Dosing & TLS prophylaxis
(tumour lysis syndrome)
VENCLYXTO + AZACITIDINE HAS A 3-DAY RAMP-UP PHASE1
VENCLYXTO is administered once daily with the dose increasing per the titration schedule below1
Tablets should be swallowed whole, not chewed crushed or broken1
Taken with a meal and water at approximately the same time each day1
Available in 10 mg,
50 mg, and 100 mg
film-coated tablets1
Footnotes
AML=acute myeloid leukaemia; AZA=azacitidine; CYP3A=cytochrome P450 3A; IV=intravenous; SC=subcutaneous;
TLS=tumour lysis syndrome; WBC=white blood cell.
Slide 1 of 3
How should VENCLYXTO be initiated in AML?
RECOMMENDED INITIATION AND TLS PROPHYLAXIS MEASURES FOR PATIENTS WITH AML1
Rates of TLS with VENCLYXTO plus AZA were low (1%, n=3) and the risk can be managed by following these prophylaxis measures1,2
In Viale-A, 3 patients (1%) experienced TLS (1 case of clinical TLS; all in the VENCLYXTO plus AZA arm)2
All cases occurred in the dose ramp-up period and were resolved with uricosuric agents and calcium supplements without treatment interruption2
Footnotes
*Risk factors for TLS include circulating blasts, high burden of leukaemia involvement in bone marrow, elevated pre-treatment LDH levels, and reduced renal function.1
†VIALE-A was a Phase 3, randomised, double-blind, placebo-controlled study comparing the efficacy and safety of VEN+AZA vs AZA alone in first-line AML patients ineligible for intensive chemotherapy. VEN+AZA reached its primary efficacy endpoints, achieving statistically significant increases in overall survival and composite complete remission rates (CR+CRi) vs AZA alone. In VIALE-A, 66.4% (190/286) patients on VEN+AZA achieved CR+CRi vs. 28.3% (41/145) patients on AZA alone (P<0.001). 43.4% of patients (124/286) on VEN+AZA achieved CR/CRi before cycle 2 compared with 7.6% (11/145) of patients on AZA alone (P<0.001).1,2
AML=acute myeloid leukaemia; AZA=azacitidine; CYP3A=cytochrome P450 3A; IV=intravenous; LDH=lactate dehydrogenase; SC=subcutaneous;
TLS=tumour lysis syndrome; WBC=white blood cell.
Slide 2 of 3
Are there any modifications in special populations?
DOSING CONSIDERATIONS FOR PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT1
Renal impairment
| SEVERITY | DOSE MODIFICATIONS |
| Mild, 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 impairment
| SEVERITY | DOSE MODIFICATIONS |
| Mild or moderate | No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase. |
| Severe | A dose reduction of at least 50% throughout treatment is recommended. These patients should be monitored more closely for signs of toxicity. |
Please refer to the SmPC for full safety information
Footnotes
CrCl=creatinine clearance; TLS=tumour lysis syndrome.
Slide 3 of 3
Prescribing information can be accessed by the Prescribing Information button on the left
UK-VNCAML-220169 | 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]
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
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 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.
