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Treatment Name: Acalabrutinib (Calquence®)

Acalabrutinib (Calquence®) is a Chemotherapy Regimen for Lymphoma, Mantle Cell

How does acalabrutinib work?
Acalabrutinib is an oral chemotherapy medication designed to cause cancerous B-lymphocytes to leave the bone marrow and lymph nodes and enter the bloodstream where they die more quickly.

Goals of therapy:
Acalabrutinib is taken to decrease the size of lymph nodes, decrease the size of an enlarged spleen, increase the number of good cells made in the bone marrow, and kill cancerous Mantle Cell Lymphoma (MCL) cells. Patients may benefit from increased appetite, disappearance of swollen lymph nodes, and improvement in normal blood cell counts. Acalabrutinib is not usually considered a cure for MCL and is used to control symptoms or prevent MCL from progressing (getting worse).

Schedule

  • Usual starting dose: 100 mg oral capsule by mouth twice daily, every day

Duration of therapy is indefinite, meaning that acalabrutinib should be taken as long as it is working and side effects are tolerable.

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

Side Effects

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

  • Headache, (38%)
  • Bleeding, mostly in the form of bleeding, (31%)
  • Diarrhea, (31%)
  • Fatigue, (27%)
  • Muscle pain, (21%)
  • Cough, (19%)
  • Nausea, (18%)
  • Fever, (15%)
  • Anemia [low red blood cells], (12%)
  • Neutropenia [low white blood cells], (10%)
  • Thrombocytopenia [low platelets], (6%)
  • Pneumonia, (6%)
  • Liver injury, (4%)
  • Urinary tract infection, (4%)
  • High blood pressure, (2%)
  • Tumor lysis syndrome, (2%)
  • Vomiting, (2%)
  • Shingles [an infectious rash caused by a virus], (2%)
  • Eye infection, (2%)

Acalabrutinib may increase your risk of developing atrial fibrillation, or afib. However, none of the 124 patients in the clinical study developed afib while taking acalabrutinib.

On average, 6% of patients discontinue treatment due to unacceptable side effects.

Note: Sepsis, a potentially life-threatening infection in the bloodstream, occurred in 2% of patients in the original clinical trial. Although sepsis is unlikely, it is important to recognize signs and symptoms of this infection in order to treat sepsis quickly if it occurs. Signs of a serious infection may include: fever, chills, shaking, word-finding difficulty or confusion, low blood pressure, flushing, and dizziness.

Side effect videos Side Effect Videos
BleedingBleedingDiarrheaDiarrheaFatigue Fatigue PainPainNausea and VomitingNausea and VomitingAnemiaAnemiaNeutropenic FeverNeutropenic Fever

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment then periodically until stable. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), uric acid, phosphorous, lactate dehydrogenase (LDH), plus any others your doctor may order.

Tumor lysis syndrome may occur. Depending on baseline uric acid level and LDH, allopurinol may need to be taken for 7 to 28 days to help your kidneys eliminate uric acid.

How often is imaging needed?
Imaging may be checked before treatment and during treatment if there is concern for bleeding or an infection. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans. An electrocardiogram (ECG, or EKG) may be recommended if you feel that your heart is racing, which could be a sign of atrial fibrillation.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue acalabrutinib as planned, reduce the dose, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

  • Ask your doctor if you are up to date on your pneumonia vaccines.  Vaccination against pneumonia could prevent this life-threatening illness
  • Bleeding risk may be increased. The reason for this is not known. Patients should report any signs of bleeding to their doctor immediately. If you are taking an antiplatelet medication to prevent a heart attack or an anticoagulant (blood thinner) for a blood clot, acalabrutinib may further increase your risk for bleeding. Talk with your doctor about the risks and benefits of taking this with other medications that increase the risk of bleeding
  • As acalabrutinib may increase the risk of bleeding, it is important to tell the hematologist (cancer doctor) when you are having surgery or dental work and what type. They will then consider the risks versus benefits of temporarily holding acalabrutinib therapy for up to 7 days pre- and post-surgery or dental procedure. The length of time to hold doses will depend upon the type of surgery and the risk of bleeding
  • Acalabrutinib may increase the risk of developing a bacterial, viral, or fungal infection. Be sure to tell your doctor if you develop any signs of an infection such as fever and chills after starting therapy. You may be given antibiotics, antifungals, and antiviral medications while taking acalabrutinib to help prevent an infection from occurring
  • Acalabrutinib may increase your risk of developing secondary cancers with the most common being skin cancer. Avoid exposure to the sun by covering your skin with clothing and wearing sunscreen
  • May interact with commonly used drugs for heartburn. Avoid taking any proton-pump inhibitors such as omeprazole (Prilosec®), esomeprazole (Nexium®), or lansoprazole (Prevacid®) while taking acalabrutinib. If you take famotidine (Pepcid®) or ranitidine (Zantac®), be sure to take your dose of acalabrutinib 2 hours before taking either of these medications. Antacids may be used as log as they are taken at least 2 hours before or 2 hours after taking a dose of acalabrutinib
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for mantle cell lymphoma. 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®), 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®). Depending upon your income, they may be able to help cover the cost of:

  • Acalabrutinib

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®) 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®)

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
  • 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 side effects from acalabrutinib 
  • 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.

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References

Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet 2018;391:659-667.

Created: December 1, 2018 Updated: December 1, 2018

What is Lymphoma, Mantle Cell?

Mantle Cell lymphoma (MCL) is one of about 30 sub-types of Non-Hodgkin Lymphoma. MCL represents up to 8% of all diagnosed lymphomas. It is a cancer of the B-lymphocyte. Most patients who have MCL are 60 years old or greater and more commonly male than female. Many patients are diagnosed with swollen lymph nodes in the neck, armpit, or groin, or an enlarged spleen, which may cause fullness under the left rib cage or abdominal pain.

The cause(s) of MCL are unknown. The stage of MCL can vary at diagnosis and throughout treatment. Stages of MCL include stage I, II, III, or IV. Although therapies are usually given with curative intent, many times the lymphoma returns within 1 – 2 years. Stem cell transplant and combined, multi-drug therapies are usually more effective than single medications.

Medications for MCL may include intravenous infusions, oral tablets or capsules, or a combination of IV and oral medications. Patients may be diagnosed with MCL without having any symptoms. Others may go to their doctor with symptoms of swollen lymph nodes, 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.