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Tumour lysis prophylaxis and monitoring during venetoclax treatment

Treatment with venetoclax can cause a rapid tumour reduction and hence an increased risk for tumour lysis syndrome (TLS) especially in the initial 5-week ramp-up phase. The risk of TLS is based on a number of factors including tumour burden, co-morbidities and reduced renal function.r 

Prior to initiation of treatment with venetoclax the following should be performed:

  • tumour burden assessment (including radiographic evaluation such as CT scan)
  • assess blood chemistry (particularly potassium, uric acid, phosphorus, calcium and creatinine)

Correction of pre-existing abnormalities in blood chemistry before initiation of treatment with venetoclax.r

Recommended tumour lysis syndrome prophylaxis based on tumour burden from clinical trials data.r 

Tumour Burden Prophylaxis

Blood Chemistry Monitoring**^
(Setting and frequency of assessments)
High

Any LN ≥ 10 cm OR

ALC ≥ 25 x 109/L AND

Any LN ≥ 5 cm

1.5 to 2 L oral hydration* AND 150-200 mL/hr intravenous as tolerated

Allopurinol (starting 2 to 3 days prior to venetoclax)

Consider rasburicase if baseline uric acid is elevated

In hospital at first dose of 20 mg and 50 mg

  • Pre-dose, 4, 8, 12 and 24 hours

Outpatient at subsequent ramp-up doses

  • Pre-dose, 6 to 8 hours, 24 hours
Medium

Any LN 5 cm to < 10 cm OR

ALC ≥ 25 x 109/L

1.5 to 2 L oral hydration* AND consider additional intravenous 

Allopurinol (starting 2 to 3 days prior to venetoclax)

Outpatient 

  • Pre-dose, 6 to 8 hours, 24 hours at first dose of 20 mg and 50 mg 
  • Pre-dose at subsequent ramp-up doses 
  • Consider hospitalisation for patients with CrCl < 80 mL/min at first dose of 20 mg and 50 mg (and follow hospital monitoring above)
Low

All LN < 5 cm AND 

ALC < 25 x 109/L

1.5 to 2 L oral hydration*

Allopurinol (starting 2 to 3 days prior to venetoclax)

Outpatient

  • Pre-dose, 6 to 8 hours, 24 hours at first dose of 20 mg and 50 mg 
  • Pre-dose at subsequent ramp-up doses

ALC = absolute lymphocyte count; LN = lymph node
* administer intravenous hydration for patients who cannot tolerate oral hydration
** Monitor potassium, uric acid, phosphorous, calcium and creatinine; review in real time
^ For patients at risk of TLS, monitor blood chemistries at 6 to 8 hours and at 24 hours at each subsequent ramp-up dose

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Version 1

Date Summary of changes
22/11/2018 Created as an additional clinical information resource for CLL venetoclax protocol 
27/03/2020 Document reviewed, introduction added with no other changes. Review in 2 years.
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https://www.eviq.org.au/p/3514

01 Mar 2021