Your SlideShare is downloading. ×
Cll patient education guide
Cll patient education guide
Cll patient education guide
Cll patient education guide
Cll patient education guide
Cll patient education guide
Cll patient education guide
Cll patient education guide
Cll patient education guide
Cll patient education guide
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Cll patient education guide

108

Published on

Published in: Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
108
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  1. A GUIDE FOR PATIENTSUnderstanding my treatment withTREANDA®(bendamustine HCI)for InjectionPlease contact your healthcaretreatment team with anyquestions that you may have.Please see Important SafetyInformation on page 2and accompanying fullPrescribing Information.
  2. For the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacyrelative to first-line therapies other than chlorambucil has not been established.Important Safety InformationWhy did your physician prescribe TREANDA®(bendamustine HCl) for Injection?TREANDA is indicated for the treatment of patients with chroniclymphocytic leukemia (CLL). Efficacy relative to first-line therapiesother than chlorambucil has not been established.Important Safety Information• Serious side effects, including low blood cell counts, infections,unexpected responses to TREANDA when placed in your blood, suddenand severe allergic responses, kidney failure due to fast breakdown ofcancer cells, other cancers, and leaking of TREANDA out of your veinand into your surrounding skin, have been seen with TREANDA. Someresponses, such as low blood counts, infections, and severe allergicskin responses (when TREANDA was given with allopurinol and othermedications known to cause severe allergic skin responses), havecaused death. Patients should be watched closely for these responsesand treated quickly if any are seen• Serious side effects may require changes in therapy, such as loweringthe amount of TREANDA given, stopping the use of TREANDA, or waitinglonger than expected between doses of TREANDA• TREANDA should not be used in patients with a known allergic responseto bendamustine or mannitol (an inactive ingredient in TREANDA).Women should be told not to become pregnant while using TREANDA• The most common non–blood-related side effects associated withTREANDA (occurring in ≥15% of patients) are fever, nausea, and vomiting.The most common blood-related side effects associated with TREANDA(frequency ≥15%) are low red blood cells (oxygen-carrying cells), lowplatelets (blood-clotting cells), and decreased number of three differenttypes of white blood cells (infection-fighting cells)You are encouraged to report side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or fax to 1-800-FDA-0178.For more information about TREANDA, ask your doctor,call 1-800-896-5855, or visit www.TREANDA.com.3ChronicLymphocyticLeukemiaWhat you can learn from this brochureIntroductionTo help you better understand what you might expect during yourtreatment with TREANDA®(bendamustine HCl) for Injection, thisbrochure addresses the following:• Who is on your treatment team• How TREANDA is given• Side effects• Frequently asked questions• Understanding the different stages of treatment with TREANDARemember, not all patients have the same reaction to treatment.Responses to therapy and side effects are different for each andevery person. Just like physical reactions to treatment, emotionalresponses vary as well. It is important to stay motivated and knowthat you are not alone on your treatment journey.This brochure may introduce new terms for you. These arehighlighted in the text and defined in the glossary on pages 16–17.The information in this brochure is not meant to take the placeof speaking with your healthcare team for medical advice aboutyour condition or treatment. If you have any questions afterreading this brochure, you should discuss them with yourhealthcare team.Please see accompanyingfull Prescribing Information.
  3. 4Please see Important Safety Information on page 2and accompanying full Prescribing Information.Knowing your treatment teamWho is on my treatment team?Other than than your doctor, there is a large group of healthcareprofessionals that make up your healthcare team. These peoplehave a wide variety of skills that will help them treat your disease,manage your side effects, and provide additional resources andguidance. They will be there to assist you and answer any of yourquestions throughout the process to make sure your treatmentjourney is as successful as possible.These are the ones you may see on a regular basis:Hematologist/oncologist: Your primary doctor who specializes intreating cancer with medicationOncology nurse: A healthcare professional whose roles range fromgiving chemotherapy, helping to manage side effects, and takingblood pressure, to coordinating care between the clinic and homeNurse practitioner/physician’s assistant: Healthcare professionalswho deliver a broad range of services such as conducting physicalexams, prescribing medication, and helping manage side effectsOncology social worker: A professional who provides services suchas counseling patients and families, helping with coping skills andlifestyle changes, and facilitating support groupsDietitian: A food and nutrition professional who answers questionsabout nutrition and helps people with cancer plan menus to copewith special needsYour healthcare team will also need help from you. It is very importantto tell your healthcare team if you have any side effects duringtreatment with TREANDA®(bendamustine HCl) for Injection.5Why TREANDA®(bendamustine HCI) forInjection may be right for youTREANDA is a chemotherapy that has been shown to kill cells thatcause CLL. The exact way that TREANDA kills these cells is stillbeing studied.How was TREANDA shown to work in patients with CLL?In a clinical study of 301 patients, of whom 153 patients receivedTREANDA and 148 received chlorambucil (another drug approved bythe Food and Drug Administration to treat CLL), 59% showed an overallresponse with TREANDA vs 26% with chlorambucil. You may want todiscuss these results with your healthcare professional.The most common non–blood-related side effects associated withTREANDA (occurring in ≥15% of patients) are fever, nausea, andvomiting. The most common blood-related side effects associated withTREANDA (frequency ≥15%) are low red blood cells (oxygen-carryingcells), low platelets (blood-clotting cells), and decreased number ofthree different types of white blood cells (infection-fighting cells).Red blood cellsPlateletsWhite blood cells
  4. 6Please see Important Safety Information on page 2and accompanying full Prescribing Information.Understanding side effectsWhat serious side effects may occur while I am takingTREANDA®(bendamustine HCI) for Injection?While the serious side effects listed below have been seen in somestudies, your experience may be different. That is why it is very importantto talk about your TREANDA treatment and any symptoms you might behaving with your doctor.• Serious side effects, including low blood cell counts, infections, unexpectedresponses to TREANDA when placed in your blood, sudden and severeallergic responses, kidney failure due to fast breakdown of cancer cells,other cancers, and leaking of TREANDA out of your vein and into yoursurrounding skin, have been seen with TREANDA. Some responses,such as low blood counts, infections, and severe allergic skin responses(when TREANDA was given with allopurinol and other medicationsknown to cause severe allergic skin responses), have caused death.Patients should be watched closely for these responses and treatedquickly if any are seen.• Serious side effects may require changes in therapy, such as loweringthe amount of TREANDA given, stopping the use of TREANDA, or waitinglonger than expected between doses of TREANDA.• TREANDA should not be used in patients with a known allergic responseto bendamustine or mannitol (an inactive ingredient in TREANDA).Women should be told not to become pregnant while using TREANDA.• The most common non–blood-related side effects associated withTREANDA (occurring in ≥15% of patients) are fever, nausea, andvomiting. The most common blood-related side effects associated withTREANDA (frequency ≥15%) are low red blood cells (oxygen-carryingcells), low platelets (blood-clotting cells), and decreased number of threedifferent types of white blood cells (infection-fighting cells).7How do I work with my doctor to treat side effects?You should tell your doctor if you develop a rash, facial swelling, or difficultybreathing during or soon after your infusion with TREANDA®(bendamustineHCl) for Injection. These are signs of an allergic reaction. You also shouldtell your doctor if you have shortness of breath, significant fatigue, bleeding,or fever. These are signs of infection. In addition, your doctor will performblood tests to see if you have low blood counts. These are lower thannormal numbers of red blood cells, white blood cells, or platelets.FPOA low number ofred blood cellsMakes you feel tired easilyor short of breathA low numberof whiteblood cellsRaises your chances forinfection. If you have afever or other signs ofinfection, like chills orcoughing, you should callyour doctor right awayA low numberof plateletsIncreases your chanceof bleeding. Call yourdoctor if you have anykind of bleeding thatis not normal for youCondition Symptom
  5. 8Please contact your healthcare team with any questionsthat you may have.Please see Important Safety Information on page 2and accompanying full Prescribing Information.Undergoing treatment with TREANDA®(bendamustine HCI) for InjectionHow will I receive treatment with TREANDA?You will get treatment with TREANDA at your doctor’s office, the hospital,or an infusion center. You will be given TREANDA as an intravenous (IV)infusion through a needle in your vein for 30 minutes. TREANDA may begiven for up to 6 cycles. Each cycle is made up of 28 days. You willbe given TREANDA on Day 1 and Day 2 of each 28-day cycle.DAY 130-minute IV infusionDAY 230-minute IV infusionIt may be necessary for your doctor to make changes to the dose ofTREANDA to find out what is right for you. Changing the dose or delayingtreatment may be necessary if you are experiencing side effects.DAY 3 DAY 4 DAY 5 DAY 6 DAY 7DAY 8 DAY 9 DAY 10 DAY 11 DAY 12 DAY 13 DAY 14DAY 15 DAY 16 DAY 17 DAY 18 DAY 19 DAY 20 DAY 21DAY 22 DAY 23 DAY 24 DAY 25 DAY 26 DAY 27 DAY 28UP TO6CYCLESDAY 1 DAY 230-min IV infusion 30-min IV infusion9This calendar represents 1 cycle of treatment with TREANDA®(bendamustine HCI) for Injection. It shows which days you will receiveyour infusion and for how long. This will be repeated up to 6 times.A review of the serious side effects is shown on page 2 of this brochure.Below are the most common side effects.You should tell your doctor if you develop a rash, facial swelling, or difficultybreathing during or soon after your infusion with TREANDA. These aresigns of an allergic reaction. You also should tell your doctor if you haveshortness of breath, significant fatigue, bleeding, or fever.
  6. 10Please see Important Safety Information on page 2and accompanying full Prescribing Information.Frequently asked questionsThis will be your first time receiving TREANDA®(bendamustine HCI) forInjection. At the infusion center you may meet other members of yourhealthcare team such as nurses and support staff. They will be able toanswer any of your questions before you begin treatment.You may feel anxious about not knowing the exact way your body willreact to treatment. Try to maintain a positive attitude and remain hopeful.How quickly does TREANDA start working?In clinical studies, TREANDA lowered the amount of CLL cells in the bodyas early as the first week of treatment and maintained this decrease foran extended period of time. Remember, not all patients react the sameway to treatment. Ask your healthcare professional for more details.If I’m experiencing side effects, what do I do?You should tell your doctor if you develop a rash, facial swelling, ordifficulty breathing during or soon after your infusion with TREANDA.These are signs of an allergic reaction. You also should tell your doctorif you have shortness of breath, significant fatigue, bleeding, or fever.Is financial assistance available?Insurance coverage and reimbursement issues can be difficult tounderstand. At Teva Oncology, we go further to support patients andhealthcare providers. CORE (Comprehensive Oncology ReimbursementExpertise) is a convenient reimbursement resource that provides a supportprogram along with online tools to help make it easier to understand thereimbursement process. Contact CORE at 1-888-587-3263.Will I lose my hair?Every patient reacts differently to therapy, but in a CLL clinical trial of 301patients, 99% of the TREANDA group (151/153) did not experience hairloss. No one in the chlorambucil group experienced hair loss.11Can I take other medications while receivingTREANDA®(bendamustine HCI) for Injection?There are a few medications that may impact treatment results withTREANDA. Notify your doctor of any medications you are taking or planto take.Do I need to change any of my habits?If you smoke, you should know that smoking can impact your health andcould possibly affect your treatment results.It will be important to meet with your doctor regularly and not to miss anyappointments. It will be beneficial to talk with your oncology social worker,who can provide useful information and services, such as counseling,suggesting lifestyle changes, and facilitating support groups, to help youthrough the treatment process. There are also online support groups youcan consider joining.Building a good support system early is very helpful. Hearing stories ofjourneys of other patients with CLL can help you learn how to cope with CLL.What are the most serious side effects?Serious side effects, including low blood cell counts, infections,unexpected responses to TREANDA when placed in your blood, suddenand severe allergic responses, kidney failure due to fast breakdown ofcancer cells, other cancers, and leaking of TREANDA out of your veinand into your surrounding skin, have been seen with TREANDA. Someresponses, such as low blood counts, infections, and severe allergicskin responses (when TREANDA was given with allopurinol and othermedications known to cause severe allergic skin responses), havecaused death. Patients should be watched closely for these responsesand treated quickly if any are seen.
  7. 12Please see Important Safety Information on page 2and accompanying full Prescribing Information.Frequently asked questionsYou may:Experience a roller coaster of emotions before and after each doctor visit,anxiety while awaiting your test results, and relief when your results comeback as planned. If your results do not come as planned, your doctor willdiscuss changes to your treatment or other options.Ask your doctor how you are responding to treatment. Based on yourtest results, he/she may recommend continuing therapy as plannedor a different treatment approach.How do I know if TREANDA®(bendamustine HCI)for Injection is working for me?During your treatment, your healthcare team will perform a physical examand will take blood samples for testing. Some imaging studies, like CTscans or MRI, may also be done. These tests will tell your doctor howyou are responding to treatment with TREANDA.If the tests do not show any trace of CLL cells, your response will beconsidered a complete response. If the number of CLL cells is reduced,your response will be considered a partial response. Sometimes, a patientmay not show a response to treatment.What if I did not respond to treatment or there is no change?It may take some time before patients start seeing positive results fromtherapy. Trust your doctor and continue the treatment schedule as plannedto see the greatest benefits.13Can I return to work or my normal activities?Each patient responds to treatment differently. Ask you doctor whatis best for your situation.Do not be ashamed to accept the help of a caregiver in order to savetime and energy, and avoid any unnecessary activities while receivingTREANDA®(bendamustine HCI) for Injection. Allowing friends and familyto give moral and physical support can be beneficial to your outcome.You may feel that you are adding a burden, but friends and family willbe willing to go the extra mile for your well-being. Having a supportgroup can allow your friends and family to rotate tasks.• The most common non–blood-related side effects associated withTREANDA (occurring in ≥15% of patients) are fever, nausea, andvomiting.The most common blood-related side effects associated withTREANDA (frequency ≥15%) are low red blood cells (oxygen-carryingcells), low platelets (blood-clotting cells), and decreased numberof three different types of white blood cells (infection-fighting cells)
  8. 14Please see Important Safety Information on page 2and accompanying full Prescribing Information.Frequently asked questionsWhen you have received your final infusion of TREANDA®(bendamustineHCl) for Injection, you may discuss with your doctor how you haveresponded to treatment. Based on your response to treatment, you mayhave achieved remission or may have to begin new therapy.When will I stop having side effects?Because every patient is different, reactions to treatment and durationsof side effects can vary. Until you stop experiencing side effects, yourhealthcare team should be consulted on how to prevent and manage them.• The most common non–blood-related side effects associated withTREANDA (occurring in ≥15% of patients) are fever, nausea, and vomiting.The most common blood-related side effects associated with TREANDA(frequency ≥15%) are low red blood cells (oxygen-carrying cells), lowplatelets (blood-clotting cells), and decreased number of three differenttypes of white blood cells (infection-fighting cells)What can I expect after treatment?Routine check-ins with your doctor should still occur in orderfor him/her to monitor your health.What happens if I don’t respond or stop respondingto treatment?If you are not responding to treatment as your doctor expected,or are still experiencing side effects, you should talk to yourdoctor about treatment options.Even after therapy, the American Cancer Society recommends youmaintain certain lifestyle changes, such as not smoking or excessivelydrinking alcohol, in order to improve your overall health. You may beencouraged to focus on eating better and exercising, as well. Thesemay help you stay at a healthy weight, give you more energy, andreduce the risk of depression and tiredness.15If you haven’t already joined a cancer support group, you may wantto consider joining one to connect with others who have CLL, in orderto share helpful information and provide one another with support.No matter the outcome of your treatment, you may be asked to checkin with your doctor from time to time to repeat some tests.In certain instances, you may respond well to therapy for several yearsbefore you no longer receive the expected benefits from therapy.This is called relapsing from therapy. Your doctor may recommenda new treatment for you.Battling cancer is a lifelong process, and it is important to have theright attitude and a good relationship with your treatment team,family, and friends.
  9. 16Please see Important Safety Information on page 2and accompanying full Prescribing Information.GlossaryAnemiaA deficiency of red blood cells or of hemoglobin in the blood,resulting in a pale look and weaknessClinical studyA research study to examine a new drug for safety and effectivenessin human beingsComplete response (CR)The absence of all signs of cancer in response to treatmentCycleA round of treatmentIntravenous (IV) infusionA liquid solution injected directly into a vein (usually in the arm)LeukopeniaA low number of leukocytes (also called white blood cells)LymphocytesA type of white blood cell found in the body’s immune systemLymphopeniaA low number of lymphocytes in the bloodNeutropeniaAn abnormally low number of neutrophils in the bloodNeutrophilsA type of white blood cell that helps destroy bacteria17Overall response (OR)The total number of patients with complete and partial responsesto treatmentPartial response (PR)A response to treatment that does not meet the full standardsof complete responsePlateletsSmall cells that help stop bleeding at the site of injuryRed blood cellsThe cells that contain hemoglobin, which is a protein that carriesoxygen from the lungs. Red blood cells circulate around the bodyto deliver oxygen to other cellsThrombocytopeniaA decrease in the number of platelets in the bloodWhite blood cellsCells that fight infection in the body (also called leukocytes)
  10. ©2012 Cephalon, Inc., a wholly owned subsidiaryof Teva Pharmaceutical Industries Ltd. All rights reserved.TRE-2552 November 2012 Printed in USA.

×