The emergence of tazemetostat provides patients with a new and well tolerated treatment option, which can significantly improve the objective response rate (ORR) and prolong the duration of response.

1、 Drug name

1. Common name: Tazesita

2. Product Name: TAZVERIK

2、 Indications

1. Suitable for adult and adolescent patients aged 16 and above with metastatic or locally advanced epithelioid sarcoma, and not suitable for complete resection.

2. Suitable for adult patients with relapsed or refractory follicular lymphoma:

3. FDA approved testing confirms the presence of EZH2 mutation in the tumor and has received at least two previous systemic treatments;

4. Or patients without satisfactory alternative treatment options.

Note: The above indications are based on accelerated approval, and subsequent approval may depend on the validation of clinical benefits in confirmatory trials.

3、 Specifications and characteristics

Each tablet contains 200mg of tazestar (equivalent to 228mg of tazestar hydrobromide).

4、 Main components

Active ingredient: Tazestat (in the form of hydrobromide).

5、 Usage and dosage

1. Recommended dosage: 800mg each time, taken orally twice a day, before or after meals. Swallow the whole piece, do not cut, crush or chew. Continue medication until disease progression or unacceptable toxicity occurs.

2. Omission or vomiting treatment: If the medication is missed or vomiting occurs after taking it, it should not be taken again, and the next dose should be taken according to the original plan.

6、 Dose adjustment

1. Adverse reaction dose adjustment:

Reduce to 600mg twice daily for the first time; Reduce the dosage to 400mg twice a day for the second time; If it is still intolerable, the medication will be permanently discontinued.

For specific adverse reactions (such as neutropenia, thrombocytopenia, anemia, etc.), medication should be temporarily suspended and reduced or stopped as appropriate after recovery.

2. Drug interaction dose adjustment:

Avoid co administration with potent or moderate CYP3A inhibitors. If it is necessary to use it together, adjust the dosage of Tazaristat (such as reducing it from 800mg to 400mg twice a day).

Avoid co administration with potent or moderate CYP3A inducers.

7、 Medication precautions

1. Medication time: not affected by food.

2. Omission or vomiting: Do not take the medication again, take the medication according to the next scheduled time.

3. Swallowing method: Swallow the entire tablet without damaging it.

4. Long term monitoring: It is necessary to monitor the occurrence of secondary malignant tumors for a long time.

8、 Medication for special populations

1. Pregnant women: There is a risk of fetal toxicity, and effective contraceptive measures should be taken during and after discontinuation of medication.

2. Breastfeeding period: It is not recommended to breastfeed during the medication period and within one week after the last dose.

3. Children: The safety and efficacy of epithelioid sarcoma patients aged 16 years and above have been established.

4. Elderly: Insufficient data, should be used with caution.

5. Liver and kidney dysfunction: Mild liver injury does not require dose adjustment; Patients with moderate to severe liver injury and any degree of kidney injury have limited data and should be closely monitored.

9、 Adverse reactions

1. The most common (≥ 20%) symptoms in patients with epithelioid sarcoma include pain, fatigue, nausea, decreased appetite, vomiting, and constipation.

2. The most common (≥ 20%) symptoms in patients with follicular lymphoma include fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain.

3. Serious adverse reactions include: secondary malignant tumors (such as myelodysplastic syndrome, acute myeloid leukemia, etc.), bleeding, infection, hematological toxicity, etc.

10、 Contraindications

There are no clear contraindications.

11、 Drug interactions

1. Avoid co administration with potent or moderate CYP3A inhibitors (such as itraconazole, fluconazole) or inducers (such as rifampicin).

2. When used in combination with tazestar, it may reduce the blood concentration of CYP3A substrates (including hormonal contraceptives), leading to a decrease in efficacy.

12、 Storage method

Store below 30 ° C (86 ° F). Keep in original packaging and avoid moisture.

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