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

Rozlytrek is also used in adults and children at least 12 years old who have solid tumors that have spread or cannot be safely removed with surgery, or when other treatments have failed or are not safe options.

Rozlytrek is used only if your cancer has a specific abnormal gene. Your doctor will test you for this gene.

Rozlytrek may cause new or worsened symptoms of congestive heart failure. Call your doctor at once if you have swelling in your lower legs, rapid weight gain, cough, wheezing, shortness of breath, or trouble breathing while lying down.

Use Rozlytrek exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Rozlytrek with or without food.

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

If you vomit shortly after taking Rozlytrek, take another dose.

Store at room temperature away from moisture and heat.

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

Usual Adult Dose for Non-Small Cell Lung Cancer:

600 mg orally once a day until disease progression or unacceptable toxicity

Use: For adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive

Usual Adult Dose for Solid Tumors:

600 mg orally once a day until disease progression or unacceptable toxicity

Uses: For adult patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed following treatment or have no satisfactory alternative therapy.

Usual Pediatric Dose for Solid Tumors:

12 years and older:
-Body surface area (BSA) greater than 1.5 m2: 600 mg orally once a day
-BSA 1.11 to 1.5 m2: 500 mg orally once a day
-BSA 0.91 to 1.1 m2: 400 mg orally once a day

Use: For pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed following treatment or have no satisfactory alternative therapy.

To make sure Rozlytrek is safe for you, tell your doctor if you have ever had:

• gout;

• heart problems;

• long QT syndrome (in you or a family member);

• liver or kidney disease;

• a nervous system disorder; or

• problems with your eyes or vision.

You may need to have a negative pregnancy test before starting this treatment.

Entrectinib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Rozlytrek if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 5 weeks after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Rozlytrek.

Do not breastfeed while using this medicine, and for at least 7 days after your last dose.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

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

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Grapefruit may interact with entrectinib and lead to unwanted side effects. Avoid the use of grapefruit products.

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

Call your doctor at once if you have:

• bone pain or problems moving;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• nausea, vomiting, loss of appetite, right-sided upper stomach pain;

• swelling in your lower legs, rapid weight gain;

• cough, wheezing, shortness of breath, trouble breathing while lying down;

• confusion, hallucinations, problems with memory or concentration;

• dizziness, mood changes, trouble sleeping; or

• blurred vision, double vision, increased sensitivity to light, or seeing flashes of light or "floaters" in your vision.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Rozlytrek side effects may include:

• changes in your mental status;

• vision changes;

• nausea, vomiting, diarrhea, constipation;

• fever, cough;

• dizziness, tiredness;

• weight gain, swelling;

• muscle or joint pain;

• trouble breathing; or

• changes in your sense of taste or touch.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with entrectinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.