What are the precautions for sevabertinib-Hyrnuo?

In the treatment of non-squamous non-small cell lung cancer (NSCLC) In clinical studies, warnings and precautions such as diarrhea, liver toxicity, interstitial lung disease/pneumonia, eye toxicity, elevated pancreatic enzymes, embryo-fetal toxicity, etc. have appeared. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Diarrhea: sevabertinib can cause severe diarrhea, leading to dehydration and electrolyte imbalance. At the first sign of diarrhea or increased bowel frequency, instruct patients to initiate antidiarrheal therapy (e.g., loperamide) and increase their fluid and electrolyte intake.

2. Hepatotoxicity: sevabertinib can cause severe hepatotoxicity, manifested by increased liver function tests, possibly increased alanine aminotransferase(ALT); increased aspartate aminotransferase(AST); increased bilirubin, etc. Patients monitor liver function tests, including baseline ALT, AST, and total bilirubin, every two weeks before first taking sevabertinib for the first month, and then monthly as clinically indicated, with more frequent testing in patients who experience elevated transaminases.

3. Interstitial lung disease/Pneumonia: sevabertinib can cause severe interstitial lung disease (ILD)/pneumonitis. Monitor patients for new or worsening symptoms of ILD/pneumonia (e.g., dyspnea, cough, fever). Upon confirmation of ILD/pneumonitis, discontinue sevabertinib.

4. Eye toxicity: sevabertinib can cause eye poisoning. Refer patients who develop new or worsening eye symptoms to an ophthalmologist immediately.

5. Elevated pancreatic enzymes: sevabertinib can lead to increased levels of amylase and lipase, and there may be an increase in amylase and an increase in lipase. During treatment, monitor amylase and lipase regularly.

6. Embryonic-Fetal Toxicity: Based on the results of animal studies and its mechanism of action, sevabertinib can cause harm to the fetus when used in pregnant women. Inform pregnant women and women of reproductive potential of the potential risks to the fetus. Advise females of reproductive potential to use effective contraception during treatment with sevabertinib and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.

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