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Now Available October 6, 2026
BEQALZI™ (sonrotoclax) Tablets
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BEQALZI is now available. The information below is provided to support timely updates to PBM,
pharmacy, and payer systems to ensure accurate dispensing, claims processing, and reimbursement.
BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory
mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine
kinase (BTK) inhibitor.1
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).
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Important Safety Information
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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).
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Please see additional Important Safety Information below.
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NDC Information:
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Package |
Number of Tablets |
10-Digit NDC |
11-Digit NDC |
WAC2 |
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Starter pack carton |
Each starter pack carton contains 4 weekly blister pack wallets: |
72579-015-04 |
72579-0015-04 |
$37,070.00 |
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Week 1 (11 × 1 mg tablets) |
72579-020-04 |
72579-0020-04 |
Not Saleable
(located inside Starter Pack) |
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Week 2 (11 × 5 mg tablets) |
72579-017-04 |
72579-0017-04 |
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Week 3 (11 × 20 mg tablets) |
72579-025-04 |
72579-0025-04 |
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Week 4 (11 × 80 mg tablets) |
72579-022-04 |
72579-0022-04 |
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Individual restart packs |
| 1 mg wallet in carton (Week 1
wallet) |
11 × 1 mg tablets |
72579-020-01 |
72579-0020-01 |
$11,143.00 |
| 5 mg wallet in carton (Week 2
wallet) |
11 × 5 mg tablets |
72579-017-01 |
72579-0017-01 |
$11,143.00 |
| 20 mg wallet in carton (Week 3
wallet) |
11 × 20 mg tablets |
72579-025-01 |
72579-0025-01 |
$11,143.00 |
| 80 mg wallet in carton (Week 4
wallet) |
11 × 80 mg tablets |
72579-022-01 |
72579-0022-01 |
$3,641.00 |
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Additional packs |
| 20 mg wallet in carton |
14 × 20 mg tablets |
72579-025-02 |
72579-0025-02 |
$14,182.00 |
| 80 mg bottle in carton |
120 × 80 mg tablets |
72579-022-08 |
72579-0022-08 |
$39,720.00 |
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NDC Compendia Identifier Information:
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11-Digit NDC |
WK Medi-Span Generic Product Identifier (GPI)2 |
First DataBank Product Identifier2 |
Redbook Merative Micromedex (GPC)2 |
ELSEVIER Gold Standard Identifier (SPID)2 |
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72579-0015-04 |
21-47-00-65-00-B7-20 |
Identifier available only to subscribers. Check drug pricing database for information. |
10289018 |
35192 |
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72579-0020-04 |
N/A |
N/A |
N/A |
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72579-0017-04 |
N/A |
N/A |
N/A |
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72579-0025-04 |
N/A |
N/A |
N/A |
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72579-0022-04 |
N/A |
N/A |
N/A |
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72579-0020-01 |
21-47-00-65-00-O3-10 |
10289013 |
35179 |
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72579-0017-01 |
21-47-00-65-00-O3-20 |
10289026 |
35185 |
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72579-0025-01 |
21-47-00-65-00-O3-30 |
10289017 |
35184 |
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72579-0022-01 |
21-47-00-65-00-O3-50 |
10289025 |
35186 |
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72579-0025-02 |
21-47-00-65-00-O3-30 |
10289021 |
35184 |
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72579-0022-08 |
21-47-00-65-00-O3-50 |
10289016 |
35186 |
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Important Safety Information (con't)
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Warnings & Precautions
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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.
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Serious Infections: BEQALZI can cause fatal or serious infections. Serious infections
occurred in 14% of patients; Grade ≥3 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.
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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.
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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.
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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%).
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Drug Interactions
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Strong or Moderate CYP3A Inhibitors: Concomitant use increases BEQALZI exposure. Strong
CYP3A inhibitors are contraindicated 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.
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Strong or Moderate CYP3A Inducers: Concomitant use decreases BEQALZI exposure. Avoid
use.
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Special Populations
Lactation: Advise women not to breastfeed during treatment with BEQALZI and for 1 week
after the last dose.
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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.
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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).
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Please see full Prescribing
Information.
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References:
1. BEQALZI. Prescribing information. BeOne Medicines USA, Inc.; 2026.
2. Data on file. BeOne Medicines USA, Inc. 2026.
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Distributed and Marketed by BeOne Medicines USA, Inc.
BEQALZI and BeOne Medicines are trademarks owned by
BeOne Medicines I GmbH or its affiliates.
© BeOne Medicines I GmbH, 2026 All Rights Reserved.
0826-BEQ-PRC-014 09/2026
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