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ASTAGRAF XL- tacrolimus extended-release capsules capsule, coated, extended release


  1. Patient Information
  2. Advise Patients Or Caregivers To:
  3. Astagraf Xl Can Cause Serious Side Effects, Including:
  4. Call Your Healthcare Provider Right Away If You Have Symptoms Of An Infection Such As:
  5. What Is Astagraf Xl?
  6. Who Should Not Take Astagraf Xl?
  7. Before You Take Astagraf Xl Tell Your Healthcare Provider If You:
  8. How Should I Take Astagraf Xl?
  9. What Should I Avoid While Taking Astagraf Xl?
  10. Astagraf Xl May Cause Serious Side Effects, Including:
  11. Active Ingredient:
  12. The Capsule Contains:
  13. The Capsule Shell Contains:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

17.1 Administration

Advise Patients Or Caregivers To: 

Inspect their ASTAGRAF XL medicine when they receive a new prescription and before taking it. If the appearance of the capsule is not the same as usual, or if dosage instructions have changed, advise patients to contact their healthcare provider as soon as possible to make sure that they have the right medicine. Other tacrolimus products cannot be substituted for 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.

What Is Astagraf Xl? 

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.

Who Should Not Take Astagraf Xl? 

Do nottake 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. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine.
have or have had liver, kidney, or heart problemsorany other medical conditions.
are pregnant or plan to become pregnant. ASTAGRAF XL may harm your unborn baby.
o
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.
o
Males who have female partners that 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.
o
There is a pregnancy registry for females who become pregnant and males who have fathered a pregnancy during treatment with ASTAGRAF XL. The purpose of this registry is to collect information about your health and of your baby. To enroll in this voluntary registry, call 1-877-955-6877 or go tohttps://www.transplantpregnancyregistry.org/
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 notstop 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 1 hour before, or at least 2 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 nottake 2 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, BCG (TB vaccine), yellow fever, chicken pox (varicella) 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.

Astagraf Xl May Cause Serious Side Effects, Including: 

Store ASTAGRAF XL at room temperature between 68 F to 77 F (20 C to 25 C).
Safely throw away medicine that is out of date or no longer needed.
Keep ASTAGRAF XL and all medicines out of reach of children.

General information about the safe and effective use of ASTAGRAF XL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ASTAGRAF XL for a condition for which it was not prescribed. Do not give ASTAGRAF XL to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about ASTAGRAF XL. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about ASTAGRAF XL that is written for health professionals.

Active Ingredient: 

tacrolimus.

The Capsule Contains: 

ethylcellulose NF, hypromellose USP, magnesium stearate NF, and lactose monohydrate NF

The Capsule Shell Contains: 

gelatin NF, titanium dioxide USP, ferric oxide NF, and sodium lauryl sulfate

Manufactured by:Astellas Ireland Co., Limited, Killorglin, County Kerry, Ireland

Marketed by:Astellas Pharma US, Inc., Northbrook, IL 60062

ASTAGRAF XLis a registered trademark of Astellas Pharma Inc.

222293-AST-MG

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: June 2019



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