• Basic Info
• Top Questions
• Clinical Info
• Interactions

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 other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

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What are the possible side effects of tacrolimus?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• pain in the lower back or side;

• urinating less than usual or not at all;

• painful urination, blood in your urine;

• problems with your vision, speech, or coordination;

• tremor (shaking), headache, confusion, numbness or tingly feeling;

• pale skin, easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, flu symptoms;

• muscle weakness, tiredness, fast or pounding heartbeat, mild shortness of breath; or

• increased urination, thirst, or hunger.

Less serious side effects may include:

• swelling in your hands or feet;

• nausea, vomiting, diarrhea, constipation, loss of appetite;

• sleep problems (insomnia); or

• itching skin or mild rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take tacrolimus?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. You may receive an injection of tacrolimus shortly after your transplant. Tacrolimus injection is given around-the-clock until you are ready to take the pill form of tacrolimus. The tacrolimus capsule is usually taken every 12 hours. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

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What is the most important information I should know about tacrolimus?
Taking tacrolimus may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. There are many other medicines that can interact with tacrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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What happens if I miss a dose?
Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect tacrolimus?
Many drugs can interact with tacrolimus. Below is just a partial list. Tell your doctor if you are using: birth control pills or hormone replacement; St John's wort; lansoprazole (Prevacid), omeprazole (Prilosec, Zegrid) rifampin (Rifadin, Rimactane, Rifater) or rifabutin (Mycobutin); a potassium supplement or a diuretic (water pill); a calcium channel blocker such as verapamil (Calan, Verelan), diltiazem (Cardizem, Dilacor XR, Tiazac), nifedipine (Adalat, Procardia), or nicardipine (Cardene);

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Tacrolimus has been assigned to pregnancy category C by the FDA. Some animal studies revealed an increased incidence of abortion, resorption, and malformations. However, maternal toxicity was also present. There are no controlled data in human pregnancy. Tacrolimus has been used successfully during pregnancy in a limited number of cases, although neonatal hyperkalemia and renal dysfunction have been reported. Tacrolimus should only be given during pregnancy when benefit outweighs risk.

Tacrolimus is known to cross the placenta. In one case report, tacrolimus maternal and placental vein plasma concentrations were 0.49 ng/mL and 0.24 ng/mL, respectively, at delivery at 36 weeks gestation. The neonatal tacrolimus plasma concentration was 0.09 ng/mL three days after delivery and was undetectable at one week. The infant was normal at twelve months of age. In a study of 100 pregnancies in 84 mothers, 71 progressed to delivery, (68 live births, 2 neonatal deaths, and 1 stillborn), 24 were terminated (12 spontaneous and 12 induced), 2 pregnancies were ongoing, and 3 were lost to follow-up. The most common complications in the neonates were hypoxia, hyperkalemia, and renal dysfunction. All were transient in nature. Four neonates presented with malformations, without any consistent pattern of affected organs. In a series of nine pregnancies in nine liver transplant patients, tacrolimus was used as the primary immunosuppressive agent throughout gestation. Tacrolimus doses ranged from 4 to 64 mg per day. Corticosteroids were used concomitantly in four cases. Hyperkalemia was present in five of seven neonates for whom potassium levels were available. Potassium levels normalized over 24 to 48 hours after delivery without treatment. One neonate with high tacrolimus cord levels was anuric for 36 hours after delivery. Renal function was normal by one week of age. One infant, delivered at 22 weeks gestation, died two hours after birth. This pregnancy, conceived one month after transplantation, was complicated by cytomegalovirus infection. Eight of the nine infants were alive and developing normally at the time of the report. One woman maintained on tacrolimus gave birth to twins at 32 weeks of gestation. Both babies developed severe respiratory distress requiring ventilator assistance and went on to develop congestive heart failure. One of the twins did not survive. Autopsy revealed a thrombotic cardiomyopathy with degeneration of cardiac muscle. The cardiomyopathy was believed to be caused by the tacrolimus used by the mother.

Limited data from the manufacturer indicate tacrolimus is excreted into human milk. The manufacturer recommends patients avoid nursing during tacrolimus therapy.

A case has been reported of a 32-year-old woman who breast-fed. The highest and mean concentrations of tacrolimus measured in her milk were 0.57 ng/mL and 0.429 ng/mL, respectively. Based on these measurements, her exclusively breast-fed infant would ingest (on average) 0.06 microgram/kg/day, which would correspond to 0.06% of the mother's weight-adjusted dose. Because of the low oral bioavailability of tacrolimus, the maximum amount the baby would receive is 0.02% of the mother's weight adjusted dose. At two and a half months of age, the infant was developing well both physically and neurologically. Another case has been reported of a 29 year old woman who was exclusively breast-feeding her healthy three month old infant while on tacrolimus. The milk-to-blood ratio was 0.23 and average tacrolimus concentrations in milk were 1.8 mcg/L. The baby ingested approximately 0.5% of the weight-adjusted maternal dose. The author's conclusion was that infant exposure to tacrolimus in milk is very low, suggesting that maternal tacrolimus therapy may be compatible with breast-feeding.

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Who should NOT use this medication?

• Known hypersensitivity to tacrolimus or any ingredient in the formulation (e.g., polyoxyl 60 hydrogenated castor oil [HCO-60] in the IV formulation).

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a tacrolimus overdose are unknown.

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What should I discuss with my healthcare provider before taking tacrolimus?
Taking tacrolimus may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk. Do not take tacrolimus if you are also using cyclosporine (Neoral, Sandimmune, Gengraf). Before taking tacrolimus, tell your doctor if you have: an allergy to castor oil; kidney disease; liver disease; or high blood pressure.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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