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Precautions and Warnings With Pomalidomide

If you have kidney disease, smoke cigarettes, or have ever had a blood clot, talk to your healthcare provider before starting treatment with pomalidomide. Other precautions involve the potential for serious drug interactions or dangerous infections. Safety warnings also apply to women who are pregnant or breastfeeding, as well as people who have certain allergies.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking pomalidomide (Pomalyst®) if you:
 
  • Have liver disease, such as hepatitis, cirrhosis, or liver failure
  • Have kidney disease, such as kidney failure (renal failure)
  • Have had a blood clot in your lungs or veins
  • Had a serious rash from taking thalidomide (Thalomid®) or lenalidomide (Revlimid®
  • Smoke cigarettes
  • Neuropathy (nerve damage that causes numbness and pain, especially in the hands and feet)
  • 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 Pomalidomide Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Pomalidomide can decrease blood cells in your body, which could increase your risk for infections (due to low white blood cells), anemia (low red blood cells), and bleeding (low platelets). Your healthcare provider will monitor your blood cell counts, with a simple blood test, at least once a week for the first eight weeks of treatment, and then once a month.

    If your blood cells become too low, you may need to temporarily stop taking pomalidomide to give your body a chance to make more blood cells. You may also need a blood transfusion, or to take certain medicines, to increase your blood cell count. Once you restart pomalidomide, you will likely be restarted on a lower dose.
 
  • This medication may cause blood clots to form in your veins and lungs. Your healthcare provider may choose to give you an anticoagulant ("blood-thinner") during treatment to reduce your risk for developing a blood clot. Let him or her know right away if you develop any signs of blood clots, such as:
    • Shortness of breath
    • Chest pain
    • Swelling of an arm or leg.
 
  • People who have had an allergic reaction to thalidomide (Thalomid®) or lenalidomide (Revlimid®) may be at risk for having an allergic reaction to pomalidomide.
 
  • You may become dizzy and confused while taking pomalidomide, which could affect your ability to perform complex tasks. Do not do anything that requires mental alertness, such as driving, operating heavy machinery, or making important decisions, until you know how this medication affects you.
 
  • Some people who take this medicine may develop nerve damage that causes sensations of numbness and pain. This is known as neuropathy. In many cases, the neuropathy occurs in the hands and feet, although it can occur in other areas as well. Let your healthcare provider know if you have signs of neuropathy, including feelings of numbness, burning, tingling, or pricking.
 
  • You should not donate blood during pomalidomide treatment and for at least one month after your last dose. Pomalidomide can cause serious birth defects. If a pregnant woman receives donated blood containing pomalidomide, it could harm her unborn child.
 
  • If you smoke, talk to your healthcare provider about ways to quit. Cigarette smoking causes your body to break down pomalidomide faster than normal, which could make the drug less effective.
 
  • You should know that there have been reports of a type of leukemia known as acute myelogenous leukemia occurring in people undergoing pomalidomide treatment. It is unknown if pomalidomide causes leukemia.
 
  • Pomalidomide is found in the semen of men who use the medication. Because the drug has the potential to cause birth defects and fetal death, men should use a condom when having sex with a female of childbearing potential during pomalidomide treatment and for at least 28 days after treatment ends. Men taking pomalidomide should also not donate sperm.
   
  • Pomalidomide is a pregnancy Category X medication because it can cause serious birth defects or death in a fetus. Women who are pregnant, or who may become pregnant, should not take pomalidomide (see Pomalyst and Pregnancy).
 
  • It is not known whether pomalidomide 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 Pomalyst and Breastfeeding).
 
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