What Is ASTAGRAF XL® (tacrolimus extended-release capsules)?

ASTAGRAF XL is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant. ASTAGRAF XL is an extended-release capsule and is not the same as tacrolimus immediate-release capsules, tacrolimus for oral suspension or tacrolimus extended-release tablets. Your healthcare provider should decide what medicine is right for you.

ASTAGRAF XL comes in extended-release capsules of three different strengths (0.5 mg, 1 mg, 5 mg) and isn’t the same as tacrolimus immediate release capsules. Your healthcare provider should decide what medicine is right for you.


Learn more about ASTAGRAF XL.

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IMPORTANT SAFETY INFORMATION

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

PROGRAF can cause serious side effects, including:

  1. Increased risk of cancer. People who take PROGRAF have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
  2. Increased risk of infection. PROGRAF is a medicine that affects your immune system. PROGRAF can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving PROGRAF that can cause death. Call your healthcare provider right away if you have any symptoms of an infection, including:
  • Fever
  • sweats or chills
  • cough or flu-like symptoms
  • muscle aches
  • warm, red, or painful areas on your skin

Do not take PROGRAF if you are allergic to tacrolimus or any of the ingredients in PROGRAF.

What should I tell my healthcare provider before taking PROGRAF?
Before you take PROGRAF, tell your healthcare provider about all of your medical conditions, including if you:

  • plan to receive any live vaccines (people taking PROGRAF should not receive live vaccines)
  • have or have had liver, kidney or heart problems
  • are pregnant or plan to become pregnant. PROGRAF can harm your unborn baby.
    • If you are able to become pregnant, you should use effective birth control before and during treatment with PROGRAF. Talk to your healthcare provider before starting treatment with PROGRAF about birth control methods that may be right for you.
    • Males who have female partners who are able to become pregnant should also use effective birth control before and during treatment with PROGRAF. Talk to your healthcare provider before starting treatment with PROGRAF about birth control methods that may be right for you.
  • are breastfeeding or plan to breastfeed. PROGRAF passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking PROGRAF.

Tell your healthcare provider about all the medicines you take, and when you start a new medicine or stop taking a medicine, including prescription and over-the-counter medicines; vitamins; natural, herbal or nutritional supplements. Especially tell your healthcare provider if you take:

  • sirolimus (RAPAMUNE®)
  • cyclosporine (GENGRAF®, NEORAL®, and SANDIMMUNE®)
  • medicines called aminoglycosides that are used to treat bacterial infections
  • ganciclovir (CYTOVENE® IV, VALCYTE®)
  • amphotericin B (ABELCET®, AMBISOME®)
  • cisplatin
  • antiviral medicines called nucleoside reverse transcriptase inhibitors
  • antiviral medicines called protease inhibitors
  • water pill (diuretic)
  • medicine to treat high blood pressure
  • nelfinavir (VIRACEPT®)
  • telaprevir (INCIVEK®)
  • boceprevir
  • ritonavir (KALETRA®, NORVIR®, TECHNIVIETM, VIEKIRA PAK®, VIEKIRA XRTM)
  • ketoconazole
  • itraconazole (ONMEL®, SPORANOX®)
  • voriconazole (VFEND®)
  • clarithromycin (BIAXIN®, BIAXIN® XL, PREVPAC®)
  • rifampin (RIFADIN®, RIFAMATE®, RIFATER®, RIMACTANE®)
  • rifabutin (MYCOBUTIN®)
  • amiodarone (NEXTERONE®, PACERONE®)

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. PROGRAF may affect the way other medicines work, and other medicines may affect how PROGRAF works. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.


How Should I Take PROGRAF?

  • Do not eat grapefruit or drink grapefruit juice while taking PROGRAF.
  • Take PROGRAF exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your PROGRAF dose if needed. Do not stop taking or change your dose of PROGRAF without talking to your healthcare provider.
  • Take PROGRAF with or without food, the same way every day. For example, if you choose to take PROGRAF with food, you should always take PROGRAF with food.
  • Take PROGRAF at the same time each day, 12 hours apart. For example, if you take your first dose at 7:00 a.m., you should take your second dose at 7:00 p.m. Taking PROGRAF at the same time each day helps to keep the amount of medicine in your body at a steady level.
  • If you take too much PROGRAF, call your healthcare provider or go to the nearest hospital emergency room right away.

PROGRAF capsules:

  • Do not open or crush PROGRAF capsules.

PROGRAF Granules:

  • Children who have trouble swallowing capsules can be given PROGRAF Granules.
  • Give the dose of PROGRAF Granules right after preparing. Do not save prepared PROGRAF Granules as a liquid to take at a later time.
  • See the Instructions for Use at the end of the Patient Information for detailed instructions about how to mix and give PROGRAF Granules as a liquid.
  • If you get the granules, or prepared oral suspension on your skin, wash the area well with soap and water.
  • If you get the granules, or prepared oral suspension in your eyes, rinse with plain water.

What should I avoid while taking PROGRAF?

  • While you take PROGRAF you should not receive any live vaccines.
  • Limit the amount of time you spend in sunlight and avoid exposure to ultraviolet (UV) light, such as tanning machines. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF).

PROGRAF may cause serious side effects, including:

  • problems from medicine errors. People who take PROGRAF have sometimes been given the wrong type of tacrolimus product. Tacrolimus extended-release medicines are not the same as PROGRAF capsules or granules and cannot be substituted for each other, unless specifically prescribed by your healthcare provider, who will send you to get blood tacrolimus levels at a lab. Check your PROGRAF when you get a new prescription and before you take it to make sure you have received PROGRAF capsules or PROGRAF Granules. Check with the pharmacist and call your healthcare provider if you think you were given the wrong medicine.
  • high blood sugar (diabetes). Your healthcare provider may do blood tests to check for diabetes. Call your healthcare provider right away if you have any symptoms of high blood sugar, including:
    • frequent urination
    • increased thirst or hunger
    • blurred vision
    • confusion
    • drowsiness
    • loss of appetite
    • fruity smell on your breath
    • nausea, vomiting, or stomach pain
  • kidney problems. Kidney problems are a serious and common side effect of PROGRAF. Your healthcare provider may do blood tests to check your kidney function.
  • nervous system problems. Nervous system problems are a serious and common side effect of PROGRAF. Call your healthcare provider right away if you get any of these symptoms that could be signs of a serious nervous system problem:
    • headache
    • confusion
    • seizures
    • changes in your vision
    • changes in behavior
    • coma
    • tremors
    • numbness and tingling
  • high levels of potassium in your blood. Your healthcare provider may do blood tests to check your potassium level.
  • high blood pressure. High blood pressure is a serious and common side effect of PROGRAF. Your healthcare provider will monitor your blood pressure and may prescribe blood pressure medicine for you, if needed. Your healthcare provider may instruct you to check your blood pressure at home.
  • changes in the electrical activity of your heart (QT prolongation).
  • heart problems (myocardial hypertrophy). Tell your healthcare provider right away if you get any of these symptoms of heart problems:
    • shortness of breath
    • chest pain
    • feel lightheaded
    • feel faint
  • severe low red blood cell count (anemia).

The most common side effects of PROGRAF in people who have received a kidney, liver or heart transplant are:

  • infections in general, including cytomegalovirus (CMV) infection
  • tremors (shaking of the body)
  • constipation
  • diarrhea
  • headache
  • stomach pain
  • trouble sleeping
  • nausea
  • high blood sugar (diabetes)
  • low levels of magnesium in your blood
  • low levels of phosphate in your blood
  • swelling of the hands, legs, ankles, or feet
  • weakness
  • pain
  • high levels of fat in your blood
  • high levels of potassium in your blood
  • low red blood cell count (anemia)
  • low white blood cell count
  • fever
  • numbness or tingling in your hands and feet
  • inflammation of your airway (bronchitis)
  • fluid around your heart

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of PROGRAF. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.


General information about the safe and effective use of PROGRAF.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PROGRAF for a condition for which it was not prescribed. Do not give PROGRAF to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about PROGRAF that is written for health professionals.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the Patient Information and full Prescribing Information, including Boxed Warning for PROGRAF.

Expand to read in Full

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ASTAGRAF XL?
ASTAGRAF XL can cause serious side effects, including:

  • Increased risk of cancer. People who take ASTAGRAF XL have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
  • Increased risk of infection. ASTAGRAF XL is a medicine that affects your immune system. ASTAGRAF XL can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ASTAGRAF XL that can cause death. Call your healthcare provider right away if you have symptoms of an infection such as:
    • fever
    • sweats or chills
    • cough or flu-like symptoms
    • muscle aches
    • warm, red or painful areas on your skin
  • Increased risk of death in females who have had a liver transplant. You should not take ASTAGRAF XL if you have had a liver transplant without talking to your healthcare provider.

Who should not take ASTAGRAF XL?
Do not take ASTAGRAF XL if you are allergic to tacrolimus or any of the ingredients in ASTAGRAF XL.


Before you take ASTAGRAF XL tell your healthcare provider if you:

  • plan to receive any live vaccines.
  • have or have had liver, kidney or heart problems, or have any other medical conditions.
  • are pregnant or plan to become pregnant. ASTAGRAF XL may harm your unborn baby.
    • If you are able to become pregnant, you should use effective birth control before and during treatment with ASTAGRAF XL. Talk to your healthcare provider before starting treatment with ASTAGRAF XL about birth control methods that may be right for you.
    • Males who have female partners who are able to become pregnant should also use effective birth control before and during treatment with ASTAGRAF XL. Talk to your healthcare provider before starting treatment with ASTAGRAF XL about birth control methods that may be right for you.
  • are breastfeeding or plan to breastfeed. ASTAGRAF XL passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking ASTAGRAF XL.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements. ASTAGRAF XL may affect the way other medicines work, and other medicines may affect how ASTAGRAF XL works.


How should I take ASTAGRAF XL?

  • Take ASTAGRAF XL exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose if needed. Do not stop taking or change your dose of ASTAGRAF XL without talking to your healthcare provider.
  • Take ASTAGRAF XL capsules whole. Do not break, crush, chew or dissolve ASTAGRAF XL capsules before swallowing. If you cannot swallow ASTAGRAF XL capsules whole, tell your healthcare provider.
  • Take ASTAGRAF XL at the same time each morning, preferably on an empty stomach at least one hour before, or at least two hours after, you have eaten a meal.
  • If you miss your dose of ASTAGRAF XL, it should be taken as soon as possible, but no longer than 14 hours after your regularly scheduled time. If it is longer than 14 hours, the missed dose should be skipped and the next dose should be taken the following morning at your regularly scheduled time. Do not take two doses at the same time.
  • If you take too much ASTAGRAF XL, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking ASTAGRAF XL?

  • Live vaccines such as flu vaccine through your nose, measles, mumps, rubella, polio by mouth, TB vaccine, yellow fever, chicken pox or typhoid.
  • Exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.
  • You should not eat grapefruit or drink grapefruit juice while taking ASTAGRAF XL.
  • You should not drink alcohol when taking ASTAGRAF XL.

What are the possible side effects of ASTAGRAF XL?
ASTAGRAF XL may cause serious side effects, including:

  • See "What is the most important information I should know about ASTAGRAF XL?"
  • Problems from medication errors such as graft rejection and other serious reactions. People who take ASTAGRAF XL have sometimes been given the wrong medicine, because some medicines have the same ingredient (tacrolimus) as ASTAGRAF XL. Serious reactions have happened including graft rejection. Check your ASTAGRAF XL when you get a new prescription to make sure you have received the right medicine.
    • Call your healthcare provider right away if you think you were given the wrong medicine
    • Ask your healthcare provider or pharmacist if you are not sure what ASTAGRAF XL should look like.
  • high blood sugar (diabetes). Your healthcare provider may do certain tests to check for diabetes. Call your healthcare provider right away if you have:
    • frequent urination
    • increased thirst or hunger
    • blurred vision
    • confusion
    • drowsiness
    • loss of appetite
    • fruity smell on your breath
    • nausea, vomiting, or stomach pain
  • kidney problems. Kidney problems are serious and common side effects of ASTAGRAF XL. Your healthcare provider may do certain tests to check your kidney function while you take ASTAGRAF XL.
  • nervous system problems. Nervous system problems are a serious and common side effect of ASTAGRAF XL. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms while taking ASTAGRAF XL. These could be signs of serious nervous system problems:
    • confusion
    • changes in alertness
    • muscle tremors
    • numbness and tingling
    • headache
    • seizures
    • vision changes
  • high levels of potassium in your blood. Your healthcare provider may do certain tests to check your potassium level while you take ASTAGRAF XL.
  • high blood pressure. High blood pressure is a serious and common side effect of ASTAGRAF XL. Your healthcare provider will monitor your blood pressure and may ask you to check your blood pressure at home.
  • changes in the electrical activity of your heart (QT prolongation).
  • Severe low blood cell count (anemia).

The most common side effects of ASTAGRAF XL are diarrhea, constipation, nausea, swelling of the hands, ankles or legs, and tremors (shaking of the body).


These are not all the possible side effects of ASTAGRAF XL. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Please see the accompanying Medication Guide and full Prescribing Information, including Boxed Warning for ASTAGRAF XL.