VENCLYXTO® offers patients with CLL a chance to
BREAK FREE with longer progression-free survival1*†
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
In 2L+ CLL:
VENCLYXTO + rituximab
*Reduced risk of progression or death vs O+Clb (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]). Median follow‑up of 28 months. Median PFS not reached in either arm.
†Reduced risk of progression or death vs BR (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]). Median follow‑up of 23.8 months. Median PFS not reached with VEN+R vs 17 months (15.5–21.6) with BR.
Additional safety and drug interactions1
- Hypersensitivity to the active substance or to any of the excipients
- Concomitant use of strong CYP3A inhibitors at initiation and during the dose‑titration phase
- Concomitant use of preparations containing St. John’s wort
- Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. VENCLYXTO should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS
- A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment
- Concomitant use of VENCLYXTO with strong CYP3A inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose‑titration phase is contraindicated
- Concomitant use of VENCLYXTO with strong or moderate CYP3A inhibitors (eg, ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) increases VENCLYXTO exposure and may increase the risk for TLS at initiation and during the dose‑titration phase and for other toxicities. Consider alternative treatments
- Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with VENCLYXTO as they contain inhibitors of CYP3A
*Avoid concomitant use of VENCLYXTO with moderate CYP3A inhibitors at initiation and during the dose‑titration phase. Consider alternative medications or reduce the VENCLYXTO dose as described.
- Patients should be monitored closely for signs of toxicities and the dose may need to be further adjusted
- Resume the VENCLYXTO dose that was used prior to initiating the CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor
- Concomitant use of VENCLYXTO with strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided
- Alternative treatments with less CYP3A induction or without CYP3A inhibition should be considered
- Preparations containing St. John’s wort are contraindicated during treatment with VENCLYXTO, as efficacy may be reduced
CLL=chronic lymphocytic leukemia; 1L=first line; 2L+=second line + later lines of therapy; O+Clb=obinutuzumab + chlorambucil; HR=hazard ratio; CI=confidence interval; PFS=progression‑free survival; BR=bendamustine + rituximab; VEN+R=VENCLYXTO + rituximab; CYP3A=cytochrome P450 3A; CrCl=creatinine clearance; TLS=tumor lysis syndrome.
[Placeholder for safety balance required by local regulations]
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.
I want to find out
more
about VENCLYXTO
I want to receive more information about VENCLYXTO
Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.>
GR-VNCCLL-200048 -JAN2021