Repotrectinib Brand names: Augtyro

What is repotrectinib used for?

From the label: indications and usage

AUGTYRO is a kinase inhibitor indicated for the treatment of

adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). ( 1.1 )

adult and pediatric patients 12 years of age and older with solid tumors that:

have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and

are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.

have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. […]

Conditions named in the indications of repotrectinib's FDA labels, with every medicine labeled for each:

• Lung cancer

From other repotrectinib labels

Lung cancer: ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Administration (2.1) ].

FDA pharmacologic class: Kinase Inhibitor.

What does the patient leaflet for repotrectinib say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about AUGTYRO?

AUGTYRO may cause serious side effects, including: • Central nervous system (CNS) effects. Tell your healthcare provider right away if you experience any new or worsening symptoms of CNS effects during treatment with AUGTYRO, including: o dizziness o vertigo o changes in mood, such as anxiety, irritability, and depression o balance or coordination problems o problems with thinking, such as forgetfulness or confusion o seeing or hearing things that are not real (hallucinations) o problems with concentration, attention, memory, and sleep • Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including a dry cough (without mucus), productive cough (with mucus), wheezing, or trouble breathing. • Liver problems. Your healthcare provider will do blood tests to check your liver function before starting treatment with AUGTYRO, every 2 weeks for the first month and as needed during treatment. Tell your healthcare provider right away if you develop symptoms of liver problems including: o your skin or the white part of your eyes turns yellow o dark or “tea-colored” urine o light-colored stools (bowel movements) o loss of appetite o nausea or vomiting o pain on the upper right side of your stomach area • Muscle problems. Your healthcare provider will do blood tests before starting treatment with AUGTYRO, every 2 weeks for the first month and as needed during treatment. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness. • Increased uric acid level in your blood (hyperuricemia). AUGTYRO may cause an excess of uric acid in your blood. […]

From the patient leaflet: What should I avoid while taking AUGTYRO?

You should not drink grapefruit juice or eat grapefruit during your treatment with AUGTYRO. It may increase the amount of AUGTYRO in your blood to a harmful level. • Do not drive or operate machinery until you know how AUGTYRO affects you. If you experience dizziness, blurred vision, memory loss, changes in mental status, confusion, hallucinations or have trouble with balance or coordination or problems with concentration and attention, do not drive or operate machinery until your symptoms have resolved.

From the patient leaflet: How should I store AUGTYRO?

Store AUGTYRO at room temperature between 68°F to 77°F (20°C to 25°C). Keep AUGTYRO and all medicines out of the reach of children.

Is there a generic for repotrectinib (Augtyro)?

No generic repotrectinib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 5 patents for Augtyro capsules: the compound patent runs to July 5, 2036, and the last listed entry to July 24, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do FAERS reports show for repotrectinib?

The FDA Adverse Event Reporting System holds 250 reports that list repotrectinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 31 are coded as a death and 61 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

• Dizziness (named in the label)42
• Death (an outcome recorded in the report)24
• Nausea (named in the label)19
• Neuropathy Peripheral (named in the label)17
• Off Label Use (a use or a product term, not a reaction)16
• Fatigue (named in the label)13
• Adverse Event12
• Pain12

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as repotrectinib?

26 other medicines are given the same way (oral) and in the same FDA class as repotrectinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Every medicine labeled for the same conditions as repotrectinib

What next?

Alternatives to repotrectinib

26 medicines for the same use

Other kinase inhibitors

the pharmacologic class, with prices and generics

Repotrectinib side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other