Read this Medication Guide before you start taking tacrolimus extended-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about tacrolimus extended-release capsules, ask your healthcare provider or pharmacist.

• Increased risk of death in females who have had a liver transplant.You should not take tacrolimus extended-release capsules if you have had a liver transplant without talking to your healthcare provider.

What is tacrolimus extended-release capsules?

• Tacrolimus extended-release capsules is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.
• Tacrolimus extended-release capsules 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 tacrolimus extended-release capsules?

• Do nottake tacrolimus extended-release capsules if you are allergic to tacrolimus or any of the ingredients in tacrolimus extended-release capsules. See the end of this leaflet for a complete list of ingredients in tacrolimus extended-release capsules.

What should I tell my healthcare provider before taking tacrolimus extended-release capsules?

Before you take tacrolimus extended-release capsules 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 problems orany other medical conditions.
• are pregnant or plan to become pregnant. Tacrolimus extended-release capsules may harm your unborn baby.

o Males who have female partners that are able to become pregnant should also use effective birth control before and during treatment with tacrolimus extended-release capsules. Talk to your healthcare provider before starting treatment with tacrolimus extended-release capsules 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 tacrolimus extended-release capsules. 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 to https://www.transplantpregnancyregistry.org/.

• are breastfeeding or plan to breastfeed. Tacrolimus extended-release capsules passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking tacrolimus extended-release capsules.

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

Especially tell your healthcare provider if you take:

• sirolimus (RAPAMUNE): You should not take tacrolimus extended-release capsules if you take sirolimus
• 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, TECHNIVIE, VIEKIRA PAK, VIEKIRA XR)
• letermovir (PREVYMIS)
• ketoconazole
• itraconazole (ONMEL, SPORANOX)
• voriconazole (VFEND)
• caspofungin (CANCIDAS)
• clarithromycin (BIAXIN, BIAXIN XL, PREVPAC)
• rifampin (RIFADIN, RIFAMATE, RIFATER, RIMACTANE)
• rifabutin (MYCOBUTIN)
• amiodarone (NEXTERONE, PACERONE)
• cannabidiol (EPIDIOLEX)

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. Tacrolimus extended-release capsules may affect the way other medicines work, and other medicines may affect how tacrolimus extended-release capsules 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 tacrolimus extended-release capsules?

• Take tacrolimus extended-release capsules 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 tacrolimus extended-release capsules without talking to your healthcare provider.
• Take tacrolimus extended-release capsules whole. Do not break, crush, chew, or dissolve tacrolimus extended-release capsules before swallowing. If you cannot swallow tacrolimus extended-release capsules whole, tell your healthcare provider.
• Take tacrolimus extended-release capsules 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 tacrolimus extended-release capsules, 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 tacrolimus extended-release capsules, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking tacrolimus extended-release capsules?

• 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 tacrolimus extended-release capsules.
• You should not drink alcohol when taking tacrolimus extended-release capsules.

• high levels of potassium in your blood.Your healthcare provider may do certain tests to check your potassium level while you take tacrolimus extended-release capsules.
• high blood pressure.High blood pressure is a serious and common side effect of tacrolimus extended-release capsules. Your healthcare provider will monitor your blood pressure while you take tacrolimus extended-release capsules 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).
• blood clotting problems:Tell your healthcare provider right away if you have fever and bruising under the skin that may appear as red dots, with or without unexplained tiredness, confusion, yellowing of the skin or eyes, decreased urination. When taken with sirolimus or everolimus, the risk of developing these symptoms may increase.

The most common side effects of tacrolimus extended-release capsules arediarrhea, constipation, nausea, swelling of the hands, ankles, or legs, and tremors (shaking of the body).

These are not all the possible side effects of tacrolimus extended-release capsules. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store tacrolimus extended-release capsules?

• Store tacrolimus extended-release capsules 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 tacrolimus extended-release capsules and all medicines out of reach of children.

General information about the safe and effective use of tacrolimus extended-release capsules.

• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tacrolimus extended-release capsules for a condition for which it was not prescribed. Do not give tacrolimus extended-release capsules 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 tacrolimus extended-release capsules. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about tacrolimus extended-release capsules that is written for health professionals.