HER2 Targeted Treatment | KADCYLA® (ado-trastuzumab emtansine)
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`What is KADCYLA?
`
`How KADCYLA is different
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`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:
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`The monoclonal antibody trastuzumab (the same monoclonal antibody in Herceptin®)
`A chemotherapy drug
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`KADCYLA is a treatment that targets HER2
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`Like Herceptin, a cancer treatment you have already taken, KADCYLA is a targeted treatment
`When you take KADCYLA, you are getting both a HER2-targeted treatment and chemotherapy—at the
`same time
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`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 click here for important safety
`
`http://www.kadcyla.com/about/her2-targeted-treatment[1/19/2015 4:53:01 PM]
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`IMMUNOGEN 2239, pg. 1
`Phigenix v. Immunogen
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`HER2 Targeted Treatment | KADCYLA® (ado-trastuzumab emtansine)
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`information
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`Next: See how KADCYLA is thought to work
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`Who is KADCYLA for?
`
` is approved to treat HER2-positive breast cancer that has spread to other parts of the
`KADCYLA®
`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.
`Important Safety Information
`What is the most important safety information I should know about KADCYLA?
`KADCYLA is not the same medicine as trastuzumab (Herceptin).
`Liver problems
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`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
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`Heart problems
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`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
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`Pregnancy
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`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
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`Contact your doctor right away if you experience symptoms associated with these side effects.
`What are the additional possible serious side effects of KADCYLA?
`Lung problems
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`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
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`Infusion-related reactions
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`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
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`Serious Bleeding
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`http://www.kadcyla.com/about/her2-targeted-treatment[1/19/2015 4:53:01 PM]
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`IMMUNOGEN 2239, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
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`HER2 Targeted Treatment | KADCYLA® (ado-trastuzumab emtansine)
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`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
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`Low platelet count
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`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
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`Nerve damage
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`Symptoms may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination,
`muscle weakness, or loss of muscle function
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`Skin reactions around the infusion site
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`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
`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.
`What are the most common side effects of KADCYLA?
`The most common side effects seen in people taking KADCYLA are:
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`Tiredness
`Nausea
`Pain that affects the bones, muscles, ligaments, and tendons
`Bleeding
`Low platelet count
`Headache
`Liver problems
`Constipation
`Nosebleeds
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`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.
`
`Please see KADCYLA full Prescribing Information, including Most Important Safety Information, for additional Important
`Safety Information.
`
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`http://www.kadcyla.com/about/her2-targeted-treatment[1/19/2015 4:53:01 PM]
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`IMMUNOGEN 2239, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
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`

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`HER2 Targeted Treatment | KADCYLA® (ado-trastuzumab emtansine)
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`© 2015 Genentech USA, Inc. All rights reserved. This site is intended for US residents only.
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`http://www.kadcyla.com/about/her2-targeted-treatment[1/19/2015 4:53:01 PM]
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`IMMUNOGEN 2239, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676
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