Source: FDA, National Drug Code (US) Revision Year: 2024
AUGTYRO 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)].
AUGTYRO 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 (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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 detect ROS1 rearrangements for selecting patients for treatment with AUGTYRO is not currently available.
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 (14.2)]. An FDA-approved test to detect NTRK1/2/3 rearrangements for selecting patients for treatment with AUGTYRO is not currently available.
Prior to initiating AUGTYRO, discontinue strong and moderate CYP3A inhibitors for 3 to 5 elimination half-lives of the CYP3A inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Prior to initiation of AUGTYRO, evaluate:
The 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.
The recommended dosage reductions of AUGTYRO for the management of adverse reactions are provided in Table 1.
Table 1. Recommended Dose Reductions for AUGTYRO Adverse Reactions:
| Dose | Dose Reduction | |
|---|---|---|
| First | Second | |
| 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 dosage modifications of AUGTYRO for the management of adverse reactions are provided in Table 2.
Table 2. Recommended Dosage Modifications for AUGTYRO Adverse Reactions:
| Adverse Reaction | Severity* | Dosage Modification |
|---|---|---|
| Central Nervous System Effects [see Warnings and Precautions (5.1)] | Intolerable Grade 2 | • Withhold AUGTYRO until ≤Grade 1 or baseline. • Resume at same or reduced dose, as clinically appropriate. |
| Grade 3 | • Withhold AUGTYRO until ≤Grade 1 or baseline. • Resume at reduced dose. | |
| Grade 4 | • Permanently discontinue AUGTYRO. | |
| Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.2)] | Any Grade | • Withhold AUGTYRO if ILD/pneumonitis is suspected. • Permanently discontinue if ILD/pneumonitis is confirmed. |
| Hepatotoxicity [see Warnings and Precautions (5.3)] | Grade 3 | • Withhold AUGTYRO until ≤Grade 1 or baseline. • Resume at same dose if resolution occurs within 4 weeks. • Resume at a reduced dose for recurrent Grade 3 events that resolve within 4 weeks. |
| Grade 4 | • Withhold AUGTYRO until ≤Grade 1 or baseline. • Resume at reduced dose. • Permanently discontinue if adverse reaction does not resolve within 4 weeks. • Permanently discontinue for recurrent Grade 4 events. | |
| ALT or AST greater than 3 times ULN with concurrent total bilirubin greater than 1.5 times ULN (in the absence of cholestasis or hemolysis) | • Permanently discontinue AUGTYRO. | |
| Creatine Phosphokinase (CPK) Elevation [see Warnings and Precautions (5.4)] | CPK elevation greater than 5 times ULN | • Withhold until recovery to baseline or to less than or equal to 2.5 times ULN, then resume at same dose. |
| CPK elevation greater than 10 times ULN or second occurrence of CPK elevation of greater than 5 times ULN | • Withhold until recovery to baseline or to less than or equal to 2.5 times ULN, then resume at reduced dose. | |
| Hyperuricemia [see Warnings and Precautions (5.5)] | Grade 3 or Grade 4 | • Withhold AUGTYRO until improvement of signs or symptoms. • Resume AUGTYRO at same or reduced dose. |
| Other Clinically Relevant Adverse Reactions [see Adverse Reactions (6.1)] | Intolerable Grade 2 or Grade 3 or Grade 4 | • Withhold AUGTYRO until ≤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 Common Terminology Criteria for Adverse Events v4.03
Take AUGTYRO at approximately the same time each day with or without food [see Pharmacokinetics (12.3)].
Swallow AUGTYRO capsules whole. Do not open, chew, crush, or dissolve the capsule prior to swallowing. Do not take any AUGTYRO capsules that are broken, cracked, or damaged.
If a dose of AUGTYRO is missed or if vomiting occurs at any time after taking a dose, skip the dose and resume AUGTYRO at its regularly scheduled time.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
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