Dosing & TLS prophylaxis
(tumour lysis syndrome)

FAQs

References

Prescribing Information

Downloadable Resources

Product Information

Do any adverse events require dose-modifications?

DOSING MODIFICATIONS BASED ON ADVERSE EVENTS?

Management of some adverse reactions may require dose interruptions or permanent discontinuation of VENCLYXTO^1,2

Dose modifications and interruptions for cytopenias are dependent on remission status¹

Grade 4 neutropenia with or without fever or infection; or Grade 4 thrombocytopenia^*

OCCURRENCE	DOSE MODIFICATIONS
Occurrence prior to achieving remission^†	In most instances, do not interrupt VENCLYXTO in combination with AZA due to cytopenias prior to achieving remission
First occurrence after achieving remission and lasting at least 7 days	Delay subsequent cycle of VENCLYXTO and AZA and monitor blood counts. Administer G-CSF if clinically indicated for neutropenia. Upon resolution to Grade 1 or 2: Resume VENCLYXTO at the same dose in combination with AZA
Subsequent occurrences in cycles after achieving remission and lasting 7 days or longer	Delay subsequent cycle of VENCLYXTO and AZA and monitor blood counts. Administer G-CSF if clinically indicated for neutropenia. Upon resolution to Grade 1 or 2: Resume VENCLYXTO at the same dose in combination with AZA, and Reduce VENCLYXTO duration by 7 days during each of the subsequent cycles, such as 21 days instead of 28 days. Refer to AZA Prescribing Information for additional information.

Grade 3 or 4 non-haematological toxicities

OCCURRENCE

DOSE MODIFICATIONS

Any occurrence

Interrupt VENCLYXTO if not resolved with supportive care
Upon resolution to Grade 1 or baseline level:

Resume VENCLYXTO at the same dose

Grading Definitions

Please refer to the SmPC for full prescribing information

Footnotes

^*Grade 4 neutropenia (ANC <500/μL) with or without fever or infection; or Grade 4 thrombocytopenia (platelet count <25,000/μL).¹

^†Consider bone marrow evaluation to assess remission.¹

ANC=absolute neutrophil count; AZA=azacitidine; G-CSF=granulocyte-colony stimulating factor.

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Prescribing information can be accessed by the Prescribing Information button on the left

UK-VNCAML-220171 | November 2022.

VENCLYXTO in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.¹

Adverse events should be reported.
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores.
Adverse events should also be reported to AbbVie on [email protected]

Grading Definitions

Neutropenia³

Grade 1: ANC 1000 to 1500/μL

Grade 2: ANC 500 to 999/μL

Grade 3: ANC 200 to 499/μL

Grade 4: ANC <500/μL

Thrombocytopenia⁴

Grade 1: Platelet count 75,000-150,000/μL

Grade 2: Platelet count 50,000-74,999/μL

Grade 3: Platelet count 25,000-49,999/μL

Grade 4: Platelet count <25,000/μL

Non-haematological toxicity⁵

Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated

Grade 2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living

Grade 3: severe or medically significant but not immediately life threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self care activities of daily living

Grade 4: life threatening consequences; urgent intervention indicated

References

VENCYLXTO Summary of Product Characteristics for UK.
DiNardo CD et al. N Engl J Med. 2020; 383(7): 617-29.
Newburger PE, Dale DC. Semin Hematol. 2013 Jul;50(3):198-206.
Tamamyan G et al. Crit Rev Oncol Hematol. 2016 Mar;99:299-307.
Eviq.org.au. Non-haematological toxicity. Available at: https://www.eviq.org.au/dose-mod-gradings/standard-ctcae/non-haematological-toxicity

Home

Efficacy & Safety

Dosing & TLS prophylaxis
(tumour lysis syndrome)

Drug-Drug Interactions

Cytopenia Management

FAQs

Do any adverse events require dose-modifications?

DOSING MODIFICATIONS BASED ON ADVERSE EVENTS?

Grade 4 neutropenia with or without fever or infection; or Grade 4 thrombocytopenia^*

Grade 3 or 4 non-haematological toxicities

Footnotes

Grading Definitions

Neutropenia³

Thrombocytopenia⁴

Non-haematological toxicity⁵

References

Our therapy areas

Additional info

This website is for UK Healthcare Professionals only

Welcome

Home

Efficacy & Safety

Dosing & TLS prophylaxis (tumour lysis syndrome)

Drug-Drug Interactions

Cytopenia Management

FAQs

Do any adverse events require dose-modifications?

DOSING MODIFICATIONS BASED ON ADVERSE EVENTS?

Grade 4 neutropenia with or without fever or infection; or Grade 4 thrombocytopenia*

Grade 3 or 4 non-haematological toxicities

Footnotes

Grading Definitions

Neutropenia3

Thrombocytopenia4

Non-haematological toxicity5

References

Our therapy areas

Additional info

This website is for UK Healthcare Professionals only

Welcome

Dosing & TLS prophylaxis
(tumour lysis syndrome)

Grade 4 neutropenia with or without fever or infection; or Grade 4 thrombocytopenia^*

Neutropenia³

Thrombocytopenia⁴

Non-haematological toxicity⁵