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Folotyn Warnings and Precautions

It is important to discuss your medical history with your healthcare provider before starting treatment with Folotyn. There are precautions for using this drug safely, including warnings of potentially life-threatening skin reactions and dangerous risks for women who are pregnant or breastfeeding. Problems may occur in people who have a history of low blood cell counts or those who have certain allergies.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to receiving Folotyn® (pralatrexate) if you have:
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure
  • Low blood cell counts, including low white blood cells or platelets
  • Anemia
  • An infection or get infections easily
  • Any allergies, including 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 Folotyn

Some warnings and precautions to be aware of prior to receiving this medication include the following:
  • Folotyn can cause low blood cell counts, such as:
    • Low red blood cells, which could cause anemia
    • Low white blood cells, which could increase your risk for infections
    • Low platelets, which could cause abnormal bleeding and bruising.
Your healthcare provider will monitor your blood cell counts each week using a simple blood test. If your blood cell counts become too low, you may need to skip a dose or stop using the medication altogether.
  • This medication can cause serious swelling, sores, and blisters of the mouth, throat, and digestive tract. These sores can make it difficult to eat. Talk to your healthcare provider about ways to reduce the risk of this complication and ways to make sure you get adequate nutrition during treatment.
  • Serious and potentially life-threatening skin reactions have been reported with Folotyn treatment. Contact your healthcare provider right away if you develop any type of rash or sores, peeling, or blisters on the skin during treatment.
  • There have been reports of tumor lysis syndrome (metabolic and electrolyte disturbances caused by the breakdown of tumor cells in people undergoing cancer treatment) in people receiving this medicine. Tumor lysis syndrome can be fatal. Your healthcare provider will monitor you for this problem using simple blood tests.
  • You will need to take folic acid and vitamin B12 to help reduce your risk for mouth sores and blood problems from Folotyn. Make sure to follow your healthcare provider's instructions for taking these products.
  • This medicine should generally not be used in people undergoing dialysis. People with moderate-to-severe kidney disease may need to be closely monitored during treatment.
  • Folotyn has been reported to increase certain liver enzymes, which could be a sign of liver damage. Your healthcare provider will monitor your liver function with a simple blood test, and may adjust your dose if you have persistent increases in liver enzymes.
  • Folotyn is a pregnancy Category D medication, which means it may harm an unborn child if used during pregnancy (see Folotyn and Pregnancy).
  • It is unknown whether Folotyn 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 Folotyn and Breastfeeding).
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Folotyn Medication Information

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