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Precautions and Warnings With Lenalidomide

If you are lactose intolerant or have liver or kidney problems, let your healthcare provider know before beginning treatment with lenalidomide. This medication can cause potentially dangerous problems, such as infections or bleeding problems. Warnings and precautions with lenalidomide also apply to women who are pregnant, as this drug can cause severe birth defects and fetal death.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking lenalidomide (Revlimid®) if you have:
 
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure (renal failure)
  • Had a blood clot in your lungs or veins
  • A lactose intolerance
  • Had a serious rash from taking thalidomide (Thalomid®)
  • Not had a hysterectomy or been in menopause for at least 24 months (for women)
  • 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 Lenalidomide Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Lenalidomide can decrease the amount of white blood cells and platelets in your body, which can increase your risk for infection and bleeding problems.

If you take this medicine for multiple myeloma, you will need to have your blood cell counts monitored every 2 weeks for the first 12 weeks of treatment, and then monthly thereafter. If you take the medicine for myelodysplastic syndrome, you will need monitoring every week for the first 8 weeks and then monthly thereafter. If you are taking the drug for mantle cell lymphoma, then you will need your blood counts monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2 through 4, and then monthly thereafter. If your blood cell counts drop too low, your healthcare provider may recommend you temporarily stop treatment. You may also need a blood transfusion.

  • People taking this medicine may have a higher risk of developing a blood clot in their veins and lungs. Contact your healthcare provider right away if you experience symptoms of a blood clot, such as:
 
    • Shortness of breath
    • Chest pain
    • Swelling of an arm or leg.
 
  • This medicine has been reported to cause an increase in certain liver enzymes, which could be a sign of liver damage. If your liver enzymes increase, your healthcare provider may recommend you temporarily stop treatment, until the levels return to normal. Let your healthcare provider know if you experience signs of liver disease, such as:
 
    • Fatigue or extreme tiredness
    • Dark urine
    • Upper-right abdominal (stomach) pain
    • Yellowing of the skin or whites of the eyes (jaundice).
 
  • Serious allergic reactions, including a potentially life-threatening skin rash called Stevens-Johnson syndrome (SJS), have been reported in people taking lenalidomide. Contact your healthcare provider right away if you notice a skin rash or have unexplained swelling of the mouth, lips, or throat while taking this medicine. Lenalidomide is similar to the medication thalidomide (Thalomid®). Therefore, you should not take lenalidomide if you have ever had a severe rash from taking thalidomide.

 

  • In clinical trials people newly diagnosed with multiple myeloma who received lenalidomide had a higher chance of developing new cancers than people who did not receive it. In particular, people given lenalidomide were more likely to develop certain blood cancers (acute myelogenous leukemia and myelodysplastic syndromes) and Hodgkin's lymphoma.

  

  • Lenalidomide can cause tumor lysis syndrome. This syndrome occurs when the breakdown of dying cancer cells leads to metabolic and electrolyte problems, including low calcium blood levels and high levels of potassium, phosphorus, and uric acid. Tumor lysis syndrome can cause kidney problems, seizures, and even death.
 
  • Because of the risks associated with lenalidomide use, especially the risks of using the medicine during pregnancy, people taking this medicine should not donate blood during treatment and for at least four weeks after treatment ends. If a pregnant woman receives donated blood containing lenalidomide, it could harm her unborn child.
 
  • Lenalidomide has been reported to cause a reaction known as tumor flare reaction when used to treat people with lymphoma or chronic lymphocytic leukemia. Lenalidomide is not approved to treat CLL, as studies suggest it may increase the risk of death in people with CLL. Tumor flare reaction can cause problems such as:
 
    • Swollen and tender lymph nodes
    • Fever
    • Pain
    • A rash.
 
  • Lenalidomide capsules contain lactose. Talk to your healthcare provider about this if you have lactose intolerance.
 
 
  • Lenalidomide is considered a pregnancy Category X medication because it can cause birth defects or death in an unborn baby. Women who are pregnant, or who may become pregnant, should not take this medication (see Revlimid and Pregnancy). Because the medication is found in sperm, men taking lenalidomide should not donate sperm, and must agree to use a latex condom during sex with females who are or may become pregnant.
 
  • It is unknown whether lenalidomide 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 Revlimid and Breastfeeding).
 
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