Dosage & administration
Augtyro prescribing information
Indications and Usage ( NTRK Gene Fusion-Positive Solid TumorsAUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). | 06/2024 |
Dosage and Administration ( NSCLC Select patients for the treatment of locally advanced or metastatic NSCLC with AUGTYRO based on the presence of ROS1 rearrangement(s) in tumor specimens[see Clinical Studies (14.1)] . An FDA-approved test to detectROS1 rearrangements for selecting patients for treatment with AUGTYRO is not currently available.Solid Tumors Select patients for the treatment of solid tumors with AUGTYRO based on the presence of NTRK1/2/3 rearrangements in tumor specimens[see Clinical Studies ] . An FDA-approved test to detectNTRK1/2/3 rearrangements for selecting patients for treatment with AUGTYRO is not currently available.
| 06/2024 |
Warnings and Precautions ( AUGTYRO can cause skeletal fractures. Among 426 adult patients who received AUGTYRO, fractures occurred in 2.3%. Fractures involved the ribs (0.5%), feet (0.5%), spine (0.2%), acetabulum (0.2%), sternum (0.2%), and ankles (0.2%). Some fractures occurred at sites of disease and prior radiation therapy. The median time to fracture was 71 days (range: 31 days to 1.4 years). AUGTYRO was interrupted in 0.3% of patients. Of 26 evaluable patients in an ongoing open-label study in pediatric patients, fractures occurred in one 12-year-old patient (ankle/foot) and one 10-year-old patient (stress fracture). AUGTYRO was interrupted in both patients. AUGTYRO is not approved for use in pediatric patients less than 12 years of age [see Pediatric Use (8.4)] .Promptly evaluate patients with signs or symptoms (e.g., pain, changes in mobility, deformity) of fractures. There are no data on the effects of AUGTYRO on healing of known fractures and risk of future fractures. | 06/2024 |
AUGTYRO is a kinase inhibitor indicated for the treatment of
• adult patients with locally advanced or metastaticROS1-positive non-small cell lung cancer (NSCLC). ()1.1ROS1-Positive Non-Small Cell Lung CancerAUGTYRO 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)].• 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. (
AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:
• have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion[see Dosage and Administration],• are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity,and• 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
• Select patients for the treatment of locally advanced or metastatic NSCLC based on the presence ofROS1rearrangement(s) in tumor specimens. ()2.1 Patient SelectionNSCLCSelect patients for the treatment of locally advanced or metastatic NSCLC with AUGTYRO based on the presence of
ROS1rearrangement(s) in tumor specimens[see Clinical Studies (14.1)]. An FDA-approved test to detectROS1rearrangements for selecting patients for treatment with AUGTYRO is not currently available.Solid TumorsSelect patients for the treatment of solid tumors with AUGTYRO based on the presence of
NTRK1/2/3rearrangements in tumor specimens[see Clinical Studies ]. An FDA-approved test to detectNTRK1/2/3rearrangements for selecting patients for treatment with AUGTYRO is not currently available.• In patients with secretory breast cancer or mammary analogue secretory cancer, consider treatment without confirmation ofNTRKrearrangements in tumor specimens.
• Select patients for treatment of locally advanced or metastatic solid tumors based on the presence of an NTRK gene fusion. ()2.1 Patient SelectionNSCLCSelect patients for the treatment of locally advanced or metastatic NSCLC with AUGTYRO based on the presence of
ROS1rearrangement(s) in tumor specimens[see Clinical Studies (14.1)]. An FDA-approved test to detectROS1rearrangements for selecting patients for treatment with AUGTYRO is not currently available.Solid TumorsSelect patients for the treatment of solid tumors with AUGTYRO based on the presence of
NTRK1/2/3rearrangements in tumor specimens[see Clinical Studies ]. An FDA-approved test to detectNTRK1/2/3rearrangements for selecting patients for treatment with AUGTYRO is not currently available.• In patients with secretory breast cancer or mammary analogue secretory cancer, consider treatment without confirmation ofNTRKrearrangements in tumor specimens.
• Recommended Dosage: 160 mg orally once daily for 14 days, then increase to 160 mg twice daily, with or without food. ()2.4 Recommended DosageThe recommended dosage of AUGTYRO for adult and pediatric patients 12 years of age and older is 160 mg taken orally once daily with or without food
[see Clinical Pharmacology (12.3)]for 14 days, then increase to 160 mg twice daily and continue until disease progression or unacceptable toxicity.
Capsules: 40 mg, white, opaque, immediate release, Size 0, hard shell capsule, filled with white to off-white powder which may appear as a plug, imprinted with “REP 40” in blue text on the cap.
Capsules: 160 mg, blue, opaque, immediate release, Size 0, hard shell capsule, filled with white to off-white powder which may appear as a plug, imprinted with “REP 160” in white text on the cap.
• Lactation: Advise not to breastfeed. ()8.2 LactationRisk SummaryThere are no data on the presence of AUGTYRO in human milk or its effects on either the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children from AUGTYRO, advise a lactating woman to discontinue breastfeeding during treatment with AUGTYRO and for 10 days after the last dose.
None.