Prograf Warnings and Precautions

If you had an organ transplant and are going to take Prograf, it is important that your doctor knows if you have a history of anemia, heart problems, or other medical issues. Although this medicine can be effective for preventing organ rejection, Prograf does have several safety warnings and precautions for people taking certain medications or those with certain allergies.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Prograf® (tacrolimus) if you have:
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure (renal failure)
  • Heart problems
  • High blood pressure (hypertension)
  • Diabetes
  • Lymphoma, skin cancer, or any other type of cancer
  • Any type of infection
  • Plans to receive a vaccine
  • A history of anemia
  • Been told you have electrolyte problems, such as low blood phosphate or magnesium
  • Any allergies, including allergies to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With Prograf

Some warnings and precautions to be aware of before taking this medication include the following:
  • You should only use this medicine under the direction of a healthcare provider who has experience prescribing medications that suppress the immune system and treating people who have had an organ transplant.
  • This medication increases your risk for developing cancer, especially skin cancer and lymphoma (cancer of the lymph nodes). You can help reduce your risk for skin cancer by limiting your time in the sun, using sunscreen with a sun protective factor (SPF) of at least 30, and wearing protective clothing, such as hats, long pants, and long sleeves. Contact your healthcare provider if you notice signs of skin cancer or lymphoma, such as any type of skin changes or lumps in your neck, underarms, or groin area.
  • Because Prograf weakens the immune system, you may be more likely to develop an infection during treatment, including potentially serious or life-threatening infections. If you received a kidney transplant, you could also become infected with certain viruses that can damage your new kidney. Contact your healthcare provider right away if you experience symptoms of an infection, such as:
    • Fever
    • Muscle aches
    • Sweats
    • Chills
    • Sores on your skin that do not heal.
  • Prograf may cause diabetes in certain people. Hispanic or African American people who have received a kidney transplant appear to be at a higher risk for diabetes with Prograf use. Contact your healthcare provider if you experience any signs of diabetes, such as:
    • Frequent urination
    • Increased thirst or hunger
    • Weight loss
    • Blurred vision.
  • This medicine can cause kidney damage, especially when used in high doses. Your healthcare provider will monitor your kidney function during treatment.
  • Prograf can cause neurotoxicity, or problems with the nervous system, particularly in high doses. Severe problems can include seizures, coma, and encephalopathy (a medical term for a disease of the brain that causes altered brain function). Less severe problems, such as tremors, tingling and numbness of the skin, and headaches, may also occur. Seek immediate medical care if you experience any signs of encephalopathy, such as:
    • Confusion
    • Vision changes
    • Muscle weakness
    • Problems with movement
    • Seizures.
  • This medicine may increase your blood pressure. You may need treatment with blood pressure medication. It can also cause abnormally high blood potassium levels (hyperkalemia). Your healthcare provider will monitor you for these and other Prograf side effects. Make sure to keep all of your healthcare provider and laboratory appointments.
  • A small number of people may experience a severe allergic reaction (medically known as an anaphylactic reaction) after receiving a Prograf injection. If you receive the injectable form of this medicine, you will be observed for at least 30 minutes after receiving your dose and frequently thereafter. Because of the potential for this reaction, Prograf injections should only be given to people who cannot take the capsules.
  • Prograf has been reported to cause heart disease in which the heart muscle thickens, preventing the heart from functioning properly. This side effect is more likely to occur with high blood levels of Prograf. If you begin to develop signs of heart problems, your healthcare provider may lower your Prograf dosage or stop your treatment altogether, as this side effect appears to be reversible.
  • Talk to your healthcare provider before getting any type of vaccination or immunization during Prograf treatment. Prograf can make vaccines less effective. Also, people taking Prograf should not receive "live" vaccinations (see Prograf Drug Interactions).
  • This medication has been reported to cause low blood cells, including red blood cells (anemia) and platelets. Your healthcare provider will monitor your blood cell counts with simple blood tests during Prograf treatment. Contact your healthcare provider if you experience any symptoms of anemia or other blood cell problems, such as:
    • Fatigue
    • Weakness
    • Infections
    • Unusual bleeding or bruising.
  • There have been cases of gastrointestinal perforation (when a hole forms in the digestive tract) in people taking Prograf. These cases were likely caused by other factors, such as cancer or transplant surgery. Nonetheless, it is important for people taking this drug to be aware of the symptoms of a gastrointestinal perforation, such as severe abdominal (stomach) pain, nausea, vomiting, fever, and chills. If you develop such symptoms, seek immediate medical attention.
  • Like many other medications, Prograf can cause a change in the heart rhythm known as QT prolongation. In many cases, this is not dangerous, but if severe enough, it can lead to life-threatening arrhythmias.
Serious problems are most likely in people who already have a condition known as long QT syndrome. Prograf is not recommended for people with this condition. Others at an increased risk for QT prolongation include people taking other QT-prolonging medications and people with heart failure, a slow heart rate, or electrolyte imbalances. Careful monitoring of the heart rhythm, electrolyte levels, and Prograf levels is recommended in such situations.
  • Prograf is a pregnancy Category C medication, which means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using this drug during pregnancy (see Prograf and Pregnancy).
  • Prograf passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Prograf and Breastfeeding).

Prograf Medication Information

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