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PHARMACEUTICALS
Tazemetostat is the world’s first orally administered, selective EZH2 (enhancer of zeste homolog 2) inhibitor approved for marketing, and it belongs to epigenetic targeted therapeutic agents.
AuthenticGuaranteeFast DeliveryPrivacy Tazemetostat is a landmark drug in the field of epigenetic targeted therapy. By precisely inhibiting EZH2 enzymatic activity, it provides an effective and convenient treatment option for patients with epithelioid sarcoma and specific types of follicular lymphoma.
Tazemetostat monotherapy is indicated for adult patients with EZH2 mutation-positive relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
The requirements for EZH2 mutation testing refer to the relevant instructions.
The above indication is approved conditionally based on the objective response rate and duration of response results from a single-arm clinical trial.
The full approval of this indication will depend on the results of subsequent confirmatory randomized controlled clinical trials.
Prior to initiation of tazemetostat, patients with relapsed or refractory FL must be confirmed to harbor EZH2 mutations (Y646, A682, or A692 mutations).
A validated assay should be used to determine the patient’s EZH2 mutation status.
Only patients with a positive EZH2 mutation result from a hospital or laboratory may receive treatment with this product.
The patient’s EZH2 mutation status should be tested using an investigational companion diagnostic assay at a facility designated by Hutchison MediPharma (Shanghai) Co., Ltd. Treatment may be continued only if the patient is confirmed to have an EZH2 mutation.
The recommended dose of this product is 800mg orally twice daily (4 tablets of 200mg each),
taken with or without food, until disease progression or unacceptable toxicity.
Swallow tablets whole.
Do not split, crush, or chew tablets.
If a dose is missed or vomiting occurs after dosing, a replacement dose should not be taken;
the next dose should be continued as scheduled.
No dose adjustment is recommended for patients with mild to severe renal impairment or end-stage renal disease (ESRD). See [Clinical Pharmacology].
No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin > 1–1.5 × upper limit of normal [ULN] or AST > ULN).
This product has not been studied in patients with moderate (total bilirubin > 1.5–3 × ULN) or severe (total bilirubin > 3 × ULN) hepatic impairment. See [Clinical Pharmacology].
The safety and efficacy of this product in pediatric patients with lymphoma have not been established.
Clinical data for this product in patients > 65 years of age are currently limited. Caution is advised and administration should be under the guidance of a physician.
No starting dose adjustment is required if used in this population.
Very common adverse reactions (≥20%) were nausea.
Serious adverse reactions (≥2%) were general condition deterioration, neutropenia, thrombocytopenia, anemia and abdominal pain.
Serious adverse reactions occurred in 30% of patients treated with this product.
Serious adverse reactions with an incidence rate ≥2% were general condition deterioration, abdominal pain, infectious pneumonia, sepsis and anemia.
Hypersensitivity to the active substance or to any of the excipients in this product is contraindicated.
Treatment with tazemetostat is associated with an increased risk of secondary malignancies.
In clinical trials, among 758 adult patients treated with this product at 800 mg twice daily as monotherapy,
myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or B‑cell acute lymphoblastic leukemia (B‑ALL) occurred in 1.7% of patients.
One pediatric patient developed T‑cell lymphoblastic lymphoma (T‑LBL).
Long‑term monitoring for secondary malignancies is required.
Pregnant women should be informed of the potential risk to the fetus.
Female patients of reproductive potential should be advised to use effective contraception during treatment with this product and for 6 months after the last dose.
Male patients with female partners of reproductive potential should be advised to use effective contraception during treatment and for 3 months after the last dose.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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Tazemetostat is used to treat advanced epithelioid sarcoma, a rare slow-growing type of soft tissue cancer. tazemetostat is used when the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery.
Tazemetostat is for use in adults and children at least 16 years old.
Tazemetostat was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.
Tazemetostat may also be used for purposes not listed in this medication guide.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
You may take tazemetostat with or without food.
Swallow the tablet whole and do not crush, chew, or break it.
If you vomit shortly after taking tazemetostat, do not take another dose. Wait until your next scheduled dose time to take the medicine again.
Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.
Grapefruit may interact with tazemetostat and lead to unwanted side effects. Avoid the use of grapefruit products.
Avoid taking an herbal supplement containing St. John's wort.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may affect tazemetostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Tazemetostat is used to treat advanced epithelioid sarcoma, a rare slow-growing type of soft tissue cancer. tazemetostat is used when the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery.
Tazemetostat is for use in adults and children at least 16 years old.
Tazemetostat was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.
Tazemetostat may also be used for purposes not listed in this medication guide.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
You may take tazemetostat with or without food.
Swallow the tablet whole and do not crush, chew, or break it.
If you vomit shortly after taking tazemetostat, do not take another dose. Wait until your next scheduled dose time to take the medicine again.
Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.
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