Generic Name: Tacrolimus Extended-Release Capsules (ta KROE li mus)
Brand Name: Astagraf XL
- This medicine may raise the chance of getting cancer like lymphoma or skin cancer. Talk with the doctor.
- This medicine may raise the chance of very bad and sometimes deadly infections. Talk with the doctor.
- In one study of patients who used Astagraf XL (tacrolimus extended-release capsules) after a liver transplant, a larger number of deaths happened in women. This medicine is not for use after a liver transplant.
Uses of Astagraf XL:
- It is used to keep the body from harming the organ after an organ transplant.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Astagraf XL?
- If you have an allergy to tacrolimus or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have a long QT on ECG.
- If you are taking any of these drugs: Cyclosporine or sirolimus.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with Astagraf XL.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Astagraf XL?
- Tell all of your health care providers that you take Astagraf XL. 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.
- Check your drug when you get a new prescription to make sure you have the right drug. Call your doctor right away if you think you were given the wrong drug or if you are not sure what your drug should look like.
- Do not switch between different forms of this medicine 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 Astagraf XL 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 this medicine.
- High blood pressure has happened with Astagraf XL. 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 this medicine.
- 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 Astagraf XL 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 this medicine. Talk with the doctor.
- A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with Astagraf XL. 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 this medicine while you are pregnant.
How is this medicine (Astagraf XL) best taken?
Use Astagraf XL (tacrolimus extended-release capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
- To gain the most benefit, do not miss doses.
- Take Astagraf XL at the same time of day.
- Take in the morning on an empty stomach. Take at least 1 hour before or at least 2 hours after breakfast.
- Swallow whole with a drink of water.
- Do not chew, break, or crush.
- If you have trouble swallowing, talk with your doctor.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it has been 14 hours or more since the missed dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
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.
- 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 this medicine. 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.
What are some other side effects of Astagraf XL?
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:
- 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.
If OVERDOSE is suspected:
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.
How do I store and/or throw out Astagraf XL?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- 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.
Consumer Information Use and Disclaimer
- 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.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Astagraf XL is refilled. If you have any questions about this medicine, please talk with the doctor, 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 Astagraf XL 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 Astagraf XL. 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: November 1, 2017
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