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About HYRNUO

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Prescribing Information

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WHAT IS HYRNUO?HYRNUO is a prescription medicine that is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that:<ul><li>has spread within your chest or to other parts of the body, and </li><li>has a certain abnormal human epidermal growth factor receptor 2 (HER2) gene(s), and</li><li>who have received a previous treatment (systemic therapy)</li></ul>Your healthcare provider will perform a test to make sure HYRNUO is right for you.It is not known if HYRNUO is safe and effective in children.

IMPORTANT SAFETY INFORMATIONBefore taking HYRNUO, tell your healthcare provider about all of your medical conditions, including if you:<ul><li>have liver problems</li><li>have lung or breathing problems other than lung cancer</li><li>are pregnant or plan to become pregnant. HYRNUO can harm your unborn baby.</li></ul>Females who are able to become pregnant:<ul><li>Your healthcare provider will do a pregnancy test before you start treatment with HYRNUO.</li><li>Use effective birth control (contraception) during treatment and for 1 week after the last dose of HYRNUO.</li><li>Talk to your healthcare provider about birth control methods that may be right for you</li><li>Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with HYRNUO.</li></ul>Males with female partners who are able to become pregnant:<ul><li>Use effective birth control (contraception) during treatment and for 1 week after your last dose of HYRNUO.</li><li>Talk to your healthcare provider about birth control methods that may be right for you and your partner.</li><li>are breastfeeding or plan to breastfeed. It is not known if HYRNUO passes into breast milk. Do not breastfeed during treatment and for 1 week after the last dose of HYRNUO.</li></ul>Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HYRNUO may affect the way other medicines work, and other medicines may affect how HYRNUO works.Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.HYRNUO may cause serious side effects, including:<ul><li>diarrhea. Diarrhea is common and can be severe during treatment with HYRNUO and usually occurs in the first week of treatment. Diarrhea can cause the loss of body fluid (dehydration) and salts (electrolyte imbalances). At the first signs of diarrhea (loose stool) or increased bowel movements, tell your healthcare provider right away, drink plenty of fluids and start treatment for diarrhea as soon as possible. You should have an anti-diarrhea medicine available before you start taking HYRNUO.</li><li>liver problems. HYRNUO can cause increases in liver blood tests which may be severe. Your healthcare provider will do blood tests to check your liver function before you start taking and during treatment with HYRNUO. Tell your healthcare provider right away if you get any signs and symptoms of liver problems including:<ul><li>yellowing of the skin or white part of your eyes (jaundice)</li><li>dark urine</li><li>pale stools</li><li>tiredness or weakness</li><li>nausea or vomiting</li><li>loss of appetite</li><li>pain on the upper right side of your stomach</li></ul></li><li>lung problems. HYRNUO can cause severe lung problems. Tell your healthcare provider right away if you develop any new or worsening symptoms of lung problems during treatment with HYRNUO, including,<ul><li>cough</li><li>fever</li><li>shortness of breath or trouble breathing</li></ul></li><li>eye problems. HYRNUO can cause eye problems that can lead to temporary loss of vision. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you develop new or worsening eye problems during treatment with HYRNUO</li><li>pancreas problems. HYRNUO may cause increases in certain pancreatic lab tests (amylase and lipase). Your healthcare provider will do blood tests to check your pancreatic function before and during treatment with HYRNUO. Tell your healthcare provider right away if you develop any signs and symptoms of pancreas problems, including:<ul><li>upper stomach pain that may spread to your back and get worse with eating</li><li>weight loss</li><li>nausea or vomiting</li></ul></li></ul>Your healthcare provider may change your dose, temporarily stop, or completely stop your treatment with HYRNUO if you have certain side effects.The most common side effects of HYRNUO include:<ul><li>rash</li><li>nail problems including infection and inflammation</li><li>mouth sores</li><li>nausea</li><li>changes in certain blood tests</li></ul>These are not all of the possible side effects of HYRNUO.Call your doctor for medical advice about side effects. You are encouraged to report side effects or quality complaints of products to the FDA by visiting <a href="http://www.fda.gov/medwatch">www.fda.gov/medwatch</a> or calling 1-800-FDA-1088.Please see full <a href="https://labeling.bayerhealthcare.com/html/products/pi/HYRNUO_PI.pdf" target="_blank">Prescribing Information</a>.

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