Tacrolimus (Injection)

Introduction

Tacrolimus (ta-KROE-li-mus)

Keeps your body from rejecting an organ transplant such as a kidney, liver, or heart. This medicine is always used together with steroids, azathioprine (Imuran®), or mycophenolate mofetil (Cellcept®).

Brand Name(s)

Prograf

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• You will only receive this medicine for a few days. Then your doctor will switch you to the oral (by mouth) form of tacrolimus.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using cisplatin (Platinol®-AQ), cyclosporine (Gengraf®, Neoral®, or Sandimmune®), or sirolimus (Rapamune®). Tell your doctor if you are also using medicine for high blood pressure (such as candesartan, diltiazem, enalapril, lisinopril, losartan, nicardipine, nifedipine, verapamil, Accupril®, Atacand®, Avapro®, Calan®, Capoten®, Cardene®, Cartia®, Cozaar®, Lotrel®, Procardia®, or Zestril®) or stomach problems (such as antacids, cimetidine, lansoprazole, metoclopramide, omeprazole, Mylanta®, Prevacid®, Prilosec®, Reglan®, or Tagamet®).
• Make sure your doctor knows if you are using bromocriptine (Parlodel®), danazol (Danocrine®), ethinyl estradiol (Estinyl®), methylprednisolone (Medrol®), nefazodone (Serzone®), or St. John's wort. Your doctor should also know if you are using medicines to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Carbatrol®, Dilantin®, or Tegretol®) or diuretics ("water pills") such as spironolactone, triamterene, Aldactone®, Dyazide®, or Dyrenium®.
• Tell your doctor if you are using medicines to treat bacterial infections (such as amikacin, chloramphenicol, clarithromycin, erythromycin, gentamicin, rifabutin, rifampin, streptomycin, troleandomycin, Amikin®, Biaxin®, Ery-Tab®, Garamycin®, Mycobutin®, Rifadin®, or Tao®), virus infections (such as ganciclovir, indinavir, nelfinavir, ritonavir, tenofovir, Cytovene®, Norvir®, Viracept®, or Viread®), or fungus infections (such as amphotericin B, caspofungin, clotrimazole, fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, Amphocin®, Cancidas®, Clotrim®, Diflucan®, Nizoral®, Noxafil®, Sporanox®, or Vfend®).
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, paresthesias (numbness or tingling in the hands, arms, legs, or feet), diabetes, myocardial hypertrophy (the heart is larger than normal), high blood pressure, high potassium in the blood, or any type of infection.
• This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor or nurse right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.
• This medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this.
• This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
• This medicine may increase your risk for developing a rare and serious virus infection with the BK polyoma virus. This virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.
• This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, confusion, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
• This medicine may cause serious nervous system problems. Tell your doctor right away if you have the following symptoms while using this medicine: blurred vision, dizziness, headache, mental changes, seizures, high blood pressure, or a fast heartbeat.
• Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; an irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.
• This medicine may cause a condition called pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Blood in the urine, lower back pain, side pain, or sharp back pain just below the ribs.
• Change in how much or how often you urinate, or painful urination.
• Chest pain, shortness of breath, cold sweat, and bluish-colored skin.
• Confusion, body weakness, uneven heartbeat, or numbness or tingling in your hands, feet, or lips.
• Dark-colored urine or pale stools.
• Dry mouth, muscle cramps, nausea, or vomiting.
• Fast, slow, or pounding heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Gaining weight around your neck, upper back, breast, face, or waist.
• Increased thirst or hunger.
• Lightheadedness, dizziness, or fainting.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Problems with hearing, vision, speech, balance, or walking.
• Rapid weight gain.
• Seeing or hearing things that are not really there.
• Seizures, tremors, or muscle twitching.
• Sudden and severe stomach pain.
• Swelling in your hands, ankles, or feet.
• Trouble breathing or swallowing.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Agitation, depression, nervousness, or mood changes.
• Diarrhea, constipation, loss of appetite, or upset stomach.
• Hair loss, or increased body hair.
• Headache.
• Joint pain or back pain.
• Mild skin rash.
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
• Sores or white patches on your lips, mouth, or throat.
• Trouble sleeping.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088