About IBTROZI™ (taletrectinib)

What is IBTROZI?

IBTROZI™ (taletrectinib) is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread within your chest or to other parts of the body and is caused by an abnormal ROS1 gene.

It is not known if IBTROZI is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IBTROZI?

IBTROZI can cause serious side effects, including:

• Liver problems (Hepatotoxicity). Changes in liver function can happen during treatment with IBTROZI and can lead to liver injury and death. Your healthcare provider will do blood tests to check your liver function before starting, every 2 weeks during the first 2 months of treatment, then monthly as needed during your treatment with IBTROZI. Tell your healthcare provider right away if you develop signs and symptoms of liver problems, including:
  • yellowing of your skin or the white part of your eyes (jaundice)
  • dark or "tea-colored" urine
  • light-colored stools (bowel movements)
  • loss of appetite

  • nausea or vomiting
  • pain on the upper right side of your stomach
  • feeling tired or weak
• Lung problems (Interstitial Lung Disease/Pneumonitis). IBTROZI can cause lung problems that are severe, life-threatening, or lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough (with or without mucus), or fever.
• Changes in the electrical activity of your heart (QT prolongation). QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will do tests before and during your treatment with IBTROZI to check the electrical activity of your heart and your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during your treatment with IBTROZI. These may be symptoms related to QT prolongation.
• Increased uric acid level in your blood (Hyperuricemia). Your healthcare provider will check your uric acid blood level before and during your treatment with IBTROZI. Your healthcare provider may prescribe medicines to lower uric acid if needed. Tell your healthcare provider if you develop any of the following symptoms of hyperuricemia:
  • red, hot, tender, or swollen joints, especially in your big toe
  • pain in your stomach-area

  • nausea or vomiting
  • pink or brown urine
• Muscle pain, tenderness, and weakness (Myalgia). IBTROZI can cause myalgia with or without an increase in the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your CPK blood levels every 2 weeks during the first month and as needed if you experience unexplained muscle pain, tenderness, or weakness with IBTROZI. Tell your healthcare provider if you develop any of these symptoms.
• Bone fractures. IBTROZI can increase your risk of bone fractures, which may happen with or without a fall or other injury. Tell your healthcare provider if you develop pain, changes in movement, or bone abnormalities.
• Harm to your unborn baby. IBTROZI should not be used in pregnancy. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with IBTROZI.
  • If you are a female who is able to become pregnant, your healthcare provider should do a pregnancy test before starting IBTROZI. Use an effective birth control (contraception) during treatment and for 3 weeks after the last dose of IBTROZI.
  • If you are a male with a female partner who is able to become pregnant, use an effective form of contraception during treatment and for 3 weeks after the last dose of IBTROZI.

What are the most common side effects of IBTROZI?

• The most common side effects of IBTROZI include: diarrhea, nausea, vomiting, dizziness, rash, constipation, tiredness, changes in your liver function tests, and decreased white blood cell levels.

These are not all the possible side effects of IBTROZI. Call your healthcare provider for more information or medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What should I tell my healthcare provider before starting IBTROZI?

Before taking IBTROZI tell your healthcare provider about all your medical conditions, including if you:

• have liver problems.
• have lung or breathing problems other than lung cancer.
• have any heart problems, including a condition called long QT syndrome.
• have gout.
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if IBTROZI passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after the last dose of IBTROZI.

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

Will medications interact with IBTROZI?

IBTROZI may affect the way other medicines work, and other medicines may affect how IBTROZI works.

• You should not start or stop any medicine before you talk with your healthcare provider who prescribed IBTROZI.

What should I avoid while taking IBTROZI?

• Avoid taking proton pump inhibitor (PPI) or H2 blocker medicine. If you take an antacid, take it at least 2 hours before or 2 hours after taking IBTROZI.
• You should limit time in the sun during treatment with IBTROZI. IBTROZI may make your skin sensitive to sunlight. Wear a hat and clothes that cover your skin and use sunscreen with sun protective factor (SPF) if you are in the sun during treatment with IBTROZI and for at least 5 days after your last dose of IBTROZI.
• You should avoid grapefruit, grapefruit juice, or products that contain grapefruit during your treatment with IBTROZI. Grapefruit may increase the amount of IBTROZI in your blood, which may increase the risk of IBTROZI side effects.

Please read the accompanying Patient Information.