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The emergence of tazerestat provides patients with a new, well-tolerated treatment option that can significantly improve patients' objective response rate (ORR) and prolong the duration of response.
1. Generic name: Tazemetostat
2. Trade name: TAZVERIK®
1. For the treatment of unresectable metastatic or locally advanced epithelioid sarcoma in adults and adolescents aged 16 years and above.
2. For the treatment of adult patients with relapsed or refractory follicular lymphoma who are confirmed by FDA-approved testing to carry EZH2 mutations and who have received at least 2 types of systemic therapy.
3. For the treatment of adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
1. Specifications: Each tablet contains 200 mg of tazerestat (equivalent to 228 mg of tazerestat hydrobromide).
2. Properties: film-coated tablets.
1. Active ingredient: tazerestat (hydrobromide form).
2. Excipients include: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, sodium starch glycolate, etc.
1. Recommended dose: 800 mg orally, twice a day, with or without food.
2. The tablet should be swallowed whole and should not be cut, crushed or chewed.
3. If you miss a dose or vomit after taking the medicine, you should not take it again and continue taking the medicine at the next dose as originally planned.
1. Adverse reaction dose adjustment: reduce the dose to 600mg twice a day for the first time, and reduce the dose to 400mg twice a day for the second time. If still not tolerated, discontinue treatment permanently.
2. Hematological toxicity: If neutrophils <1×10⁹/L or platelets <50×10⁹/L, the medication needs to be suspended. After recovery, the dose should be reduced or discontinued based on the number of occurrences.
3. Non-hematological toxicity: Reduce the dose after a pause for grade 3 adverse reactions, reduce the dose for the first time if a grade 4 adverse reaction occurs, and discontinue the drug if it occurs for the second time.
4. Drug interactions: Combination with strong or moderate CYP3A inhibitors should be avoided. If it cannot be avoided, the dose needs to be adjusted (for example, the original 800 mg twice a day is changed to 400 mg twice a day).
1. It can be taken before or after meals.
2. If you miss a dose or do not take it after vomiting, continue with the next dose as originally planned.
3. The tablet must be swallowed whole and the tablet must not be broken.
1. Pregnancy: There is a risk to the fetus and it is contraindicated for pregnant women. Women and men of childbearing potential need to use effective non-hormonal contraceptive measures during treatment and after discontinuation (6 months for women and 3 months for men).
2. Breastfeeding: Breastfeeding is not recommended during treatment and within 1 week after the last dose.
3. Children: Adolescents aged 16 years and above can be used for epithelioid sarcoma, but safety has not been established for children under 16 years of age.
4. Hepatic and renal insufficiency: No dosage adjustment is required for mild to moderate liver damage or any degree of renal damage; there is a lack of data on patients with severe liver damage.
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, and abdominal pain.
3. Serious risks: Secondary malignant tumors (such as myelodysplastic syndrome, acute leukemia, etc.) require long-term monitoring.
No clear contraindications.
1. Avoid coadministration with strong or moderate CYP3A inhibitors (such as itraconazole) or inducers (such as rifampicin).
2. The combined use of tazerestat may reduce the effectiveness of hormonal contraceptives. It is recommended to use non-hormonal contraceptive methods.
3. Avoid using St. John's wort, grapefruit and their products at the same time.
1. The storage temperature should not exceed 30°C (86°F).
2. The medicine bottle contains desiccant and needs to be sealed and stored.