BEQALZI dosing and administration

4-week ramp-up helps patients reach target dose and reduce the risk of TLS¹

RAMP-UP SCHEDULE FOR BEQALZI

BEQALZI™ (sonrotoclax) dosing ramp-up schedule chart

TLS risk assessment and monitoring¹

Gradual dose increases during ramp-up, along with prophylaxis and monitoring, are designed to help mitigate the risk of TLS. Assess all patients for risk of TLS prior to initiation.

Prophylaxis

Advise patients to drink 6-8 glasses of water before initiation and on any day BEQALZI dosing is increased, including on initiation, to reduce the risk of TLS
Antihyperuricemics should be given prior to initiating BEQALZI

Get full details on risk assessment and monitoring for TLS

BEQALZI provides the option for an outpatient ramp-up approach^1,2

Same-day lab monitoring during ramp-up

Assess blood chemistries pre-dose and as early as 4 hours post-dose at:
- Treatment initiation
- Each dose increase
- Restart following dosage interruption
Consider hospitalization with IV hydration and employ more frequent monitoring for patients with high TLS risk, or as clinically indicated

No dose adjustments recommended for patients with mild or moderate renal or hepatic impairment¹*

*BEQALZI has not been studied in patients with severe renal or hepatic impairment.¹

Access dosing details in one convenient guide

Download the Dosing & Administration Guide

BEQALZI dosing and monitoring summary^1,2

How is BEQALZI dosed?	Once-daily oral tablets, taken with food
Starting dose?	4-week ramp-up to target dose starting at 1 mg. See details above Available in a starter pack
Target dose?	320 mg once daily (after 4-week ramp-up)
Ramp-up schedule?	Week 1: 1 mg → 2 mg once daily Week 2: 5 mg → 10 mg once daily Week 3: 20 mg → 40 mg once daily Week 4: 80 mg → 160 mg once daily Week 5+: 320 mg once daily See ramp-up chart above for full details
TLS risk?	Yes—requires prophylaxis and monitoring
Hospitalization required?	Option for outpatient initiation and monitoring Consider hospitalization for patients with high risk of TLS See risk assessment and monitoring for TLS for full guidance
Monitoring schedule?	Blood chemistry assessments pre-dose and 4-6 hours post-dose at treatment initiation, with each dose increase, and upon restart following dose interruption*
Patient hydration?	6-8 glasses of water 1-2 days prior to treatment initiation, on any day with a dose increase, and at restart, if applicable Hydration is a critical measure to help reduce risk of TLS
With or without food?	With a meal
Missed dose guidance?	<8 hours late: Take as soon as possible with a meal; resume next day at normal schedule ≥8 hours late: Skip; resume next day at normal schedule If the patient vomits following a dose, instruct the patient to not take an additional dose that day, and resume the usual dosing schedule the next day
Dose restart?	≤7 days: Resume scheduled dose once adverse reaction resolves >7 days: Restart at reduced dose per dose to restart table, re-escalate per schedule, and reassess TLS risk for required monitoring/prophylaxis See guidance for dose modifications for full details

*Changes in blood chemistries consistent with TLS require prompt management and can occur as early as 4 hours after the first dose, at each dose increase, and upon restart following a dosage interruption.¹

See risk assessment and monitoring for TLS

IV=intravenous; TLS=tumor lysis syndrome.

Safety Starting BEQALZI

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome (TLS).

WARNINGS & PRECAUTIONS

Tumor Lysis Syndrome (TLS):

BEQALZI can cause rapid tumor reduction and changes in blood chemistries consistent with TLS, which may be serious or life-threatening and require prompt management. TLS may occur as early as 4 hours after the first dose, with dose increases, or upon reinitiation following treatment interruption. Laboratory or clinical TLS occurred in 7% of patients who followed the recommended dose ramp-up. Assess all patients for TLS risk and initiate prophylaxis, including adequate hydration and antihyperuricemics. For patients at high risk of TLS, consider hospitalization with intravenous hydration and employ frequent monitoring. Monitor blood chemistries closely and manage abnormalities promptly. Interrupt BEQALZI for TLS; upon reinitiation, follow dose modification guidance in the Prescribing Information.

Serious Infections:

BEQALZI can cause fatal or serious infections. Serious infections occurred in 14% of patients; Grade 3-4 occurred in 17% (fatal: 2.6%). The most common Grade 3 or greater infection was pneumonia (10%). Monitor for signs and symptoms of infection and treat appropriately. Consider prophylactic antimicrobials and immunoglobulins. Interrupt, reduce dose, or permanently discontinue BEQALZI based on severity.

Neutropenia:

BEQALZI can cause serious or severe cytopenias, including neutropenia. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%); febrile neutropenia occurred in 1.7% of all patients. Monitor complete blood counts throughout treatment. Interrupt treatment, reduce the dose, or permanently discontinue BEQALZI based on severity.

Embryo-Fetal Toxicity:

BEQALZI can cause fetal harm when administered to pregnant women. Advise patients of the potential risk to a fetus. Verify pregnancy status prior to initiation. Advise females to use effective contraception and males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.

ADVERSE REACTIONS

The most common adverse reactions (≥15%) are pneumonia (16%) and fatigue (16%). The most common Grade 3-4 laboratory abnormalities (≥15%) are decreases in lymphocytes (29%) and neutrophils (18%).

DRUG INTERACTIONS

Strong or Moderate CYP3A Inhibitors:

Concomitant use increases BEQALZI exposure. Avoid use of strong CYP3A inhibitors during BEQALZI initiation and ramp-up. Avoid use of moderate CYP3A inhibitors at the 1 mg and 2 mg doses; for all other doses, reduce the BEQALZI dose with concomitant use. See approved labeling for dose modifications.

Strong or Moderate CYP3A Inducers:

Concomitant use decreases BEQALZI exposure. Avoid use.

SPECIAL POPULATIONS

Lactation: Advise women not to breastfeed during treatment with BEQALZI and for 1 week after the last dose.

To report SUSPECTED ADVERSE REACTIONS, contact BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

INDICATION

BEQALZI™ (sonrotoclax) is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).