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Treatment Name: Luspatercept (Reblozyl®)

Luspatercept (Reblozyl®) is a Treatment Regimen for Myelodysplastic Syndromes (MDS)

How does luspatercept work?

Luspatercept binds to proteins in the blood that often cause decreased production of red blood cells by the bone marrow. When luspatercept binds to these proteins, they cannot function properly, and the bone marrow is able to make red blood cells more easily.

Goals of therapy:

Luspatercept given to treat anemia caused by MDS by increasing the amount of red blood cells in the blood so the need for blood transfusions decreases. Luspatercept is not given with the goal of cure.

Schedule

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How is luspatercept therapy for MDS given?

  • Luspatercept subcutaneous (SubQ) injection once every 3 weeks
    • If your need for blood transfusions doesn’t decrease after 6 weeks, your dose of luspatercept may increase
    • If your hemoglobin increases too rapidly in-between treatments, your dose of luspatercept may need to be decreased

Luspatercept is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, it may be given in the hospital if someone is too sick.

Luspatercept is repeated every 21 days. This is known as one Cycle. Each cycle may be repeated until the treatment no longer works or until unacceptable side effects occur. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.

Click here for the common luspatercept starting doses.

Side Effects

What are the most common side effects from luspatercept for MDS?

In clinical studies, the most commonly reported side effects of luspatercept are shown here:

  • Fatigue (27%)
  • Diarrhea (22%)
  • Weakness (20%)
  • Dizziness (20%)
  • Nausea (20%)
  • Back pain (19%)
  • Cough (18%)
  • Headache (16%)
  • Swelling in arms and legs (16%)
  • Shortness of breath (15%)
  • Constipation (11%)
  • Lung inflammation (11%)
  • Urinary tract infection [UTI] (11%)
  • Joint pain (5%)

On average, 8% of patients discontinue treatment due to unacceptable side effects.

Importantly, not all people who experience a side effect from luspatercept will experience it in the same way. It may be mild in some or severe in others, depending upon the individual. Everybody is different. Additionally, side effects may vary over time. For some, side effects may be a reason to delay or switch treatment, reduce the dose, or avoid treatment with a certain medication altogether.

Side effects may be treatable when they occur or preventable by taking certain medications before they happen. When medications are taken to prevent a problem, this is known as prophylaxis, or "prophy" for short.

After starting treatment with luspatercept, be sure to come back and watch all of the side effect videos shown below. Each of these videos contain valuable information about side effect management that will hopefully help you to both feel better and stay out of the hospital.

Watch videos on common luspatercept therapy side effects below

Side effect videos Side Effect Videos
Fatigue Fatigue DiarrheaDiarrheaNausea and VomitingNausea and VomitingPainPainConstipationConstipation

Monitoring

How often is monitoring needed?

Labs (blood tests) may be checked before each treatment. Labs often include: Complete Blood Count (CBC) plus any others your doctor may order. Your blood pressure is also typically checked prior to each treatment.

How often is imaging needed?

Imaging is not typically needed unless there are concerns for certain side effects. If imaging is needed, it may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans.

How might blood test results/imaging affect treatment?

Depending upon the results, your doctor may advise to continue luspatercept as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

What are the most important things to know about luspatercept while receiving therapy?

  • Luspatercept may cause your blood pressure to increase while on therapy. Your blood pressure will be checked before each injection. If your blood pressure is too high, you may have to be started on medications to control your blood pressure or if you are already on these types of medications, they may need to be adjusted
  • 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. If not, go to clinicaltrials.gov to search for 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 Luspatercept (Reblozyl®), 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 Luspatercept (Reblozyl®). Depending upon your income, they may be able to help cover the cost of:

  • Luspatercept

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 Luspatercept (Reblozyl®) 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 Luspatercept (Reblozyl®)

Individual Drug Label Information

Luspatercept (Reblozyl®)

  • Is a subcutaneous (SubQ) injection
  • Injections may be given in the upper arm, thigh, or abdomen
  • Dosage adjustments may be required to achieve desired response, if blood hemoglobin rises too fast, or if serious side effects occur
  • May cause fetal harm if given while pregnant. Use effective contraception during therapy and or at least 3 months after stopping therapy
  • Do not breastfeed during therapy and or at least 3 months after stopping therapy
General side effects from luspatercept
  • Fatigue and weakness
  • Diarrhea or constipation
  • Dizziness
  • Nausea
  • Back pain
  • Headache
  • Swelling in arms and legs
  • Shortness of breath and cough
  • Joint pain
  • Click on the luspatercept (Reblozyl®) package insert below for reported side effects, possible drug interactions, and other luspatercept prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPain

See DailyMed package insert.

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References

1) Fenaux P, Platzbecker U, Mufti GJ, et al. Luspatercept in Patients With Lower-Risk Myelodysplastic Syndromes. N Engl J Med 2020;382(2):140-151

Created: September 3, 2020 Updated: September 3, 2020

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.

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.

Common Starting Doses

  • Typical starting dose: 1 mg/kg subcutaneous (SubQ) injection once every 3 weeks
    • If your need for blood transfusions doesn’t decrease after 6 weeks, your dose of luspatercept may increase
    • If your hemoglobin increases too rapidly inbetween treatments, your dose of luspatercept may need to be decreased

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

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.