Tacrolimus (Prograf®)

Synonym

FK506

What Is Tacrolimus?

Tacrolimus (Prograf ®) is an immunosuppressant drug used to prevent and treat organ rejection in children who have had liver transplants. It is used for long-term immunosuppression.

Studies suggest that children generally tolerate tacrolimus well; they are less likely to suffer from hypertension or need steroid or insulin treatments. Graft loss from acute or chronic rejection is extremely rare under tacrolimus.

The use of this potent medication should only be managed by a transplant surgeon familiar with it.

Tacrolimus Uses

Tacrolimus prevents rejection by inhibiting T lymphocyte cells, specific cells of the immune system.

Tacrolimus Dosage

Tacrolimus mediation is taken by mouth or given by injection. The oral medication is available in 1-mg (white) capsules and 5-mg (pink) capsules.

How to Properly Take Tacrolimus

Take tacrolimus on a regular schedule, at the same time each day. Usually tacrolimus is taken twice a day, 12 hours apart, such as at 8 a.m. and 8 p.m. Occasionally it is taken only once a day (usually in the morning and at the same time each day) or as often as three times a day (8 hours apart, such as at 7 a.m., 3 p.m., and 11 p.m.).

Tacrolimus can be taken with or without food.

Check with your transplant coordinator if you want to change the time(s) that your child takes tacrolimus. If you are traveling to a different time zone, contact your coordinator for advice.

Missed Doses

If your child misses a dose of tacrolimus, call your coordinator for advice. If fewer than three hours have passed since the dose was missed, your coordinator may tell you to give the missed dose and get back on schedule. If more than three hours have passed since the missed dose, the coordinator may advise you otherwise. Taking doses too close to each other may produce toxic effects.

If your child misses several doses of tacrolimus due to vomiting, surgery, inability to swallow, or other reasons, he or she can receive the medication intravenously. Tell your transplant coordinator if your child is having trouble taking this medicine.

Tacrolimus Side Effects

Common side effects of tacrolimus include:

• Increased risk of infection.
• Burning or tingling of the mouth, hands, or feet. This is more likely to occur with high doses; the symptoms should improve as the dose is reduced.
• Insomnia (difficulty sleeping). Your child’s sleep patterns will probably improve as the dose is reduced.
• Headaches. If your child’s dose is increased to treat rejection, he or she may experience headaches. Contact your coordinator for any undiagnosed headache that lasts more than 24 hours or is accompanied by a fever or a stiff neck.
• Hyperglycemia (high blood sugar). Your child’s blood sugar (glucose) will be checked as part of regular laboratory studies, but you should be aware of the common signs of high blood sugar: thirst, excessive urination, and fatigue. Report symptoms of high blood sugar to your coordinator or doctor immediately. Some patients require oral medication or insulin injections for a time, to control their glucose. In addition, a nutritionist is available to talk with you about changing your child’s diet in ways that will benefit his or her blood sugar level.
• Hypertension (high blood pressure). Ask your coordinator if he or she recommends that you get a blood pressure cuff to monitor your child’s blood pressure.
• Nausea and vomiting. Report unexplained nausea and vomiting that lasts more than 24 hours.
• Increased blood potassium level. This may require restricting the amount of potassium in your diet and/or using medication to lower your potassium level.
• Decreased magnesium. Your child may need to take a magnesium supplement.
• Increased risk of cancer. Because patients who are immunosuppressed have a greater than average risk of getting skin cancer, avoid excessive sunlight. When playing outside, make sure your child uses a sunscreen with a sun protection factor (SPF) of at least 15. A hat provides additional protection. Report any new skin growths or changes in a mole to your coordinator, and see your child’s doctor or dermatologist to have the growth examined. You should be checked yearly for skin growths.
• Growths. Sometimes, the immunosuppressants that protect your child’s new organ can allow other growths to develop. These growths can be internal or external, such as swollen glands in the neck, armpit, tonsil area, or groin. Do not assume that a swollen gland is normal or a sign of infection. Any swelling should be reported to your coordinator immediately. You may be asked to return to the medical center for evaluation of a growth or swelling. A biopsy is necessary to determine if a swelling is a swollen lymph gland or is due to posttransplant lymphoproliferative disorder (PTLD). If not diagnosed and treated quickly, PTLD can progress from a benign, noncancerous swelling to a malignant, cancerous lesion. Only a transplant expert should manage PTLD.

Other common side effects include:

• Tremors
• Diarrhea
• Loss of appetite
• Hair loss
• Insomnia
• Burning or tingling of the hands or feet

Rare side effects include:

• Skin rash
• Vomiting
• Dizziness
• Anxiety
• Fever
• Chills
• Weakness
• Vision changes
• Chest pain
• Bruising or bleeding swelling of the feet or ankles
• Breathing trouble
• Constant hunger or thirst

If any of these side effects continues or becomes bothersome, inform your doctor immediately.

Tacrolimus Drug Interactions

Magnesium oxide, sodium bicarbonate, Sucralfate, or other antacids should not be taken within two hours of taking tacrolimus. For example, if your child takes tacrolimus at 8:00 a.m., magnesium oxide should not be given until 10:00 a.m. or later.

Many medications may affect tacrolimus absorption. For this reason, it is extremely important that you notify your coordinator of any medication changes. If your child needs to take a medication that may affect tacrolimus absorption or metabolism, your transplant surgeon may recommend that the tacrolimus dose be changed. Also, the surgeon may order more frequent blood tests to monitor tacrolimus levels.

Be sure to tell your doctor or pharmacist about any prescription or over- the-counter medication your child is taking, so you can be warned of interactions and prevent them.

Tacrolimus Storage

Store tacrolimus at room temperature.

Precautions for Children

Your child should receive tacrolimus exactly as prescribed, at the same times each day. Never stop this medication unless a transplant surgeon or your transplant coordinator advises you to do so.

One exception is the morning of a scheduled clinic visit. At this time, your child should not take the morning dose of tacrolimus. Bring a dose to the clinic with you, and your child can take his or her medication after blood is drawn.

We recommend that patients wear a medical alert bracelet or pendant (such jewelry marked under the name Medic Alert) that says "taking immunosuppressant".

Tacrolimus Availability

Not all pharmacies stock tacrolimus. Call your pharmacist at least five working days before you need to fill a prescription, to make sure the medication will be available.

Tacrolimus can be obtained through Falk Pharmacy, Monday through Friday, 9:00 a.m. to 5:00 p.m.

Learn more about other Intestine Transplant Drugs.