When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to tacrolimus.

How to Use This Medicine:
Capsule, Long Acting Capsule, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Immediate-release capsule: You may take this medicine with or without food, but take it the same way each time (for example, always with food).
• Extended-release capsule: Take it every morning on an empty stomach at least 1 hour before or 2 hours after breakfast. Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• Extended-release tablet: Take it on an empty stomach at the same time every day, usually in the morning. Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• This medicine is always used together with other medicines. Make sure you understand when to take each medicine during the day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  
  • You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.
  • Astagraf XL™ (extended-release capsule) or Envarsus XR® (extended-release tablet): If you miss a dose and remember within 14 hours, take the missed dose right away. If more than 14 hours have passed since your regular dose time, skip the missed dose. Return to your regular schedule on the next day.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many drugs that can interact with tacrolimus. Make sure your doctor knows about all other medicines you are using.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Do not drink alcohol while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, heart disease, heart rhythm problems, high blood pressure, or any type of infection.
• This medicine may cause the following problems:
  
  • Higher risk of infection
  • Higher risk of cancer, including skin cancer and lymphoma
  • Diabetes
  • High blood pressure, changes in heart rhythm, enlarged heart
  • Nervous system disorder
  • Kidney problems
  • Anemia (low red blood cell counts)
  • High potassium levels in your blood
  • Gastrointestinal perforation (hole in your stomach or bowel)
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful urination, bloody urine
• Confusion, weakness, uneven heartbeat, trouble breathing, numbness in your hands, feet, or lips
• Dizziness, lightheadedness, fainting
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Headache, vision changes, tremors, seizures, tingling or numbness
• Increased thirst or hunger
• Rapid weight gain, swelling in your hands, ankles, or feet
• Skin changes or growths
• Swollen glands in your armpits or groin
• Unusual bleeding, bruising, or weakness
• Weakness on one side, confusion, clumsiness, trouble thinking clearly

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, nausea, vomiting
• Joint pain or back pain
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088