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Treatment Name: Pomalidomide (Pomalyst®)

Pomalidomide (Pomalyst®) is a Chemotherapy Regimen for Multiple Myeloma (MM)

How does pomalidomide work?
It is designed to kill or slow the growth of myeloma cells.

Goals of therapy:
Pomalidomide is given to decrease symptoms and slow the progression of multiple myeloma. It is not commonly given with the goal of cure.

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Schedule

  • Pomalidomide 4 mg by mouth daily for 21 days continuously, on Days 1 - 21 of a 28-day Cycle
  • Dexamethasone 40 mg (ten 4 mg tablets) by mouth on Days 1, 8, 15 and 22
    OR
  • Dexamethasone 20 mg (five 4 mg tablets) by mouth on Days 1, 8, 15 and 22

Pomalidomide is a human teratogen. In order to decrease the risk of embryo-fetal exposure, pomalidomide is available only through a restricted distribution program (Pomalyst REMS) and is dispensed by a specialty pharmacy enrolled in the R.E.M.S. Program

Pomalidomide is given for 3 consecutive weeks, followed by one week off, for a 28-day Cycle. Typically, therapy with pomalidomide is continued until the drug no longer works or unacceptable toxicity is experienced.

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Side Effects

In clinical studies, the most commonly reported side effects with pomalidomide are shown here. Side effects sometimes have percentage ranges [example: 41 – 65% have low white blood cells] because they differed between clinical studies:

  • Low white blood cells (41 - 65%)
  • Fever (27%)
  • Anemia [low red blood cells] (22 - 52%)
  • Diarrhea (22%)
  • Constipation (22%)
  • Cough (20%)
  • Increased bleeding risk [low platelets] (19 - 30%)
  • Fluid accumulation, swelling (17%)
  • Sinus infection (16%)
  • Muscle spams (16%)
  • Nausea (15%)
  • Bone pain (14 - 17%)
  • Fatigue (14 - 34%)
  • Trouble breathing (12 - 20%)
  • Dizziness (12%)
  • Back pain (10 - 20%)
  • Urinary tract infection (9%)
  • Pneumonia (7 - 22%)
  • Kidney failure (5 - 16%)
  • Blood stream infection (5%)

On average, 2% - 9% of patients discontinue pomalidomide due to unacceptable side effects.

Side effect videos Side Effect Videos
DiarrheaDiarrheaConstipationConstipationNausea and VomitingNausea and VomitingFatigue Fatigue Blood ClotsBlood ClotsPainPainNeutropenic FeverNeutropenic FeverAnemiaAnemiaBleedingBleeding

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, weekly during the first eight weeks of treatment, then every two weeks for up to two months, then once per month thereafter. Bone marrow biopsies (samples) are done before starting treatment, after 12 weeks, after 24 weeks, then every 24 weeks thereafter and when disease progresses (gets worse). Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order. 

How often is imaging needed?
Imaging may be checked if there is concern for an infection or internal bleeding. Imaging may include: computerized tomography (CT) scans, Doppler ultrasound, and X-rays.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to decrease your dose, continue pomalidomide as planned, delay, or switch therapy.

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ChemoExperts Tips

  • Report any unusual reactions to this medication to your cancer doctor, especially since this medication is taken at home
  • If a female patient becomes pregnant or a male partner taking this drug impregnates a female, report to your cancer doctor immediately
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for Multiple Myeloma. Ask your doctor if any studies are currently enrolling in your area or go to clinicaltrials.gov and search “Multiple Myeloma” to find other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Pomalidomide (Pomalyst®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Pomalidomide (Pomalyst®). Depending upon your income, they may be able to help cover the cost of:

  • Pomalidomide

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Pomalidomide (Pomalyst®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Pomalidomide (Pomalyst®)

Individual Drug Label Information

Pomalidomide (Pomalyst)

  • Pomalidomide is an oral capsule available in 1 mg, 2 mg, 3 mg, and 4 mg strengths 
  • Can be taken on an empty stomach with a large glass of water. Do not eat two hours before and until two hours after taking a dose. Swallow capsule whole and do not break, open, or chew 
  • If you miss a dose, take it as soon as possible ONLY if it is within 12 hours since the dose should have been taken, then return to the normal schedule. If it is already been past 12 hours since the dose should have been taken, do not take the dose. Wait until your next dose is due 
  • Store at room temperature 
  • Dosage adjustments may be required for liver function, low platelets, or low white blood cells 
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions 
  • May interact with grapefruit and grapefruit juice causing increased blood levels of pomalidomide. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment 
  • Avoid therapy with St. Johns Wort as it will decrease blood levels of pomalidomide. This could decrease the effectiveness of pomalidomide 
  • Smoking while on therapy with pomalidomide may reduce its effectiveness. Talk to your doctor or pharmacist about smoking cession and available nicotine replacement therapies 
General Pomalidomide (Pomalyst) Side Effects 
  • Low white blood cells and platelets are common during therapy. Your dose of pomalidomide may need to be adjusted to held for a period of time 
  • Pomalidomide causes a higher chance of developing a blood clot, especially when used with dexamethasone. An “blood thinner” such as aspirin or warfarin may be used to decrease the risk of a clot forming 
  • Nerve pain in hands or feet may occur. Tell your doctor if you are experiencing these symptoms  
  • Although rare, pomalidomide may increase your risk of developing secondary cancers such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)  
  • Click on the pomalidomide (Pomalyst) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemiaNeutropenic FeverNeutropenic FeverBlood ClotsBlood Clots

See DailyMed package insert.

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References

1. Leleu X, Attal M, Arnulf B, et al. Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide–refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02. Blood. 2013;121:1968-1975.

2. Richardson PG, Siegel DS, Vij R, et al. Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. Blood. 2014;123:1826-1832.

3. San Miguel J, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14:1055-1066.

Created: September 5, 2015 Updated: September 10, 2018

What is Multiple Myeloma (MM)?

Multiple Myeloma is a disease of the white blood cells, called plasma cells, found in the blood or bone marrow. Plasma cells are a type of white blood cell known as a B-lymphocyte.

Sometimes plasma cells form collections on bone and weaken or destroy it. These are known as "lytic lesions". Multiple Myeloma is a rare condition with an unknown cause. The stage can vary at diagnosis and throughout treatment. Staging is based on the international staging system (ISS). The type and effectiveness of the treatment may depend upon the stage.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is a teratogen?

A drug that is known to cause severe birth defects or fetal death. These drugs should NOT be used during pregnancy and patients should avoid becoming pregnant while taking these drugs.

Women, if taking a teratogenic medication, should abstain from heterosexual intercourse or use two forms of reliable contraception at least 4 weeks prior to, during, and for 4 weeks after treatment.

Males (even after vasectomy), if taking a teratogenic medication, must use a latex or synthetic condom during any sexual contact with women of childbearing potential and must not donate sperm for up to 28 days following discontinuation of therapy.

What is the Pomalyst R.E.M.S. Program?

REMS stands for Risk Evaluation and Mitigation Strategy. This program requires that all patients must sign a Patient-Physician agreement form acknowledging pregnancy risks before starting treatment.

If you are female who can get pregnant, you must have 2 negative pregnancy tests before starting thalidomide and will have pregnancy tests performed periodically throughout treatment. Thalidomide is only dispensed from certain pharmacies and the pharmacy will contact you before every prescription is dispensed.

A confidential survey must also be taken every month before thalidomide can be dispensed.

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1. Leleu X, Attal M, Arnulf B, et al. Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide–refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02. Blood. 2013;121:1968-1975.

2. Richardson PG, Siegel DS, Vij R, et al. Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. Blood. 2014;123:1826-1832.

3. San Miguel J, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14:1055-1066.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.