This instruction manual provides key information on Tazemetostat, including its approved indications, recommended usage, possible side effects, and important precautions. It aims to help patients and healthcare providers understand how to use the medicine safely and effectively in the treatment of specific cancers.

Drug indications and applicable populations

Tazemetostat is an oral targeted therapeutic agent that targets two specific types of malignant related diseases:

Epithelioid sarcoma

Suitable for metastatic or locally advanced epithelioid sarcoma that cannot be completely removed by surgery in patients aged 16 years and older. This indication requires the patient to be diagnosed by pathology and the progress of the patient meets the clinical treatment standards.

Recurrent or refractory follicular lymphoma (R/RFL)

It is applicable in two scenarios:

Adult patients may be used for recurrent or refractory follicular lymphoma when they lack effective alternative treatment options.

Adult patients who tested positive for EZH2 mutations by FDA and who had received at least two systemic treatments.

Recommended Usage and Dosage Management

Tazemetostat's standard treatment plan must strictly follow the following guidelines:

Conventional dosage

Take 800mg orally twice a day, and can be taken on an empty stomach or with meals. The whole tablet is required and the tablets are not cut, chewed or crushed. Treatment continues until the disease progresses or in tolerance toxicity occurs.

Missing or vomiting

If you miss a dose or vomit after taking the medicine, you do not need to take it again and continue the subsequent dose as planned. Increasing the dose without authorization may aggravate adverse reactions.

Dosage adjustment for special populations

Elderly patients and liver and renal insufficiency need to adjust the dosage under the guidance of a doctor. The use data for patients with moderate to severe liver impairment (total bilirubin >1.5 times normal) or end-stage renal disease is limited, and risk should be assessed with caution.

Common and severe side effects

The adverse reactions of Tazemetostat vary according to the indications:

Patients with epithelioid sarcoma

High reactions (≥20%): pain, fatigue, nausea, loss of appetite, vomiting and constipation.

Beware of hematological abnormalities such as anemia and thrombocytopenia.

Patients with follicular lymphoma

High reactions (≥20%): fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

Monitoring is required: increased risk of infection and abnormal liver function indicators.

Long-term risk warning

Long-term use may increase the risk of secondary malignant-related diseases (such as myelodysplastic syndrome), and it is recommended to conduct comprehensive screening of related diseases every 6 months during the treatment period.