PROGRAF (tacrolimus) Capsules and Injection
July 25, 2001: Fujisawa
Revisions to the PRECAUTIONS and ADVERSE REACTIONS sections. A new Patient’s Information leaflet is added to the PROGRAF Capsules labeling
PRECAUTIONS
*Drugs That May Decrease Tacrolimus Blood Concentrations:
AnticonvulsantsAntibiotics
carbamazepine rifabutin
phenobarbital rifampin
phenytoin
Herbal Preparations
St. John’s Wort
*This table is not all inclusive.
St. John’s Wort (hypericum perforatum) induces CYP3A4 and P-glycoprotein. Since tacrolimus is a substrate for CYP3A4, there is the potential that the use of St. John’s Wort in patients receiving Prograf could result in reduced tacrolimus levels.
ADVERSE REACTIONS
Post Marketing
The following have been reported: increased amylase including pancreatitis, hearing loss including deafness, leukoencephalopathy, thrombocytopenic purpura, hemolytic-uremic syndrome, acute renal failure, Stevens-Johnson syndrome, stomach ulcer, glycosuria, and cardiac arrhythmia and gastroenteritis.
Patient Information
PROGRAF
(tacrolimus capsules)
Read this important information before you start using PROGRAF [PRO-graf] and each time you refill your prescription. This summary does not take the place of talking with your transplant team.
Talk with your transplant team if you have any questions or want more information about PROGRAF. You can also visit the Fujisawa Internet site at www.fujisawa.com.
What Is PROGRAF?
PROGRAF is a medicine that slows down the body’s immune system. For this reason, it works as an anti-rejection medicine.
PROGRAF helps patients who have had a liver or kidney transplant protect their new organ and prevent it from being rejected by the body.
How Does PROGRAF Protect My New Organ?
The body’s immune system protects the body against anything that it does not recognize as part of the body. For example, when the immune system detects a virus or bacteria it tries to get rid of it to prevent infection. When a person has a liver or kidney transplant, the immune system does not recognize the new organ as a part of the body and tries to get rid of it, too. This is called "rejection." PROGRAF protects your new organ by slowing down the body’s immune system.
Who Should Not Take PROGRAF?
Do not take PROGRAF if you are allergic to any of the ingredients in PROGRAF. The active ingredient is tacrolimus. Ask your doctor or pharmacist about the inactive ingredients.
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Tell your transplant team about all your health conditions, including kidney and/or liver problems. Discuss with your transplant team the use of any other prescription and non- prescription medications, including any herbal or over-the-counter remedies that you may take while on Prograf. In very rare cases you may not be able to take Prograf.
Tell your transplant team if you are pregnant, planning to have a baby or are breastfeeding. Talk with your transplant doctor about possible effects PROGRAF could have on your child. Do not nurse a baby while taking PROGRAF since the medicine will be in the breast milk.
How Should I Take PROGRAF?
PROGRAF can protect your new kidney or liver only if you take the medicine correctly.
Your new organ needs around-the-clock protection so your body does not reject it. The success of your transplant depends a great deal upon how well you help PROGRAF do its job. Here is what you can do to help.
Take PROGRAF exactly as prescribed
It is important to take PROGRAF capsules exactly as your transplant team tells you to.
PROGRAF comes in several different strength capsules--0.5 mg, 1 mg and 5 mg. Your transplant team will tell you what dose to take and how often to take it. Your transplant team may adjust your dose until they find what works best for you.
Never change your dose on your own. Never stop taking PROGRAF even if you are feeling well. However, if you feel poorly on Prograf, discuss this with your transplant team.
Take PROGRAF two times a day, 12 hours apart
Try to pick times that will be easy for you. For example, if you take your first dose at 7:00 a.m. you should take your second dose at 7:00 p.m. Do not vary the times. You must take PROGRAF at the same times every day. If you decide to take PROGRAF at 7:00 a.m. and 7:00 p.m., take it at these same times every day. This will make sure you always have enough medicine in your body to give your new organ the around-the-clock protection it needs.
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