Pomalyst® (pomalidomide) capsules

Pomalyst® is an immun­omodulatory drug (IMiD®). Approved by the FDA in 2013, Pomalyst is chemically related to thalidomide and lenalidomide, which was approved by the FDA in 2006, but Pomalyst has been enhanced to be more effective.

For more information about Pomalyst visit their website www.pomalyst.com

General Information

Pomalyst website

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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Understanding Pomalyst® (pomalidomide) capsules 

This booklet is about a drug that is used only for patients with relapsed and refractory myeloma. It pres­ents information on Pomalyst® and how it works, the results of clinical trials and ongoing research with Pomalyst, how and when to take Pomalyst, and its possible side effects and how to manage them. 

Pomalyst® (pomalidomide) capsules Tip Card

This handy tip card includes indications, dosage, and potential side effects.

Possible Side Effects

Hypersensitivity reactions

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 Pomalyst. 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

Neutropenia (decreased white blood cell count) of any grade was reported in 50% of patients and was the most frequently reported serious adverse event, followed by anemia (low red blood cell count) and thrombocytopenia (low platelet count). Since your white blood cells make up your immune system, which is your defense against viral and bacterial illnesses, having too few of these 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.

When patients with relapsed myeloma begin therapy with Pomalyst, neutropenia is often a problem that results from the combined effects of myeloma infiltration of the bone marrow, the impact of prior therapy, and the impact of the Pomalyst. In the first 2–3 months of therapy, it is especially important to try to maintain the full dose of Pomalyst as much as possible and, if need be, to support the white blood cells with a drug such as Neupogen® (G-CSF, colony-stimulating factor), a growth factor to stimulate neutrophil production. As the myeloma cells are cleared out of the bone marrow, the neutrophils recover, and tolerance for the full dose of Pomalyst improves.

With ongoing Pomalyst therapy beyond the initial cycles, support for white cell production may be an on-going concern. This can be achieved with a G-CSF. If the white blood cell count remains low, dose reduction of Pomalyst may also be required once response has been achieved.

 

Deep vein thrombosis (DVT)

Patients receiving Pomalyst have developed venous thromboembolisms (VTE, blood clots) reported as serious adverse reactions. In the clinical trial used for FDA approval, all patients were required to receive treatment to prevent blood clots. The rate of deep vein thrombosis (DVT) or pulmonary embolism (PE) was 3%.

DVT is a serious condition and is poten-tially 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.

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.

Neuropathy

18% of patients experienced neuropathy (toxicity to nerve tissue), approximately half of which was peripheral neuropathy. There were no cases of serious neuropathic adverse events. Symptoms of neuropathy include dizziness and fainting; symptoms of peripheral neuropathy include numbness, tingling, and pain in the hands and/or feet.

Fatigue

Feeling unusually tired is a common side effect of treatment for 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. The IMF has a publication called Understanding Fatigue that will be useful if you or someone you care for experiences this side effect.

Asthenia

 

Thrombocytopenia

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.

Anemia

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

 

Clinical Trials

Pomalyst® (pomalidomide) clinical trials

Open clinical trials on clinicaltrials.gov