Repotrectinib

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

Repotrectinib is also used in adults and children who are at least 12 years old and have tumors (cancer) that have spread to other parts of the body (metastatic), cannot be removed with surgery, or when other treatments did not work or have stopped working.

Your doctor will make sure you have the correct tumor type to be treated with repotrectinib.

Repotrectinib may also be used for purposes not listed in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Do not change your dose or stop taking repotrectinib without your doctor's advice. Use the medicine exactly as directed.

You can take repotrectinib with or without food, but do it the same way each time.

Swallow the capsule whole with water and do not crush, chew, break, or open it. Do not take a capsule that is damaged in any way.

You will need frequent medical tests before and during treatment with repotrectinib, and your next dose may be delayed, reduced, or permanently stopped based on the results.

You may receive other medications to help prevent serious side effects. Keep taking these medicines for as long as your doctor has prescribed. Your doctor will monitor you for these side effects.

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

Store at room temperature away from moisture and heat.

Call your doctor if you have nervous system problems such as dizziness, vertigo (spinning sensation), mood changes, loss of balance or coordination, problems with thinking, memory or concentration, hallucinations, or trouble sleeping.

Tell your doctor if you have or have ever had:

• nervous system problems;
• gout or high levels of uric acid in the blood;
• lung or breathing problems (other than lung cancer);
• kidney disease (or if you are on dialysis); or
• liver disease.

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

Repotrectinib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use non-hormonal birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Ask your doctor about the best form of birth control while you are using repotrectinib.

Repotrectinib can harm an unborn baby if the mother or the father is using repotrectinib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use a non-hormonal form of birth control while using this medicine and for at least 2 months 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 for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 10 days after your last dose.

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

Repotrectinib may cause serious side effects. Call your doctor right away if you have:

• sudden chest pain, wheezing, dry cough, feeling short of breath;
• sudden pain or trouble moving your hip, wrist, or back;
• nervous system problems—dizziness, vertigo (spinning sensation), mood changes, loss of balance or coordination, problems with thinking, memory or concentration, hallucinations, or trouble sleeping;
• high levels of uric acid in blood—joint problems, stomach pain, little or no urination, nausea, vomiting, pink or brown urine;
• muscle problems—unexplained muscle pain, tenderness, weakness; or
• liver problems—loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed, reduced, or permanently stopped if you have certain side effects.

Common side effects of repotrectinib may include:

• dizziness, tiredness;
• changes in your sense of taste, nausea;
• constipation;
• numbness or tingling in your arms or legs, loss of balance or coordination, trouble walking;
• muscle weakness;
• shortness of breath; or
• hallucinations, confusion, forgetfulness, problems with thinking or memory.

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 FDA at 1-800-FDA-1088.

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.

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

Avoid driving or doing hazardous activities until you know how repotrectinib will affect you. This medicine may cause dizziness, blurred vision, balance or memory problems, and this may impair your reactions or cause falls, accidents, or severe injuries.

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

Tell your doctor about all your other medicines, especially:

• birth control pills and other hormones.

Other drugs may affect repotrectinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.