TAZVERIK Film coated tablet (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Epizyme, Inc.
Λέξεις κλειδιά
72607-100
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1. Indications and Usage
1.1 Epithelioid Sarcoma TAZVERIK is 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 ...
2. Dosage and Administration
2.1 Patient Selection Select patients with R/R FL for treatment with TAZVERIK based on the presence of EZH2 mutation of codons Y646, A682, or A692 in tumor specimens <em>[see Clinical Studies (14.2)]</em> ...
3. Dosage Forms and Strengths
Tablets: 200 mg film-coated, red, round, biconvex shape and debossed with EZM 200 on one side and plain on the other.
4. Contraindications
None.
5. Warnings and Precautions
5.1 Secondary Malignancies The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in labeling: Secondary Malignancies <em>[see Warnings and Precautions (5.1)]</em>.
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...
7. Drug Interactions
7.1 Effect of Other Drugs on TAZVERIK Strong and Moderate CYP3A Inhibitors Coadministration of TAZVERIK with a strong or moderate CYP3A inhibitor increases tazemetostat plasma concentrations <em>[see Clinical ...
8.1. Pregnancy
Risk Summary Based on findings from animal studies and its mechanism of action <em>[see Clinical Pharmacology (12.1)]</em>, TAZVERIK can cause fetal harm when administered to pregnant women. There are ...
8.2. Lactation
Risk Summary There are no animal or human data on the presence of tazemetostat in human milk or on its effects on the breastfed child or milk production. Because of the potential risk for serious adverse ...
8.3. Females and Males of Reproductive Potential
Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating TAZVERIK <em>[see Use in Specific Populations (8.1)]</em>. Risk Summary TAZVERIK can cause fetal harm ...
8.4. Pediatric Use
The safety and effectiveness of TAZVERIK have been established in pediatric patients aged 16 years and older (adolescents) with metastatic or locally advanced epithelioid sarcoma. Use of TAZVERIK for this ...
8.5. Geriatric Use
Clinical studies of TAZVERIK did not include sufficient numbers of patients with epithelioid sarcoma or relapsed or refactory follicular lymphoma aged 65 and over to determine whether they respond differently ...
8.6. Renal Impairment
No dose adjustment of TAZVERIK is recommended for patients with mild to severe renal impairment or end stage renal disease <em>[see Clinical Pharmacology (12.3)]</em>.
8.7. Hepatic Impairment
No dose adjustment of TAZVERIK is recommended for patients with mild hepatic impairment (total bilirubin >1 to 1.5 times upper limit of normal [ULN] or AST > ULN). TAZVERIK has not been studied in patients ...
11. Description
Tazemetostat is a methyltransferase inhibitor. Tazemetostat hydrobromide has the following chemical name: [1,1'-Biphenyl]-3-carboxamide, <em>N</em>-5[ethyl(tetrahydro-2<em>H</em>-pyran-4-yl)amino]-4-methyl-4'-(4-morpholinylmethyl)-, ...
12.1. 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 ...
12.2. Pharmacodynamics
Tazemetostat exposure-response relationships and the time course of pharmacodynamic responses are unknown. Cardiac Electrophysiology The effect of orally administered TAZVERIK, at doses ranging from 100 ...
12.3. Pharmacokinetics
The systemic exposure of tazemetostat is approximately dose proportional over the dose range of 200 mg to 1600 mg twice daily of TAZVERIK (0.25 to 2 times the approved recommended dosage). Following TAZVERIK ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Dedicated carcinogenicity studies were not conducted with tazemetostat, but T-LBL, MDS, and AML have been reported clinically and T-LBL occurred in juvenile and adult rats after ~9 or more weeks of tazemetostat ...
14. Clinical Studies
14.1 Epithelioid Sarcoma The efficacy of TAZVERIK was evaluated in an open-label, single-arm cohort (Cohort 5) of a multi-center study (Study EZH-202, NCT02601950) in patients with histologically confirmed, ...
15. References
1. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. <em>J Clin Oncol.</em> 2007;25(5):579-586.
16.1. How Supplied
TAZVERIK 200 mg film-coated tablets are red, round, biconvex shape and debossed with EZM 200 on one side and plain on the other. TAZVERIK is available in: Bottles of 240 tablets with a desiccant; NDC 72607-100-00 ...
16.2. Storage and Handling
Do not store above 30°C (86°F).
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Secondary Malignancies Advise patients of the increased risk of secondary malignancies, including AML, MDS, and T-LBL. Advise ...