Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).
AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and
Treatment with AUGTYRO should be initiated and supervised by physicians experienced in the use of anticancer medicinal products.
Patient selection for treatment with repotrectinib, based on ROS1-positive status in NSCLC should be assessed by a CE-marked IVD with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used (see sections 4.1, and 5.1).
Patient selection for treatment with repotrectinib, based on NTRK-positive status in solid tumours should be assessed by a CE-marked IVD with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used (see sections 4.1, 4.4 and 5.1).
The recommended dose in adults is 160 mg repotrectinib once daily for 14 days, followed by 160 mg repotrectinib twice daily until disease progression or unacceptable toxicity.
The recommended dose in adults and paediatric patients 12 year and older is 160 mg repotrectinib once daily for 14 days, followed by 160 mg repotrectinib twice daily until disease progression or unacceptable toxicity.
If a dose is missed or if a patient vomits at any time after taking a dose, subsequent doses should be resumed as prescribed. Two doses should not be taken at the same time.
The recommended dose reductions for adverse reactions are provided in Table 1:
Table 1. Recommended dose reductions for adverse reactions:
| Prescribed dose | Dose reduction | |
|---|---|---|
| First occurrence | Second occurrence | |
| 160 mg once daily | 120 mg once daily | 80 mg once daily |
| 160 mg twice daily | 120 mg twice daily | 80 mg twice daily |
Recommended dose modifications for specific adverse reactions are provided in Table 2 (see sections 4.4 and 4.8).
Table 2. Recommended dose modifications for specific adverse reactions:
| Adverse reactions | Severity* | Dosage modification |
|---|---|---|
| Central nervous system effects | Intolerable Grade 2 | • Withhold until less than or equal to Grade 1 or baseline. • Resume at same or reduced dose, as clinically appropriate. |
| Grade 3 | • Withhold until less than or equal to Grade 1 or baseline. • Resume at reduced dose. | |
| Grade 4 | • Permanently discontinue. | |
| Interstitial lung disease (ILD)/Pneumonitis | Any Grade | • Withhold if ILD/pneumonitis is suspected. • Permanently discontinue if ILD/pneumonitis is confirmed. |
| Other clinically relevant adverse reactions | Intolerable Grade 2 | • Withhold until less than or equal to Grade 1 or baseline. • Resume at the same or reduced dose if resolution occurs within 4 weeks. |
| Grade 3 or 4 | • Withhold until adverse reaction resolves or improves to recovery or improvement to Grade 1 or baseline. • Resume at the same or reduced dose if resolution occurs within 4 weeks. • Permanently discontinue if adverse reaction does not resolve within 4 weeks. • Permanently discontinue for recurrent Grade 4 events. |
* Graded per NCI Common Terminology Criteria for Adverse Events 4.0
No dose adjustment is required for elderly patients (≥65 years) (see section 5.2).
No dose adjustment is required for patients with mild or moderate renal impairment. AUGTYRO has not been studied in patients with severe renal impairment (see section 5.2).
No dose adjustment is required for patients with mild hepatic impairment (total bilirubin >1.0 to 1.5 times ULN or AST > ULN). AUGTYRO has not been studied in patients with moderate (total bilirubin >1.5 to 3 times ULN) or severe (total bilirubin >3 times ULN) hepatic impairment, and AUGTYRO should not be used in patients with moderate/severe hepatic impairment (see sections 4.4 and 5.2).
The safety and efficacy of AUGTYRO in paediatric patients below 18 years of age with ROS1-positive NSCLC have not been established.
The safety and efficacy of AUGTYRO in paediatric patients below 12 years of age with NTRK-positive solid tumours have not been established. Currently, available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
AUGTYRO is for oral use. The capsules should be swallowed whole at the same time every day. The capsules must not be opened, crushed, chewed, and the contents of the capsule must not be dissolved.
AUGTYRO may be taken with or without food (see section 5.2) but should not be taken with grapefruit, grapefruit juice or Seville oranges (see section 4.5).
There is limited experience of overdose with AUGTYRO. Symptoms of overdose are not established. In the event of overdose, physicians should follow general supportive measures and treat symptomatically.
3 years.
This medicinal product does not require any special storage conditions.
AUGTYRO 40 mg hard capsules:
High-density polyethylene (HDPE) bottles with 2-piece child-resistant continuous thread (CRCT) polypropylene (PP) closures.
Each bottle contains 60 hard capsules packed in a cardboard carton.
Each bottle contains 120 hard capsules packed in a cardboard carton.
Each carton contains one bottle.
AUGTYRO 160 mg hard capsules:
PVC/polychlorotrifluoroethylene clear blister with push through aluminium foil lidding.
Packs of 20 or 60 hard capsules with 10 hard capsules in blister cards.
Not all pack sized may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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