Source: FDA, National Drug Code (US) Revision Year: 2025
HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)], and who have received a prior systemic therapy.
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Select patients for treatment of locally advanced or metastatic non-squamous NSCLC based on the presence of HER2 (ERBB2) TKD activating mutations in tumor specimens [see Clinical Studies (14)].
Information on FDA-approved tests is available at http://www.fda.gov/CompanionDiagnostics.
The recommended dosage of HYRNUO is 20 mg orally twice daily with food, until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3)]. Swallow tablets whole. Do not cut, crush, or chew tablets.
If a dose is missed, take the missed dose as soon as you remember prior to the next scheduled dose. Do not take 2 doses at the same time to make up for the missed dose.
If a dose is vomited, do not take an additional dose. Resume dosing at the next scheduled time.
The recommended dosage reductions for adverse reactions are provided in Table 1.
Table 1. Recommended HYRNUO Dosage Reductions for Adverse Reactions:
| Dose Reduction | Dosage Modification |
|---|---|
| First | 10 mg twice daily |
| Second | 10 mg once daily |
Permanently discontinue HYRNUO in patients who are unable to tolerate 10 mg once daily.
The recommended dosage modifications for adverse reactions are provided in Table 2.
Table 2. Recommended HYRNUO Dosage Modifications for Adverse Reactions:
| Adverse Reaction | Severity* | Dosage Modification |
|---|---|---|
| Diarrhea [see Warnings and Precautions (5.1)] | Intolerable Grade 2 or Grade 3 | • Interrupt HYRNUO until recovery to Grade ≤1. • Resume HYRNUO at the same dose or the next lower dose. • For recurrence, resume HYRNUO at the next lower dose. |
| Grade 4 | • Permanently discontinue HYRNUO. | |
| Hepatotoxicity [see Warnings and Precautions (5.2)] | Grade 2, 3 or 4 ALT and/or AST without increased total bilirubin or Grade 3 total bilirubin | • Interrupt HYRNUO until recovery to Grade ≤1 or baseline. • Resume HYRNUO at the next lower dose. |
| ALT or AST ≥ 3× ULN with total bilirubin ≥ 2× ULN or Grade 4 total bilirubin | • Permanently discontinue HYRNUO. | |
| Interstitial lung disease (ILD)/ pneumonitis [see Warnings and Precautions (5.3)] | Any Grade | • Permanently discontinue HYRNUO. |
| Ocular toxicity [see Warnings and Precautions (5.4)] | Grade 2 | • Interrupt HYRNUO until recovery to Grade ≤1. • Resume HYRNUO at the next lower dose. • For recurrence, permanently discontinue HYRNUO. |
| Grade 3 or Grade 4 | • Permanently discontinue HYRNUO. | |
| Pancreatic Enzyme Elevation [see Warnings and Precautions (5.5)] | Grade 3 | • Interrupt HYRNUO until recovery to Grade ≤2 or baseline. • Resume HYRNUO at the next lower dose. |
| Grade 4 | • Permanently discontinue HYRNUO. | |
| Other adverse reactions [see Adverse Reactions (6.1)] | Intolerable or recurrent Grade 2 or Grade 3 | • Interrupt HYRNUO until recovery to Grade ≤1. • Resume HYRNUO at the same dose or the next lower dose. • For recurrence, resume HYRNUO at the next lower dose. |
| Grade 4 | Permanently discontinue HYRNUO. |
* Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Avoid concomitant use of strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce HYRNUO dosage as shown in Table 3. After the CYP3A inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the HYRNUO dosage that was used prior to initiating the inhibitor [see Drug Interactions (7.1)].
Table 3. Recommended HYRNUO Dosage Modifications for Concomitant Use with Strong CYP3A Inhibitors:
| Current Dosage | Recommended Dosage |
|---|---|
| 20 mg twice daily | 10 mg twice daily |
| 10 mg twice daily | 10 mg once daily |
| 10 mg once daily | Withhold HYRNUO until strong CYP3A inhibitor is discontinued |
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].
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.