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BEQALZI safety information: Adverse reactions

ADVERSE REACTIONS IN ≥10% OF PATIENTS WHO RECEIVED BEQALZI (N=115)1

Adverse reactions All Grades (%) Grade 3 or 4 (%)
Infections
Pneumonia* 16† 10
Upper respiratory tract infection‡ 12 1.7
General disorders
Fatigue§ 16 0.9
Edema 14 0
Pyrexia 10 0.9
Gastrointestinal disorders
Diarrhea 14 1.7
Constipation 10 0
Skin and subcutaneous tissue disorders
Rash# 10 0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain** 10 0

*Includes pneumonia, COVID-19 pneumonia, pneumonia bacterial, and other related terms.

†Additionally includes 3 fatal cases (2.6%) of pneumonia.

‡Includes upper respiratory tract infection, pharyngitis, sinusitis, and other related terms.

§Includes fatigue and asthenia.

Includes edema peripheral, generalized edema, and other related terms.

#Includes rash, dermatitis, drug eruption, and other related terms.

**Includes musculoskeletal pain, back pain, bone pain, and other related terms.

  • Serious adverse reactions were reported in 37% of patients. The most frequent (≥2%) serious adverse reaction was pneumonia (10%). Fatal adverse reactions occurred in 4.3% of patients, including from pneumonia (2.6%) and sudden death (1.7%)1
  • Clinically relevant adverse reactions in <10% of patients who received BEQALZI included: TLS, headache, nausea, vomiting, mucositis, peripheral sensory neuropathy, febrile neutropenia, pneumonitis, herpes zoster infection, and sepsis1

SELECT LABORATORY ABNORMALITIES (≥20%) THAT WORSENED FROM BASELINE1

Laboratory abnormality* All Grades (%) Grade 3 or 4 (%)
Hematology
Lymphocytes decreased 66 29
Hemoglobin decreased 52 9
Neutrophils decreased 50 18
Platelets decreased 36 9
Chemistry
Calcium decreased 42 1.7
Uric acid increased 42 0
Glucose increased 35 0
Creatinine increased 32 1.7
Potassium decreased 30 4.3
Sodium decreased 29 9
Aspartate aminotransferase increased 27 2.8
Alkaline phosphatase increased 25 0
Alanine aminotransferase increased 22 0.9
Calcium increased 21 0

Laboratory test* All grades†
n (%)		 Grade 3 or higher†
n (%)
Hematology
Lymphocytes decreased 75 (66.4) 33 (29.2)
Hemoglobin decreased 60 (52.2) 10 (8.7)
Neutrophils decreased 58 (50.4) 21 (18.3)
Leukocytes decreased 56 (48.7) 14 (12.2)
Chemistry
Calcium decreased‡ 48 (41.7) 2 (1.7)
Urate increased 48 (41.7) 0 (0.0)

*The denominator used to calculate the rate varied from 103 to 115 based on the number of patients with a baseline value and at least 1 post-treatment value.

TLS may occur with BCL-2 inhibition, including with BEQALZI1

Incidence1,2

  • The incidence of TLS was 7% (n=8/115)
    • Laboratory TLS was observed in 6 patients (5%)
    • Clinical TLS was observed in 2 patients (2%)
  • All TLS events resolved without clinical sequelae

Management1

  • Monitor blood chemistries and manage abnormalities promptly. Interrupt dosing if needed; restart BEQALZI following dose modification guidance in the Prescribing Information

Dose interruption rate
due to TLS3

1.7%

(n=2/115)

Dose reduction rate
due to TLS3

0%

(n=0/115)

Discontinuation rate
due to TLS2

0%

(n=0/115)

BEQALZI dose modification rates due to ARs1

Dose interruption rate

27%

(n=31/115)

Dose reduction rate

0.9%

(n=1/115)

Discontinuation rate

8%

(n=9/115)

  • The most common reasons for dose interruption were infections (10%) and neutropenia (5%)1
  • The most common AR that led to treatment discontinuation was infection (1.7%)1

AR=adverse reaction; BCL-2=B-cell lymphoma 2; TLS=tumor lysis syndrome.

Efficacy Dosing

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.

References: 1. BEQALZI. Prescribing Information. BeOne Medicines USA, Inc.; 2026. 2. Eyre TA, Song Y, Hermine O, et al. Phase I/II study of sonrotoclax (BGB-11417) monotherapy in patients with mantle cell lymphoma previously treated with anti-CD20 therapy and a Bruton tyrosine kinase inhibitor. J Clin Oncol. Published online July 1, 2026. doi:10.1200/JCO-26-00550 3. Data on file. BeOne Medicines USA, Inc.

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