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Treatment Name: Acalabrutinib (Calquence®) + Obinutuzumab (Gazyva®)

Acalabrutinib (Calquence®) + Obinutuzumab (Gazyva®) is a Treatment Regimen for Chronic Lymphocytic Leukemia (CLL)

How does acalabrutinib (Calquence®) + obinutuzumab (Gazyva®) for chronic lymphoid leukemia (CLL) work?

Acalabrutinib is a small molecule inhibitor of Bruton tyrosine kinase (BTK). By blocking BTK, acalabrutinib is designed to help slow or stop the growth of new cancer cells. Acalabrutinib is a type of targeted therapy.

Acalabrutinib-calquence-mechanism-of-action-image.

Obinutuzumab is designed to bind to a specific protein on the surface of cancerous cells, specifically B-lymphocytes, and target these cells for destruction by your own immune system. The binding alone of obinutuzumab to the CLL cell may be enough to cause direct leukemia cell death. Obinutuzumab is a type of immunotherapy.

Primary-mechanism-of-action-obtinutuzumab-Gazyva-for-CLL-direct-cell-death-and-complement-mediated-pathways-image.jpg.         

What are the goals of acalabrutinib (Calquence®) + obinutuzumab (Gazyva®) therapy?

Acalabrutinib plus obinutuzumab treatment is given to decrease symptoms of CLL such as enlarged or swollen lymph nodes, enlarged liver or spleen, or symptoms of abnormal bone marrow function, such as frequent infections. Acalabrutinib and obinutuzumab are given in combination with the goal of keeping CLL in remission for months or even years.

What are other names for this treatment?

Calquence® + Gazyva®, AO, CG

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How are Acalabrutinib and Obinutuzumab taken by the patient?

  • Acalabrutinib is an oral capsule commonly taken at home
  • Obinutuzumab is an intravenous (I.V.) infusion usually given in an outpatient infusion center, allowing the person to go home after treatment. On occasion, it may be given in the hospital setting if someone is too sick.

Cycle 1 (Days 1 - 28)

  • Acalabrutinib 100 mg capsule by mouth twice every day for 28 days in a row, approximately 12 hours between doses

Cycle 2 (begins on Day 29; cycle length is 28 days)

  • Acalabrutinib 100 mg capsule by mouth twice every day, approximately 12 hours between doses. Take capsule before obinutuzumab when having both on the same day
  • Obinutuzumab
    Day 1: Obinutuzumab 100 mg IV over four hours
    Day 2: Obinutuzumab 900 mg IV over four or more hours (4 hours if no infusion reactions, more time if reactions occur)
    Day 8: Obinutuzumab 1000 mg IV over four or more hours
    Day 15: Obinutuzumab 1000 mg IV over four or more hours

Cycles 3 through 7 (Cycle 3 begins on Day 57; cycle length is 28 days)

  • Days 1 - 28: Acalabrutinib 100 mg capsule by mouth twice every day, approximately 12 hours between doses. Take capsule before obinutuzumab when having both on the same day
  • Day 1: Obinutuzumab 1000 mg IV over four or more hours

Cycles 8 +

  • Acalabrutinib 100 mg capsule by mouth twice every day, approximately 12 hours between doses
  • No Obinutuzumab

Estimated total infusion time for Obinutuzumab:

  • Obinutuzumab infusion times are based on clinical studies and wil vary depending doctor preference or patients' tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time.  The IV infusions start as short as 4 hours and can extend several hours longer if reactions occur. See our section on the individual drug, obinutuzumab, below for more on infusion reactions

Estimated duration of acalabrutinib treatment:

  • Acalabrutinib is taken continuously until disease progression or unacceptable toxicity
  • Acalabrutinib capsules should be swallowed whole with water. Acalabrutinib can be taken with or without food. Capsules should not be opened, broken apart or chewed. If a dose is missed by more than 3 hours, it should be skipped and the next dose taken at the regular time. Extra doses should not be taken for a missed dose

Side Effects

What are the most common side effects from acalabrutinib and obinutuzumab for CLL?

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported side effects (any Grade) of acalabrutinib + obinutuzumab are shown here:

A note about side effect percentages

In one clinical study, 11% of patients discontinued treatment due to unacceptable side effects.

Importantly, not all people who experience a side effect from (Calquence®) acalabrutinib + obinutuzumab (Gazyva®) 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 acalabrutinib + obinutuzumab, 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 acalabrutinib + obinutuzumab therapy side effects below

Side effect videos Side Effect Videos
DiarrheaDiarrheaNausea and VomitingNausea and VomitingBleedingBleedingAnemiaAnemiaNeutropenic FeverNeutropenic Fever

Monitoring

How often is monitoring for acalabrutinib plus obinutuzumab needed?

  • Labs (blood tests) may be checked before acalabrutinib + obinutuzumab treatment cycles and in between cycles at the discretion of your doctor. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), Lactate Dehydrogenase (LDH), phosphorous, uric acid, IgG level, plus any others your doctor may order
  • Baseline screening for Atrial fibrillation (commonly called "A-fib") or flutter may be needed. Risk may be increased in patients with heart risk factors, hypertension, previous heart rhythm problems, and acute infection
  • Because acalabrutinib can cause bruising or bleeding, a baseline measurement of your body's blood clotting ability may be needed. These tests commonly include the PT (Prothrombin Time) and the aPTT (activated Partial Thromboplastin Time)
  • Tumor lysis syndrome is rare, but may occur. Depending on baseline uric acid level and LDH level, the drug, allopurinol, may need to be taken to help your kidneys eliminate uric acid
  • CLL may increase the risk of infection risk. For certain patients with a history of severe infection, and a low IgG level, intravenous immune globulin, or "IVIG," may be offered to decrease the risk of infection.

How often is imaging needed?

Imaging may be checked before treatment begins, or as recommended by your doctor. Imaging may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans. Re-imaging scans may be recommended every few months to assess response to therapy.

How might blood test results/imaging affect acalabrutinib plus obinutuzumab treatment?

Depending upon the results, your doctor may advise to continue acalabrutinib + obinutuzumab 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 6 most important things to know about acalabrutinib and obinutuzumab when receiving therapy?

  • Premedications such as diphenhydramine (Benadryl®), acetaminophen (Tylenol®), and methylprednisolone (Solu-Medrol®) may be given before obinutuzumab to help avoid infusion related reactions
  • The first dose of obinutuzumab is often the hardest. It may lead to fever, shaking, and chills even if premedications are given to help prevent this. Reactions generally go away when the obinutuzumab infusion is stopped. When symptoms go away, it may be restarted at a slower rate. If a reaction occurs, most patients are still able to receive the entire dose, although it may take longer. In some cases, after the first dose, obinutuzumab can be give over as short as 4 hours
  • Patients should contact their doctor immediately if they develop lightheadedness or feel their heart racing
  • Doctors may consider the benefit-risk of withholding acalabrutinib for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for CLL. 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 Acalabrutinib (Calquence®) + Obinutuzumab (Gazyva®), 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 Acalabrutinib (Calquence®) + Obinutuzumab (Gazyva®). Depending upon your income, they may be able to help cover the cost of:

  • Acalabrutinib
  • Obinutuzumab

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 Acalabrutinib (Calquence®) + Obinutuzumab (Gazyva®) 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 Acalabrutinib (Calquence®) + Obinutuzumab (Gazyva®)

Individual Drug Label Information

Acalabrutinib (Calquence®)

  • ​Is an oral capsule available in 100 mg
  • Can be taken with or without food with a large glass of water. Swallow capsules whole and do not break, open, or chew capsules
  • Do not take within 2 hours of any antacids. Take two hours before any H2-antagonists (Prilosec [omeprazole] for example)
  • If you miss a dose by more than 3 hours, skip that dose and take the next dose at the regularly scheduled time. DO NOT take two doses to make up for the missed dose
  • Should be stored at 20°C-25°C (68°F-77°F) 
  • Therapy may need to be temporarily interrupted for low white blood cells or blood platelets
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions as your dose of acalabrutinib may need to be adjusted if you are taking any of these medications
  • May interact with grapefruit and grapefruit juice causing increased blood levels of acalabrutinib. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment
  • May cause fetal harm if taken while pregnant. Pregnant woman should talk to their doctor about the risks of taking acalabrutinib while pregnant
  • Women should not breastfeed during treatment and for at least 2 months after the last dose
General acalabrutinib side effects: 
  • Headache
  • Bleeding
  • Diarrhea
  • Fatigue
  • Muscle pain
  • Cough
  • Nausea
  • Fever
  • Low red blood cells, white blood cells, and platelets
  • Click on the acalabrutinib (Calquence®) package insert link below for reported side effects, possible drug interactions, and other acalabrutinib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

Obinutuzumab (Gazyva®)

  • ​Obinutuzumab is an intravenous infusion
  • Acetaminophen (Tylenol®), an antihistamines (e.g. diphenhydramine = Benadryl®), and a glucocorticoid (dexamethasone or methylprednisolone) should be given prior to the Cycle 1 dose.  If no reactions, patients take acetaminophen + antihistamine as premeds
  • Patients should be screened for hepatitis B as obinutuzumab can cause a re-activation of this infection
  • May cause vaccines to work less well. It is advised that vaccines be given two to four weeks prior to obinutuzumab if possible
General Obinutuzumab (Gazyva) Side Effects
  • May cause an infusion reaction, which could include skin reaction, shaking, chills, fever, or shortness of breath. These reactions may be severe, but are very rarely life-threatening
  • Infusion reactions do not commonly happen after the first dose, but are possible
  • May increase the risk of infection. Your doctor may prescribe antibiotics to prevent certain infections associated with obinutuzumab use
  • Patients should report any late-onset hypersensitivity (infusion reactions), diagnosed as serum sickness, with symptoms that include chest pain, diffuse joint pain and fever.
  • Low blood platelets (thrombocytopenia) can occur which increases bleeding risk.  Taking other medications that affect blood clotting can be a risk and should be reported to your doctor or pharmacist
  • Click on the obinutuzumab (Gazyva) package insert link below for more reported side effects and potential drug Interactions

Side Effect Videos
BleedingBleedingNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

1) Sharman JP, Banerji V, Fogliatto LM, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 2019 Nov 13;134(Supplement_1):31.

Created: December 6, 2019 Updated: April 5, 2020

What is Chronic Lymphocytic Leukemia (CLL)?

Chronic Lymphocytic Leukemia (CLL) is the most common type of leukemia diagnosed in adults. It is a cancer of the B-lymphocyte. In rare cases, CLL may be hereditary, but most causes are unknown. The stage of CLL can vary at diagnosis and throughout treatment. Stages of CLL include Rai stage 0, I, II, III, or IV. Many therapies are not curative, however, newer therapies are able to suppress the cancer for many months or even years.

As depicted in the picture, CLL may affect lymph nodes, the spleen, bone marrow, and the blood.

CLL may affect lymph nodes, the spleen, bone marrow, and the blood

Medications for CLL may include intravenous infusions, oral tablets or capsules, or a combination of IV and oral medications. Patients may be diagnosed with CLL without having any symptoms. Others may go to their doctor with symptoms of fatigue, a large spleen, or decreased appetite. The effectiveness of the treatment may depend upon the stage at diagnosis.

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.

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 is Atrial Fibrillation?

Atrial fibrillation, or “Afib,” is when part of your heart, the atria, beats abnormally fast. A fast heart rate can sometimes be felt. This may be referred to as a palpitation. Afib can lead to low blood pressure, shortness of breath, lightheadedness or dizziness.

Afib may also increase the risk of a blood clot forming. Blood clots may be life threatening, especially if they occur in the brain, lungs, or a blood vessel leading to the heart. If you develop these symptoms, seek emergency care immediately.

What is Tumor Lysis Syndrome (TLS)?

Tumor lysis syndrome, or TLS, 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.

A note about side effect percentages

The number you see next to the percent sign (%) means how many people out of 100 are likely to experience this side effect.

For example, if the side effect is reported to occur in 8% of patients, this means that roughly 8 out of 100 people receiving this treatment will experience this side effect. 

How does IVIG prevent severe infections in patients with CLL and hypogammaglobulinemia?

Image showing how IVIG may prevent severe infections in patients with CLL and hypogammaglobulinemia