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Important Safety Information

What Warnings should I know about TEPMETKO?

TEPMETKO may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you develop any new or worsening symptoms of lung problems, including: trouble breathing; shortness of breath; cough; or fever.

TEPMETKO may cause abnormal liver blood test results. One patient died from liver failure. Your healthcare provider will do blood tests to check your liver function before you start treatment and during treatment with TEPMETKO. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including: your skin or the white part of your eyes turns yellow; dark or “tea colored” urine; light-colored stools (bowel movements); confusion; tiredness; loss of appetite for several days or longer; nausea and vomiting; pain, aching, or tenderness on the right side of your stomach-area (abdomen); weakness; or swelling in your stomach-area.

TEPMETKO may cause increases in your blood amylase and lipase levels that may indicate a problem with your pancreas. Your healthcare provider will do blood tests to check your pancreatic function before you start treatment and during treatment with TEPMETKO. Tell your healthcare provider right away if you develop upper stomach (abdominal) pain, weight loss, nausea, or vomiting.

TEPMETKO can cause harm to an unborn baby in pregnant women. 

Females who are able to become pregnant: 

• Your healthcare provider may do a pregnancy test before you start treatment with TEPMETKO.
• You should use effective birth control (contraception) during treatment and for 1 week after the last dose of TEPMETKO. Talk to your healthcare provider about birth control methods that may be right for you. 

Males with female partners who are able to become pregnant should use effective birth control during treatment with TEPMETKO and for 1 week after the last dose of TEPMETKO. 

What should I tell my health care provider? 

Tell your healthcare provider about all of your medical conditions, including if you: 

• have or have had lung or breathing problems other than your lung cancer 
• have or have had liver problems
• have or have had pancreatic problems
• are pregnant or plan to become pregnant. TEPMETKO can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if TEPMETKO passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of TEPMETKO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the side effects of TEPMETKO? 

The most common side effects of TEPMETKO include: swelling in your face or other parts of your body; nausea; tiredness; diarrhea; muscle and joint pain; diarrhea; shortness of breath; loss of appetite; rash; and changes in certain blood tests. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TEPMETKO if you develop serious side effects during treatment. These are not all of the possible side effects of TEPMETKO. Call your doctor for medical advice about side effects. 

You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.