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Understanding Chromosomal Changes in CLL/SLL Cells2

CLL/SLL cells can have chromosomal deletions (part of a chromosome lost or deleted), gene mutations (change), or a combination of both.

Chromosomal deletions2,3

  • Parts of a chromosome can be lost (deleted) during cell division. Chromosomal deletions are named “del” for “deletion” followed by the name of the missing piece.

Gene mutations1

  • Genes can become mutated (changed). Some mutations may cause cancer, but not all mutations are dangerous.

Gene mutations and chromosomal deletions can affect how CLL/SLL progresses and may change your treatment plan.

How will my doctor know of chromosomal abnormalities in my CLL/SLL cells?1,2

One of the tests known to search for chromosomal deletions is FISH. FISH stands for “fluorescence in situ hybridization.” Chromosomal deletions are written as “del” followed by the part of the chromosome that is deleted—for example, del 17p and del 11q. A different lab test, called DNA sequencing, examines CLL/SLL cells for gene mutations. It can identify the mutational status of IGHV (immunoglobulin heavy-chain variable region gene) and other genes.

What might my test results mean?1,4,5

Your test results may help you and your doctor better understand your disease. More than 50% of patients with CLL/SLL have a sign of high-risk disease that can inform how their disease will progress. To learn more about genetic testing, contact your doctor.

Some genetic risk factors for CLL/SLL are:

Del 17p1,5-10

  • This chromosomal deletion indicates that CLL/SLL may be more severe compared to people with a complete chromosome.
  • Among people with CLL/SLL who have not had any treatment, approximately 1 in 10 have the 17p chromosome deletion. Del 17p can become more common as CLL progresses.

Del 11q1,11

  • Another chromosomal deletion that can mean that CLL/SLL may be more severe than in people with a complete chromosome.
  • About 1 in 5 people with CLL have 11q deletion.

Unmutated IGHV1,4

  • The unmutated IGHV gene is a risk factor linked to more aggressive disease.
  • Approximately 1 in 2 people with CLL have unmutated IGHV.

 

References:

  1. Leukemia & Lymphoma Society. Chronic lymphocytic leukemia. https://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/leukemia/pdf/cll.pdf. Accessed April 10, 2019.
  2. National Comprehensive Cancer Network. NCCN Guidelines for Patients®: Chronic lymphocytic leukemia. https://www.nccn.org/patients/guidelines/cll/index.html. Accessed April 10, 2019.
  3. American Cancer Society. Chronic lymphocytic leukemia. https://www.cancer.org/cancer/chronic-lymphocytic-leukemia.html. Accessed April 10, 2019.
  4. Kröber A, Seiler T, Benner A, et al. VH mutation status, CD38 expression level, genomic aberrations, and survival in chronic lymphocytic leukemia. Blood. 2002;100:1410-1416.
  5. Döhner H, Stilgenbauer S, Benner A, et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med. 2000;343(26):1910-1916.
  6. Stilgenbauer S, Zenz T, Winkler D, et al. Genomic aberrations, VH mutation status and outcome after fludarabine and cyclophosphamide (FC) of FC plus rituximab (FCR) in the CLL8 trial. Presented at: 50th Annual ASH Meeting; December 6-9, 2008; San Francisco, CA. Abstract 781.
  7. Stilgenbauer S, Kröber A, Busch R, et al. 17p deletion predicts for inferior overall survival after fludarabine-based first line therapy in chronic lymphocytic leukemia: first analysis of genetics in the CLL4 trial of the GCLLSG. Blood (ASH Annual Meeting Abstracts). 2005;106(11):Abstract 715.
  8. Schnaiter A, Stilgenbauer S. 17p deletion in chronic lymphocytic leukemia: risk stratification and therapeutic approach. Hematol Oncol Clin North Am. 2013;27(2):289-301.
  9. Grever MR, Lucas DM, Dewald GW, et al. Comprehensive assessment of genetic and molecular features predicting outcome in patients with chronic lymphocytic leukemia: results from the US Intergroup phase III trial E2997. J Clin Oncol. 2007;25(7):799-804.
  10. Hallek M, Cheson BD, Catovsky D, et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018;131(25):2745-2760.
  11. Döhner H, Stilgenbauer S, James MR, et al. 11q deletions identify a new subset of B-cell chronic lymphocytic leukemia characterized by extensive nodal involvement and inferior prognosis. Blood. 1997;89(7):2516-2522.

IMPORTANT SIDE EFFECT INFORMATION

Before taking IMBRUVICA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA® for any planned medical, surgical, or dental procedure.
  • have bleeding problems.
  • have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
  • have an infection.
  • have liver problems.
  • are pregnant or plan to become pregnant. IMBRUVICA® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA®.
    • Females should not become pregnant during treatment and for 1 month after the last dose of IMBRUVICA®.
    • Males should avoid getting female partners pregnant during treatment and for 1 month after the last dose of IMBRUVICA®.
  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA® or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA® with certain other medicines may affect how IMBRUVICA® works and can cause side effects.

How should I take IMBRUVICA®?

  • Take IMBRUVICA® exactly as your healthcare provider tells you to take it.
  • Take IMBRUVICA® 1 time a day.
  • Swallow IMBRUVICA® capsules and tablets whole with a glass of water.
  • Do not open, break, or chew IMBRUVICA® capsules.
  • Do not cut, crush, or chew IMBRUVICA® tablets.
  • Take IMBRUVICA® at about the same time each day.
  • If you miss a dose of IMBRUVICA® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA® at your regular time on the next day. Do not take extra doses of IMBRUVICA® to make up for a missed dose.
  • If you take too much IMBRUVICA®, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking IMBRUVICA®?

  • You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA®. These products may increase the amount of IMBRUVICA® in your blood

What are the possible side effects of IMBRUVICA®?

IMBRUVICA® may cause serious side effects, including:

  • Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA®, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time.
  • Infections can happen during treatment with IMBRUVICA®. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA®.
  • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA®, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
  • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter). Serious heart rhythm problems and death have happened in people treated with IMBRUVICA®, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA® dose.
  • High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA®. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
  • Second primary cancers. New cancers have happened during treatment with IMBRUVICA®, including cancers of the skin or other organs.
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

The most common side effects of IMBRUVICA® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

  • diarrhea
  • muscle and bone pain
  • rash
  • bruising
  • nausea
  • tiredness
  • fever

The most common side effects of IMBRUVICA® in adults with cGVHD include:

  • tiredness
  • bruising
  • diarrhea
  • mouth sores (stomatitis)
  • muscle spasms
  • nausea
  • pneumonia

Diarrhea is a common side effect in people who take IMBRUVICA®. Drink plenty of fluids during treatment with IMBRUVICA® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMBRUVICA®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA® for a condition for which it was not prescribed. Do not give IMBRUVICA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA® that is written for health professionals.

Please see the full Important Product Information.

INDICATIONS

What is IMBRUVICA® (ibrutinib)?

IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with:

  • Mantle cell lymphoma (MCL) who have received at least one prior treatment
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
  • Waldenström's macroglobulinemia (WM)
  • Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment
  • Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy 

It is not known if IMBRUVICA® is safe and effective in children.

IMPORTANT SIDE EFFECT INFORMATION

INDICATIONS