维耐托克,维耐托克Venclyxto filmcoated tablets 10mg(venetoclax)



所属类别: 10毫克/片 14片/盒

包装规格: 10毫克/片 14片/盒



生产厂家英文名:AbbVie Ltd

原产地英文商品名:Venclyxto filmcoated 10mg/tablets 14tablets/box


中文参考商品译名:Venclyxto薄膜片 10毫克/片 14片/盒

















薄膜包衣片10mg ×5、7、10、14、112片盒50mg ×5、7、10、14、112片盒100mg ×5、7、10、14、112片盒

生产厂家:艾伯维(英国 AbbVie Ltd)



Venclyxto 10mg, 50mg and 100mg Film-coated TabletsEuropean Commission Grants Conditional Marketing Approval for AbbVie’s VENCLYXTO™ (venetoclax) Monotherapy for Appropriate Patients with Difficult-To-Treat Chronic Lymphocytic Leukaemia– VENCLYXTO monotherapy is also indicated for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor1– In a Phase 2 clinical trial of VENCLYXTO in 107 patients with previously treated CLL with 17p deletion, overall response rate (ORR) was 79 percent1– In a second Phase 2 clinical trial of VENCLYXTO in 64 patients with CLL who had been previously treated with and failed ibrutinib or idelalisib, combined ORR was 64 percent1Important EU Safety InformationContraindicationsConcomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as VENCLYXTO efficacy may be reduced. Hypersensitivity to the active substance or to any of the excipients is contraindicated.Special Warnings & Precautions for UseTumour lysis syndrome (TLS), including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with VENCLYXTO. VENCLYXTO poses a risk for TLS in the initial 5-week ramp-up phase. Changes in blood chemistries consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLYXTO and at each dose increase. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS. Blood chemistries should be monitored and abnormalities managed promptly. More intensive measures (including hospitalization) should be employed as overall risk increases.Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period.Live vaccines should not be administered during treatment or thereafter until B-cell recovery.Drug InteractionsCYP3A inhibitors may increase VENCLYXTO plasma concentrations. At initiation and dose-titration phase: Strong CYP3A inhibitors are contraindicated and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations. At steady daily dose: If moderate or strong CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations.Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.CYP3A4 inducers may decrease VENCLYXTO plasma concentrations. Avoid coadministration with strong or moderate CYP3A inducers.Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.Adverse ReactionsThe most commonly occurring adverse reactions (>=20%) of any grade were neutropenia/neutrophil count decreased, diarrhoea, nausea, anemia, upper respiratory tract infection, fatigue, hyperphosphatemia, vomiting and constipation.The most frequently occurring adverse reactions (>=2%) were pneumonia, febrile neutropenia and TLS.Discontinuations due to adverse reactions occurred in 9.1% of patients and dosage adjustments due to adverse reactions occurred in 11.8% of patients.Specific PopulationsVENCLYXTO may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during treatment. Advise nursing women to discontinue breastfeeding during treatment.This is not a complete summary of all safety information. See VENCLYXTO full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.https://www.medicines.org.uk/emc/product/2267/smpc


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