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BEQALZI drug interactions

Contraindications

Concomitant use of BEQALZI with strong CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated in patients due to the potential for increased risk of TLS.

Effects of other drugs on BEQALZI

CYP3A inhibitors
BEQALZI is a CYP3A substrate. Concomitant use with strong and moderate CYP3A inhibitors increases BEQALZI exposure, which may increase the risk of adverse reactions, including TLS. Consider alternative medicinal products or reduce the BEQALZI dose as described below.

Strong CYP3A inhibitors: Contraindicated with BEQALZI during the ramp-up phase. After the ramp-up phase, reduce BEQALZI dose to 20 mg if coadministered with a strong CYP3A inhibitor.

Moderate CYP3A inhibitors: Avoid moderate CYP3A inhibitors during the first week of ramp-up. Follow dose reductions in the table below.

BEQALZI
ramp-up week		 Original BEQALZI
dose		 When administering a moderate CYP3A inhibitor
BEQALZI dose Blister pack to order or use
Week 1 1 mg 1 mg; avoid moderate CYP3A inhibitor 1 mg restart pack or Week 1 blister pack
2 mg 2 mg; avoid moderate CYP3A inhibitor
Week 2 5 mg 1 mg 1 mg restart pack or Week 1 blister pack
10 mg 2 mg
Week 3 20 mg 5 mg 5 mg restart pack or Week 2 blister pack
40 mg 10 mg
Week 4 80 mg 20 mg 20 mg restart pack or Week 3 blister pack
160 mg 40 mg
Target dose 320 mg 80 mg 80 mg tablets in bottle

BEQALZI ramp-up week
Week 1
Blister pack to order or use: 1 mg restart pack or Week 1 blister pack
Original BEQALZI
dose
When administering a moderate CYP3A inhibitor and BEQALZI dose

1 mg
1 mg; avoid moderate CYP3A inhibitor

2 mg
2 mg; avoid moderate CYP3A inhibitor

BEQALZI ramp-up week
Week 2
Blister pack to order or use: 1 mg restart pack or Week 1 blister pack
Original BEQALZI
dose
When administering a moderate CYP3A inhibitor and BEQALZI dose

5 mg
1 mg

10 mg
2 mg

BEQALZI ramp-up week
Week 3
Blister pack to order or use: 5 mg restart pack or Week 2 blister pack
Original BEQALZI
dose
When administering a moderate CYP3A inhibitor and BEQALZI dose

20 mg
5 mg

40 mg
10 mg

BEQALZI ramp-up week
Week 4
Blister pack to order or use: 20 mg restart pack or Week 3 blister pack
Original BEQALZI
dose
When administering a moderate CYP3A inhibitor and BEQALZI dose

80 mg
20 mg

160 mg
40 mg

BEQALZI ramp-up week
Target dose
Blister pack to order or use: 80 mg tablets in bottle
Original BEQALZI
dose
When administering a moderate CYP3A inhibitor and BEQALZI dose

320 mg
80 mg

Resume the BEQALZI dosage that was used prior to treatment with a strong or moderate CYP3A inhibitor at least 5 days after discontinuation of the inhibitor.

CYP3A inducers

BEQALZI is a CYP3A substrate. Avoid concomitant use of strong or moderate CYP3A inducers with BEQALZI, as they decrease BEQALZI exposure and may reduce its effectiveness.

No Brand X DOSAGE Adjustments Needed for the following1:

P-gp and BCRP inhibitors

In vitro studies show that BRAND X is a substrate of P-gp and BCRP. No clinically significant differences in BRAND X pharmacokinetics were observed when coadministered with P-gp and BCRP inhibitors.

Gastric acid reducing agents

No clinically significant differences in BRAND X pharmacokinetics were observed when coadministered with gastric acid reducing agents (eg, proton pump inhibitors, H2-receptor antagonists). 

Access dosing details in
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Download the Dosing & Administration Guide

TLS=tumor lysis syndrome.

Dose modifications Resources

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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