KADCYLA: A different kind of treatment
`for HER2-positive metastatic breast cancer
`has emerged
`
`Who is KADCYLA for?
`KADCYLA is approved to treat HER2-positive breast cancer that has spread to other parts of the
`body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin®) and a taxane.
`Prior treatment could have been for the initial treatment of breast cancer or for the treatment of
`cancer that had spread to other parts of the body.
`
`Please see KADCYLA full Prescribing Information, including
`Most Important Safety Information, and pages 2, 3, 12, and 13
`for additional Important Safety Information.
`
`IMMUNOGEN 2232, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`for HER2-positive metastatic breast cancer
`has emerged
`
`Who is KADCYLA for?
`KADCYLA is approved to treat HER2-positive breast cancer that has spread to other parts of the
`body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin®) and a taxane.
`Prior treatment could have been for the initial treatment of breast cancer or for the treatment of
`cancer that had spread to other parts of the body.
`
`Please see KADCYLA full Prescribing Information, including
`Most Important Safety Information, and pages 2, 3, 12, and 13
`for additional Important Safety Information.
`
`IMMUNOGEN 2232, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
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`
`
`What is the most important safety
`information I should know about KADCYLA?
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` KADCYLA is not the same medicine as
`trastuzumab (Herceptin)
`
`Liver problems
`
`• KADCYLA may cause severe liver problems that can be
`life-threatening. Symptoms of liver problems may include vomiting,
`nausea, eating disorder (anorexia), yellowing of the skin (jaundice),
`stomach pain, dark urine, or itching
`
`Heart problems
`
`• KADCYLA may cause heart problems, including those without
`symptoms (such as reduced heart function) and those with
`symptoms (such as congestive heart failure). Symptoms may
`include swelling of the ankles or legs, shortness of breath, cough,
`rapid weight gain of greater than 5 lbs in less than 24 hours,
`dizziness or loss of consciousness, or irregular heartbeat
`
`Pregnancy
`
`• Receiving KADCYLA during pregnancy can result in the death of an
`unborn baby and birth defects. Birth control should be used while
`you receive KADCYLA and for 6 months after your last dose
`of KADCYLA
`
`• If you are exposed to KADCYLA during pregnancy, contact your
`healthcare provider right away; you are also encouraged to enroll
`in the MotHER Pregnancy Registry by calling 1-800-690-6720
`
`• If you are a mother who is breastfeeding, you should talk with your
`doctor about either stopping breastfeeding or stopping KADCYLA
`
`Contact your doctor right away if you experience symptoms
`associated with these side effects.
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 12-13 for additional possible side effects.
`
`2
`
`IMMUNOGEN 2232, pg. 2
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`
`
`
`Table of contents
`
`Understanding your type of cancer ............................................................... 4
`
`How KADCYLA is different ........................................................................... 6
`
`KADCYLA may help you live longer ............................................................... 8
`
`Getting started with KADCYLA .................................................................... 10
`
`Additional side effects with KADCYLA ......................................................... 12
`
`Getting support during treatment ................................................................. 14
`
`Questions to ask your doctor or nurse ......................................................... 17
`
`Glossary ........................................................................................................ 18
`
`Additional Possible Serious Side Effects include:
`• Lung problems
`
`• Infusion-related reactions
`
`• Serious bleeding
`
`• Low platelet count
`
`• Nerve damage
`
`• Skin reactions around infusion site
`
`For more information on these side effects, please see pages 12-13.
`
`About this brochure
`Living with HER2-positive metastatic breast cancer is hard. Your healthcare
`team may have given you a lot of information on treatment options.
`This brochure explains treatment with KADCYLA and how it may help you.
`The information in this brochure should not replace the advice of your
`healthcare team. If you have questions about your treatment, be sure to talk
`with your doctor or nurse.
`
`3
`
`IMMUNOGEN 2232, pg. 3
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`Understanding your type of cancer
`
`HER2 receptor:
`A type of protein that
`is found on the surface
`of cells in everyone.
`This protein tells cells
`to grow and divide. Too
`much HER2 is called
`“HER2 overexpression.”
`
`What is HER2-positive metastatic breast cancer?
`Both normal cells and cancer cells have HER2 receptors. In HER2-positive
`metastatic breast cancer, cancer cells have more HER2 receptors than
`normal cells.
`
`• Too many HER2 receptors on cancer cells makes this type of cancer
`grow faster
`
`HER2-positive or
`HER2+:
`Breast cancer cells
` that have too many
` HER2 receptors.
`
`Metastatic
`breast cancer:
`Breast cancer that
`has spread to other
`parts of the body,
`such as the lungs,
`liver, or bones.
`
`NORMAL CELL
`
`HER2-POSITIVE CANCER CELL
`
`HER2 receptor
`
`HER2 receptor
`
`Normal amount of HER2
`
`• Cells grow and divide normally
`
`Too much HER2
`
`• Cells grow and divide faster
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 2, 3, 12, and 13 for additional Important Safety Information.
`
`4
`
`IMMUNOGEN 2232, pg. 4
`Phigenix v. Immunogen
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`
`What HER2-targeted treatments do
`HER2-targeted treatments are designed to attack cells that have
`HER2 receptors. The treatments bind to the HER2 receptors on your cells.
`If you have HER2-positive metastatic breast cancer, you may be able to
`take HER2-targeted treatments.
`
`• KADCYLA, Herceptin (trastuzumab), and Tykerb® (lapatinib) are types of
`HER2-targeted treatments discussed in this brochure
`
`How will my doctor know if KADCYLA is right for me?
`You must have a HER2 test to determine if your cancer is HER2 positive before
`taking KADCYLA, because benefit has been shown only in patients whose
`tumors are HER2 positive.
`
`5
`
`IMMUNOGEN 2232, pg. 5
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`
`How KADCYLA is different
`
`KADCYLA is the first HER2-targeted treatment of its kind for
`metastatic breast cancer
`
`• It is made up of 2 cancer-fighting drugs in 1
` – The monoclonal antibody
`trastuzumab (the same monoclonal
`antibody in Herceptin)
` – A chemotherapy drug
`
`KADCYLA
`
`
`
`
`
`
`Chemotherapy
`
`
`
`
`
`Monoclonal antibody
`
`Monoclonal antibody
`cancer therapy:
`A molecule that is
`made to target
`specific cancer cells.
`
`Chemotherapy:
`A type of cancer
`treatment that kills
`cells that grow and
`divide quickly. This
`can include cancer
`cells or fast-growing
`normal cells.
`
`KADCYLA is a treatment that targets HER2
`• Like Herceptin, a cancer treatment you have already taken, KADCYLA is
`a targeted treatment
`
`• When you take KADCYLA, you are getting both HER2-targeted treatment
`and chemotherapy—at the same time
`
`What makes KADCYLA different
`• KADCYLA is made to bring chemotherapy inside HER2-positive cancer
`cells and kill them. It is designed to cause less harm to normal cells
`
`• KADCYLA may still impact normal cells and cause serious side effects.
`Please see pages 2, 3, 9, 12, and 13 of this brochure for important
`safety information
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 2, 3, 12, and 13 for additional Important Safety Information.
`
`6
`
`IMMUNOGEN 2232, pg. 6
`Phigenix v. Immunogen
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`How KADCYLA is thought to work
`
`
`
`Attaches to a HER2 receptor
`
`KADCYLA
`HER2 receptor
`
`Immune system:
`Your body’s natural
`defense against
`infections and disease.
`
`STEP 1
`KADCYLA is made to find
`HER2-positive cells and
`attach to them. It tells the
`cells to stop growing and
`tells the body’s immune
`system to destroy them.
`
`STEP 2
`KADCYLA also goes inside
`the cell to keep fighting
`from the inside.
`
`Goes inside the cell
`
`
`
`
`
`Breaks apart inside the cell
`
`STEP 3
`KADCYLA releases
`the chemotherapy inside
`the cell.
`
`
`
`Works to help kill the cell
`
`STEP 4
`The chemotherapy goes
`to work inside the cell,
`causing the cell to die.
`
`7
`
`IMMUNOGEN 2232, pg. 7
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`IPR2014-00676
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`
`KADCYLA may help you live longer
`
`Is KADCYLA right for you?
`KADCYLA is for the treatment of HER2-positive metastatic breast cancer.
`Because you have this type of breast cancer, KADCYLA may be an option
`for you.
`
`Only women with HER2-positive metastatic breast cancer can
`take KADCYLA
`Because everyone is different, no one can say for sure if KADCYLA will work
`for you, or for how long it will keep working.
`
`• KADCYLA has been studied only in women with HER2-positive metastatic
`breast cancer. These women had already received Herceptin and a taxane
`(chemotherapy)
`
`• In the study, women took either KADCYLA or a combination of Tykerb and
`Xeloda® (capecitabine)
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 2, 3, 12, and 13 for additional Important Safety Information.
`
`8
`
`IMMUNOGEN 2232, pg. 8
`Phigenix v. Immunogen
`IPR2014-00676
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`
`
`KADCYLA helped women live longer
`• Women taking KADCYLA lived longer, on average, than women taking the
`combination of Tykerb and Xeloda
`
`KADCYLA made cancer stop growing and spreading for a
`longer time
`• KADCYLA increased the chance of stopping the growth and spread of
`cancer by 35% over Tykerb and Xeloda
`
`Hair loss was not common in either study group
`• Less than 5% of women who took KADCYLA or Tykerb and Xeloda lost
`their hair (3.5% and 4.5%, respectively)
`
`What are the most common side effects of KADCYLA?
`The most common side effects seen in people taking KADCYLA were:
`
`• Tiredness
`
`• Nausea
`
`• Pain that affects the bones, muscles, ligaments, and tendons
`
`• Bleeding
`
`• Low platelet count
`
`• Headache
`
`• Liver problems
`
`• Constipation
`
`• Nosebleeds
`
`9
`
`IMMUNOGEN 2232, pg. 9
`Phigenix v. Immunogen
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`
`
`IV infusion:
` Getting medicine
`through a needle
`directly into a vein.
`Some medicines,
`such as KADCYLA,
`can only be given
`by IV infusion.
`
`Getting started with KADCYLA
`
`How do I take KADCYLA?
`Like many cancer medicines, KADCYLA is given by intravenous (IV) infusion.
`KADCYLA is given in your doctor’s office or at a hospital or infusion center.
`
`How often will I get KADCYLA?
`You will get an infusion of KADCYLA once every 3 weeks.
`
`KADCYLA infusion time
`
`1st INFUSION
`
`90
`
`Minutes
`
`ALL OTHER INFUSIONS
`(if first infusion was tolerated)
`
`3 WEEKS
`
`30
`
`Minutes
`
`• After each infusion, your healthcare team will take some extra time to
`watch how you respond to treatment
`
`• If side effects occur, your healthcare team may adjust, delay, or stop
`your treatment
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 2, 3, 12, and 13 for additional Important Safety Information.
`
`10
`
`IMMUNOGEN 2232, pg. 10
`Phigenix v. Immunogen
`IPR2014-00676
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`
`
`Before you start taking KADCYLA
`• Talk with your doctor about any other medical conditions you have. Tell your
`doctor if you are pregnant, nursing, or plan on getting pregnant
`
`• Always tell your doctor about any medicines you are taking. Be sure to
`include over-the-counter medicines, vitamins, and herbal supplements
`
`What to do if you miss a treatment
`• If you miss a dose of KADCYLA, do not wait until your next 3-week cycle
`of treatment
`
`• Tell your doctor or nurse right away. Work with them to reschedule the
`treatment you missed
`
`11
`
`IMMUNOGEN 2232, pg. 11
`Phigenix v. Immunogen
`IPR2014-00676
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`
`
`Additional side effects with KADCYLA
`
`What are the additional possible serious side effects
`of KADCYLA?
`
`Not all people have serious side effects; however, side effects with
`KADCYLA treatment are common. It is important to know what side
`effects may happen and what symptoms you should watch for.
`
` Lung problems
`
`
`
` KADCYLA may cause lung problems, including inflammation
`of the lung tissue, which can be life-threatening. Signs of lung
`problems may include trouble breathing, cough, tiredness, and
`fluid in the lungs.
`
` Infusion-related reactions
`
`
`
` Symptoms of an infusion-related reaction may include one or
`more of the following: the skin getting hot or red (flushing),
`chills, fever, trouble breathing, low blood pressure, wheezing,
`tightening of the muscles in the chest around the airways, or a
`fast heartbeat. Your doctor will monitor you for infusion-related
`reactions.
`
` Serious Bleeding
`
`
`
` KADCYLA can cause life-threatening bleeding. Taking KADCYLA
`with other medications used to thin your blood (antiplatelet) or
`prevent blood clots (anticoagulation) can increase your risk of
`bleeding. Your doctor should provide additional monitoring if
`you are taking one of these other drugs while on KADCYLA.
`Life-threatening bleeding may also happen with KADCYLA even
`when blood thinners are not also being taken
`
` Low platelet count
`
`
`
` Low platelet count may happen during treatment with KADCYLA.
`Platelets help your blood to clot. Signs of low platelets may
`include easy bruising, bleeding, and prolonged bleeding from
`cuts. In mild cases there may not be any symptoms.
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 2 and 3 for additional possible side effects.
`
`12
`
`IMMUNOGEN 2232, pg. 12
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
` Nerve damage
`
`
`
` Symptoms may include numbness and tingling, burning or sharp
`pain, sensitivity to touch, lack of coordination, or muscle weakness or
`loss of muscle function.
`
` Skin reactions around the infusion site
`
`
`
` KADCYLA may leak from the vein or needle and cause reactions
`such as redness, tenderness, skin irritation, or pain or swelling at
`the infusion site. If this happens, it is more likely to happen within
`24 hours of the infusion.
`
`What are the most common severe side effects of KADCYLA?
`The most common severe side effects of KADCYLA are:
`
`• Low platelet count
`
`• Liver problems
`
`• Low levels of red blood cells
`
`• Nerve problems
`
`• Low levels of potassium in the blood
`
`• Tiredness
`
`What to do if you notice side effects
`If you notice any side effects while taking KADCYLA, be sure to tell your doctor
`or nurse right away.
`
` You are encouraged to report side effects to Genentech and the FDA. You may
`contact Genentech by calling 1-888-835-2555. You may contact the FDA by
`visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
`
`13
`
`IMMUNOGEN 2232, pg. 13
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Getting support during treatment
`
`Financial support and resources
`
`KADCYLA Access Solutions® Genentech-Access.com/KADCYLA
`KADCYLA Access Solutions
`can connect you to the
`medicine you need. If you
`are concerned about paying
`for KADCYLA, we are here to help.
`
`Whether you have healthcare coverage or not, we can help you by:
`
`• Finding out if your healthcare plan pays for your medicine
`
`• Guiding you through the process of getting your medicine
`
`• Connecting you with our patient assistance programs
`
`To learn more about how we can help, contact us. Call 1-888-249-4918
`to speak live with one of our specialists. You can also visit
`Genentech-Access.com/KADCYLA.
`
`BioOncology Co-pay Card
`Genentech-Access.com/KADCYLA
`Genentech® offers the BioOncology Co-pay Card to help you with the out-of-
`pocket (OOP) costs of your KADCYLA prescription.
`
`To learn more about the BioOncology Co-pay Card, call 1-888-249-4918 to
`speak live with one of our specialists. To enroll directly, call 1-855-MYCOPAY
`(1-855-692-6729).
`
`Genentech Access to Care Foundation (GATCF)
`GATCF helps patients who don’t have a healthcare plan to pay for KADCYLA.
`GATCF helps qualified patients receive their medicine free of charge.
`
`If you have no healthcare plan, or if your healthcare plan says it won’t pay for
`KADCYLA, we might be able to help you. You can work with your doctor’s
`office to apply to GATCF for free medicine.
`
`The KADCYLA and Access Solutions logos are registered trademarks of Genentech, Inc.
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 2, 3, 12, and 13 for additional Important Safety Information.
`
`14
`
`IMMUNOGEN 2232, pg. 14
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`IPR2014-00676
`
`
`
`KADCYLA Patient Support Line
`We’re here to help
`
`Call the Patient Support Line anytime. Our nurses will be able to answer your
`treatment questions, including:
`
`• How KADCYLA is designed to work
`
`• The potential benefits of KADCYLA
`
`• Side effects of KADCYLA
`
`• What to expect from KADCYLA treatment
`
`• Finding reimbursement help for KADCYLA
`
`Expert information anytime you need it
`When you have important questions about KADCYLA treatment, you want
`to get information you can trust. With the KADCYLA Patient Support Line,
`registered oncology nurses are always available to answer your questions
`and provide information about KADCYLA.
`
`Every nurse on our team:
`
`• Specializes in oncology
`
`• Has about 20 years of experience
`
`• Is knowledgeable about KADCYLA treatment
`
`FOR PATIENT SUPPORT, CALL 1-855-KADCYLA (1-855-523-2952)
`
`The information you receive from the KADCYLA Patient Support Line is
`not meant to replace the advice of your healthcare team. Genentech will not
`provide medical advice regarding your medical condition.
`
`15
`
`IMMUNOGEN 2232, pg. 15
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Getting support during treatment
`
`Breast cancer information and support*
`
`HER2 Support Group | www.her2support.org
`News and information about HER2-positive breast cancer. Includes online
`message boards.
`
`BREASTCANCER.ORG | www.breastcancer.org
`Provides medical information about cancer symptoms, diagnosis, and
`treatment options.
`
`Metastatic Breast Cancer Network |
`www.mbcn.org | 1-888-500-0370
`Advocacy group dedicated to women and men living with metastatic
`breast cancer.
`
`Susan G. Komen for the Cure |
`www.komen.org | 1-877-465-6636
`Information for people living with cancer, families, friends, and survivors.
`
`Young Survival Coalition |
`www.youngsurvival.org | 1-877-YSC (972)-1011
`Dedicated to young women with breast cancer and their families.
`
`American Cancer Society | www.cancer.org |
`1-800-227-2345
`Information for people living with cancer, families, friends, and survivors.
`
`Living Beyond Breast Cancer | www.lbbc.org |
`1-888-753-LBBC (5222)
`Support and information for people who are newly diagnosed, in treatment,
`or living with metastatic breast cancer.
`
`*Genentech is neither affiliated with nor endorses these organizations. The information provided by
`Genentech or by these organizations is meant for informational purposes only and is not meant to
`replace a physician’s medical advice.
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 2, 3, 12, and 13 for additional Important Safety Information.
`
`16
`
`IMMUNOGEN 2232, pg. 16
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Questions to ask your doctor or nurse
`
`Talk with your doctor or nurse to learn more about KADCYLA. Here are some
`questions to help you get started.
`
`Is KADCYLA right for me?
`
`How is KADCYLA different from other breast
`cancer medicines?
`
`How will I know if KADCYLA is working?
`
`For how long will I need to take KADCYLA?
`
`
`
`
`
`
`
`
`
` What should I do to get ready for my first infusion?
`
` What side effects could I have with KADCYLA?
`
` Do I need to change my diet or activities while taking
`KADCYLA?
`
`Notes:
`
`17
`
`IMMUNOGEN 2232, pg. 17
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Glossary
`
`Chemotherapy
`A type of cancer treatment that kills cells that grow and divide quickly. This
`can include cancer cells or fast-growing normal cells.
`
`HER2
`Human epidermal growth factor receptor 2 (HER2). HER2 helps cells grow
`and is found on the surface of both normal and cancer cells.
`
`HER2 receptor
`A type of protein that is found on the surface of cells in everyone. This
`protein tells cells to grow and divide. Too much HER2 is called “HER2
`overexpression.”
`
`HER2-positive or HER2+
`Breast cancer cells that have too many HER2 receptors.
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety
`Information, and pages 2, 3, 12, and 13 for additional Important Safety Information.
`
`18
`
`IMMUNOGEN 2232, pg. 18
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Immune system
`Your body’s natural defense against infections and disease.
`
`IV infusion
`Getting medicine through a needle into a vein. Some medicines, such as
`KADCYLA, can only be given by IV infusion.
`
`Metastatic breast cancer
`Breast cancer that has spread outside the breast to other parts of the body,
`such as the lungs, liver, or bones.
`
`Monoclonal antibody cancer therapy
`A molecule that is made to target specific cancer cells.
`
`19
`
`IMMUNOGEN 2232, pg. 19
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`KADCYLA is designed for women with
`HER2-positive metastatic breast cancer
`
`• KADCYLA is approved to treat HER2-positive breast cancer that has spread to other
`parts of the body (metastatic breast cancer) after prior treatment with trastuzumab
`(Herceptin®) and a taxane. Prior treatment could have been for the initial treatment of
`breast cancer or for the treatment of cancer that had spread to other parts of the body
`
`• KADCYLA contains 2 cancer-fighting drugs in a single treatment
`
`• Treatment with KADCYLA helped some women live longer
`
`• KADCYLA slowed the growth and spread of tumors
`
`• The most important safety information when taking KADCYLA includes:
`— KADCYLA is not the same medicine as Herceptin
`— Liver problems, which can be life-threatening
`— Heart problems
`— Possible birth defects or death of an unborn baby
`— Please see page 2 of this brochure for a full description of the most important safety
`information
`
`• KADCYLA is taken as a single IV infusion every 3 weeks
`
`Genentech is responsible for the content in this brochure.
`Please see KADCYLA full Prescribing Information, including Most Important Safety Information, and pages 2, 3, 12,
`and 13 for additional Important Safety Information.
`
`Tykerb is a registered trademark of GlaxoSmithKline.
`
`© 2014 Genentech USA, Inc. All rights reserved. TDM0002652600 (09/14)
`
`IMMUNOGEN 2232, pg. 20
`Phigenix v. Immunogen
`IPR2014-00676
`
`
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