Tuesday, November 15, 2011

Prograf


What is Prograf (Tacrolimus)?

Tacrolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.
Tacrolimus is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.
Tacrolimus may also be used for other purposes not listed Libidus in this medication guide.

What is the most important information I should know about Prograf (Tacrolimus)?

Taking tacrolimus may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
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.
Do not consume grapefruit or grapefruit juice during treatment with tacrolimus unless your doctor has told you do. Tacrolimus can have a dangerous interaction with grapefruit or grapefruit juice.
Tacrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.
Some people receiving tacrolimus after a kidney transplant have developed diabetes, most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes.

What should I discuss with my healthcare provider before taking Prograf (Tacrolimus)?

You should not take this medication if you are allergic to tacrolimus or hydrogenated castor oil.
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking tacrolimus, tell your doctor if you have:
  • kidney disease
  • liver disease
  • high blood pressure; or
  • if you have used cyclosporine (Neoral, Sandimmune, Gengraf) within the past 24 hours
Some people receiving tacrolimus after a kidney transplant have developed diabetes. This effect has been seen most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes if you have concerns.
Taking tacrolimus may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk.
FDA pregnancy category C. It is not known whether tacrolimus is harmful to an unborn baby. Before taking tacrolimus, tell your doctor if you are pregnant or plan to become pregnant during treatment.
Tacrolimus can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Tacrolimus (Oral Route, Intravenous Route)


US Brand Names

  • Prograf

Description

Tacrolimus belongs to a group of medicines Libitol known as immunosuppressive agents. It is used to lower the body's natural immunity in patients who receive organ (for example, kidney, liver, pancreas, lung, and heart) transplants.
When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by preventing the white blood cells from getting rid of the transplanted organ.
Tacrolimus may also be used for other indications, as determined by your doctor.
Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also reduce the body's ability to fight infections. You and your doctor should talk about the good this medicine will do as well as the risks of using it.
Tacrolimus is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in the product labeling, tacrolimus is used in certain patients with the following medical conditions:
  • Bone marrow transplantation
  • Uveitis, severe, refractory (an eye condition)
For patients receiving bone marrow transplantation, tacrolimus may work by preventing the cells from the transplanted bone marrow from attacking the cells of the patient. The dose of tacrolimus for patients receiving bone marrow transplantation is based on body weight. The usual dose is 0.12 to 0.3 mg per kg (0.05 to 0.14 mg per pound) of body weight a day for patients taking tacrolimus by mouth, and 0.04 to 0.1 mg per kg (0.018 to 0.045 mg per pound) of body weight a day for patients receiving tacrolimus by injection.
The dose of tacrolimus for patients with severe, refractory uveitis is based on body weight. For severe, refractory uveitis, the usual dose is 0.1 to 0.15 mg per kg (0.045 to 0.068 mg per pound) of body weight a day.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
This medicine does not cause different types of side effects or problems in children than it does in adults, although some side effects may occur more or less often than they do in adult patients.
Geriatric
There is no specific information comparing the use of tacrolimus in the elderly with the use in other age groups. Tacrolimus is not expected to cause different side effects or problems in older people than it does in younger adults. However, older patients may need lower doses of tacrolimus.
Pregnancy
Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
  • Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
  • Aceclofenac
  • Acemetacin
  • Alclofenac
  • Amikacin
  • Amiloride
  • Amiodarone
  • Apazone
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Basiliximab
  • Benoxaprofen
  • Bromfenac
  • Bufexamac
  • Carbamazepine
  • Carprofen
  • Caspofungin
  • Cisplatin
  • Clometacin
  • Clonixin
  • Colchicine
  • Cyclosporine
  • Darunavir
  • Dexketoprofen
  • Dibekacin
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Efavirenz
  • Etodolac
  • Etofenamate
  • Etravirine
  • Felbinac
  • Fenbufen
  • Fenoprofen
  • Fentiazac
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Gentamicin
  • Ibuprofen
  • Indomethacin
  • Indoprofen
  • Isoxicam
  • Itraconazole
  • Kanamycin
  • Ketoprofen
  • Ketorolac
  • Lornoxicam
  • Measles Virus Vaccine, Live
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mumps Virus Vaccine, Live
  • Nabumetone
  • Naproxen
  • Nefazodone
  • Nelfinavir
  • Neomycin
  • Netilmicin
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxyphenbutazone
  • Pazopanib
  • Phenobarbital
  • Phenylbutazone
  • Phenytoin
  • Pirazolac
  • Piroxicam
  • Pirprofen
  • Poliovirus Vaccine, Live
  • Posaconazole
  • Propyphenazone
  • Proquazone
  • Rifabutin
  • Rifampin
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Sirolimus
  • Smallpox Vaccine
  • Spironolactone
  • St John's Wort
  • Streptomycin
  • Sulindac
  • Suprofen
  • Telaprevir
  • Tenidap
  • Tenofovir
  • Tenoxicam
  • Tiaprofenic Acid
  • Tobramycin
  • Tolmetin
  • Triamterene
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Vemurafenib
  • Voriconazole
  • Yellow Fever Vaccine
  • Zomepirac
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Amprenavir
  • Chloramphenicol
  • Clarithromycin
  • Clotrimazole
  • Dalfopristin
  • Danazol
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Diltiazem
  • Erythromycin
  • Fluconazole
  • Fosphenytoin
  • Ketoconazole
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Metoclopramide
  • Metronidazole
  • Mibefradil
  • Nevirapine
  • Nifedipine
  • Quinupristin
  • Rifapentine
  • Ritonavir
  • Saquinavir
  • Schisandra sphenanthera
  • Theophylline
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
  • Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
  • Cancer—Tacrolimus can make this condition worse.
  • Chickenpox (including recent exposure) or
  • Herpes zoster (shingles)—The risk of severe disease affecting other parts of the body may be increased.
  • Diabetes mellitus (sugar diabetes)—Tacrolimus can increase the amount of sugar in the blood.
  • Hepatitis or
  • Kidney disease or
  • Liver disease—Tacrolimus can have harmful effects on the kidney in patients with these conditions; a lower dose of tacrolimus may be needed in patients with these conditions.
  • Hyperkalemia (high amount of potassium in the blood) or
  • Nervous system problems—Tacrolimus can make these conditions worse.
  • Infection—Tacrolimus decreases the body's ability to fight infection.