What is Augtyro used for?

Augtyro is used to treat adults with ROS1-positive non-small cell lung cancer and adults or children (12+) with solid tumors that have an NTRK gene fusion.

How should I take REPOCTRECTINIB?

The usual dose is 160 mg once daily for 14 days, then it increases to 160 mg twice daily. You can take it with or without food.

Can Augtyro cause lung problems?

Yes, Augtyro can cause lung inflammation called interstitial lung disease or pneumonitis. Tell your doctor immediately if you have new breathing problems.

Is Augtyro safe to take while pregnant?

No, Augtyro can cause harm to an unborn baby and should not be used during pregnancy.

What are the most common side effects of Augtyro?

Common side effects (affecting 20% or more) include dizziness, changes in taste, constipation, fatigue, and nausea.

Does Augtyro affect my liver?

Yes, it can cause liver toxicity, so your doctor will likely monitor your liver function tests regularly.

What should I do if I experience muscle pain while taking Augtyro?

You should report unexplained muscle pain, tenderness, or weakness to your doctor, as it may be related to muscle issues or CPK elevation.

repotrectinib | CAS 1802220-02-5 | FIKPXCOQUIZNHB

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Kinase inhibitor

REPOTRECTINIB (brand name Augtyro) is a kinase inhibitor used to treat certain types of advanced or metastatic cancers. It is specifically indicated for adults with ROS1-positive non-small cell lung cancer (NSCLC) and for adults and children (12 years and older) with solid tumors that have an NTRK gene fusion. The drug works by blocking specific proteins that help cancer cells grow and multiply.

How it worksRepoctrectinib works by blocking proteins called ROS1 and TRK (specifically TRKA, TRKB, and TRKC). These proteins act like switches that, when fused with other genes, stay 'on' and tell cancer cells to grow uncontrollably.

Brand names:AUGTYRO

Used for

Locally advanced or metastatic ROS1-positive non-small cell lung cancer in adults.Locally advanced or metastatic solid tumors with an NTRK gene fusion in adults and children 12 years of age and older.

Conditions

ROS1-positive non-small cell lung cancer (NSCLC)NTRK gene fusion-positive solid tumors

Class

Kinase InhibitorKinase inhibitorRespiratoryCentral Nervous SystemHepaticMusculoskeletal

How to take

FormsOral capsule

RoutesOral

The recommended dose starts at 160 mg once daily for 14 days, then increases to 160 mg twice daily. It can be taken with or without food.

Patients must be selected based on testing for ROS1 rearrangements or NTRK gene fusions.

Key warnings

·May cause central nervous system effects such as dizziness or cognitive changes.
·May cause lung inflammation (ILD/pneumonitis); watch for new or worsening breathing issues.
·May cause liver toxicity; liver function tests are required.
·May cause muscle pain and elevated CPK levels.
·May cause high uric acid levels in the blood.
·May increase the risk of bone fractures.
·Can cause harm to a fetus during pregnancy.

Do not use if

·None listed

Side effects

Common

DizzinessTaste changes (dysgeusia)Nerve tingling or numbness (peripheral neuropathy)ConstipationShortness of breath (dyspnea)FatigueCoordination problems (ataxia)Thinking or memory issues (cognitive impairment)Muscle weaknessNausea

Serious

·Central Nervous System (CNS) issues like dizziness or confusion
·Lung inflammation (Interstitial Lung Disease or pneumonitis)
·Liver problems (hepatotoxicity)
·Muscle pain with high CPK levels
·High uric acid levels (hyperuricemia)
·Bone fractures
·Harm to an unborn baby

Seek help if

·Difficulty breathing
·Severe dizziness
·Muscle pain
·Yellowing of eyes/skin (jaundice)
·Confusion

Interactions

·Avoid using with strong or moderate CYP3A inhibitors.
·Avoid using with P-gp inhibitors.
·Avoid using with strong or moderate CYP3A inducers.
·Avoid using with certain drugs that rely on the CYP3A pathway if small changes in their levels could make them less effective.
·Avoid using with hormonal contraceptives.
·Known interactions include ROZLYTREK, XALKORI, and STIVARGA.

FoodCan be taken with or without food.

Special populations

PregnancyAugtyro can cause harm to a developing baby. Animal studies showed fetal malformations when the drug was given during pregnancy. There are no specific studies on humans yet.

PediatricAugtyro is approved for children 12 years and older with NTRK gene fusion-positive solid tumors. Its safety and effectiveness have not been established for children under 12 or for children with ROS1-positive lung cancer.

GeriatricIn clinical studies, there were no significant differences in how safe or effective the drug was for patients 65 years or older compared to younger patients.

Talk to your doctor

Monitor

·Liver function
·Pulmonary symptoms (breathing)
·Serum CPK levels
·Serum uric acid levels
·Signs of bone fractures

Questions to ask

·What tests do I need to confirm my ROS1 or NTRK status?
·How often will my liver function be monitored?
·What should I do if I experience new shortness of breath?
·Are there any specific medications I must avoid while on Augtyro?

Pharmacokinetics

OnsetSteady state achieved within 14 days

Bioavailability45.7%

MetabolismAutoinduction of CYP3A4

Ingredients

Allergens

FD&C colors

Inactive

microcrystalline cellulosesodium lauryl sulfatecroscarmellose sodiumcolloidal silicon dioxidegelatintitanium dioxideshellacFD & C blue #2 aluminum lakemagnesium stearateFD & C blue #1

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.