Tacrolimus, Oral/Injection

What are other names for this medicine?

Type of medicine: immunosuppressant

Generic and brand names: tacrolimus, injection; tacrolimus, oral; 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. It may be used for 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
• cancer
• diabetes
• heart disease
• high blood pressure
• kidney disease
• liver disease
• hyperkalemia (high potassium levels in the blood)

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.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. 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. Take it 2 times a day, 12 hours apart. If you do not understand how or when to take your medicine, ask your healthcare provider to explain.

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?

Symptoms of an acute overdose have not been reported.

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

If you need emergency care, surgery, 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.

Diabetics: 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; diarrhea; nausea; trouble urinating; fast, slow, pounding, or irregular heartbeat; numbness or tingling in hands or feet; fever, chills, sore throat, seizures, ringing in the ears, yellowing of the skin or eyes, unusual weakness, unusual bleeding or bruising.

Other: Trouble sleeping, constipation, vomiting, itching, rash, abdominal pain, back pain, blurred vision, abnormal dreams, muscle cramps.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as enalapril (Vasotec), lisinopril (Prinivil, Zestril), fosinopril (Monopril), captopril (Capoten), quinapril (Accupril), ramipril (Altace), and benazepril (Lotensin)
• alcohol
• antacids such as Maalox, Mylanta, Tums (take them at least 2 hours before or after this medicine)
• antibiotics such as amikacin (Amikin), gentamicin (Garamycin), streptomycin, clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), tobramycin (Nebcin), rifampin (Rifadin, Rimactane), rifabutin (Mycobutin), and chloramphenicol (Chloromycetin)
• antidepressant medicines such as fluoxetine (Prozac), fluvoxamine (Luvox), and nefazodone
• antifungals such as clotrimazole (Mycelex), fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• anti-HIV medicines such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Fortovase, Invirase)
• antiseizure medicines such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin)
• bromocriptine (Parlodel)
• calcium channel blockers such as diltiazem (Cardizem, Dilacor), nifedipine (Procardia, Adalat), and verapamil (Calan, Isoptin, Verelan)
• cisplatin (Platinol)
• danazol (Danocrine)
• diuretics (water pills) such as amiloride (Midamor), spironolactone (Aldactone), or triamterene (Dyrenium)
• ethinyl estradiol (Estinyl)
• immunosuppressant medicine such as cyclosporine (Sandimmune) and sirolimus (Rapamune)
• medicines to treat stomach acid such as cimetidine (Tagamet), ranitidine (Zantac), nizatidine (Axid), famotidine (Pepcid), omeprazole (Prilosec), esomeprazole (Nexium), pantoprazole (Protonix), and lansoprazole (Prevacid)
• metoclopramide (Reglan)
• potassium supplements such as K-Dur and Klor-Con
• St. John's wort
• vaccines

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

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.

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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.

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