Brand Name
Hyrnuo
Generic Name
Sevabertinib
View Brand Information FDA approval date: November 19, 2025
Form: Tablet
What is Hyrnuo (Sevabertinib)?
HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test [see Dosage and Administration.
Approved To Treat
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Brand Information
HYRNUO (SEVABERTINIB)
1INDICATIONS AND USAGE
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
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR)
2DOSAGE FORMS AND STRENGTHS
Tablets: red brown film-coated, round, biconvex tablets debossed with "SE" on one side and "10" on the other side containing 10 mg of sevabertinib.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Diarrhea
- Hepatotoxicity
- Interstitial Lung Disease (ILD)/Pneumonitis
- Left Ventricular Dysfunction
- Ocular Toxicity
- Pancreatic Enzyme Elevation
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population in the WARNINGS AND PRECAUTIONS reflects exposure to HYRNUO at 20 mg orally twice daily in 287 patients with locally advanced or metastatic NSCLC harboring
In this pooled safety population, the most common (>20%) adverse reactions were diarrhea, rash, paronychia, nausea, vomiting, and stomatitis. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased potassium, increased lipase, decreased phosphate, decreased lymphocyte count, decreased sodium, increased amylase, decreased hemoglobin, increased ALT, increased AST, and decreased calcium.
Locally Advanced or Metastatic Non-squamous NSCLC whose tumors have HER2 (ERBB2) TKD Activating Mutations
The safety of HYRNUO at 20 mg orally twice daily was evaluated in 191 patients with locally advanced or metastatic non-squamous NSCLC harboring
Among 191 patients who received HYRNUO, 66% were exposed for greater than 6 months and 43% were exposed for greater than 1 year. The median age of patients who received HYRNUO was 62 years (range: 29 to 91); 65% female; 68% Asian, 26% White, 2.1% Black or African American; and 1.6% were of Hispanic or Latino ethnicity.
Serious adverse reactions occurred in 33% of patients who received HYRNUO. Serious adverse reactions in ≥2% of patients were diarrhea (3.7%), dyspnea (3.1%), vomiting (3.7%), pneumonia (2.6%), and pleural effusion (2.1%). A fatal adverse reaction of cerebral infarction occurred in one patient (0.5%) who received HYRNUO.
Permanent discontinuation of HYRNUO due to an adverse reaction occurred in 4.2% of patients. Adverse reactions which resulted in permanent discontinuation were corneal epithelial microcysts, hepatic function abnormal, increased blood alkaline phosphatase, electrocardiogram QT prolonged, pain in extremity, renal failure and dyspnea (0.5%, 1 patient each).
Dosage interruptions of HYRNUO due to an adverse reaction occurred in 49% of patients. Adverse reactions which resulted in dosage interruptions in >2% of patients were diarrhea, potassium decreased, hepatotoxicity, nausea, vomiting, rash, pneumonia, paronychia, decreased appetite, pruritus, acute kidney injury, and stomatitis.
Dose reductions of HYRNUO due to adverse reactions occurred in 32% of patients. Adverse reactions which resulted in dose reductions in >2% of patients were diarrhea, hepatotoxicity, rash, potassium decrease, stomatitis, vomiting, and decreased appetite.
Table 4 summarizes the adverse reactions in SOHO-01 (Groups D, E and F).
Clinically relevant adverse reactions in <15% of patients who received HYRNUO included abdominal pain (14%), cardiac arrhythmia (10%; including arrhythmia, atrial fibrillation, atrial tachycardia, atrioventricular block complete, atrioventricular block first degree, electrocardiogram QT prolonged, sinus arrhythmia, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, supraventricular tachycardia, tachycardia, and ventricular extrasystoles) and alopecia (7%).
Table 5 summarizes the laboratory abnormalities in SOHO-01 (Groups D, E and F).
Laboratory abnormalities in <20% of patients who received HYRNUO include bilirubin increased (19%; all were Grades 1 and 2), platelet count decreased and neutrophil count decreased (16% each).
5DESCRIPTION
HYRNUO tablets contain sevabertinib, a kinase inhibitor. The chemical name of the drug substance is 3-(3-chloro-2-methoxyanilino)-2-{3-[(2S)-1,4-dioxan-2-ylmethoxy]pyridin-4-yl}-1,5,6,7-tetrahydro-4H-pyrrolo[3,2-c]pyridin-4-one hydrate. The molecular formula is C
The structural formula is shown below:
Sevabertinib is present as a non-stoichiometric hydrate as a white to off-white to yellow to pinkish powder. It is slightly soluble in aqueous solution at pH 2, and practically insoluble in aqueous solutions at pH 4.5 and above.
The strength of HYRNUO is based on the anhydrate form. Each HYRNUO tablet for oral use contains 10 mg of sevabertinib. The inactive ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, and magnesium stearate. The tablet film coating contains ferric oxide red, hypromellose 5 cP, and macrogol 3350.
6HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
HYRNUO 10 mg tablets are supplied as red brown film-coated, round, biconvex tablets debossed with "SE" on one side and "10" on the other side.
HYRNUO tablets are packaged in a HDPE bottle of 120 tablets closed with a child-resistant screw cap.
NDC 50419-397-01
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Diarrhea
Inform patients that HYRNUO can cause severe diarrhea. At the first sign of diarrhea or increased bowel movement frequency, instruct patients to start an antidiarrheal treatment (e.g., loperamide), to increase their fluid and electrolyte intake, and to immediately contact their healthcare provider
Hepatotoxicity
Inform patients that HYRNUO can cause severe hepatotoxicity characterized by elevations of liver function tests. Inform patients that they will need to undergo lab tests to monitor hepatic function. Advise patients to immediately contact their healthcare provider for signs and symptoms of hepatotoxicity
Interstitial Lung Disease (ILD)/Pneumonitis
Inform patients that HYRNUO can cause ILD/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms
Left Ventricular Dysfunction
Inform patients that HYRNUO can cause severe left ventricular dysfunction. Advise patients to immediately contact their healthcare provider for new or worsening cardiovascular symptoms
Ocular Toxicity
Inform patients that HYRNUO can cause ocular toxicity. Advise patients to immediately contact their healthcare provider for new or worsening ocular symptoms
Pancreatic Enzyme Elevation
Inform patients that HYRNUO can cause pancreatic enzyme elevation. Inform patients that they will need to undergo lab tests to monitor pancreatic function. Advise patients to immediately contact their healthcare provider for signs and symptoms associated with pancreatic enzyme elevation
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use effective contraception during treatment with HYRNUO and for 1 week after the last dose
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with HYRNUO and for 1 week after the last dose
Lactation
Advise women not to breastfeed during treatment with HYRNUO and for 1 week after the last dose
Dosage and Administration
- Instruct patients to take HYRNUO twice daily with food. Each tablet should be swallowed whole
- Instruct patients that if a dose of HYRNUO is missed to take the missed dose as soon as they remember prior to the next scheduled dose. Advise patients not to take two doses together to make up for a missed dose
- Instruct patients that if a dose of HYRNUO is vomited not to take an additional dose but to take the next dose at the next scheduled time
Drug Interactions
Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Inform patients to avoid grapefruit, or grapefruit juice while taking HYRNUO
8PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
NDC 50419-397-01
HYRNUO
10 mg
Rx Only
BAYER
120 film-coated tablets
9PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton
NDC 50419-397-01
HYRNUO
10 mg
— 120 film-coated tablets
BAYER
