Fludara Warnings and Precautions

Specific Precautions and Warnings for Fludara

Some warnings and precautions to be aware of prior to receiving this medication include the following:
  • Fludara is a potent chemotherapy medicine that can cause significant side effects. It should only be given under the supervision of a healthcare provider with experience prescribing chemotherapy medicines.
  • Fludara can cause serious nervous system problems, including agitation, confusion, seizures, and coma. Nervous system side effects may occur at the usual recommended Fludara dose, but appear to be more severe at higher doses. These side effects may be delayed, appearing as late as seven to eight months after the last Fludara dose.
  • Like many other chemotherapy medicines, Fludara can cause significant bone marrow suppression (when the bone marrow is unable to make adequate amounts of red blood cells, white blood cells, and platelets). This could increase your risk for life-threatening infections, anemia, and bleeding problems. Your healthcare provider will monitor your blood cell counts frequently during treatment. Let him or her know if you experience signs of bone marrow suppression, such as:
    • Signs of infection, such as:
    • Signs of anemia, such as:
      • Extreme tiredness
      • Pale skin
      • Dizziness
      • Shortness of breath
    • Signs of bleeding, such as:
      • Any unusual bleeding or bruising
      • Blood in the urine
      • Black, tarry, or bloody stools.
  • There have been reports of serious autoimmune reactions in which the body attacks and destroys its own blood cells in people receiving Fludara. Let your healthcare provider know if you have symptoms of an autoimmune blood reaction, such as:
    • Bleeding from the gums or nose
    • Blood in the urine or stools
    • Easy bruising
    • Heavy menstrual flows
    • Bleeding that can't be easily stopped
    • Coughing up blood
    • Fatigue
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Pain in the upper abdomen (stomach).
  • People who have been treated with Fludara may be at risk for a life-threatening reaction to a blood transfusion. If you need a blood transfusion during or any time after treatment with Fludara you will need to receive irradiated blood products (blood products used to prevent a serious reaction in people who have a weakened immune system). Make sure your healthcare provider knows if you have ever been treated with Fludara before you receive a blood transfusion.
  • In a clinical study, people with chronic lymphocytic leukemia who received Fludara in combination with a medication known as pentostatin (Nipent®) had a higher risk for lung damage which, in some cases, caused death. These medicines should not be used together.
  • Fludara may damage the testicles and sperm in males. This could affect fertility (the ability to have children) or increase the risk for birth defects. Men with female partners of childbearing potential should use an effective form of birth control during and after treatment with Fludara. Talk to your healthcare provider about when it may be safe to have children after Fludara treatment.
  • This medication should be used cautiously in people who are unwell, especially people with significantly severe bone marrow problems, a weak immune system, or a history of getting infections because of a weak immune system. If you have a history of infections due to a weak immune system, your healthcare provider may give you other medicines to help reduce your risk for developing an infection during Fludara treatment.
  • You should know that this medicine may cause fatigue, weakness, vision problems, confusion, agitation, and seizures. These side effects can impair your ability to drive or operate heavy machinery, and you should avoid these activities until you know how Fludara affects you.
  • This medication has been associated with a condition known as tumor lysis syndrome, which occurs when dying cancer cells break down and release their contents into the body faster than the body can clear them. This can lead to potentially serious problems, including kidney failure, seizures, and death. People with a large amount of tumors may have a higher risk for tumor lysis syndrome. Your healthcare provider will monitor you for this condition and may give you medicines to help prevent it.
  • People with kidney disease may need lower-than-usual Fludara doses, and close monitoring for Fludara side effects during treatment. This medicine should generally not be used in people with severe kidney disease.
  • There have been reports of Richter's syndrome occurring in people with chronic lymphocytic leukemia treated with Fludara. Richter's syndrome is a rare but aggressive form of non-Hodgkin's lymphoma that starts as chronic lymphocytic leukemia.
  • You should not receive a live vaccination during Fludara treatment. Talk to your healthcare provider about when it may be safe to receive a live vaccine after treatment ends.
  • Fludara is a pregnancy Category D medication, which means it may cause fetal harm if used during pregnancy. Talk to your healthcare provider about the risks and benefits of using this medication during pregnancy (see Fludara and Pregnancy).
  • It is unknown whether Fludara passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Fludara and Breastfeeding).
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