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.
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.
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
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
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
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
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.
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:
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.
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®)