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Treatment Name: Ibrutinib (Imbruvica®)

Ibrutinib (Imbruvica®) is a Chemotherapy Regimen for Lymphoma, Mantle Cell

How does ibrutinib work?
Ibrutinib 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:
Ibrutinib 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 MCL cells. Patients may benefit from increased appetite, disappearance of swollen lymph nodes, and improvement in normal blood cell counts. Ibrutinib is not usually considered a cure for MCL and is used to control symptoms or prevent MCL from progressing (getting worse).

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Schedule

  • Usual starting dose: Ibrutinib 560 mg tablet by mouth (four 140 mg capsules) by mouth once daily, every day

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability. For patients who prefer to take capsules, ibrutinib is available in capsule formulation. If using capsules, the most commonly recommended dosage is ibrutinib 560 mg (four 140 mg capsules) by mouth once daily, every day of the week. Typically, all 4 capsules are taken at the same time and around the same time of day. Duration of therapy is indefinite, meaning that ibrutinib should be taken as long as it is working and side effects are tolerable.

 

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Side Effects

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

  • Diarrhea (50%)
  • Fatigue (41%)
  • Nausea (31%)
  • Water retention or swelling (28%)
  • Shortness of breath (27%)
  • Constipation (25%)
  • Upper respiratory tract infection (23%)
  • Vomiting (23%)
  • Decreased appetite (21%)
  • Cough (18%)
  • Fever (18%)
  • Abdominal pain (17%)
  • Bruising or bleeding (17%)
  • Rash (15%)
  • Abnormal heart rate, also known as atrial fibrillation (6 - 9%)

The percentage of patients that discontinued ibrutinib due to unacceptable side effects is low (about 7%). Most side effects resolve without having to stop ibrutinib therapy.

If atrial fibrillation develops after beginning therapy, your doctor may advise that you continue ibrutinib, stop for a short time, or change to an alternative medication if you prefer. Ibrutinib-related atrial fibrillation can be managed a variety of different ways.

Side effect videos Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue Nausea and VomitingNausea and VomitingConstipationConstipationBleedingBleedingPainPain

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Monitoring

How often is monitoring needed?
Labs may be checked before treatment, weekly during the first month, then every other week during the second month, and then once monthly until stable. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), lactate dehydrogenase (LDH), magnesium, phosphorous, uric acid, 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?
In the clinical studies, computerized tomography scans (CT scans) were repeated at months 3, 5, and 7, then every three months thereafter. A positron-emission tomography scan (PET scan) was used to confirm complete disappearance of mantle cell lymphoma for those patients responding to treatment. 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 chemotherapy as planned, or delay or switch therapy. If atrial fibrillation is diagnosed, additional medication may be recommended to treat this problem.

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ChemoExperts Tips

  • Patients should contact their doctor immediately if they develop lightheadedness or feel their heart racing while taking ibrutinib. This could be a sign of atrial fibrillation
  • Taking capsules with food can double its absorption, so it is best to take on an empty stomach to avoid an increase in side effects. Consider taking at bedtime since ibrutinib may cause nausea
  • As ibrutinib 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 ibrutinib 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
  • Splitting the dose is NOT advised; all capsules should be taken together so that it works properly
  • Your doctor may recommend that the daily dose be reduced by one capsule per day if you have a moderate or severe side effect
  • Ibrutinib may increase the risk of developing a sinus infection or pneumonia. Be sure to tell your doctor if you develop a fever or new cough after starting therapy
  • 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, ibrutinib 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
  • Talk to your healthcare provider before eating grapefruit or drinking grapefruit juice, Squirt, Fresca, Sundrop, or things that say “citrus blend” as these may increase the risk of side effects
  • High blood pressure may occur in patients taking ibrutinib. If the blood pressure increases, it often starts after about 4 months of therapy. If you are already taking medications for blood pressure, the doses may need to be adjusted when adding ibrutinib, or changed to a different blood pressure medication if they interact with ibrutinib
  • Two out of three people (67%) taking ibrutinib for 6 - 12 months report fingernail changes such as splitting or cracking. Toenails may also become more brittle and it may take a few months longer to notice these changes. In addition, hair may change in texture in about one in four people (25%), and may be noticeable between 6 - 12 months after starting ibrutiinb. Some people have tried taking biotin (vitamin B7, an over-the-counter supplement) to help restore normal nail growth. Talk to your doctor before trying biotin for ibrutinib-related nail changes
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for MCL. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov and type in “mantle cell lymphoma” 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 Ibrutinib (Imbruvica®), 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 Ibrutinib (Imbruvica®). Depending upon your income, they may be able to help cover the cost of:

  • Ibrutinib

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 Ibrutinib (Imbruvica®) 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 Ibrutinib (Imbruvica®)

Individual Drug Label Information

Ibrutinib (Imbruvica®)

  • Ibrutinib is available as an oral TABLET in 140 mg, 280 mg, 420 mg, and 560 mg strengths
  • Ibrutinib is available as an oral CAPSULE in 70 mg and 140 mg strengths
  • Ibrutinib should be swallowed whole. It is usually taken without food, at bedtime, and with a large glass of water 
  • Food increases ibrutinib absorption so it is best to take on an empty stomach to avoid an increase in side effects
  • If you miss a dose, take the dose as soon as possible on the same day, then return to the normal schedule. If already the next day, do not take extra doses. Wait until your next dose is due 
  • Dosage adjustments may be required if taken with certain medicines or if the liver is not working properly 
  • May interact with grapefruit or grapefruit juice, as well as medicines used to prevent clotting 
  • Store ibrutinib at room temperature 
General Ibrutinib (Imbruvica) Side Effects
  • Bruising or bleeding: patients taking other medicines that affect clotting or platelet count or platelet function may be at increased risk. Report any signs of bleeding immediately 
  • Diarrhea: drink plenty of fluids to prevent losing too much fluid (dehydration). Can often be treated using anti-diarrhea medicines 
  • Infection: patients should call their doctor if they experience a fever, chills, or other signs of infection 
  • Tiredness 
  • Bone pain 
  • Rash 
  • Water retention or swelling 
  • Muscle spasms 
  • Headache
  • Nausea or vomiting
  • Constipation
  • Abnormal heart rate, also known as atrial fibrillation may occur. Signs or symptoms include fast heart beat, dizziness, shortness of breath, chest discomfort, or feeling faint 
  • Rarely, new cancers such as skin cancer, have been diagnosed in people taking ibrutinib 
  • Click on the ibrutinib (Imbruvica) package insert below for reported side effects and potential drug Interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingConstipationConstipationPainPain

See DailyMed package insert.

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References

1) Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013; 369:507-516.

2) Stephens DM, Spurgeon SE. Ibrutinib in mantle cell lymphoma patients: glass half full? Evidence and opinion. Ther Adv Hematol. 2015;6:242-252.

3) Bitar C, Farooqui MZ, Valdez J, et al. Hair and Nail Changes During Long-term Therapy With Ibrutinib for Chronic Lymphocytic Leukemia. JAMA Dermatol. 2016;152:698-701.

Created: January 18, 2016 Updated: July 4, 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 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. It 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?

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.

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 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.

What is MCL?

An abbreviation for Mantle Cell Lymphoma.

Ibrutinib-Related Atrial Fibrillation (AFib)

Click here for a proposed algorithm for managing ibrutinib-related afib