Repotrectinib is used to treat adults with a certain type of non-small cell lung cancer.

Repotrectinib is used when the cancer has progressed or has spread to other parts of the body (metastatic).

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.

Tell your doctor if you have ever had:

• nervous system problems;
• gout or high levels of uric acid in the blood;
• lung or breathing problems (other than lung cancer); 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 barrier 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 this medicine.

• If you are a woman, you will need a pregnancy test to make sure you are not pregnant. Use a barrier 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.

Use Augtyro (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Call your doctor at once if you have:

• nervous system problems--weakness, vision or hearing problems, dizziness, mood changes, vertigo (spinning sensation), problems with balance or coordination, problems with thinking or memory, hallucinations, sleep problems;
• high levels of uric acid in blood--joint problems, stomach pain, little or no urination, nausea, vomiting, pink or brown urine;
• lung problems--fever, wheezing, dry cough, chills, cough with mucus, chest pain, feeling short of breath;
• muscle or bone problems--severe bone pain, severe joint or 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 changed or permanently discontinued if you have certain side effects.

Common side effects may include:

• dizziness, tiredness;
• changes in your sense of taste, nausea;
• constipation;
• numbness or tingling, loss of balance or coordination;
• shortness of breath; or
• hallucinations, 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.

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

Avoid driving or hazardous activity until you know how this medicine 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.