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Guidance for dose modifications

RECOMMENDED BEQALZI DOSE MODIFICATIONS FOR ADVERSE REACTIONS1

Adverse reaction* Occurrence Dose modification
Tumor lysis syndrome
Any blood chemistry changes or symptoms suggestive of TLS Any Interrupt BEQALZI.
Upon resolution of lab abnormalities, resume BEQALZI.

  • For interruptions lasting 7 days or less, resume planned dosing
  • For interruptions lasting more than 7 days, see the table below for dosage when resuming treatment
Hematologic toxicity
Grade ≥3 febrile neutropenia First Interrupt BEQALZI.

Resume BEQALZI at the same dose upon recovery.

Second and subsequent Interrupt BEQALZI.†

Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines for restart and modified target dose below.

  • Platelet count <50,000/mm³ with significant bleeding
  • Platelet count <25,000/mm³
  • Neutrophil count <500/mm³ lasting greater than 7 consecutive days
 First Interrupt BEQALZI.

Resume BEQALZI at the same dose upon recovery to Grade 1 or baseline level.

Second and subsequent Interrupt BEQALZI.†

Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines for restart and modified target dose below.

Nonhematologic toxicity
Grade 3 nonhematologic toxicity‡ First Interrupt BEQALZI.

Upon recovery to Grade 1 or baseline level, resume BEQALZI at the same dose.

Second and subsequent Interrupt BEQALZI.†

Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines for restart below.

Grade 4 nonhematologic toxicity Any Interrupt BEQALZI.†

Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines for restart and modified target dose below.

Adverse reaction* Occurrence Dosage modification
Tumor lysis syndrome
Any events of TLS† Any Interrupt BRAND X.

Upon recovery, resume BRAND X.
Hematologic toxicity
  • Grade ≥3 febrile neutropenia
  • Grade ≥3 febrile thrombocytopenia that results in clinically significant bleeding
  • Grade 4 thrombocytopenia
  • Grade 4 neutropenia lasting >7 consecutive days
 First Interrupt BRAND X.

Resume BRAND X at the same dose upon recovery to Grade 1 or baseline level.
Second and subsequent Interrupt BRAND X.

Follow dose reduction guideline in table below when resuming treatment with BRAND X.

A maximum of 2 dose reductions is recommended.
Nonhematologic toxicity
Any Grade ≥3 nonhematologic toxicity‡ First Interrupt BRAND X.

Upon recovery to Grade 1 or baseline level, resume BRAND X at the same dose for Grade 3 toxicity and at 50% decreased dose for Grade 4 toxicity.
Second and subsequent Interrupt BRAND X.

Follow dose reduction guideline in table below when resuming treatment with BRAND X.

A maximum of 2 dose reductions is recommended.

Adverse reaction*
Tumor lysis syndrome
Any blood chemistry changes or symptoms suggestive of TLS
Occurrence
Dose modification

Any
Interrupt BEQALZI.
Upon resolution of lab abnormalities, resume BEQALZI.

  • For interruptions lasting 7 days or less, resume planned dosing
  • For interruptions lasting more than 7 days, see the table below for dosage when resuming treatment

Adverse reaction*
Hematologic toxicity
Grade ≥3 febrile neutropenia
Occurrence
Dose modification

First
Interrupt BEQALZI.

Resume BEQALZI at the same dose upon recovery.

Second and subsequent
Interrupt BEQALZI.†

Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines for restart and modified target dose below.

Adverse reaction*
Hematologic toxicity

  • Platelet count <50,000/mm³ with significant bleeding
  • Platelet count <25,000/mm³
  • Neutrophil count <500/mm³ lasting greater than 7 consecutive days
Occurrence
Dose modification

First
Interrupt BEQALZI.

Resume BEQALZI at the same dose upon recovery to Grade 1 or baseline level.

Second and subsequent
Interrupt BEQALZI.†

Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines for restart and modified target dose below.

Adverse reaction*
Nonhematologic toxicity
Grade 3 nonhematologic toxicity‡
Occurrence
Dose modification

First
Interrupt BEQALZI.

Upon recovery to Grade 1 or baseline level, resume BEQALZI at the same dose.

Second and subsequent
Interrupt BEQALZI.†

Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines for restart below.

Adverse reaction*
Nonhematologic toxicity
Grade 4 nonhematologic toxicity
Occurrence
Dose modification

Any
Interrupt BEQALZI.†

Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines for restart and modified target dose below.

Adverse reaction*
Tumor lysis syndrome
Any events of TLS†
Occurrence
Dose modification
Any
Interrupt BRAND X.

Upon recovery, resume BRAND X.

Adverse reaction*
Hematologic toxicity

  • Grade ≥3 febrile neutropenia
  • Grade ≥3 febrile thrombocytopenia that results in clinically significant bleeding
  • Grade 4 thrombocytopenia
  • Grade 4 neutropenia lasting >7 consecutive days
Occurrence
Dose modification
First
Interrupt BRAND X. Resume BRAND X at the same dose upon recovery to Grade 1 or baseline level.
Second and subsequent
Interrupt BRAND X. Follow dose reduction guideline in table below when resuming treatment with BRAND X. A maximum of 2 dose reductions is recommended.
Adverse reaction*
Nonhematologic toxicity
Any Grade ≥3 nonhematologic toxicity‡
Occurrence
Dose modification
First
Interrupt BRAND X. Upon recovery to Grade 1 or baseline level, resume BRAND X at the same dose for Grade 3 toxicity and at 50% decreased dose for Grade 4 toxicity.
Second and subsequent
Interrupt BRAND X. Follow dose reduction guideline in table below when resuming treatment with BRAND X. A maximum of 2 dose reductions is recommended.
* Adverse reactions were graded using NCI CTCAE version 5.0.
† A maximum of 2 dose reductions is recommended.
‡ Patients may continue taking BEQALZI for the following:
  • Grade 3 gastrointestinal toxicity (ie, nausea, vomiting, diarrhea) unless unresponsive to treatment ≥3 days
  • Asymptomatic biochemical laboratory abnormalities, other than TLS, that resolve in 7 days or less
For patients with a dose interruption lasting 7 days or less: For patients with a dose interruption lasting more than 7 days:
  • During ramp-up phase (Weeks 1 to 4): Resume BEQALZI and continue the remaining ramp-up schedule
  • During the target dose (Week 5 and beyond): Resume BEQALZI once the adverse reaction has resolved. Refer to the table above and the recommended modifications of target dose table if a modified target dose is needed
  • During ramp-up phase (Weeks 1 to 4): Restart BEQALZI at the dose shown in the dose to restart table based on the dose at the time of interruption, then reescalate following the ramp-up schedule
  • During the target dose (Week 5 and beyond): Restart BEQALZI at the dose shown in the dose to restart table based on the dose at the time of interruption. Then, reescalate to target dose per the recommended modifications of target dose table when clinically appropriate

DOSE TO RESTART BEQALZI AFTER A DOSE INTERRUPTION GREATER THAN 7 DAYS1

Dose at time of interruption Highest restart dose*
1 mg 1 mg†
2 mg 1 mg†
5 mg 2 mg‡
10 mg 5 mg†
20 mg 10 mg‡
40 mg 20 mg†
80 mg 40 mg‡
160 mg 80 mg†
320 mg 160 mg‡
* The physician may restart at a lower dose than noted above.
† Resume on Day 1 of the individual restart pack. Instruct patients to follow the dosing schedule printed on the blister pack starting on Day 1 (1 tablet daily on Days 1 through 3, then 2 tablets daily on Days 4 through 7).
‡ Resume on Day 4 of the individual restart pack. Instruct patients to remove and dispose of single tablets labeled Days 1 through 3 and restart taking tablets labeled Day 4 (2 tablets daily) of the individual restart pack.

RECOMMENDED MODIFICATIONS OF TARGET DOSE LEVEL FOR ADVERSE REACTIONS1

Target dose level at interruption Modified target dose level
320 mg 160 mg
160 mg 80 mg
80 mg Discontinue
Toxicity occurrence Target dose level at interruption Modified target dose level
First 320 mg QD 320 mg QD
Second* 320 mg QD 160 mg QD
Third 160 mg QD 80 mg QD
Fourth 80 mg QD Discontinue

NO DOSAGE ADJUSTMENTS NEEDED FOR PATIENTS WITH MILD OR MODERATE RENAL OR HEPATIC IMPAIRMENT1

  • BEQALZI has not been studied in patients with severe renal or hepatic impairment

DOSING PACKAGES

BEQALZI tablets come in different dose strengths, and are provided in the starter pack carton, individual restart packs, a reduced dose pack, and the target dose bottle. These options allow for the ramp-up dosing, dose modifications, and regular target dose based on patient needs.

Package Contents NDC Number
Ramp-up starter pack and target dose bottle
Starter pack carton Each starter pack carton contains 4 weekly blister pack wallets:

  • Week 1 (11 × 1 mg tablets)
  • Week 2 (11 × 5 mg tablets)
  • Week 3 (11 × 20 mg tablets)
  • Week 4 (11 × 80 mg tablets)
 72579-015-04
80 mg tablets in bottle 120 × 80 mg tablets 72579-022-08
Individual restart packs for dose modifications
1 mg blister pack (Week 1 blister pack) 11 × 1 mg tablets 72579-020-01
5 mg blister pack (Week 2 blister pack) 11 × 5 mg tablets 72579-017-01
20 mg blister pack (Week 3 blister pack) 11 × 20 mg tablets 72579-025-01
80 mg blister pack (Week 4 blister pack) 11 × 80 mg tablets 72579-022-01
Additional pack for use with strong CYP3A inhibitors
20 mg blister pack 14 × 20 mg tablets 72579-025-02

Package
Ramp-up starter pack and target dose bottle
Starter pack carton
Contents
NDC Number

Each starter pack carton contains 4 weekly blister pack wallets:

  • Week 1 (11 × 1 mg tablets)
  • Week 2 (11 × 5 mg tablets)
  • Week 3 (11 × 20 mg tablets)
  • Week 4 (11 × 80 mg tablets)
72579-015-04

Package
Ramp-up starter pack and target dose bottle
80 mg tablets in bottle
Contents
NDC Number

120 × 80 mg tablets
72579-022-08

Package
Individual restart packs for dose modifications
1 mg blister pack (Week 1 blister pack)
Contents
NDC Number

11 × 1 mg tablets
72579-020-01

Package
Individual restart packs for dose modifications
5 mg blister pack (Week 2 blister pack)
Contents
NDC Number

11 × 5 mg tablets
72579-017-01

Package
Individual restart packs for dose modifications
20 mg blister pack (Week 3 blister pack)
Contents
NDC Number

11 × 20 mg tablets
72579-025-01

Package
Individual restart packs for dose modifications
80 mg blister pack (Week 4 blister pack)
Contents
NDC Number

11 × 80 mg tablets
72579-022-01

Package
Additional pack for use with strong CYP3A inhibitors
20 mg blister pack
Contents
NDC Number

14 × 20 mg tablets
72579-025-02

Access dosing details in
one convenient guide

Download the Dosing & Administration Guide

AST=aspartate aminotransferase; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; TLS=tumor lysis syndrome; ULN=upper limit of normal.

Risk assessment and prophylaxis for TLS Drug interactions

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).

Please see full Prescribing Information.

Reference: 1. BEQALZI. Prescribing Information. BeOne Medicines USA, Inc.; 2026.

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