Pomalyst® is an oral (in capsule form) treatment for multiple myeloma that belongs to a class of medications known as immunomodulatory drugs, or IMiD® compounds. IMiDs regulate the functioning of the immune system. Approved by the FDA in 2013, Pomalyst is chemically related to Thalomid® (thalidomide) and Revlimid® (lenalidomide).
How Is It Used?
Pomalyst is indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
In June, 2017, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody Darzalex® (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with MM who have received at least two prior therapies including Revlimid and a proteasome inhibitor.
Possible Side Effects
Patients with a prior history of serious sensitivity to Thalomid or Revlimid were excluded from studies with Pomalyst and may be at higher risk of allergic reactions to it. Drug hypersensitivity results from the interaction of a drug and the immune system. Risk factors for drug hypersensitivity reactions include age, female gender, concurrent illnesses, and previous hypersensitivity to related drugs. Symptoms may include difficulty breathing, rash, hives, fever, swelling, vomiting, or diarrhea
Neutropenia (low levels of our most abundant type of white blood cell) was the most frequently reported serious side effect among patients in clinical trials with Pomalyst, followed by anemia (low red blood cell count) and thrombocytopenia (low platelet count). White blood cells make up your immune system. Your immune system defends against viral and bacterial illnesses. Therefore, having too few white blood cells can lead to infection. Fever is the most common sign of having too few neutrophils, and is a sign that you need immediate medical attention. Other common symptoms associated with a low neutrophil count include sore throat and mouth sores. For more information on neutropenia, visit Myelosuppression.
Deep vein thrombosis (DVT)
Patients receiving Pomalyst may develop deep vein thrombosis (DVT, or blood clot). In the clinical trial submitted to the FDA for approval of the drug, all patients were required to receive treatment to prevent blood clots.
DVT is a serious condition and is potentially life threatening. DVT is a blood clot in a deep vein of the lower extremities (usually occurring in the leg or thigh, and very occasionally in the neck or upper arm). A blood clot from a DVT can break loose (embolize) and travel to the heart or lungs. An embolus is very dangerous. If you are taking Pomalyst and you experience warmth, swelling, redness, difficulty breathing, and/or pain in an extremity, notify your doctor immediately. For more information on DVT, see Heart and Lung Complications.
Dizziness and confusion
18% of patients in the clinical trial leading to FDA approval of Pomalyst experienced dizziness and 12% of patients experienced some mental confusion. Patients should be aware that these are potential side effects, and should avoid situations where this would pose a risk to, or be a problem for, themselves and others. Be mindful of taking other medications that cause dizziness or confusion. Discuss your other medications with your pharmacist.
In the clinical trial submitted to the FDA for approval of Pomalyst, 18% of the patients experienced neuropathy (toxicity to nerve tissue), approximately half of which was peripheral neuropathy. There were no cases of serious side effects affecting nerve tissue. Symptoms of neuropathy include dizziness and fainting; symptoms of peripheral neuropathy include numbness, tingling, and pain in the hands and/or feet.
Feeling unusually tired is a common side effect of treatment for multiple myeloma (and other cancers). Although many of the patients in clinical trials with Pomalyst felt fatigued, very few had severe fatigue that prevented them from performing the activities of daily living. As a general rule, any patient suffering from fatigue should exercise caution if operating machinery, including automobiles.
Patients taking Pomalyst may experience a decrease in the level of blood cells called thrombocytes, or platelets, which are responsible for clotting the blood. Low levels of platelets can result in bruising, bleeding, and slower healing. For more information on thrombocytopenia, visit Myelosuppression.
Red blood cells contain hemoglobin, a protein that contains iron and transports oxygen from the lungs to the body’s organs and tissues. When a patient has anemia, the result is low levels of oxygen in the body, which may cause shortness of breath and feelings of exhaustion
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
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Open clinical trials on clinicaltrials.gov.