Taletrectinib

Taletrectinib is used in adults to treat non-small cell lung cancer that has spread within your chest or to other parts of the body (metastatic).

Your doctor will confirm that you have the right tumor type to be treated with taletrectinib.

Taletrectinib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor will perform tests to ensure taletrectinib is the right treatment for you.

Taletrectinib is usually taken once per day, but take it the same way each time.

Take on an empty stomach, at least 2 hours before or 2 hours after a meal.

Do not change your dose or stop taking taletrectinib without your doctor's advice.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you vomit shortly after taking taletrectinib, do not take another dose. Take your next dose as scheduled.

You will need frequent medical tests including tests to check your liver and heart function. Your cancer treatments may change, be delayed or discontinued based on the results.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• gout or high levels of uric acid in the blood;
• heart problems, including long QT syndrome (in you or a family member);
• lung or breathing problems (other than lung cancer); or
• liver disease.

You may be more likely to have a broken bone while using taletrectinib. Talk with your doctor about ways to keep your bones healthy.

Taletrectinib can harm an unborn baby if the mother or the father is using taletrectinib.

• If you are a woman, you will need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 3 weeks after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control during treatment and for at least 3 weeks after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.

Taletrectinib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Taletrectinib may cause serious side effects. Call your doctor right away if you experience:

• sudden pain or trouble moving your hip, wrist, or back;
• heart problems, including swelling, rapid weight gain, feeling short of breath, fast or pounding heartbeats, fluttering in your chest, or sudden dizziness (like you might faint);
• high levels of uric acid in your blood, which may cause joint problems, stomach pain, little or no urination, nausea, vomiting, or pink or brown urine;
• lung problems, such as sudden chest pain, wheezing, dry cough, or feeling short of breath;
• muscle problems, including unexplained muscle pain, tenderness, or weakness; or
• liver problems, which may include loss of appetite, nausea, vomiting, stomach pain (in the upper right side), tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or stopped permanently if you experience certain side effects.

Common side effects of taletrectinib may include:

• nausea, vomiting, diarrhea, constipation;
• abnormal blood tests;
• dizziness, tiredness; or
• rash.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Non-Small Cell Lung Cancer:

600 mg orally once a day on an empty stomach Duration of therapy: Until disease progression or unacceptable toxicityComments:-Select patients for the treatment based on the presence of ROS1 rearrangement(s) in tumor specimens; a US FDA-approved test to detect ROS1 rearrangements is not currently available.-Administer at least 2 hours before and 2 hours after food intake. Use: For the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Taletrectinib could make you more likely to get sunburned. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors while using taletrectinib and for at least 5 days after your last dose.

Ask your doctor before taking an antacid, and take only the type your doctor recommends.

Grapefruit may interact with taletrectinib and cause side effects. Avoid consuming grapefruit products.

Avoid taking an antacid within 2 hours before or after you take taletrectinib.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can change how much of other drugs are in your blood, which may increase side effects or reduce how well the medicines work.

Taletrectinib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can affect taletrectinib, especially:

• stomach acid reducers such as omeprazole, pantoprazole, famotidine.

This list is not complete and many other drugs may affect taletrectinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.