tacrolimus

Pronunciation

Generic Name: tacrolimus (oral) (ta KROE li mus)
Brand names: Prograf, Hecoria

What is tacrolimus?

Tacrolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Tacrolimus is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

Tacrolimus may also be used for purposes not listed in this medication guide.

What is the most important information I should know about tacrolimus?

Treatment with tacrolimus may increase your risk of developing certain life-threatening conditions, including serious infections, cancer, or transplant failure. Talk with your doctor about the risks and benefits of using this medication. You will need regular medical tests to be sure this medication is not causing harmful effects. Do not miss any follow up visits to your doctor for blood or urine tests. Avoid being near people who are sick or have infections.

Tacrolimus can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using tacrolimus, tell your doctor about all other medicines you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Some people receiving tacrolimus after a kidney transplant have developed diabetes, most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes.

What should I discuss with my healthcare provider before taking tacrolimus?

You should not use this medication if you are allergic to tacrolimus or hydrogenated castor oil, or if you have used cyclosporine (Neoral, Sandimmune, Gengraf) within the past 24 hours. Tacrolimus can lower blood cells that help your body fight infections, or cause your body to produce too much of a certain type of white blood cells. This can lead to serious and sometimes fatal conditions, including cancer, a severe brain infection that can lead to disability or death, or a virus that can cause failure of a transplanted kidney. Call your doctor right away if you have symptoms of a serious brain infection, such as a change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly. Using tacrolimus may increase your risk of developing skin cancer, especially if you are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your specific risk.

Some people taking tacrolimus after a kidney transplant have developed diabetes. This effect has been seen most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes if you have concerns.

To make sure you can safely take tacrolimus, tell your doctor if you have any of these other conditions:

  • kidney or liver disease;

  • high blood pressure;

  • liver disease;
  • high cholesterol or triglycerides (a type of fat in the blood); or

  • if you are using other drugs that weaken your immune system such as cancer medicine or steroids.

FDA pregnancy category C. It is not known whether tacrolimus will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Tacrolimus can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using tacrolimus.

How should I take tacrolimus?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

You may receive an injection of tacrolimus shortly after your transplant. Tacrolimus injection is given until you are ready to take the pill form of tacrolimus.

The tacrolimus capsule is usually taken every 12 hours. Take the medicine at the same time each day.

You may take tacrolimus with or without food, but take it the same way each time.

You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly. Do not miss any follow up visits to your doctor for blood or urine tests. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tacrolimus?

Grapefruit and grapefruit juice may interact with tacrolimus and lead to potentially dangerous effects. Do not use grapefruit products while you are taking tacrolimus.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid exposure to sunlight or tanning beds. Tacrolimus can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a "live" vaccine while using tacrolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Tacrolimus side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • pain in the lower back or side, blood in your urine, pain or burning when you urinate;

  • urinating less than usual or not at all;

  • dry cough, cough with mucus or blood, sweating, pale skin, shortness of breath, wheezing, gasping for breath, chest pain;

  • tremors (shaking), confusion, changes in your mental state, vision changes, seizure (convulsions);

  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

  • low magnesium (jerky muscle movements, muscle weakness or limp feeling, slow reflexes);

  • high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats); or

  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects may include:

  • nausea, stomach pain, diarrhea, constipation;

  • headache, weakness;

  • sleep problems (insomnia); or

  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Tacrolimus Dosing Information

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

For use in the prophylaxis of allograft rejection in transplant recipients:

Initial Dose: 0.03 to 0.05 mg/kg/day as a continuous IV infusion no sooner than 6 hours after transplantation. Adult patients should receive doses at the lower end of the dosing range.

Doses as high as 0.1 mg/kg/day as a continuous IV infusion may be appropriate.

Continuous IV infusion of tacrolimus injection should be continued only until the patient can tolerate oral administration of the capsules.

Initial Oral Dose for kidney transplant patients: 0.2 mg/kg/day administered every 12 hours in 2 divided doses.

Initial Oral Dose for liver transplant patients: 0.1 to 0.15 mg/kg/day administered every 12 hours in 2 divided doses.

Initial Oral Dose for heart transplant patients: 0.075 mg/kg/day administered every 12 hours in 2 divided doses.

Doses as high as 0.3 mg/kg/day administered every 12 hours in 2 divided doses may be appropriate.

Usual Adult Dose for Graft Versus Host Disease:

Prevention:
Initial dose: 0.03 mg/kg/day (based on lean body weight) as a continuous infusion. Treatment should begin at least 24 hours prior to stem cell infusion and continued only until oral medication can be tolerated.

Treatment:
Initial dose: 0.03 mg/kg/day (based on lean body weight) as a continuous infusion.

Conversion from IV to oral dose (1:4 ratio): Multiply total daily IV dose times 4 and administer in 2 divided oral doses per day, every 12 hours.

Usual Pediatric Dose for Organ Transplant -- Rejection Reversal:

Liver transplant:
Oral: Initial dose: 0.15 to 0.2 mg/kg/day divided every 12 hours
IV: 0.03 to 0.05 mg/kg/day as a continuous infusion
Dose adjustments may be required. Doses as high as 0.15 mg/kg/day IV or 0.3 mg/kg/day orally have been used.

Heart transplant:
Oral: Initial dose: 0.1 to 0.3 mg/kg/day divided every 12 hours
IV: 0.01 to 0.03 mg/kg/day as a continuous infusion

Kidney transplant:
Oral: Initial dose: 0.2 to 0.3 mg/kg/day divided every 12 hours
IV: 0.06 mg/kg/day as a continuous infusion

Usual Pediatric Dose for Graft Versus Host Disease:

Prevention:
Initial dose: 0.03 mg/kg/day (based on lean body weight) as continuous infusion. Treatment should begin at least 24 hours prior to stem cell infusion and continued only until oral medication can be tolerated.
Conversion from IV to oral dose (1:4 ratio): Multiply total daily IV dose times 4 and administer in 2 divided oral doses per day, every 12 hours.

What other drugs will affect tacrolimus?

Tacrolimus can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys, such as: chemotherapy, antiviral medication, pain or arthritis medicine, injected antibiotics, or medicines to treat a bowel disorder or prevent organ transplant rejection. You may need dose adjustments or special tests if you have recently used any of these medications.

Many drugs can interact with tacrolimus. Below is just a partial list. Tell your doctor about all other medicines you use, especially:

  • bromocriptine (Cycloset, Parlodel);

  • danazol (Danocrine);

  • isoniazid (for treating tuberculosis);

  • metoclopramide (Reglan);

  • mycophenolate mofetil (CellCept) or mycophenolic acid (Myfortic);

  • nefazodone;

  • sirolimus (Rapamune);

  • St. John's wort;

  • antacids such as Amphojel, Maalox, Mylanta, Rolaids, Rulox, and others;

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), and others;

  • antifungal medication such as caspofungin (Cancidas), clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend);

  • birth control pills or hormone replacement;

  • heart or blood pressure medicine such as diltiazem (Cartia, Cardizem), verapamil (Calan, Covera, Isoptin, Verelan, Tarka), and others;

  • indinavir (Crixivan), ritonavir (Norvir, Kaletra), or other medicines to treat HIV or AIDS;

  • carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and other seizure medications;

  • steroid medicine such as methylprednisolone (Medrol); or

  • stomach acid reducers such as cimetidine (Tagamet), lansoprazole (Prevacid), or omeprazole (Prilosec, Zegerid).

This list is not complete and there are many other drugs that can interact with tacrolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about tacrolimus.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2011-10-14, 3:00:57 PM.
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