Drug Notebook

FDA Alerts

Special Alerts:

[Posted 02/22/2007] Roche and FDA notified cardiac transplant healthcare practitioners about a clinical study (Heart Spare The Nephron) that was terminated due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from calcineurin inhibitor and mycophenolate (CellCept) to sirolimus (Rapamune) and mycophenolate at 12 weeks post heart transplantation. The safety and efficacy of mycophenolate in combination with sirolimus following withdrawal of initial calcineurin inhibitor therapy has not been established. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#CellCept and http://www.fda.gov/medwatch/safety/2007/cellcept_DHCPletter_02-01-2007.pdf.

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tacrolimus
(ta CRAL ih mus)

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);

  • antifungal medicines such as ketoconazole (Nizoral), itraconazole (Sporanox), fluconazole (Diflucan), clotrimazole (Mycelex Troche), voriconazole (VFEND);

  • erythromycin (Ery-Tab, E-Mycin, E.E.S.), clarithromycin (Biaxin), or troleandomycin (TAO);

  • HIV medicines such as amprenavir (Agenerase), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept);

  • an antacid containing magnesium or aluminum such as Rulox, Amphojel, Milk of Magnesia; or

  • seizure medicine such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal), phenytoin (Dilantin).

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.

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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