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Treatment Name: Blinatumomab (Blincyto®)

Blinatumomab (Blincyto®) is a Chemotherapy Regimen for Acute Lymphoid Leukemia (ALL)

How does Blinatumomab work?
Blinatumomab is known as a Bispecific T-cell Engager or a BiTE antibody. One part of the antibody will attach to a healthy T-cell and the other part of the antibody will attach to a leukemia cell. This brings both cells close together and allows the healthy T-cell to focus on and kill the leukemia cell.

Goals of therapy:
Blinatumomab is given to kill leukemia cells and restore normal bone marrow activity. Blinatumomab is given with the goal of achieving disease remission, and possibly a cure. If remission is achieved, some patients may receive a bone marrow transplant with the goal of cure.

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Schedule

  • Blinatumomab is an intravenous (I.V.) infusion, usually given as a continuous 24-hour infusion on Days 1 - 28 of Cycles 1, 2, 3, 4, and 5

Hospital stay required

  • Blinatumomab requires at least a 9-day stay in a hospital for Cycle 1, and a 2-day stay in a hospital for Cycle 2.
  • Once patients leave the hospital, they will then have their infusion bag changed every 24 or 48 hours in an outpatient clinic or by a home infusion company for the remainder of the cycle
  • Cycles 3, 4, 5, and 6 do not require a hospital stay and the entire treatment is completed at home, if tolerated

Blinatumomab is repeated every six weeks (four weeks receiving the drug: two weeks of no drug infusion). This is known as one Cycle. Typically, two cycles of therapy are initially offered. If it is tolerated and disease remission is achieved, patients may continue to receive up to five total cycles or proceed to bone marrow transplant.

Click here for common starting doses.

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Side Effects

In clinical studies, the most commonly reported side effects with blinatumomab are shown here:

  • Fever (60%)
  • Neutropenic fever 25%)
  • Nausea (25%)
  • Low blood potassium (24%)
  • Anemia [low red blood cells] (20%)
  • Constipation (20%)
  • Low white blood cells (17%)
  • Muscle twitching (17%)
  • Fatigue (17%)
  • Dizziness (14%)
  • High blood sugar (13%)
  • Increased bleeding risk [low platelets] (8%)
  • Pneumonia (10%)
  • Confusion (7%)
  • Blood stream infection (7%)
  • Altered consciousness (5%)
  • Loss of coordination (5%)
  • Trouble speaking (4%)
  • Seizure (2%)

On average, 18% of patients discontinue blinatumomab due to unacceptable side effects.

Side effect videos Side Effect Videos
Neutropenic FeverNeutropenic FeverNausea and VomitingNausea and VomitingAnemiaAnemiaConstipationConstipationFatigue Fatigue BleedingBleeding

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Monitoring

How often monitoring needed?
Labs (blood tests) may be checked before treatment and periodically during treatment. 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 before treatment and then periodically during treatment to assess any possible side effects. Imaging may include: computerized tomography (CT) scans or magnetic resonance imaging (MRI).

How might blood test results/imaging affect treatment?
Depending upon the results after two cycles of therapy, your doctor may advise to continue chemotherapy as planned, or delay or switch therapy.

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ChemoExperts Tips

  • Allopurinol may be prescribed for the first cycle of chemotherapy to help prevent tumor lysis syndrome
  • Dexamethasone is given every cycle one hour before blinatumomab starts. It is also given one hour before the first time the higher dose of blinatumomab is started on Day 8 of Cycle 1
  • If you experience problems with your infusion device (pump), contact the clinic or home health care company IMMEDIATELY. Blinatumomab should not be interrupted for more than four hours. If the infusion is interrupted for more than four hours, you must be given a dose of dexamethasone and directly observed by a health care professional
  • Blinatumomab may cause a wide variety of neurological symptoms that may not happen until a week after therapy is first started. Some of these symptoms include headache, altered consciousness, trouble speaking, confusion, loss of coordination, trouble with balance, and seizures. To test for early signs of these problems, various neurological tests are done periodically during treatment
  • Typically, filgrastim (Neupogen®) or pegfilgrastim (Neulasta®) is given after chemotherapy to stimulate production of white blood cells and avoid periods of neutropenia (low white blood cell count)
  • Antibiotics, antifungal agents, and antiviral medications are commonly used to prevent infection. Be sure to tell your doctor if you experience discomfort anywhere as this may be a clue to an infection
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for ALL. 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 Blinatumomab (Blincyto®), 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 Blinatumomab (Blincyto®). Depending upon your income, they may be able to help cover the cost of:

  • Blinatumomab

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 Blinatumomab (Blincyto®) 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 Blinatumomab (Blincyto®)

Individual Drug Label Information

Blinatumomab (Blincyto®)

  • Blinatumumab is a continuous intravenous (I.V.) infusion 
  • FDA Black Box Warning for cytokine release syndrome. Some symptoms include fever, nausea, low blood pressure, fluid accumulation (build up), nausea, headache, and liver injury. Blinatumomab may need to be interrupted or discontinued if these are experienced 
  • FDA Black Box Warning for various neurological effects including, but not limited to, headache, altered consciousness, trouble speaking, confusion, loss of coordination, trouble with balance, and seizures. Blinatumomab may need to be interrupted or discontinued if these are experienced 
  • Dosage adjustments may be required for various side effects if experienced 
General Blinatumumab (Blincyto) Side Effects 
  • Infections are common. Preventative antibiotics may be started to avoid an infection from occurring 
  • May cause temporary liver injury. Liver function will be monitored periodically during treatment 
  • May cause low white blood cells, red blood cells, and platelets 
  • Click on the blinatumumab (Blincyto) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingFatigue Fatigue BleedingBleedingConstipationConstipationAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

1. Topp MS, Gökbuget N, Zugmaier G, et al. Phase II trial of the anti-CD19 bispecific T cell-engager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory B-precursor acute lymphoblastic leukemia. J Clin Oncol. 2014;32:4134-4140.

2. Topp MS, Gökbuget N, Stein AS, et al. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015;16:57-66.

Created: September 7, 2015 Updated: December 11, 2016

What is Acute Lymphoid Leukemia (ALL)?

Acute Lymphoid Leukemia (ALL), also known as acute lymphoblastic leukemia, is a disease of the lymphoid cells found in the bone marrow. Lymphoid cells are responsible for developing into cells of the immune system called B-cells, T-cells, or Natural Killer cells. In ALL, immature lymphoid cells know as "blasts" replicate at a very fast rate. Sometimes blasts crowd out the normal cells in the bone marrow so that red blood cells or platelets are unable to develop.

Common symptoms of ALL include fatigue, infection, and bruising or bleeding. ALL is the most common cancer diagnosed in children, but is rare in adults. Most cases of ALL are considered "de novo" meaning that the cause is unknown; however, some cases can be linked to certain genetic syndromes. There is no staging system for ALL. Chromosomes are often analyzed to determine which mutations in the chromosomes exist. The effectiveness of the treatment may depend upon the specific chromosome mutations that are present.

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 your therapy.

Clinical Trial Results

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

1. Topp MS, Gökbuget N, Zugmaier G, et al. Phase II trial of the anti-CD19 bispecific T cell-engager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory B-precursor acute lymphoblastic leukemia. J Clin Oncol. 2014;32:4134-4140.

2. Topp MS, Gökbuget N, Stein AS, et al. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015;16:57-66.

What is Tumor Lysis Syndrome?

Tumor lysis syndrome occurs when many cancer cells die quickly and release their contents into the bloodstream. Many times the body has the ability to flush these substances out through the kidneys or metabolize them via the liver. However, sometimes the body needs medicines to help eliminate these substances and to prevent organ damage.

Common Starting Doses

  • Blinatumomab 9 mcg/day given as a 24-hour continuous I.V. infusion on Days 1 - 7 of Cycle 1
  • Blinatumomab 28 mcg/day given as a 24-hour continuous I.V. infusion on Days 8 - 28 of Cycle 1
  • Blinatumomab 28 mcg/day given as a 24-hour continuous I.V. infusion on Days 1 - 28 of Cycles 2 - 5

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.

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

1. Coiffier B, L epage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346:235-242.
2. Habermann TM, Weller EA, Morrison VA, et al. Rituximab-CHOP versus CH OP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol. 2006;24:3121-3127.
3. Flinn IW, van der Jagt R, Kahl BS, et al. Randomized trial of bendamustine-rituximab or R-CHOP/R-C VP in first-line treatment of indolent NH L or MCL : the BRIGHT study. Blood. 2014;123:2944-2952.
4. Pfreundschuh M1, Müller C, Zeynalova S et al. Suboptimal dosing of rituximab in male and female patients with DLBCL. Blood. 2014; 123:640-646.