TM Owner Bristol Myers Squibb
Repotrectinib 40mg Capsule
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Indications & Clinical Uses
- Repotrectinib is the active-ingredient (molecule) name; there is no marketed brand called "Repotrectinib" — the approved product is Augtyro (repotrectinib) capsules from Bristol Myers Squibb, and this content is based on Augtyro's US FDA prescribing information.
- Augtyro 40 mg capsules are a tyrosine kinase inhibitor taken by mouth, approved in the United States for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), and, under accelerated approval, for adults and children aged 12 years and older with NTRK gene fusion-positive solid tumours that are locally advanced or metastatic, or where surgery would cause severe illness, and that have progressed after treatment or have no satisfactory alternative.
- Augtyro was first approved in the US in November 2023 for ROS1-positive NSCLC and later expanded to the NTRK indication in June 2024.
- It is taken continuously, for as long as it provides benefit, under the supervision of a cancer specialist.
Side Effects
- Very commonly reported side effects (affecting more than 1 in 5 people) with Augtyro (repotrectinib) capsules include dizziness, altered taste (dysgeusia), numbness or tingling in the hands and feet (peripheral neuropathy), constipation, shortness of breath, tiredness, unsteady walking or coordination problems (ataxia), difficulty concentrating, muscle weakness and nausea.
- Augtyro carries no boxed warning, but the label lists several important warnings: inflammation of the lung tissue (interstitial lung disease or pneumonitis), liver problems, muscle pain with raised creatine kinase, raised uric acid levels, and an increased risk of bone fractures.
- Report new or worsening breathlessness, cough or fever, yellowing of the skin or eyes, dark urine, severe muscle pain, or any fall or bone pain to your cancer team immediately, as these may need urgent dose interruption or investigation.
Precautions & Warnings
- Because Augtyro (repotrectinib) commonly causes dizziness, unsteadiness and cognitive effects, avoid driving or operating machinery until you know how it affects you, and your dose may be reduced or paused if these become severe.
- Blood tests to check liver function are recommended every two weeks for the first month of treatment, and periodically afterwards, along with monitoring of creatine kinase and uric acid levels.
- Augtyro can cause fetal harm, so effective contraception is required for women of childbearing potential during treatment and for a period after the last dose, and for male patients with partners who could become pregnant; it should not be used in pregnancy or while breastfeeding.
- There are no absolute contraindications listed, but your specialist will weigh existing lung, liver or muscle conditions before starting treatment.
- Augtyro capsules are for oral use only and must be swallowed whole.
Avoid Interactions
- Avoid Interactions : Augtyro (repotrectinib) is broken down mainly by the CYP3A4 liver enzyme, so strong or moderate CYP3A4 inhibitors — including certain antifungals (itraconazole, ketoconazole), some antibiotics (clarithromycin) and grapefruit or grapefruit juice — should be avoided, as they can raise repotrectinib levels and increase toxicity.
- Strong or moderate CYP3A4 inducers, such as rifampicin, carbamazepine, phenytoin and St John's Wort, should also be avoided, as they can lower repotrectinib levels and reduce its cancer-fighting effect.
- Repotrectinib itself induces CYP3A4 and can reduce the effectiveness of hormonal contraceptives, so a non-hormonal backup method is recommended.
- Tell your cancer care team about every prescription medicine, over-the-counter product, herbal remedy and supplement you take, since many common drugs interact through this pathway.
References
Frequently Asked Questions
Augtyro is the approved brand of repotrectinib, made by Bristol Myers Squibb. It treats adults with ROS1-positive metastatic non-small cell lung cancer, and adults and children 12 and over with NTRK gene fusion-positive solid tumours that progressed after earlier treatment. There is no separate product simply called "Repotrectinib."
Augtyro (repotrectinib) 40 mg capsules are swallowed whole, once or twice daily depending on your dose and indication, with or without food. Treatment continues for as long as your cancer responds and side effects stay manageable, under regular review by your oncology team.
Very common side effects of Augtyro (repotrectinib) include dizziness, taste changes, numbness or tingling, constipation and tiredness. Augtyro has no boxed warning, but tell your doctor urgently about new breathlessness, yellowing skin or eyes, severe muscle pain, or a fall, as these can signal lung, liver or muscle problems.
Avoid grapefruit, grapefruit juice and strong CYP3A4-affecting drugs, such as certain antifungals, some antibiotics, rifampicin, carbamazepine and St John's Wort, while taking Augtyro (repotrectinib); they can raise or lower drug levels. Augtyro also reduces hormonal contraceptive effectiveness, so use a non-hormonal backup method.
Your care team checks liver blood tests every two weeks for the first month of Augtyro (repotrectinib), then periodically, along with creatine kinase and uric acid levels. You may also be assessed for breathing changes, dizziness, coordination problems and bone pain, since these guide dose adjustments.
No. Augtyro (repotrectinib) can harm an unborn baby, so effective non-hormonal contraception is required during treatment and for a period afterwards for both female and male patients with partners who could become pregnant. Tell your oncology team immediately if you become pregnant while taking Augtyro.
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