Treatment with AUGTYRO should be initiated and supervised by physicians experienced in the use of anticancer medicinal products. 3 ROS1 testing 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.
1). NTRK testing 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. 1). Posology ROS1-positive non-small cell lung cancer 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.
NTRK gene fusion-positive solid tumours 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.
Missed dose 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. 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.
4 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. 2). Renal impairment No dose adjustment is required for patients with mild or moderate renal impairment.
2). 2). Paediatric population 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.
1 but no recommendation on a posology can be made. Method of administration 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.
5).