Thalomid Side Effects - Thalidomide Side Effect - Multiple Myeloma

MULTIPLE MYELOMA KNOWLEDGE CENTER

What are Thalomid side effects?

Thalomid® (thalidomide, Celgene) side effects have been observed in clinical studies. The side effects associated with Thalomid can range from mild to severe, and not everyone will experience them. It is important to note that the frequency of side effects usually increases as the dose of Thalomid is increased. The incidence of severe side effects is low, and severe effects appear to be related to higher doses of the drug. You should also know that side effects may also occur when treatment consists of dexamethasone alone.

Fatigue and peripheral neuropathy, a disorder of the nerves that can result in abnormal or decreased sensation or burning/tingling in the hands and feet, are usually the most common reasons for discontinuing treatment with Thalomid. Other side effects seen in clinical studies of Thal-dex include:

  • Low blood calcium levels (hypocalcemia)
  • Swelling (edema)
  • Constipation
  • Difficulty breathing
  • Muscle weakness
  • Low white blood cell and neutrophil counts
  • Rash and skin reactions resulting in blistering or peeling

Side effects can usually be minimized or controlled by reducing the dose of Thalomid or by using an appropriate strategy to manage a particular side effect.

Serious side effects

The most serious side effect associated with Thalomid is its effect on a fetus. If Thalomid is taken immediately prior to conception or at any time during pregnancy, the drug is associated with serious birth defects, including malformed limbs, gastrointestinal disorders, and fetal death. To ensure that Thalomid is used safely, Celgene has developed a unique restricted distribution program called Thalomid REMS™. Individuals eligible to receive Thalomid must be registered in the program.

Seizures (including grand mal seizures) have been reported in association with Thalomid. However, these seizures occurred in individuals who were likely to have other conditions that could cause seizure activity. Because of this, it is unclear whether Thalomid causes seizures directly or triggers an existing predisposition to seizures. An FDA warning recommends that individuals with a history of seizure or risk factors for seizures should be monitored carefully when treated with Thalomid.

Deep-vein thrombosis (DVT), a blood clot that develops and obstructs blood flow in one of the large veins in the legs (or less commonly, the arms), is a side effect of Thalomid that can be serious if not recognized and treated. Signs and symptoms of DVT include an area on one limb that is warm, painful, or tender to the touch; is reddened or discolored; or feels hardened. If you have any of these symptoms, you should contact your doctor immediately.

The risk of DVT is higher when Thalomid is used with dexamethasone and some chemotherapy agents, such as doxorubicin. However, patients receiving Thalomid will also receive preventative treatment with a blood thinner (anticoagulant). The choice of agent will be based on a patient’s individual risk factors for blood clots and may include aspirin, a low-molecular weight heparin, or warfarin.

Other Thalomid side effects that can be severe at times include peripheral neuropathy, dizziness and sleepiness, heart attack and stroke, increased heart rate, and skin reactions resulting in blistering or peeling.