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Tazemetostat tablets LuciTaze Tazverik
Tazemetostat is a methyltransferase inhibitor indicated for the treatment of: • Adult and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection.
Description
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Product Description
Product Name: LuciTaze
Chinese Name: Tazemetostat Tablets
English Name: Tazemetostat Tablets
Specification: 200 mg/tablet; 56 tablets/box.
[Indications]
Tazemetostat is a methyltransferase inhibitor indicated for the treatment of:
Adult and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test, and who have received at least 2 prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma for whom there are no satisfactory alternative treatment options.
[Dosage and Administration]
The recommended dosage is 800 mg taken orally twice daily, with or without food.
[Contraindications] None.
[Warnings and Precautions]
Secondary Malignancies: LuciTaze may increase the risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia. Monitor patients for the development of secondary malignancies.
Embryo-Fetal Toxicity: May cause fetal harm. Advise patients of the potential risk to the fetus and to use effective non-hormonal contraception.
[Adverse Reactions]
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting, and constipation.
The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain.
[Drug Interactions]
Strong and Moderate Cytochrome P450 (CYP)3A Inhibitors: Avoid coadministration of strong and moderate CYP3A inhibitors with LuciTaze. If coadministration with a moderate CYP3A inhibitor cannot be avoided, reduce the dosage of LuciTaze. Strong and Moderate CYP3A Inducers: Avoid co-administration with LuciTaze.
[Use in Specific Populations]
Lactation: Breastfeeding is not recommended.
[Storage]
Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.
