tacrolimus, Prograf

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: tacrolimus

BRAND NAME: Prograf

DRUG CLASS AND MECHANISM: Tacrolimus is a drug that suppresses the immune system and is used to prevent rejection of transplanted organs. Tacrolimus accomplishes its immune-suppressing effect by inhibiting an enzyme (calcineurin) that is crucial for the multiplication of T-cells which are vital to the immune process. The use of oral tacrolimus allows transplantation specialists to reduce the dose of steroids which also are used to prevent rejection. This "steroid-sparing effect" is important because of the many side effects that can occur when larger doses of steroids are used for a long period of time. Tacrolimus was approved by the FDA in April, 1994 for liver transplantation and also has been used in patients for transplantation of the heart, kidney, small bowel, and bone marrow.

GENERIC AVAILABLE: Yes

PRESCRIPTION: Yes

PREPARATIONS: Capsule: 0.5, 1, and 5 mg. Injection: 5 mg/ml

STORAGE: Tacrolimus should be stored at room temperature between 15-30 C (59-F).

PRESCRIBED FOR: Tacrolimus is used for the prevention of rejection of transplanted kidneys, liver, or heart. It can be combined with steroids, azathioprine (Imuran Azasan) or mycophenolate mofetil.

DOSING: Oral tacrolimus is taken twice daily. Starting doses range between 0.075 mg/kg/day to 0.2 mg/kg/day. Doses vary widely and are based on tests that measure the amount of tacrolimus in the blood. Taking tacrolimus with food can reduce some of the abdominal pain that can occur with this medicine; however, food can reduce the amount of tacrolimus that is absorbed. This is especially true with fatty foods. Capsules should be taken consistently with or without food in order to avoid major swings in blood levels. Grapefruit juice increases blood levels of tacrolimus and should be avoided. The injection is only used for patients who cannot tolerate tacrolimus capsules.

DRUG INTERACTIONS: The destruction of tacrolimus by the body may be inhibited by a large number of drugs, resulting in higher blood levels of tacrolimus and possibly increasing its side effects. Such drugs include lansoprazole (Prevacid), omeprazole (Prilosec), protease inhibitors (for example, nelfinavir [Viracept] and ritonavir [Norvir]), bromocriptine (Parlodel), cimetidine (Tagamet), cisapride (Propulsid), clarithromycin (Biaxin), cyclosporine (Sandimmune; Neoral), danazol (Danocrine), diltiazem (Cardizem, Tiazac), erythromycin, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), metoclopramide (Reglan), methylprednisolone (Medrol), nicardipine (Cardene), troleandomycin (Tao), and verapamil (Calan, Isoptin, Verelan, Covera-HS). Grapefruit juice has a similar effect on tacrolimus and should be avoided.

Other drugs can stimulate the break-down of tacrolimus, decreasing its blood concentration and possibly reducing its effectiveness. Such drugs include carbamazepine (Tegretol), nifedipine (Procardia; Adalat); phenobarbital, phenytoin (Dilantin), St. John's Wort, rifabutin, and rifampin.

Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088. Need help identifying pills and medications? Use the pill identifier tool on RxList.