MULTIPLE MYELOMA KNOWLEDGE CENTER

What are Revlimid side effects?

Revlimid® (lenalidomide, Celgene) can have a variety of side effects depending on the patient’s health history as well as the stage of their multiple myeloma. Most side effects of Revlimid-dex can be managed.

The most common side effects of Revlimid-dex seen in large clinical studies are:

  • Gastrointestinal effects (diarrhea, constipation, or nausea)
  • Fatigue or loss of strength
  • Low red blood cell or white blood cell counts
  • Swelling in the arms and legs (peripheral edema)
  • Insomnia
  • Muscle cramps
  • Back pain
  • Fever
  • Rash

The most common severe side effects of Revlimid-dex seen in large clinical studies are:

  • Low white blood cell, red blood cell, or platelet counts
  • Fatigue
  • Pneumonia
  • Blood clots

Due to the possibility of low blood counts, patients taking Revlimid-dex will have their blood counts checked weekly during the first 2 cycles, every other week during cycle 3, and monthly afterward.

Because Revlimid-dex can increase the risk of blood clots in the legs and lungs, patients taking Revlimid-dex also receive a blood thinner (anticoagulant) such as aspirin or heparin. The choice of agent will be tailored to the patient based on their individual risk factors.

Other serious side effects that have been seen with Revlimid-dex include heart attack and stroke, liver failure, and allergic reactions, including severe skin reactions.

Women who are pregnant or who plan to become pregnant must not take Revlimid. This precaution is due to its similarity to Thalomid® (thalidomide, Celgene), and some signs of birth defects in animals. A program called RevlimidREMSTM has been created to prevent exposure to Revlimid during pregnancy. Patients must register and meet all the conditions of the program in order to take Revlimid.

How are side effects of Revlimid-dex managed?

Management of side effects depends on the type and severity of the problem. Some side effects such as mild or moderate diarrhea can be managed with additional medications.

More serious side effects may require you to stop Revlimid-dex either temporarily or permanently. In many cases, Revlimid-dex is stopped temporarily, until the side effect improves, and then re-started at a lower dose. Studies have shown that Revlimid-dex is still effective at lower doses.

Does Revlimid cause second cancers?

There have been reports of new second cancers (also called second primary malignancies or SPMs) developing in a small number of myeloma patients who received Revlimid therapy in clinical studies. In all of these studies Revlimid was used in combination with melphalan chemotherapy. The types of second cancers seen include MDS (myelodysplastic syndrome, a form of preleukemia) and AML (acute myelogenous leukemia). There have been very few additional second cancers in other studies with Revlimid where melphalan was not part of the treatment. Overall, the information available to date indicates that therapy with Revlimid significantly decreases the risk of myeloma disease progression. Hence, some doctors believe that the benefits of Revlimid therapy may outweigh any potential risk of second cancers.