Pomalyst (pomalidomide)

POMALYST® (also known as pomalidomide, its generic drug name) is an immunomodulatory agent taken by mouth in capsule form. It is the third immunomodulatory agent to receive approval from the U.S. Food and Drug Administration (FDA) for use in myeloma: thalidomide was approved in 2003, Revlimid® (lenalidomide) was approved in 2006, and Pomalyst was approved in 2013. 

What Are the Indications for Treatment with Pomalyst?

Pomalyst is indicated for the treatment of adult patients with relapsed and refractory myeloma who have received at least 2 prior therapies, including the immunomodulatory agent Revlimid and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy. 

Pomalyst is used in many regimens as therapy for previously treated myeloma, including the following combination therapies: 

• Pomalyst and the steroid dexamethasone [Pd]. 
• Darzalex® (daratumumab) intravenous (IV) infusion, Pomalyst, and dexamethasone [DPd]. 
• Darzalex Faspro® (daratumumab plus hyaluronidase-fihj) subcutaneous (SQ) injection, Pomalyst, and dexamethasone [DPd]. 
• Empliciti® (elotuzumab), Pomalyst, and dexamethasone [EPd]. 
• Ninlaro® (ixazomib), Pomalyst, and dexamethasone [IPd]. 
• Pomalyst, Cytoxan® (cyclophosphamide), and dexamethasone [PCd]. 
• Pomalyst, Velcade® (bortezomib), and dexamethasone [PVd]. 
• Kyprolis® (carfilzomib), Pomalyst, and dexamethasone [KPd]. 
• Sarclisa® (isatuximab-irfc), Pomalyst, and dexamethasone [Isa-Pd].
• Xpovio® (selinexor), Pomalyst, and dexamethasone [XPd] 

What Are the Dose and Schedule of Pomalyst? 

Pomalyst is taken by mouth in the form of a a capsule with a dose of 2 mg to 4 mg on days 1 through 21 of repeated 28-day Cycles until disease progression. Pomalyst should be swallowed with water at the same time of the day, with or without food.

If you are experiencing an unwanted or unexpected side effect or reaction, your doctor will determine if it is appropriate to adjust your dose of Pomalyst and/or dexamethasone. Be sure to report new problems to your doctor promptly. 

How Is Pomalyst Taken?

• Pomalyst is taken in capsule form by mouth. 
• On the days that Pomalyst is taken, it should be taken at the same time of the day. 
• Swallow Pomalyst with water. Pomalyst may be taken with or without food. 
• Do not break, chew, or open the capsules. 
• Do not handle the capsules more than needed. 
• If you touch a broken Pomalyst capsule, wash the area of your body that came in contact with the medicine immediately and thoroughly with soap and water. 
• If you miss a dose of Pomalyst, and it has been less than 12 hours since your regular time to take it, you should take it as soon as possible. If it has been more than 12 hours since your regular time, just skip your missed dose. Do NOT take two doses at the same time. 
• If you take either too much or too little Pomalyst instead of your prescribed dose, promptly alert your doctor or poison control center. 
• Store Pomalyst at room temperature. 
• Keep Pomalyst and all medications out of the reach of children. 

Warnings and Precautions with Pomalyst 

Most of the side effects associated with Pomalyst are manageable and predictable. However, there are certain potential side effects that are serious enough to require a “Boxed Warning,” the highest safety-related warning that a medication can have assigned by the FDA. A Boxed Warning is intended to bring the patient’s attention to the risks of a drug. 

Before starting treatment with Pomalyst, discuss the warnings, precautions, and side effects with the doctor treating your myeloma. After starting treatment with Pomalyst, promptly report to your doctor any problems or changes in your health so that appropriate steps can be taken. No problem is too small to report. 

Pomalyst REMS 

Pomalyst is available only through a restricted program called “Risk Evaluation and Mitigation Strategy (REMS).” The FDA requires a REMS program if a specific drug or treatment has serious safety concerns. REMS programs support the use of such drugs or treatments and help ensure that the potential benefits outweigh the risks. Prescribers and pharmacists must be certified with the REMS program, and patients must sign an agreement and comply with its requirements.

Females of reproductive potential  

Pomalyst is contraindicated in pregnancy. Pomalyst is a chemical analog of thalidomide. Thalidomide is known to cause severe birth defects or embryo-fetal death. During laboratory studies, it was discovered that Pomalyst harms the developing fetuses of laboratory animals. 

Females of reproductive potential must have pregnancy tests weekly for 4 weeks, then every 4 weeks (if your menstrual cycle is regular) or every 2 weeks (if your menstrual cycle is irregular). 

Patients must agree to use 2 acceptable forms of effective birth control at the same time for at least 4 weeks before starting Pomalyst, while taking Pomalyst or during any interruptions in treatment, and for at least 4 weeks after stopping treatment with Pomalyst. 

If you become pregnant while taking Pomalyst, stop taking it and contact your doctor immediately. If your doctor is not available, contact FDA MedWatch at 1.800.FDA.1088.

Male patients 

Pomalyst is present in the semen of male patients who take it. For that reason, they must also comply with mandatory contraceptive measures. If your female partner becomes pregnant, alert your doctor right away. In addition, do not donate blood. If a pregnant female gets your donated blood, her baby may be born with birth defects. 

Nursing mothers 

Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, considering the importance of the drug to the mother. 

Blood clots 

Deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as myocardial infarction (heart attack) and stroke can occur in myeloma patients treated with Pomalyst. In the clinical trial data submitted to the FDA for approval of Pomalyst, all study patients were required to receive antithrombotic medication to reduce the risk of blood clots forming and growing. Your doctor will assess your individual risk factors to determine which medication is most appropriate for you. 

Before starting Pomalyst, tell your doctor about all the medicines you take. Also let them know if you have had a blood clot in the past, if you smoke, have high blood pressure, or have hyperlipidemia (high level of fat in your blood). 

Get emergency medical help if you experience the following: 

• swelling of your lips, mouth, tongue, or throat 
• trouble breathing or swallowing 
• skin hives (raised red areas on your skin) 
• a very fast heartbeat 
• dizziness or fainting 

Get medical help right away if you experience the following: 

• arm or leg swelling 
• shortness of breath 
• feeling sweaty 
• severe itching 
• vomiting 
• fever 
• severe headache or confusion 
• problems with vision, speech, or balance 
• a red skin rash or peeling of your skin or blisters 
• chest pain (that may or may not spread to the arms, neck, jaw, back, or abdomen) 
• sudden numbness or weakness (especially if on one side of the body) 

Neutropenia 

Neutropenia is a reduced level of neutrophils, a type of white blood cell necessary to combat bacterial infection. Having too few neutrophils can lead to infection. Fever is the most common sign of neutropenia and indicates that you need immediate medical attention. 

Neutropenia of any Grade was reported in 50% of clinical trial patients and was the most frequently reported serious side effect. 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. 

During the first 2–3 months of therapy, it is especially important to try to maintain the full dose of Pomalyst. As your neutrophils recover, your tolerance for the full dose of Pomalyst should improve. Your doctor may prescribe a colony-stimulating factor (CSF) to stimulate the development and growth of your blood cells. 

For the first 8 weeks of treatment, patients should be monitored with a weekly complete blood count (CBC), and with a monthly CBC thereafter. 

Treatment can be modified if blood counts are too low. Tell your doctor if you have any cold- or flu-like symptoms, because neutropenia accompanying a viral infection may resolve quickly after the infection has cleared. 

With ongoing Pomalyst therapy beyond the initial cycles, support for white blood cell production may be an ongoing concern. Mild neutropenia generally has no symptoms and may not need treatment. 

Renal and hepatic impairment 

Pomalyst is metabolized in the liver. Pomalyst and its metabolites are excreted by the kidneys. The influence of renal (kidney) and hepatic (liver) impairment on the safety, efficacy, and pharmacokinetics (PK) of Pomalyst has not been evaluated. Pomalyst should not be taken by the following patients: 

• Patients whose serum creatinine is > 3.0 mg/dL. 
• Patients whose serum bilirubin is > 2.0 mg/dL. 
• Patients whose AST/ALT liver enzymes ratio in the blood is > 3.0 x ULN  (upper limit of normal). 

Hypersensitivity reactions 

Patients with a prior history of serious sensitivity to thalidomide 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 the following: 

• difficulty breathing 
• rash 
• hives 
• fever 
• swelling 
• vomiting 
• diarrhea 

Treatment is largely supportive and includes discontinuation of the medication and treatment of the symptoms. Contact your healthcare provider immediately if you experience any symptoms after taking Pomalyst. 

Drug interactions 

No formal drug interaction studies have been conducted with Pomalyst, but patients should not take Pomalyst with drugs that are strong inhibitors of CYP1A2, CYP3A, or P-gp. Cigarette smoking may reduce the efficacy of Pomalyst due to CYP1A2 activation. Any concerns or questions about possible drug interactions or smoking should be discussed with your doctor. 

Age 

Safety and effectiveness of Pomalyst in patients under the age of 18 have not been established. No dosage adjustment is required for Pomalyst based on age. However, clinical trial patients aged 65 years or older were more likely to experience pneumonia than patients younger than age 65. 

Second primary malignancy 

Cases of acute myelogenous leukemia (AML) have been reported in patients receiving Pomalyst in clinical trials, although none of these were patients in myeloma trials. 

Possible Side Effects of Pomalyst

Possible side effects of Pomalyst include low blood cell counts, unusual tiredness or physical weakness, nausea, back pain, neuropathy, upper respiratory infection or pneumonia, constipation, diarrhea, fever, dizziness and confusion, and shortness of breath.

Tell your doctor about any side effects that bother you or that do not go away. Make sure you know how to get in touch with your doctor after office hours, on the weekend, and over a holiday.

In a clinical trial of 219 patients who received Pomalyst alone or the Pd combination therapy, all patients experienced at least one side effect. 

The most common side effects occurring in 30% or more of patients included the following: 

• asthenia 
• neutropenia 
• anemia 
• constipation 
• nausea 
• diarrhea 
• difficulty breathing 
• upper respiratory tract infection 
• back pain 
• fever 

The most common serious side effects were low blood counts and pneumonia. Your doctor may decide to interrupt your treatment with Pomalyst until your side effect resolves, then restart it at a lower dose. 

Dizziness and confusion 

In the clinical trial that led to FDA approval of Pomalyst, 18% of patients experienced dizziness and 12% of patients experienced some mental confusion. 

Prevention of dizziness and confusion 

Patients should be aware that dizziness and confusion are potential side effects and should avoid situations where this would pose a risk to or problem for themselves or others. You must discuss all your medications with your doctor because dizziness and confusion may be caused by other medications you are taking. 

Neuropathy 

Symptoms of neuropathy that affect the sensory and motor nerves include numbness, tingling, and pain in the hands or feet, which 18% of patients experienced in the clinical trial of Pomalyst. Symptoms of neuropathy that affect the autonomic nervous system include dizziness and fainting. There were no cases of serious neuropathic side effects. 

Prevention and treatment of neuropathy 

We strongly urge you to contact your doctor if you experience new or worsening symptoms of this condition. Many myeloma patients have underlying neuropathy from their disease before they are diagnosed and treated for myeloma. Early detection and dose modification can prevent progression of neuropathy. For more information, read the IMF’s publication Understanding Peripheral Neuropathy in Myeloma. 

Fatigue 

Fatigue caused by cancer or cancer treatment is a distressing, persistent, subjective sense of tiredness or exhaustion that is not proportional to recent activity and interferes with usual functioning. 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. 

Prevention and treatment of fatigue  

If your fatigue is severe, your doctor may have to intervene with appropriate supportive care measures. There are medications to treat this problem. The effects of fatigue may be minimized by maintaining: 

• A moderate level of activity (because inactivity breeds greater fatigue). 
• A healthy diet and proper fluid intake. 
• A consistent sleeping schedule with enough rest. 
• Regularly scheduled visits with your healthcare providers to discuss your fatigue issues. 

For more information, read the IMF’s publication Understanding Fatigue. 

Asthenia 

Asthenia is a condition in which the body lacks or has lost strength either as a whole or in any of its parts. It is a common complication of a number of drugs that are used to treat myeloma, and of cancer treatments in general. 

Prevention and treatment of asthenia 

First and easiest, try taking your Pomalyst at night before you go to bed in order to limit the side effects to the hours when you’re asleep. If you are still experiencing asthenia during your waking hours, your doctor may reduce your dose of Pomalyst or may prescribe medication to be taken in the mornings that may help you be more active during the day. Finally, asthenia may improve by itself with prolonged therapy or may improve as your myeloma disease burden is decreased. 

Thrombocytopenia 

Thrombocytopenia is a low number of platelets in the blood. Platelets help blood to clot; fewer platelets can lead to easier bruising, bleeding, and slower healing. The “normal” level of platelets varies from laboratory to laboratory. For example, the “normal” level is 150,000 or more platelets per microliter of circulating blood. If the platelet count is less than 50,000, bleeding problems could occur. Major bleeding is usually associated with a reduction to less than 10,000. 

Prevention and treatment of thrombocytopenia 

You should inform your doctor if you experience excessive bruising or bleeding. Management may include platelet transfusions at the discretion of your doctor. 

Anemia 

Red blood cells contain hemoglobin, a protein that carries oxygen to the body’s tissues and organs. Anemia is usually defined as a decrease in hemoglobin < 10 g/dL or as a decrease of ≥ 2 g/dL from the normal level for an individual. More than 13–14 g/dL is considered normal. Low levels of oxygen in the body may cause shortness of breath and feelings of exhaustion. Many newly diagnosed myeloma patients have anemia. 

Prevention and treatment of anemia 

In addition to lowering the dose of Pomalyst, if this is deemed appropriate, your doctor may determine that a treatment regimen for anemia may be best suited and safest for you. 

The following are options for treatment of anemia: 

• adjusting medications 
• blood transfusions 
• erythropoietic (red blood cell-making) agents 

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