INITIATING VENCLEXTA1

When you’re ready to start VENCLEXTA, here is information to help you assess, prep, and initiate your patients. VENCLEXTA can cause rapid reduction in tumor and thus poses a risk for tumor lysis syndrome (TLS). The 3-step initiation protocol is designed to help reduce the risk of TLS.

TUMOR BURDEN

Perform tumor burden assessment, including radiographic evaluation (eg, CT scan). The risk of TLS may decrease as tumor burden decreases.

TUMOR BURDEN

LOW MEDIUM HIGH

All LN <5 cm

AND

ALC <25 × 109/L

Any LN 5 cm
to <10 cm

OR

ALC ≥25 × 109/L

Any LN ≥10 cm

OR

Any LN ≥5 cm
and
ALC ≥25 × 109/L

BLOOD CHEMISTRY ASSESSMENT

Assess blood chemistry and correct preexisting abnormalities prior to initiation of treatment.

  • Potassium
  • Phosphorus
  • Creatinine
  • Uric acid
  • Calcium

MEDICATION RECONCILIATION

Determine if your patient is currently taking any of the following, which may require VENCLEXTA dose modifications:

  • Posaconazole or other strong CYP3A inhibitor
  • Moderate CYP3A inhibitor
  • P-gp inhibitor

ADDITIONAL CONSIDERATIONS

Consider all patient comorbidities before final determination of prophylaxis and monitoring schedule.

  • Renal function
  • Splenomegaly
  • Other patient comorbidities

ALC=absolute lymphocyte count; CT=computed tomography; CYP3A=cytochrome P450 3A; LN=lymph node; P-gp=P-glycoprotein.

At least 2 days prior to the first dose:

HYDRATION

TUMOR BURDEN

LOW MEDIUM HIGH

Oral hydration*

(1.5 to 2 L)

Oral hydration*

(1.5 to 2 L)

IV hydration

Consider for patients with medium tumor burden, occurring during outpatient therapy

Oral hydration*

(1.5 to 2 L)

IV hydration

150 to 200 mL/hr as tolerated prior to first dose

ANTI-HYPERURICEMICS

TUMOR BURDEN

LOW MEDIUM HIGH

Allopurinol

Allopurinol

Allopurinol

Rasburicase
Consider for elevated uric acid (>8 mg/dL)2

*1.5 to 2 L (~56 oz) of water should be consumed every day starting at least 2 days before the first dose and throughout the ramp-up phase, especially the first day of each dose increase. Administer IV hydration for any patient who cannot tolerate oral hydration.

Start allopurinol or xanthine oxidase inhibitor 2 to 3 days prior to initiation of VENCLEXTA.

IV=intravenous.

Monitor blood chemistry* for first dose of each ramp-up week.

LOW Tumor Burden OR MEDIUM Tumor Burden

OUTPATIENT

DAY 1, WEEK
1
2
3
4
5
Dosage
20 mg
50 mg
100 mg
200 mg
400 mg
Blood chemistry labs
Pre-dose
6 to 8 hrs
 
 
 
24 hrs
 
 
 
For the first doses of 20 mg and 50 mg, consider hospitalization for patients with medium tumor burden and CLcr <80 mL/min; for these patients, see table on the right for monitoring in hospital.

HIGH Tumor Burden

HOSPITAL

OUTPATIENT

DAY 1, WEEK
1
2
3
4
5
Dosage
20 mg
50 mg
100 mg
200 mg
400 mg
Blood chemistry labs
Pre-dose
4 hrs
 
 
 
8 hrs
12 hrs
 
 
 
24 hrs

*Evaluate blood chemistries (potassium, uric acid, phosphorus, 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 dose ramp-up.

CLcr=creatinine clearance.