This website is for UK Healthcare Professionals only

This promotional website is for UK healthcare professionals involved in the care of patients with cancer. Adverse event reporting information can be found below.

UK-VNCAML-240003  |  April 2024.

UK-VNCAML-240065  |  April 2024. 

VENCLYXTO RAMP-UP IN CLL1

In CLL, VENCLYXTO is administered as an oral tablet daily, with the dose increasing each week per the 5-week ramp-up schedule

You are advised to read the Prescribing Information and Summary of Product Characteristics (GB SmPC; NI SmPC) to evaluate patient suitability for VENCLYXTO.

VENCLYXTO in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated CLL.1

VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.1

VENCLYXTO monotherapy is indicated for the treatment of CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a BCRi, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both CIT and a BCRi.1

BCRi=B-cell receptor pathway inhibitor; CIT=chemoimmunotherapy; CLL=chronic lymphocytic leukaemia; TP53=Tumour protein 53.

PRIOR TO INITIATION1

1. WBC count <25 x109/L

Cytoreduction may be required

2. Assess blood chemistries and correct pre-existing abnormalities

  • Potassium
  • Phosphorus
  • Calcium
  • Uric acid
  • Creatinine

3. Administer prophylaxis

All patients should be adequately hydrated and receiving anti-hyperuricaemic agents prior to initiation of VENCLYXTO and throughout the dose titration period

Additional measures should be considered for patients with risk factors for TLS*

PRIOR TO INITIATION1

1. WBC count <25 x109/L

Cytoreduction may be required

2. Assess blood chemistries and correct pre-existing abnormalities

  • Potassium
  • Phosphorus
  • Calcium
  • Uric acid
  • Creatinine

3. Administer prophylaxis

All patients should be adequately hydrated and receiving anti-hyperuricaemic agents prior to initiation of VENCLYXTO and throughout the dose titration period

Additional measures should be considered for patients with risk factors for TLS*

SPECIAL POPULATIONSSEVERITYDOSE MODIFICATIONS 
Renal impairmentMild, moderate or severe 

No dose adjustment is needed for patients with mild, moderate or severe renal impairment (CrCI > 15 mL/min and <90 mL/min). 

Patients with reduced renal function (CrCI <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. 

VENCLYXTO should be administered to patients with severe renal impairment (CrCI ≥ 15 mL/min and <30 mL/min) only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.

Hepatic impairmentModeratePatients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase.
SevereA dose reduction of at least 50% throughout treatment is recommended. These patients should be monitored more closely for signs of toxicity.

References

  1. VENCYLXTO Summary of Product Characteristics.
  2. DiNardo CD et al. N Engl J Med. 2020; 383(7): 617-29.