Regorafenib contraindicated population: severe liver and kidney dysfunction and pregnant women's notice
Regorafenib has a clear use of the "red line". The following two groups of people belong to the category of absolute or relative contraindications, and strict screening must be carried out before medication, otherwise it may induce fatal toxicity or fetal damage.
1、 Severe liver dysfunction patients: prohibited
Defining standards
Patients with Child Pugh classification of C (total bilirubin>3 times the upper limit of normal, accompanied by significantly prolonged prothrombin time) are prohibited from using this product.
core risk
The liver is unable to metabolize drugs, resulting in abnormal accumulation of blood drug concentrations, exacerbating hepatic encephalopathy or jaundice liver failure.
Alternative Path
This type of patient needs to be evaluated by a multidisciplinary team, with priority given to local treatment or non hepatic metabolic targeted drugs. Regorafenib cannot be used as an alternative.
2、 Severe renal insufficiency patients: use with caution or prohibited
Defining standards
Patients with estimated glomerular filtration rate (eGFR)<30mL/min/1.73m ² or undergoing regular dialysis.
core risk
Obstruction of drug and its metabolite excretion increases the risk of renal tubular injury and hyperkalemia, and there is a lack of dialysis clearance data.
Action Recommendations
EGFR must be reviewed before medication; If the baseline is below the threshold, treatment should not be initiated and non renal clearance drugs can be used instead.
3、 Pregnant women and women preparing for pregnancy: absolutely prohibited
Clear taboos
Women who are pregnant or planning to conceive are prohibited from taking regorafenib.
Teratogenicity and risk of miscarriage
Animal experiments have shown that it has embryonic toxicity and teratogenicity, which can lead to abnormal fetal bone development and miscarriage.
Contraception and discontinuation time limit
Women with fertility must use highly effective contraceptive measures (such as oral contraceptives combined with barrier therapy) during the medication period and for at least 2 months after discontinuation. If unexpected pregnancy occurs during treatment, medication should be stopped immediately and obstetrics and oncology specialists consulted.
Disclaimer：《Regorafenib contraindicated population: severe liver and kidney dysfunction and pregnant women's notice》Edited and sorted by Seagull Pharmacy's editors. Please contact us in time if there is any infringement. In addition, the suggestions for drug usage, dosage and disease mentioned in the article are only for medical staff's reference, and can not be used as any basis for medication！