1/21/2015
`
`Is it Right for your Cancer | KADCYLA® (ado­trastuzumab emtansine)
`
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`Patients & Caregivers
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`What is KADCYLA?
`
`Are there financial
`assistance programs?
`
`How can KADCYLA
`help?
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`Register for
`How can
`What can I expect
`HERConnection
`KADCYLA help?
`while on KADCYLA?
`View Full Prescribing
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`support are there?
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`Safety First!
`Before you start exploring, please read
`side effect information. ›› View now
`
`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.
`
`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® (trastuzumab) and a
`taxane (chemotherapy)
`In the study, women took either KADCYLA or a combination of Tykerb® (lapatinib) and
`Xeloda® (capecitabine)
`
`KADCYLA helped women live longer
`
`Women taking KADCYLA lived longer, on average, than
`women taking the combination of Tykerb and Xeloda
`4HER Patient Support App
`KADCYLA Patient Support Line
`KADCYLA made cancer stop growing and
`1 (855) KADCYLA (523-2952)
`For women with HER2+ Breast Cancer ›
`spreading for a longer time
`
`http://www.kadcyla.com/how­can­it­help
`
`Free
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`IMMUNOGEN 2344, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
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`1/21/2015
`
`Is it Right for your Cancer | KADCYLA® (ado­trastuzumab emtansine)
`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
`
`Tykerb is a registered trademark of GlaxoSmithKline.
`
`Next: See how KADCYLA is given
`
`Who is KADCYLA for?
`
` is approved to treat HER2-positive breast cancer that has spread to
`KADCYLA®
`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.
`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
`
`KADCYLA may cause severe liver problems that can be life-threatening.
`
`http://www.kadcyla.com/how­can­it­help
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`Phigenix v. Immunogen
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`1/21/2015
`
`Is it Right for your Cancer | KADCYLA® (ado­trastuzumab emtansine)
`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.
`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
`
`http://www.kadcyla.com/how­can­it­help
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`3/5
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`IMMUNOGEN 2344, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
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`

`

`1/21/2015
`
`Is it Right for your Cancer | KADCYLA® (ado­trastuzumab emtansine)
`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
`
`Nerve damage
`
`Symptoms may include numbness and tingling, burning or sharp pain,
`sensitivity to touch, lack of coordination, 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
`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 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
`
`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
`
`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
`
`http://www.kadcyla.com/how­can­it­help
`
`4/5
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`IMMUNOGEN 2344, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`1/21/2015
`
`Is it Right for your Cancer | KADCYLA® (ado­trastuzumab emtansine)
`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.
`
`Important Safety Information
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`http://www.kadcyla.com/how­can­it­help
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`5/5
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`IMMUNOGEN 2344, pg. 5
`Phigenix v. Immunogen
`IPR2014-00676
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