BEQALZI sonrotoclax 80 mg Tablet, Film Coated, 11-count
🆔 Identity & classification
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
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UNII 6T47AS764T
Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
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UNII A7ZHS2RJ34
A cellulose-derived polymer made by chemically modifying plant fiber. It acts as a film-former and enteric coating to protect medicine from stomach acid and control where it dissolves in the digestive tract.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
13 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Beqalzi 80 mgthis 72579-0022-01 | BeOne | 11 tablets | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11420968 ↗ | Drug substance | — | Apr 29, 2039 |
| US 11420968 ↗ | Drug substance | — | Apr 29, 2039 |
| US 11420968 ↗ | Drug substance | — | Apr 29, 2039 |
| US 11420968 ↗ | Drug substance | — | Apr 29, 2039 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | May 13, 2031 |
| NCE | New Chemical Entity (5-year) | May 13, 2031 |
| NCE | New Chemical Entity (5-year) | May 13, 2031 |
| NCE | New Chemical Entity (5-year) | May 13, 2031 |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72579-0022-01 You're viewing this | 1 BLISTER PACK in 1 CARTON (72579-022-01) / 11 TABLET, FILM COATED in 1 BLISTER PACK | 2026-08-31 | Active |
| 72579-0022-08 | 1 BOTTLE in 1 CARTON (72579-022-08) / 120 TABLET, FILM COATED in 1 BOTTLE | 2026-08-31 | Active |
Pack size FAQ
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE BEQALZI is 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. 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) [see Clinical Studies (14.1) ] .
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).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended dosage: 320 mg orally once daily following completion of a 4-week dose ramp-up schedule. ( 2.2 ) Swallow tablets whole with food and water. Do not break, chew, or crush tablets. ( 2.5 ) Provide prophylaxis for tumor lysis syndrome. ( 2.1 , 2.3 ) See Full Prescribing Information for dosage modifications. ( 2.2 , 2.3 , 2.4 )
2.1Important Safety Information BEQALZI can cause tumor lysis syndrome (TLS), especially during the ramp-up phase or during restart after a dosage interruption [see Warnings and Precautions (5.1) ] . Initiate BEQALZI with a dose ramp-up. For dose interruption lasting greater than 7 days, adjust the restart BEQALZI dose as instructed [see Dosage and Administration (2.3) and (2.4) ] .
Assess patient risk for TLS and whether hospitalization for monitoring is warranted. Initiate prophylactic hydration and anti-hyperuricemics before the first dose of BEQALZI and continue as appropriate. Correct pre-existing electrolyte abnormalities before the first dose.
Monitor blood chemistries closely [see Warnings and Precautions (5.1) ] .
2.2Recommended Dosage for Mantle Cell Lymphoma BEQALZI dosing begins with a 4-week ramp-up. The ramp-up dosing schedule is designed to gradually reduce tumor burden (debulk) and decrease the risk of TLS. 4-Week Dose Ramp-Up Schedule Administer BEQALZI orally once daily, according to the ramp-up dosing schedule shown in Table 1.
Table 1: Dosing Schedule for 4-Week Ramp-Up Phase Week Number Days Daily Dose Number of Tablets per Dose Week 1 Days 1 to 3 1 mg One 1 mg tablet Days 4 to 7 2 mg Two 1 mg tablets Week 2 Days 1 to 3 5 mg One 5 mg tablet Days 4 to 7 10 mg Two 5 mg tablets Week 3 Days 1 to 3 20 mg One 20 mg tablet Days 4 to 7 40 mg Two 20 mg tablets Week 4 Days 1 to 3 80 mg One 80 mg tablet Days 4 to 7 160 mg Two 80 mg tablets The Starter Pack provides the first 4 weeks of BEQALZI according to the ramp-up schedule [see How Supplied/Storage and Handling (16) ] .
Target Dose Week 5 and Beyond After completion of the 4-week ramp-up phase, the recommended dosage of BEQALZI is 320 mg (four 80 mg tablets) taken orally once daily until disease progression or unacceptable toxicity. Dosing after treatment interruption greater than 7 days is described in Table 3 [see Dosage Modifications for Adverse Reactions (2.3) ] .
2.3Dosage Modifications for Adverse Reactions Table 2 provides recommended BEQALZI dosage modifications for adverse reactions. Table 3 provides temporary dose modifications upon restart after dose interruptions lasting more than 7 days. Table 4 provides recommended modifications to the target dose after adverse reactions are resolved.
Table 2: Recommended BEQALZI Dosage Modifications for Adverse Reactions Adverse Reaction Adverse reactions were graded using NCI CTCAE version 5.0. Occurrence Dosage Modification Tumor Lysis Syndrome Any blood chemistry changes or symptoms suggestive of TLS [see Warnings and Precautions (5.1) ] 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 Table 3 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. A maximum of 2 dose reductions is recommended.
Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines in Table 3 and Table 4. Platelet count <50,000/mm 3 with significant bleeding Platelet count <25,000/mm 3 Neutrophil count <500/mm 3 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 in Table 3 and Table 4. Nonhematologic Toxicity Grade 3 nonhematologic toxicity Pa…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablet Strength Description 1 mg Purple, oval, film-coated tablets with 1 debossed on one side. 5 mg Purple, oval, film-coated tablets with 5 debossed on one side. 20 mg Purple, oblong, film-coated tablets with 20 debossed on one side. 80 mg Purple, oval, film-coated tablets with 80 debossed on one side. Tablets: 1 mg, 5 mg, 20 mg, and 80 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Concomitant use of sonrotoclax with strong CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated in patients due to the potential for increased risk of tumor lysis syndrome [see Drug Interactions (7.1) ]. Concomitant use of sonrotoclax with strong CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated. ( 2.4 , 4 , 7.1 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Tumor Lysis Syndrome (TLS) : Anticipate TLS; assess risk in all patients. Premedicate with anti-hyperuricemics, ensure adequate hydration, and monitor. ( 5.1 ) Serious Infections : Monitor for infection and treat promptly.
( 5.2 ) Neutropenia: Monitor blood counts regularly. ( 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
( 5.4 , 8.1 , 8.3 )
5.1Tumor Lysis Syndrome BEQALZI can cause serious or life-threatening tumor lysis syndrome (TLS). BEQALZI can cause rapid reduction in tumor and changes in blood chemistries consistent with TLS that require prompt management. This can occur as early as 4 hours after the first dose, at any dose increases, and upon restart following dosage interruption.
Laboratory or clinical TLS occurred in 7% of the 115 patients with MCL who followed the recommended dose ramp-up. Risk factors for TLS include higher tumor burden such as bulky lymphadenopathy or lymphocytosis and reduced renal function. Assess all patients for TLS risk and provide appropriate prophylaxis, including hydration and anti-hyperuricemics begun prior to the first dose of BEQALZI.
Correct relevant chemistry abnormalities prior to starting BEQALZI. Consider hospitalization with intravenous hydration and monitoring and employ more frequent monitoring for patients with high TLS risk. Monitor blood chemistries and manage abnormalities promptly.
Interrupt dosing if needed; when restarting BEQALZI, follow the dose modification guidance [see Dosage and Administration (2.3) ] . Concomitant use of sonrotoclax with strong or moderate CYP3A inhibitors increases sonrotoclax exposure, which may increase the risk of TLS at initiation and during the ramp-up phase [see Dosage and Administration (2.4) and Drug Interactions (7.1) ] .
5.2Serious Infections BEQALZI can cause fatal or serious infections [see Adverse Reactions (6.1) ] . Among patients who received BEQALZI at the recommended dosage in the clinical trial, serious infections occurred in 14% of patients and Grade 3 or higher infections in 17%, with fatal infections in 2.6% of patients. 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 according to guidelines. Withhold or dose reduce BEQALZI based on severity [see Dosage and Administration (2.3) ] .
5.3Neutropenia BEQALZI can cause serious or severe cytopenias, including neutropenia. Among 115 patients with MCL who received BEQALZI, new or worsening Grade 3 or 4 decrease in neutrophils developed in 18% (Grade 4, 6%). Febrile neutropenia occurred in 1.7% of patients. Monitor complete blood counts throughout treatment. Based on severity, reduce dose, interrupt, or permanently discontinue BEQALZI [see Dosage and Administration (2.3) ] .
5.4Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, BEQALZI can cause fetal harm when administered to a pregnant woman. In embryo-fetal development toxicity studies conducted in pregnant mice and rabbits, oral administration of sonrotoclax during the period of organogenesis caused adverse developmental outcomes, including structural abnormalities and altered fetal growth at approximately ≥2 times the clinical exposure based on the area under the concentration-time curve (AUC) at the recommended dose in humans (320 mg/day).
Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BEQALZI and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose [see Use in Specific Populations (8.1 , 8.3) ] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Tumor Lysis Syndrome [see Warnings and Precautions (5.1) ] Serious Infections [see Warnings and Precautions (5.2) ] Neutropenia [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥15%) are pneumonia and fatigue. The most common Grade 3-4 laboratory abnormalities (≥15%) are decreases in lymphocytes and neutrophils. ( 6.1 ) 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.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Mantle Cell Lymphoma The safety of BEQALZI was evaluated in 115 adult patients with previously treated MCL in a single-arm, multicenter clinical trial, BGB-11417-201 (NCT05471843) [see Clinical Studies (14.1) ] . The trial required prior receipt of anti-CD20–based therapy and a BTK inhibitor.
The trial excluded patients on moderate or strong CYP3A inhibitors or strong CYP3A inducers and required an absolute neutrophil count (ANC) ≥1000/mm 3 ; platelets ≥75,000/mm 3 ; creatinine clearance ≥50 mL/min; AST and ALT ≤3 × upper limit of normal (ULN); and serum total bilirubin ≤2 × ULN. Patients received BEQALZI 320 mg orally once daily following completion of a 4-week ramp-up dosing schedule. Of the 115 patients who received BEQALZI, 52% were exposed for at least 6 months and 34% were exposed for at least 1 year.
Serious adverse reactions were reported in 37% of patients who received BEQALZI, most frequently (≥2%) from pneumonia (10%). Fatal adverse reactions occurred in 4.3% of patients, including from pneumonia (2.6%) and sudden death (1.7%). Adverse reactions led to dose interruption of BEQALZI in 27% of patients, dose reduction in 0.9%, and permanent discontinuation in 8%.
The most common reasons for dose interruption were infections (10%) and neutropenia (5%). The most common adverse reaction leading to treatment discontinuation was infection (1.7%). Table 7 summarizes select adverse reactions in Study BGB-11417-201, excluding laboratory terms.
Table 7: Adverse Reactions (≥10%) in Patients with MCL Who Received BEQALZI in BGB-11417-201 Adverse Reaction BEQALZI (N=115) All Grades (%) Grade 3 or 4 (%) Infections Pneumonia Includes pneumonia, COVID-19 pneumonia, pneumonia bacterial, and other related terms. 16 Additionally includes three fatal cases (2.6%) of pneumonia. 10 Upper respiratory tract infection Includes upper respiratory tract infection, pharyngitis, sinusitis, and other related terms.
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1.7General Disorders Fatigue Includes fatigue and asthenia. 16
0.9Edema Includes edema peripheral, generalized edema, and other related terms. 14 0 Pyrexia 10
0.9 Gastrointestinal Disorders Diarrhea 14
1.7Constipation 10 0 Skin and Subcutaneous Tissue Disorders Rash Includes rash, dermatitis, drug eruption, and other related terms. 10 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain Includes musculoskeletal pain, back pain, bone pain, and other related terms. 10 0 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 sepsis.
Table 8 summarizes new or worsening laboratory abnormalities throughout treatment. Grade 4 laboratory abnormalities in ≥2% of patients included decreases in neutrophils (6%) and platelet count (3.5%). Table 8: Select Laboratory Abnormalities (≥20%) That Worsened from Baseline in Patients with Previously Treated MCL Who Received BEQALZI Laboratory Abnormality The denominator used to calculate the rate varied from 103 to 115 based on the number of pat…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Strong CYP3A inhibitors: Contraindicated at initiation and during the ramp-up phase. Reduce target dose after ramp-up. ( 2.4 , 7.1 ) Moderate CYP3A inhibitors: Avoid concomitant use at 1 mg and 2 mg doses of BEQALZI and reduce all other doses. ( 7.1 ) Strong or moderate CYP3A inducers: Avoid coadministration. ( 7.1 )
7.1Effects of Other Drugs on BEQALZI Strong or Moderate CYP3A Inhibitors Concomitant use of strong CYP3A inhibitors during the initiation and ramp-up phase with BEQALZI is contraindicated. After the ramp-up phase, reduce the target dose of BEQALZI as in Table 5 [see Dosage and Administration (2.4) ] . For dose modifications of sonrotoclax with moderate CYP3A inhibitors, see Dosage and Administration (2.4) .
Sonrotoclax is a CYP3A substrate [see Clinical Pharmacology (12.3) ] . Concomitant use with strong and moderate CYP3A inhibitors increase sonrotoclax exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of BEQALZI adverse reactions. Strong or Moderate CYP3A Inducers Avoid concomitant use of strong or moderate CYP3A inducers with BEQALZI.
Sonrotoclax is a CYP3A substrate [see Clinical Pharmacology (12.3) ] . Concomitant use with strong CYP3A inducers decreases sonrotoclax exposure [see Clinical Pharmacology (12.3) ] , which may reduce effectiveness of sonrotoclax.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology (12.1) ] , BEQALZI can cause embryo-fetal harm when administered to pregnant women. There are no available data on BEQALZI use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, oral administration of sonrotoclax to pregnant mice and rabbits during the period of organogenesis resulted in adverse developmental outcomes, including structural abnormalities and altered fetal growth, at maternal exposures approximately ≥2 times the human exposure (AUC) at the recommended dose of 320 mg daily (see Data ).
Advise patients of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Sonrotoclax was administered orally to pregnant mice at doses of 100, 300, and 1000 mg/kg/day during organogenesis (gestation days 6-15).
Decreased fetal body weight and crown-rump length were noted at all doses. At the dose of 100 mg/kg/day in mice, the maternal exposure was approximately 8 times the human exposure at the recommended dose of 320 mg once daily. Sonrotoclax was administered orally to pregnant rabbits at doses of 15, 75, and 300 mg/kg/day during organogenesis (gestation days 6-19).
Fetal external (absent or open eye, cleft lip, misshapen mouth, acephalostoma) malformations were noted at 300 mg/kg/day. At the dose of 300 mg/kg/day in rabbits, the maternal exposure was approximately 2 times the human exposure at the recommended dose of 320 mg once daily.
8.2Lactation Risk Summary There are no data on the presence of sonrotoclax or its metabolites in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with BEQALZI and for 1 week after the last dose.
8.3Females and Males of Reproductive Potential Based on findings in animals and its mechanism of action, BEQALZI can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating BEQALZI. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with BEQALZI and for 1 week after the last dose.
Males Advise males with female partners of reproductive potential to use effective contraception during treatment with BEQALZI and for 1 week after the last dose. Infertility Based on findings in animals, BEQALZI may impair male and female fertility. Fertility findings were reversible in animals [see Nonclinical Toxicology (13.1) ] .
8.4Pediatric Use The safety and effectiveness of BEQALZI in pediatric patients have not been established.
8.5Geriatric Use Of the 115 patients with MCL who were treated with BEQALZI, 74 (64%) were 65 years old or older and 26 (23%) were 75 years old or older. Patients aged 65 years and older experienced higher rates of serious adverse reactions (42%) compared to younger patients (29%). Clinical studies of BEQALZI did not include sufficient numbers of patients to determine whether efficacy differs in patients 65 years of age or older compared to younger patients.
8.6Renal Impairment No dose adjustments are recommended for patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥30 mL/min). BEQALZI has not been studied in patients with severe renal impairment (eGFR <30 mL/min) [see Clinical Pharmacology (12.3) ] .
8.7Hepatic Impairment No dose adjustments are recommended for patients with mild or moderate hepatic impairment (bilirubin ≤3 × upper limit of normal [ULN] and any aspartate aminotransferase [AST]). BEQALZI has not been s…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology (12.1) ] , BEQALZI can cause embryo-fetal harm when administered to pregnant women. There are no available data on BEQALZI use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, oral administration of sonrotoclax to pregnant mice and rabbits during the period of organogenesis resulted in adverse developmental outcomes, including structural abnormalities and altered fetal growth, at maternal exposures approximately ≥2 times the human exposure (AUC) at the recommended dose of 320 mg daily (see Data ).
Advise patients of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Sonrotoclax was administered orally to pregnant mice at doses of 100, 300, and 1000 mg/kg/day during organogenesis (gestation days 6-15).
Decreased fetal body weight and crown-rump length were noted at all doses. At the dose of 100 mg/kg/day in mice, the maternal exposure was approximately 8 times the human exposure at the recommended dose of 320 mg once daily. Sonrotoclax was administered orally to pregnant rabbits at doses of 15, 75, and 300 mg/kg/day during organogenesis (gestation days 6-19).
Fetal external (absent or open eye, cleft lip, misshapen mouth, acephalostoma) malformations were noted at 300 mg/kg/day. At the dose of 300 mg/kg/day in rabbits, the maternal exposure was approximately 2 times the human exposure at the recommended dose of 320 mg once daily.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of BEQALZI in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 115 patients with MCL who were treated with BEQALZI, 74 (64%) were 65 years old or older and 26 (23%) were 75 years old or older. Patients aged 65 years and older experienced higher rates of serious adverse reactions (42%) compared to younger patients (29%). Clinical studies of BEQALZI did not include sufficient numbers of patients to determine whether efficacy differs in patients 65 years of age or older compared to younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sonrotoclax is an inhibitor of B-cell lymphoma 2 (BCL-2) protein. Overexpression of BCL-2 in various cancers mediates cell survival and has been associated with chemotherapeutic resistance. Sonrotoclax binds to the BCL-2 protein, displacing pro-apoptotic proteins, thereby inducing apoptosis of cells.
In nonclinical studies, sonrotoclax demonstrated cytotoxicity in cancer cells overexpressing BCL-2, with a series of intrinsic apoptotic events, including caspase activation.
12.2Pharmacodynamics Sonrotoclax exposure-response relationships and the time course of pharmacodynamic response have not been fully characterized. Cardiac Electrophysiology Administration of sonrotoclax has the potential to increase the QTc interval. The largest mean increase in QTc interval was 7 ms (upper confidence interval = 14 ms) after administration of sonrotoclax (320 mg once daily) with a low-fat meal in patients with mature B-cell malignancies.
There is insufficient information to characterize the QTc effects of sonrotoclax at higher concentrations above recommended dose.
12.3Pharmacokinetics Sonrotoclax pharmacokinetics were determined following a single dose or at steady state at the approved recommended dosage of 320 mg once daily and are presented as mean (CV%), unless otherwise specified. Sonrotoclax area under the plasma drug concentration-time curve (AUC 0-24 h ) is 3395 (55%) ng∙h/mL and maximum plasma concentration (C max ) is 353 (49%) ng/mL, following 320 mg once daily with a low-fat meal. Sonrotoclax C max and AUC 0-tau increase in a less than dose proportional manner over the dosage range of 320 mg to 640 mg (1 to 2 times the highest approved recommended dosage).
Limited systemic accumulation of sonrotoclax was observed following repeated administration. Absorption The median T max of sonrotoclax is 4 hours (ranged from 1 to 8 hours) following 320 mg once daily dosing. Effect of Food Sonrotoclax AUC and C max increased by approximately 1.5-fold following administration with a low-fat meal (approximately 333-500 kilocalories, 25% fat calories).
Sonrotoclax AUC increased by 2-fold and C max by 2.4-fold following administration with a high-fat meal (1000 kilocalories, 50% fat). Distribution The geometric mean apparent volume of distribution of sonrotoclax is 482 (38%) L. Sonrotoclax plasma protein binding is 99% across a concentration range of 1 to 10 µM.
The blood-to-plasma ratio is 0.6 to 0.7. Elimination The mean terminal elimination half-life (t ½ ) of sonrotoclax ranges from 4 to 6 hours. The geometric mean apparent oral clearance (CL/F) of sonrotoclax is 94 (62%) L/h.
Metabolism Sonrotoclax is primarily metabolized by CYP3A and to a lesser extent by CYP2C8 in vitro . Excretion After a single radiolabeled sonrotoclax dose of 20 mg to healthy subjects, approximately 86% of the dose was recovered in feces (19.5% unchanged) and 0.28% in urine (0.04% unchanged). Specific Populations No clinically meaningful differences in the pharmacokinetics of sonrotoclax were observed based on race, age (27-91 years), sex, weight (37-165 kg), mild to moderate renal impairment (eGFR ≥30 mL/min) or mild to moderate hepatic impairment (bilirubin ≤3 × upper limit of normal (ULN) and any aspartate aminotransferase (AST)).
The effect of severe renal impairment (eGFR <30 mL/min) or severe hepatic impairment (total bilirubin >3 × ULN with any AST) on sonrotoclax pharmacokinetics is unknown. Drug Interactions Studies Clinical Studies and Model-Informed Approaches Strong CYP3A inhibitors : Sonrotoclax AUC increased 11-fold and C max increased 4-fold following concomitant administration of itraconazole (strong CYP3A inhibitor and P-gp inhibitor). Sonrotoclax AUC increased 13-fold and C max increased 7-fold following concomitant administration of posaconazole (strong CYP3A inhibitor).
Strong CYP3A inducers : Sonrotoclax AUC decreased to 35% and C max to 58% following concomitant use of phenytoin (strong CYP3A in…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sonrotoclax is an inhibitor of B-cell lymphoma 2 (BCL-2) protein. Overexpression of BCL-2 in various cancers mediates cell survival and has been associated with chemotherapeutic resistance. Sonrotoclax binds to the BCL-2 protein, displacing pro-apoptotic proteins, thereby inducing apoptosis of cells.
In nonclinical studies, sonrotoclax demonstrated cytotoxicity in cancer cells overexpressing BCL-2, with a series of intrinsic apoptotic events, including caspase activation.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Package Number of Tablets NDC Number 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 Individual restart packs 1 mg wallet in carton (Week 1 wallet) 11 × 1 mg tablets 72579-020-01 5 mg wallet in carton (Week 2 wallet) 11 × 5 mg tablets 72579-017-01 20 mg wallet in carton (Week 3 wallet) 11 × 20 mg tablets 72579-025-01 80 mg wallet in carton (Week 4 wallet) 11 × 80 mg tablets 72579-022-01 Additional packs 20 mg wallet in carton 14 × 20 mg tablets 72579-025-02 80 mg bottle in carton 120 × 80 mg tablets 72579-022-08 BEQALZI 1 mg film-coated tablets are purple, oval, and debossed with 1 on one side.
BEQALZI 5 mg film-coated tablets are purple, oval, and debossed with 5 on one side. BEQALZI 20 mg film-coated tablets are purple, oblong, and debossed with 20 on one side. BEQALZI 80 mg film-coated tablets are purple, oval, and debossed with 80 on one side.
Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Storage of blister wallets: Store tablets in the original blister package; do not transfer the tablets to a different container.
📦 Storage and Handling ▾
Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Storage of blister wallets: Store tablets in the original blister package; do not transfer the tablets to a different container.
📋 Description ▾
11 DESCRIPTION BEQALZI tablets contain sonrotoclax, a B-cell lymphoma 2 (BCL-2) inhibitor. The molecular formula of sonrotoclax is C 49 H 59 N 7 O 7 S and the chemical name is N -[4-({[(1 r ,4 r )-4-hydroxy-4-methylcyclohexyl]methyl}amino)-3-nitrobenzene-1-sulfonyl]-4-(2-{(2 S )-2-[2-(propan-2-yl)phenyl]pyrrolidin-1-yl}-7-azaspiro[3.5]nonan-7-yl)-2-[(1 H -pyrrolo[2,3- b ]pyridin-5-yl)oxy]benzamide. The molecular weight of sonrotoclax is 890.11 Daltons.
Sonrotoclax has the following structure: BEQALZI tablets for oral use contain 1, 5, 20, or 80 mg of sonrotoclax. Each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide (20 and 80 mg only), croscarmellose sodium, hydroxypropyl methylcellulose acetate succinate, magnesium stearate, microcrystalline cellulose, talc (20 and 80 mg only). The tablet film coating contains FD&C Blue No.
1/brilliant blue FCF aluminum lake, FD&C Red No. 40/allura red ac aluminum lake, polyethylene glycol, polyvinyl alcohol, soy lecithin, talc, and titanium dioxide. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide). Tumor Lysis Syndrome Advise patients of the potential risk of TLS, particularly at treatment initiation, during the ramp-up phase, and with restarting the dose after an interruption, and to immediately report any signs and symptoms associated with this event (fever, chills, nausea, vomiting, confusion, shortness of breath, seizure, irregular heartbeat, decreased urination, unusual tiredness, muscle cramps or twitches) to their healthcare provider (HCP) for evaluation [see Warnings and Precautions (5.1) ] .
Advise patients to be adequately hydrated when taking BEQALZI to reduce the risk of TLS. The recommended volume is 6 to 8 glasses (approximately 1.5 to 2 liters) of water daily starting 1-2 days before taking BEQALZI, on the day of the first dose, on any day the dose is increased until target dose is reached, and at restart, if applicable [see Dosage and Administration (2.1) ] . Advise patients of the importance of keeping scheduled appointments for blood work or other laboratory tests [see Dosage and Administration (2.1) ] .
Advise patients that it may be necessary to take BEQALZI in the hospital or medical office setting to allow monitoring for TLS. Serious Infections Advise patients to contact their healthcare provider immediately if they develop a fever or any signs of infection [see Warnings and Precautions (5.2) ] . Neutropenia Advise patients of the need for periodic monitoring of blood counts [see Warnings and Precautions (5.3) ] .
Drug Interactions Advise patients to avoid consuming grapefruit products, Seville oranges, or star fruit during treatment with BEQALZI. BEQALZI may interact with some drugs; therefore, advise patients to inform their healthcare provider of the use of any prescription medication, over-the-counter drugs, vitamins, and herbal products [see Contraindications (4) and Drug Interactions (7.1) ] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with BEQALZI and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BEQALZI and for 1 week after the last dose [see Use in Specific Populations (8.3) ] .
Lactation Advise women not to breastfeed during treatment with BEQALZI and for 1 week after the last dose [see Use in Specific Populations (8.2) ] . Infertility Advise males and females of reproductive potential that BEQALZI may impair fertility [see Use in Specific Populations (8.3) ] . Administration Instructions Advise patients to take BEQALZI exactly as prescribed and not to change their dose or to stop taking BEQALZI unless they are told to do so by their healthcare provider.
Advise patients to take BEQALZI orally once daily, at approximately the same time each day, according to their healthcare provider's instructions and that the tablets should be swallowed whole with a meal and a glass of water without being broken, chewed, or crushed [see Dosage and Administration (2.5) ] . Missed Dose Advise patients if BEQALZI is missed within 8 hours, to take it as soon as possible with a meal on the same day with a return to the normal schedule the following day. If they miss a dose by more than 8 hours, advise patients to not take the missed dose and resume the usual dosing schedule the next day.
Advise patients not to take any additional dose that day if they vomit after taking BEQALZI, and to take the next dose at the usual time the following day [see Dosage and Administration (2.5) ] . Restarting After Treatment Interruption Advise patients to contact their healthc…
💬 Medication Guide ▾
MEDICATION GUIDE BEQALZI™ [bee KAHL zee] (sonrotoclax) Tablets This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 5/2026 What is the most important information I should know about BEQALZI? BEQALZI can cause serious side effects, including: Tumor lysis syndrome (TLS).
TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and can be life-threatening. TLS can happen when you first start treatment with BEQALZI, when your dose is increased, or when you restart BEQALZI after stopping treatment.
You will receive other medicines before starting and during treatment with BEQALZI to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check your risk for TLS before you start treatment and during treatment with BEQALZI.
It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you get any symptoms of TLS during treatment with BEQALZI, including: nausea vomiting diarrhea muscle cramps, weakness, or twitching fatigue decreased urination swelling in your legs, ankles, or feet numbness or tingling, especially around your mouth or in your hands and feet confusion or difficulty staying alert irregular or fast heart rate seizures Drink plenty of water during treatment with BEQALZI to help reduce your risk of getting TLS.
Drink 6 to 8 glasses (about 1.5 to 2 liters) of water daily: starting 1 to 2 days before your first dose, on the day of your first dose, each time your dose is increased, and if you restart BEQALZI after stopping treatment. Serious infections. BEQALZI can cause death or serious infections.
Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop a fever or any signs of an infection. See " What are the possible side effects of BEQALZI? " for more information about side effects.
What is BEQALZI? BEQALZI is a prescription medicine used to treat adults with: mantle cell lymphoma (MCL) that has come back or did not respond to previous treatment, and who have already received at least 2 treatments for their cancer, including a Bruton's tyrosine kinase (BTK) inhibitor medicine. It is not known if BEQALZI is safe and effective in children.
Who should not take BEQALZI? Certain medicines must not be taken when you first start taking BEQALZI and while your dose is being slowly increased because of the increased risk of tumor lysis syndrome (TLS). Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
BEQALZI and other medicines may affect each other causing serious side effects. Do not start new medicines during treatment with BEQALZI without first talking with your healthcare provider. Before taking BEQALZI, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems. have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium. have a history of high uric acid levels in your blood or gout. are pregnant or plan to become pregnant.
BEQALZI can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with BEQALZI. Use effective birth control (contraception) during treatment and for 1 week after the last dose of BEQALZI.
Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with BEQALZI. Males with female partners who are able to become pregnant: Use effective birth control (contraception) during treatment and for 1 week after the last dose of BEQALZI. are breastfeeding or plan to breastfeed. It is not known if BEQALZI passes into your breast milk.
Do not breastfeed during treatment and fo…