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:Daxiong
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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. Used for the treatment of metastatic or locally advanced epithelioid sarcoma that cannot be completely resected in adults and adolescents aged 16 and above.
2. Used to treat adult patients with recurrent or refractory follicular lymphoma who have been confirmed by FDA approved testing to carry EZH2 mutations and have received at least two systemic treatments.
3. Used to treat adult patients with recurrent or refractory follicular lymphoma who have no satisfactory alternative treatment options.
3、 Specifications and characteristics
1. Specification: Each tablet contains 200mg of tazestar (equivalent to 228mg of tazestar hydrobromide).
2. Appearance: Film coated tablets.
4、 Main components
1. Active ingredient: Tazestat (in the form of hydrobromide).
2. Auxiliary materials include: hydroxypropyl cellulose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, sodium starch glycolate, etc.
5、 Usage and dosage
1. Recommended dosage: 800mg orally, twice daily, with meals or on an empty stomach.
2. It should be swallowed whole and should not be cut, crushed, or chewed.
3. If missed or vomiting occurs after taking the medication, it should not be taken again. Continue taking the medication according to the original plan for the next dose.
6、 Dose adjustment
1. Adverse reaction dose adjustment: The first dose was reduced to 600mg twice daily, and the second dose was reduced to 400mg twice daily. If it is still intolerable, the medication will be permanently discontinued.
2. Hematological toxicity: If the neutrophil count is less than 1 × 10 ⁹/L or the platelet count is less than 50 × 10 ⁹/L, the medication should be temporarily suspended. After recovery, the dosage should be reduced or stopped according to the frequency of occurrence.
3. Non hematological toxicity: Discontinue dosage after a grade 3 adverse reaction, reduce dosage for the first time after a grade 4 adverse reaction, and discontinue medication upon a second occurrence.
4. Drug interactions: When used in combination with strong or moderate CYP3A inhibitors, they should be avoided. If unavoidable, the dosage should be adjusted (such as changing from 800mg twice daily to 400mg twice daily).
7、 Medication precautions
1. It can be taken before and after meals.
2. If missed or vomited, continue with the next dose according to the original plan.
3. Swallow the entire tablet and do not damage it.
8、 Medication for special populations
1. Pregnancy period: There is a risk to the fetus, pregnant women should avoid using it. Women and men of childbearing age should take effective non hormonal contraceptive measures during treatment and after discontinuation (6 months for women and 3 months for men).
2. Breastfeeding period: It is not recommended to breastfeed during the treatment period and within one week after the last dose.
3. Children: Adolescents aged 16 and above can be used for epithelioid sarcoma, but safety has not been established for those under 16 years old.
4. Liver and kidney dysfunction: mild to moderate liver injury or any degree of kidney injury does not require dose adjustment; Lack of data on patients with severe liver injury.
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 risk: Secondary malignant tumors (such as myelodysplastic syndrome, acute leukemia, etc.) require long-term monitoring.
10、 Contraindications
There are no clear contraindications.
11、 Drug interactions
1. Avoid co administration with strong or moderate CYP3A inhibitors (such as itraconazole) or inducers (such as rifampicin).
2. The combination of Tazaristat may reduce the effectiveness of hormonal contraceptives, and it is recommended to use non hormonal contraceptive methods.
3. Avoid using St. John's wort, grapefruit, and their products simultaneously.
12、 Storage method
1. The storage temperature should not exceed 30 ° C (86 ° F).
2. The medicine bottle contains a desiccant and needs to be sealed for storage.
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