All Names: Tazverik、tazemetostat、他泽司他、达唯珂
Indications:Patients aged ≥ 16 years with metastatic or locally advanced tumors that cannot be completely resected, as well as adult patients with follicular lymphoma who are EZH2 mutation positive or have no alternative treatment options
Manufacturer:LUCIUS PHARMACEUTICAL (LAOS) CO., LTD
Customs Clearance Procedure:If the customs requires the package for customs clearance, please pay the customs clearance fee according to the content of EMS SMS and customs regulations.
The emergence of Tazesi provides patients with a new and well tolerated treatment option, which can significantly improve the objective response rate (ORR) of patients and prolong the duration of response.
1、 Drug name
1. Common name: Tazemetostat
2. Product Name: TAZVERIK ®
2、 Indications
1. Adults and adolescents over 16 years old: Treatment for metastatic or locally advanced epithelioid sarcoma that cannot be completely resected.
2. Adult relapsed/refractory follicular lymphoma:
EZH2 mutation positive (FDA approved test) and who have received at least 2 systemic treatments;
There are no satisfactory alternative treatment options available.
3、 Specifications and characteristics
200mg film coated tablets.
4、 Main components
Active ingredient: Tazaristat hydrobromide (each tablet contains 200 milligrams of Tazaristat, equivalent to 228 milligrams of hydrobromide).
5、 Usage and dosage
1. Standard dose: 800 milligrams orally, twice daily (with an interval of about 12 hours), with or without meals.
2. Usage: Swallow the whole tablet, do not break, crush or chew.
6、 Dose adjustment
1. Adverse reaction adjustment:
Reduce to 600 milligrams twice daily for the first dose and to 400 milligrams twice daily for the second dose. If unable to tolerate 400 milligrams, the medication will be permanently discontinued.
Specific adjustments are based on the severity of neutropenia, thrombocytopenia, anemia, etc. (such as grade 3 or above requiring suspension or reduction).
2. Drug interaction adjustment:
Avoid using strong/medium acting CYP3A inhibitors in combination (if necessary, reduce the dosage by half).
Avoid using strong/medium acting CYP3A inducers in combination.
7、 Medication precautions
1. Dietary impact: A high-fat diet does not affect absorption and does not require specific fasting or postprandial intake.
2. Missed/Vomiting: If missed or vomited after taking the medication, there is no need to take it again. Please take the next dose according to the original plan.
8、 Medication for special populations
1. Pregnant women: There is a risk to the fetus and effective contraception is required (during treatment and 6 months after discontinuation of medication for women, and 3 months after discontinuation of medication for men).
2. Breastfeeding period: Breastfeeding is prohibited during the treatment period and within one week after the last dose.
3. Children: Safety has not been established for those under 16 years old.
4. Liver and kidney dysfunction: mild to moderate without adjustment; There is no data available for severe liver damage (total bilirubin>3 times ULN).
9、 Adverse reactions
1. Common reactions of epithelioid sarcoma (≥ 20%): pain, fatigue, nausea, decreased appetite, vomiting, constipation.
2. Common reactions of follicular lymphoma (≥ 20%): fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, abdominal pain.
3. Serious risks: secondary malignant tumors (such as leukemia), embryotoxicity.
10、 Contraindications
There are no clear contraindications.
11、 Drug interactions
1. CYP3A inhibitors/inducers: significantly affect blood drug concentration (see dosage adjustment for details).
2. CYP3A substrate drugs (such as hormonal contraceptives): may reduce their efficacy and require switching to non hormonal contraception.
12、 Storage method
Not explicitly stated, it is recommended to refer to the packaging label for room temperature dry storage.
tazemetostatinformation