Instructions for taking VENCLYXTO

When administering VENCLYXTO, advise patients as follows:

Be adequately hydrated every day when taking VENCLYXTO to reduce the risk of TLS.

Adequate hydration is particularly important 2 days before and on the day of the first dose, and every time the dose is increased. The recommended volume is 1.5–2 L of water (6–8 glasses) each day.

Take VENCLYXTO orally once daily with a meal and water at approximately the same time each day.

Swallow the VENCLYXTO tablets whole.
The tablets should not be chewed, crushed, or broken before swallowing.

In case of a missed dose, advise patients as follows:

If a patient misses a dose within 8 hours from the time it is usually taken:
The patient should take the missed dose right away and take the next dose as usual.

If a patient misses a dose by more than 8 hours:
The patient should not take the missed dose and should take the next dose at the usual time.

If a patient vomits following dosing:
No additional dose should be taken that day. The next prescribed dose should be taken at the usual time the next day.

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; TLS=tumor lysis syndrome.

[Placeholder for safety balance required by local regulations]

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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.>

GR-VNCCLL-200048 -JAN2021