high blood sugar or diabetes. The risk is higher among black and Hispanic patients after a kidney transplant. High blood sugar may make you feel confused, drowsy, hungry, or thirsty. It can also make you flush, breathe faster, urinate more often, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including blood potassium or glucose levels; blood levels of tacrolimus extended-release capsules; heart or kidney function; and blood pressure may be performed while you take tacrolimus extended-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Caution is advised when using tacrolimus extended-release capsules in CHILDREN; they may be more sensitive to its effects.
  • Tacrolimus extended-release capsules should be used with extreme caution in CHILDREN younger than 16 years old who have had a kidney transplant; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Tacrolimus extended-release capsules has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking tacrolimus extended-release capsules while you are pregnant. Tacrolimus extended-release capsules is found in breast milk. Do not breast-feed while taking tacrolimus extended-release capsules.

Possible side effects of tacrolimus extended-release capsules:

All medicines cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; headache; nausea; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; burning, numbness, or tingling; chest pain; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, agitation, anxiety, depression); muscle cramps, pain, or weakness; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, light-headedness, or headache; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; sluggishness; swelling of the hands, ankles, feet, or legs; tremor; trouble speaking; unusual bruising or bleeding; unusual or persistent weakness or tiredness; unusually pale skin; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of tacrolimus extended-release capsules:

Store tacrolimus extended-release capsules between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tacrolimus extended-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about tacrolimus extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Tacrolimus extended-release capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take tacrolimus extended-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 tacrolimus extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tacrolimus extended-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using tacrolimus extended-release capsules.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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