`
`Tykerb | Tykerb.com
`
`Prescribing Information including BOXED WARNING (https://w w w .gsksource.com/gskprm/htdocs/documents/TYKERBPIPIL.PDF)
`Patient Information Leaflet (https://w w w .gsksource.com/gskprm/htdocs/documents/TYKERBPIPIL.PDF#nameddest=PIL)
`|
`Healthcare Professionals (https://w w w .gsksource.com/tykerb)
`IMPORTANT SAFETY INFORMATION
`
` |
` For US
`
` (/index.html)
`
`Some people may develop liver damage while taking TYKERB. Liver problems can be severe and deaths have
`happened. Before taking TYKERB, tell your doctor if you have liver problems. You may need a lower dose of TYKERB.
`Your doctor should do blood tests to check your liver before and during treatment with TYKERB.
`
`See full Important Safety Information below ▼
`
`TYKERB with Xeloda
`For HER2+ Metastatic
`Breast Cancer
`
`TYKERB with Xeloda
`TYKERB is used with a medicine called Xeloda (capecitabine) for
`®
`the treatment of people with advanced or metastatic breast cancer
`whose tumors overexpress HER2, and who have received prior
`therapy including an anthracycline, a taxane, and Herceptin
`®
`(trastuzumab). Tumors that are HER2 positive make a large amount
`of a protein called human epidermal growth factor receptor2.
`
`TYKERB with Femara
`For HR+/HER2+
`Metastatic Breast Cancer
`
`TYKERB with Femara
`TYKERB is used with the medicine Femara (letrozole) for the
`®
`treatment of postmenopausal women with hormone receptor positive
`metastatic breast cancer that overexpresses the HER2 receptor for
`whom hormonal therapy is indicated.
`
` (/tykerbxeloda/index.html)
`
` (/tykerbfemara/index.html)
`
`IMPORTANT SAFETY INFORMATION
`
`Some people may develop liver damage while taking TYKERB. Liver problems can be severe and deaths have happened. Before taking
`TYKERB, tell your doctor if you have liver problems. You may need a lower dose of TYKERB. Your doctor should do blood tests to check your liver
`before and during treatment with TYKERB. You should contact your doctor right away if you have itching, yellowing of your skin or the white part
`of your eyes, dark urine, pain or discomfort in the right upper stomach area.
`
`Do not take TYKERB if you are allergic to any of the ingredients in TYKERB.
`
`It is not known if TYKERB is safe and effective in children.
`
`Before taking TYKERB, tell your doctor if you have heart problems. Some people may develop heart problems while taking TYKERB, including decreased pumping
`of blood from the heart and an abnormal heartbeat. Call your doctor right away if you feel like your heart is pounding or racing; if you are dizzy, tired, or light
`headed; or if you are short of breath. Your doctor should check your heart before and during treatment with TYKERB.
`
`Diarrhea is common with TYKERB and may sometimes be severe. Severe diarrhea can cause loss of fluid (dehydration) and some deaths have happened. Call
`your doctor right away if you have a change in bowel pattern or if you have severe diarrhea. Follow your doctor's instructions for what to do to help prevent or treat
`diarrhea.
`
`If you have a cough that will not go away or are short of breath, talk with your doctor. These may be signs of lung problems.
`
`Tell your doctor right away if you are or plan to become pregnant. You should not become pregnant when taking TYKERB because the unborn baby can be
`harmed. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if TYKERB passes into breast milk. You and your doctor should decide if
`you will take TYKERB or breastfeed. You should not do both.
`
`http://www.tykerb.com/
`
`1/2
`
`IMMUNOGEN 2342, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`12/18/2014
`
`Tykerb | Tykerb.com
`
`When TYKERB is taken with Xeloda or Femara, common side effects include diarrhea; red, painful hands and feet; nausea; rash; vomiting; feeling tired or weak;
`mouth sores; loss of appetite; indigestion; unusual hair loss or thinning; nosebleeds; headache; dry skin; itching; and nail disorders such as nail bed changes, nail
`pain, infection, and swelling of the cuticles.
`
`Tell your doctor about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. Do not eat or drink
`grapefruit products while taking TYKERB.
`
`Xeloda is a registered trademark of Roche Laboratories Inc.
`Herceptin is a registered trademark of Genentech, Inc.
`Femara is a registered trademark of Novartis Pharmaceuticals Corporation.
`
`Manage Communications (https://www.contactus.gsk.com/optout/index.html)
`
`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, (http://www.fda.gov/Safety/MedWatch/default.htm) or call 1
`800FDA1088.
`
` | Privacy Statement
`Legal Notices (http://www.imgw.com/disclaimer.htm)
`(http://www.imgw.com/privacy.htm)
`| Medicine Savings (http://www.gskcta.com/)
`|
`Contact Us (https://www.contactus.gsk.com/callback.html)
`
`This w ebsite is funded and developed by GSK.
`This site is intended for US residents only.
`©2014 GSK group of companies. All rights reserved.
`
`(http://www.gskcta.com/)
`
`(https://www.contactus.gsk.com/callback.html)
`
` (http://us.gsk.com)
`
`http://www.tykerb.com/
`
`2/2
`
`IMMUNOGEN 2342, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`