Big Bear TAZEDX Tazemetostat 200mg

Product Information

• Product name: TAZEDX Tazemetostat 200mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Tazemetostat
• Current strength: 200mg
• SKU: BB-ITEM-22
• Site category: epithelioid sarcoma, lymphoma, other cancer

Product Summary

TAZEDX Tazemetostat 200mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Tazemetostat is the active ingredient used for this product page. Public prescribing information for Tazemetostat was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Tazemetostat is an inhibitor of the methyltransferase, EZH2, and some EZH2 gain-of-function mutations including Y646X, A682G, and A692V. Tazemetostat also inhibited EZH1 with a half-maximal inhibitory concentration (IC 50 ) of 392 nM, approximately 36 times higher than the IC 50 for inhibition of EZH2. The most well-characterized function of EZH2 is as the catalytic subunit of the polycomb repressive complex 2 (PRC2), catalyzing mono-, di-, and trimethylation of lysine 27 of histone H3. Trimethylation of histone H3 leads to transcriptional repression.

Reference Indications

Tazemetostat is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma 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 who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Reference Dosage and Administration

Recommended dosage is 800 mg taken orally twice daily with or without food.

With this 200mg product, that corresponds to 4 x 200mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Secondary Malignancies : Tazemetostat increases the risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, acute myeloid leukemia, and B-cell acute lymphoblastic leukemia. Monitor patients long-term for the development of secondary malignancies. Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective non-hormonal contraception. Across clinical trials of 758 adults who received Tazemetostat 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). Monitor patients long-term for the development of secondary malignancies.

Common Adverse Reactions and Monitoring

Patients received Tazemetostat 800 mg orally twice daily (n=62). Among patients who received Tazemetostat, 44% were exposed for 6 months or longer and 24% were exposed for greater than one year. One patient (2%) permanently discontinued Tazemetostat due to an adverse reaction of altered mood. Dosage interruptions due to an adverse reaction occurred in 34% of patients who received Tazemetostat. Dose reduction due to an adverse reaction occurred in one (2%) patient who received Tazemetostat; the dose was reduced in this patient for decreased appetite.

Drug Interactions and Special Populations

Strong or Moderate Cytochrome P450 (CYP)3A Inhibitors : Avoid coadministration of strong or moderate CYP3A inhibitors with Tazemetostat. Reduce the dose of Tazemetostat if coadministration of strong or moderate CYP3A inhibitors cannot be avoided. ( 2.3 , 7.1 ) Strong or Moderate CYP3A Inducers : Avoid coadministration with Tazemetostat. Avoid coadministration of strong or moderate CYP3A inhibitors with Tazemetostat. If coadministration of strong or moderate CYP3A inhibitors cannot be avoided, reduce Tazemetostat dose . Strong or Moderate CYP3A Inducers Coadministration of Tazemetostat with a strong CYP3A inducer decreases tazemetostat plasma concentrations , and coadministration of Tazemetostat with a moderate CYP3A inducer may also decrease tazemetostat plasma concentrations.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: TAZVERIK public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.