Ripretinib does not list any absolute contraindications in its prescribing information, but there are clear usage restrictions or risks for specific physiological states and populations.
I. Clear Contraindications and High-Risk Populations
1. No Absolute Contraindications
No absolute contraindications are listed in the ripretinib prescribing information, meaning there are no clinical situations in which its use is completely prohibited.
2. Pregnancy and Embryo-Fetal Toxicity
(1) Animal studies have shown that this drug can cause cardiovascular and skeletal system malformations, and can lead to miscarriage and reduced fetal weight.
(2) Women of childbearing potential must confirm their pregnancy status before starting treatment, and effective contraception must be used during treatment and for 1 week after discontinuation.
(3) Male patients with partners of childbearing potential should also use contraceptive measures during the same period.
3. Undetermined Populations
The safety and efficacy in pediatric and adolescent patients have not been established, and use is not recommended.
II. Special Populations Requiring Cautious Use
1. Breastfeeding Women
Data on whether the drug is excreted in human milk are currently lacking, but due to the potential for serious adverse reactions, breastfeeding should be discontinued during treatment and for 1 week after discontinuation.
2. Severe Renal Impairment
Pharmacokinetic data for this drug in patients with severe renal impairment (creatinine clearance 15–29 mL/min) are insufficient; use with extreme caution and close monitoring of tolerability is required.
3. Patients with Baseline Low Cardiac Function
The safety of this drug in patients with baseline ejection fraction below 50% has not been evaluated; cautious use and enhanced cardiac function monitoring are recommended.
4. Elderly Patients
No dose adjustment is required based on age for patients aged 65 years and older, but existing clinical data are limited, making it difficult to fully determine whether their responses differ from those of younger patients; enhanced observation during treatment is advised.
III. Ancillary Management Measures for Safe Use
1. Preoperative Discontinuation Management
This drug may affect wound healing. For elective surgery, it should be discontinued at least 1 week before surgery, and after major surgery, resumption should be considered only after at least 2 weeks and when wound healing is adequate.
2. Use in Patients with Hepatic Impairment
No dose adjustment is required for mild to severe hepatic impairment (Child-Pugh A, B, or C), but routine monitoring of drug tolerability should be performed.
3. Fertility Effects and Contraceptive Guidance
(1) Animal studies suggest that this drug may impair male fertility; male patients with reproductive intentions should be informed of this risk in advance.
(2) Contraceptive and discontinuation times related to lactation and pregnancy should be strictly followed as per medical advice to avoid accidental exposure.
