Description
Indication & Scope
HYRNUO® (Sevabertinib) is an oral, reversible kinase inhibitor developed by Bayer for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations following prior systemic therapy. It provides a targeted treatment option for HER2-mutated NSCLC.
- Mechanism: Sevabertinib reversibly inhibits HER2 (ERBB2) tyrosine kinase activity, blocking downstream signaling pathways involved in tumor cell proliferation and survival.
- Drug class: Kinase inhibitor (HER2 tyrosine kinase inhibitor).
- Clinical use: Treatment of adult patients with locally advanced or metastatic HER2-mutated non-squamous NSCLC after prior systemic therapy.
| Generic Name | Sevabertinib |
| Brand Name | HYRNUO® |
| Ingredient | Each tablet contains sevabertinib. |
| Dosage Form | Film-coated Tablet |
| Package | 10 mg × 120 tablets |
| Conditions Treated | Adult patients with locally advanced or metastatic HER2-mutated non-squamous NSCLC after prior systemic therapy |
| Taboos | Hypersensitivity to sevabertinib or any component of the product |
| Place of origin | United States |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Refer to the approved package labeling. |
| Manufacturer | Bayer HealthCare Pharmaceuticals Inc. |
| Registration Authority | U.S. Food and Drug Administration (FDA) |
| Approval number | CXHS2500065 |
| Date of Revision | 2025 |
| Shelf Life | Refer to the approved package labeling |
How to use ?
Recommended Dose: 20 mg administered orally twice daily with food until disease progression or unacceptable toxicity.
Time: Administer twice daily, approximately 12 hours apart.
Instructions for use: Swallow tablets whole with food. Do not split, crush, or chew the tablets. If a dose is missed, take it as soon as possible unless it is close to the next scheduled dose. Do not take two doses at the same time. If vomiting occurs after taking a dose, do not take an additional dose; continue with the next scheduled dose.
Interaction: Avoid concomitant use with strong CYP3A inhibitors or strong CYP3A inducers, as they may alter sevabertinib exposure.
Side effects: Common adverse reactions include diarrhea, rash, paronychia, stomatitis, and nausea. Serious adverse reactions may include hepatotoxicity, ocular toxicity, and severe diarrhea.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is HYRNUO (Sevabertinib)?
HYRNUO® is an oral HER2 tyrosine kinase inhibitor (HER2-TKI) for the treatment of HER2-mutated non-small cell lung cancer (NSCLC).
What is HYRNUO used to treat?
It is indicated for adult patients with locally advanced or metastatic HER2-mutated non-squamous NSCLC after prior systemic therapy.
How does Sevabertinib work?
Sevabertinib selectively inhibits HER2 tyrosine kinase activity, blocking signaling pathways that promote tumor cell growth and survival.
How should HYRNUO be taken?
The recommended dose is 20 mg orally twice daily with food, following the approved prescribing information.
HYRNUO® | Sevabertinib | HER2-Mutated NSCLC Treatment | DengYueRX
INN: Sevabertinib
Indications: HER2-mutated NSCLC
Dosage Form: Film-coated Tablet
Strength: 10 mg
