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Treatment Name: Lenalidomide (Revlimid®)

Lenalidomide (Revlimid®) is a Chemotherapy Regimen for Myelodysplastic Syndromes (MDS)

How does Lenalidomide work?
Lenalidomide is designed to help the bone marrow produce more healthy and normal functioning cells. It is particularly effective in patients with MDS who are missing a piece of one of their chromosomes. This is known as “deletion 5q”. 

Goals of therapy: 
Lenalidomide is taken to help increase blood cell counts, reduce the amount of blood transfusions needed, and to prevent MDS from transforming to acute leukemia. Lenalidomide is not commonly given with the goal of cure for MDS. 

Schedule

  • Usual starting dose: Lenalidomide 10 mg oral capsule by mouth once daily for 21 days in a 28-day Cycle

Lenalidomide is dispensed by a specialty pharmacy in the R.E.M.S. Program and taken at home. Some patients may have doses for all 28 days or others may have seven days off to allow for blood cell counts to build back up (recover). This drug is taken until it no longer works or unacceptable side effects occur.

Side Effects

In clinical studies, the most commonly reported side effects with lenalidomide are shown here. Side effects sometimes have percentage ranges [example 55 – 75%] because they differed between in clinical studies:

Side effect videos Side Effect Videos
AnemiaAnemiaBlood ClotsBlood ClotsFatigue Fatigue Nausea and VomitingNausea and VomitingDiarrheaDiarrheaBleedingBleeding

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, weekly during the first 8 weeks of treatment, then every 2 weeks for 8 weeks, then every 4 weeks thereafter. Bone marrow biopsy (sample) 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 lenalidomide as planned, delay, or switch therapy.

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 MDS. Ask your doctor if any studies are currently enrolling in your area or go to clinicaltrials.gov and search “myelodysplastic syndrome” or "MDS" 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 Lenalidomide (Revlimid®), 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 Lenalidomide (Revlimid®). Depending upon your income, they may be able to help cover the cost of:

  • Lenalidomide

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 Lenalidomide (Revlimid®) 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 Lenalidomide (Revlimid®)

Individual Drug Label Information

Lenalidomide (Revlimid®)

  • Lenalidomide is a capsule
  • Is not to be used during pregnancy; it may cause human embryo toxicity and birth defects. Females must avoid pregnancy while taking this and for 4 weeks after finishing therapy 
  • Is only available through the R.E.M.S. program, which is Risk Evaluation and Mitigation Strategy http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm 
  • Women should not breast feed while on this drug
  • Can cause severe low white blood cells and platelet cell counts. Patients who have “del 5q myelodysplastic syndromes” should have complete blood counts (CBC) monitored every week for the first eight weeks of treatment
  • Patients may require dose decreases and periodic stopping of doses for low blood cell counts, poor kidney function, or other reasons
  • Some patients may require growth factors to help stimulate blood cell production
  • Patients are at increased risk of blood clots in limbs (DVT- deep vein thrombosis) or lungs (PE- pulmonary embolism), as well as risk for heart attack and stroke.  A "blood thinner" such as aspirin or warfarin may be prescribed to decrease risk of clots
  • Is swallowed whole with or without food and with a large glass of water; take at the same time every day
  • If you miss a dose and it’s less than 12 hours late, take the dose.  If it’s more than 12 hours late skip the dose.  Do not take two doses at the same time
  • This capsule contains lactose.  Patients should advise their physician if they are lactose intolerant
  • Do not open capsules.  If powder from capsule touches skin, wash immediately with soap and water
  • Should be stored at controlled room temperature
  • May interact with digoxin, estrogen containing therapies, and erythropoietin
  • Has been linked to the development of other cancers in a small number of people
  • Do not donate blood during therapy and for one one month after completion of therapy
General Lenalidomide (Revlimid) Side Effects
  • Low while blood cells
  • Low platelet cells
  • Blood clots
  • Bleeding
  • Diarrhea
  • Constipation
  • Itching
  • Cough or shortness of breath
  • Skin rash
  • Pain
  • Nausea
  • Fatigue, dizziness
  • Muscle cramps
  • Low red blood cells
  • Swelling of arms and legs
  • Liver toxicity
  • Allergic reactions
  • Tumor Lysis Syndrome (TLS)
  • Click on the lenalidomide (Revlimid) package insert below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemiaNeutropenic FeverNeutropenic FeverBlood ClotsBlood Clots

See DailyMed package insert.

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References

1. List A, Dewald G, Bennett J, et al. Lenalidomide in the Myelodysplastic Syndrome with Chromosome 5q Deletion. N Engl J Med 2006;355:1456-65.

2. Fenaux P, Giagounidis A, Selleslag D, et al. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood 2011;118:3765-76.

Created: October 6, 2015 Updated: September 10, 2018

What is Myelodysplastic Syndromes (MDS)?

Myelodysplastic Syndromes (MDS) are a group of blood disorders where the bone marrow either fails to make mature blood cells, or immature cells build up and crowd out normal cells preventing them from developing normally.

This often results in the bone marrow producing too few blood cells leading to: 1) A low white blood cell count (neutropenia), which can increase the risk of infection; 2) A low red blood cell count (anemia), which may contribute to weakness, fatigue, or shortness of breath; or 3) A low platelet count (thrombocytopenia), which can increase the risk of bleeding. Depending upon the type of MDS, some patients have neutropenia, AND anemia, AND thrombocytopenia.

In newly diagnosed cases of MDS, the causes are not always known. This is sometimes referred to as “de novo” MDS. However, exposure to certain chemicals, radiation, and chemotherapy are known to increase the risk of MDS. When causes are known, this is referred to as "secondary MDS." There are various subtypes of MDS and treatment depends on the specific subtype and risk level. High risk patients may be treated more aggressively than low risk patients. The effectiveness of treatment often depends upon the type of MDS as not all types respond the same way to treatment.

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.

R.E.M.S. Program

The R.E.M.S. program, which is Risk Evaluation and Mitigation Strategy, is an FDA (Food and Drug Administration) program that manages drugs known to cause potential serious risks. To make sure the benefits of these special drugs outweigh the risks, the FDA only allows designated pharmacies and doctors to dispense and prescribe these medications. There are many rules and regulations guiding the use of these drugs. This weblink to the FDA website will tell you more: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

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.