sevabertinib-Hyrnuo’s Chinese instruction manual

1. Common name:sevabertinib

Product name:Hyrnuo

Other names: cervatinib, cervatinib, BAY-2927088

2. Indications:

Sevabertinib（sevabertinib）-Hyrnuo is indicated for the treatment of patients with locally advanced or metastatic non-squamousnon-small cell lung cancer（NSCLC） adult patients whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations as detected by an FDA-approved test and who have received prior systemic therapy.

3. Usage and dosage:

1. Patient selection: Select patients who receive treatment for locally advanced or metastatic non-squamous non-small cell lung cancer based on the presence of HER2 (ERBB2) TKD activating mutations in tumor specimens.

2. Recommended dose: The recommended dose of sevabertinib is 20 mg twice daily, taken orally with food until disease progression or unacceptable toxicity occurs. Swallow slices whole. Do not cut, crush, or chew tablets.

1) Missed dose: If you miss a dose, take the missed dose as soon as possible before the next scheduled dose. Do not take 2 doses at the same time to make up for a missed dose.

2) Vomiting dose: If you vomit after one dose, do not take additional doses. Resume dosing at the next scheduled time.

3. For dose adjustment of adverse reactions, the first dose can be reduced to twice a day, each time10 mg; the second dose can be reduced to once a day, 10 mg; patients who cannot tolerate 10 mg once a day should permanently discontinue sevabertinib.

4. Adverse reactions:

In clinical studies of sevabertinib, common adverse reactions (>20%) were diarrhea, rash, paronychia, stomatitis, and nausea; the most common grade 3 or 4 laboratory abnormalities (≥2%) were decreased potassium, increased lipase, decreased lymphocyte count, decreased sodium, increased amylase, increased aspartate aminotransferase (AST), and increased alanine aminotransferase (ALT).

5. Supply and storage:

Sevabertinib 10 mg tablets are reddish-brown film-coated tablets packaged in 120-tablet HDPE bottles closed with child-proof screw caps. Store at 20°C to 25°C (68°F to 77°F); tolerances allowed are 15°C to 30°C (59°F to 86°F).

6. Special groups:

1. Women: According to the results of animal studies and its mechanism of action, taking Sevabertinib by pregnant women may cause harm to the fetus. Verify the pregnancy status of females of childbearing potential before initiating HYRNUO; advise females of childbearing potential to use effective contraception during treatment and within 1 week after the last dose; and not to breastfeed during treatment and within 1 week after the last dose.

2. Men: It is recommended that men with female partners of reproductive potential use effective contraceptive measures during treatment and within 1 week after the last dose.

7. Mechanism of action:

Sevabertinib is a reversible kinase inhibitor of human epidermal growth factor receptor 2 (HER2). It also exhibits activity against the epidermal growth factor receptor (EGFR). In vitro, sevabertinib inhibits HER2 phosphorylation and downstream signaling in cancer cells with altered HER2, as well as the proliferation of cancer cells that overexpress wild-type HER2 or carry HER2 mutations. In vivo, sevabertinib demonstrated antitumor activity in a subcutaneous mouse xenograft model derived from human non-small cell lung cancer tumors containing activating HER2 exon 20 mutations.

8. Listing situation:

Original research version:

1) China: Not yet listed

2) United States:2025-11-19

Reference materials:https://en.wikipedia.org/wiki/Sevabertinib