Daraxonrasib should be used with caution in specific populations. The following introduces medication guidance for patients with severe hepatic or renal impairment and for pregnant patients.

Patients with Severe Hepatic or Renal Impairment:

The effects of severe hepatic impairment (total bilirubin >3 to 10 times the upper limit of normal) or severe renal impairment (creatinine clearance <30 mL/min) on the pharmacokinetics of daraxonrasib are currently unknown. Safety data in these patients are limited, and use should be cautious.

No dosage adjustment is required for patients with mild to moderate hepatic impairment.

Liver and kidney function and related parameters should be monitored regularly during treatment. If abnormalities occur, seek medical attention promptly so the doctor can assess whether to continue treatment or adjust the regimen.

Information for Pregnant Patients:

Based on animal study findings, daraxonrasib can cause fetal harm.

In animal reproductive studies, oral administration to pregnant mice during the period of organogenesis resulted in embryo mortality, altered growth, and structural abnormalities.

Therefore, use of this product in pregnant women may pose a risk to the fetus, and patients should be informed of the potential harm.

Females of reproductive potential should confirm pregnancy status before starting treatment and should use effective contraception during treatment and for 1 week after the last dose.

If pregnancy occurs or is suspected during treatment, inform the doctor immediately.

Male patients with female partners of reproductive potential should also use effective contraception during treatment and for 1 week after the last dose.

Breastfeeding Women:

There are no data on whether this product or its metabolites are present in human milk. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding should not occur during treatment and for 1 week after the last dose.

Summary:

Patients with severe hepatic or renal impairment should use this product with caution. Pregnant women and males and females of reproductive potential should strictly use contraception. Breastfeeding women should stop breastfeeding. Close monitoring during treatment is required to ensure safety.