What are the contraindications for Tazemetostat in Laos and its use in special populations
The contraindications for Tazemetostat mainly involve specific populations and drug interactions, and medication for special populations needs to be adjusted based on age, liver function, and reproductive status. The following content is based on existing clinical data and instruction manual requirements, listing specific precautions for each item.
1. Contraindications
(1) Prohibited during pregnancy: Animal studies have shown a risk of embryo fetal toxicity, which may lead to deformities or developmental abnormalities, and there is no clear safety data to support its use by pregnant women.
(2) Breastfeeding prohibition: Medications may be secreted through breast milk, posing potential risks to infants. Breastfeeding should be stopped during treatment and within one week after the last administration.
(3) Severe liver function impairment: Child Pugh Class C patients are contraindicated as drug metabolism may be significantly affected, increasing the risk of toxicity.
2. Medication for special populations
(1) Patients of childbearing age: Before treatment, it is necessary to confirm that they are not pregnant. During the medication period and 6 months after discontinuation, efficient contraceptive measures should be taken, which are applicable to both men and women.
(2) Pediatric patients: Safety and efficacy have not been established for patients under 16 years old, and only for specific indications (such as epithelioid sarcoma with INI1 deficiency) for those aged 16 and above.
(3) Elderly patients: Patients over 65 years old do not need to adjust the dosage, but close monitoring of liver function and hematological indicators is necessary.
(4) Liver dysfunction: Children Pugh A/B grade patients should reduce their dosage by 50%, while patients with moderate to severe impairment should avoid using it.
(5) Renal insufficiency: Mild to moderate damage does not require dose adjustment, and there is insufficient data for end-stage renal disease or dialysis patients, requiring careful evaluation.
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