Tacrolimus, Oral/Injection

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth, along with other medicines, to prevent rejection of transplanted kidneys. Take all medicines exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• You may develop diabetes when you take this medicine. If you already have diabetes, it may get worse. This medicine may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: immunosuppressant

Generic and brand names: tacrolimus, injection; tacrolimus, oral; Astragraf XL; Hecoria; Prograf

What is this medicine used for?

This medicine is taken by mouth or given by IV infusion (slow drip through a needle into your vein) to keep your body from rejecting a new organ after a transplant.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to castor oil
• Diabetes
• Heart disease
• High blood pressure
• High levels of potassium in the blood
• Kidney or liver disease. You should not take this medicine if you have had a liver transplant.
• Long QT syndrome (problems with electrical activity in the heart muscle)

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This is a very strong medicine. Only healthcare providers experienced with this drug should prescribe it. While taking this medicine, you need to be monitored closely.

At first you may receive this medicine through an IV, and later you may take it by mouth (in the form of capsules). The infusions are given by your healthcare provider.

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill. Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval.

This medicine is available as immediate release or as extended-release capsules. Do NOT switch from one kind to the other without your healthcare provider’s approval. Talk with your provider or pharmacist about this.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Whether you take this medicine with or without food, it is important to take it the same way every day. For example, if you take the medicine with food, you should always take it with food. If you have the extended release capsules, do not break, crush, or chew them. Swallow them whole.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: trembling, trouble urinating, dizziness, problems with balance, headache, confusion, sudden swelling.

What should I watch out for?

You will need to have regular tests to find out how this medicine affects you. Keep all appointments for these tests.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

This medicine may cause lymphoma or abnormal growths on your skin. Ask your healthcare provider what to look for, and report any growths right away.

Do not drink alcohol while receiving this medicine. It may increase the risk of serious side effects.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may lead to diabetes in some people. Notify your healthcare provider if you develop increased thirst or hunger or need to urinate more often.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe headache; trembling; trouble urinating; fast, slow, pounding, or irregular heartbeat; numbness or tingling in hands or feet; fever; chills; sore throat; confusion; seizures; ringing in the ears; yellowing of the skin or eyes; unusual weakness; unusual bruising or bleeding; unexplained or sudden swelling; loss of hearing; increased thirst; increased urination; muscle or joint pain.

Other: Trouble sleeping, constipation, diarrhea, nausea, vomiting, itching, stomach pain, back pain, blurred vision, abnormal dreams, headache.

What products might interact with this medicine?

Be sure to check with your healthcare provider or pharmacist before starting or stopping any other medicine. When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Also, using these medicines together might cause harmful side effects.

Caution: This medicine may interact with MANY other medicines and vaccines. It is extremely important that you tell the healthcare provider who prescribed this medicine about any other medicines you are taking.

This medicine can also interact with natural remedies, such as St. John's wort and schisandra. Do not take any other medicines, including nonprescription products, herbs, or supplements, unless your healthcare provider approves them.

The effects of this medicine may be dangerously increased if you drink grapefruit juice or eat grapefruit. Talk with your healthcare provider about this.

Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.