Beqalzi
sonrotoclax · Tablet, Film Coated · Oral
Uses
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
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 ) 2.1 Important 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) ] . 2.2 Recommended 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) ] . 2.3 Dosage 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 Patients may continue taking BEQALZI for the following: Grade 3 gastrointestinal toxicity (i.e., nausea, vomiting, diarrhea) unless unresponsive to treatment ≥3 days. Asymptomatic biochemical laboratory abnormalities, other than TLS, that resolve in 7 days or less. 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 in Table 3 and Table 4. Grade 4 nonhematologic toxicity First Interrupt BEQALZI. Upon recovery to Grade 1 or baseline level, resume BEQALZI and follow dose reduction guidelines in Table 3 and Table 4. 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. For patients with a dose interruption lasting 7 days or less: 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 Table 2 and Table 4 if a modified target dose is needed. For patients with a dose interruption lasting more than 7 days: During ramp-up phase (Weeks 1 to 4): Restart BEQALZI at the dose shown in Table 3 based on the dose at the time of interruption, then re-escalate following the ramp-up schedule. During the target dose (Week 5 and beyond): Restart BEQALZI at the dose shown in Table 3 based on the dose at the time of interruption. Then, re-escalate to target dose determined per Table 4 when clinically appropriate. Table 3: Dose to Restart BEQALZI After a Dose Interruption Greater than 7 Days Dose at Time of Interruption (mg) Highest Restart Dose (mg) The physician may restart at a lower dose than noted. 1 mg 1 mg Resume on Day 1 of the individual restart pack.
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
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 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 ) 5.1 Tumor 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) ] . 5.2 Serious 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) ] . 5.3 Neutropenia 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) ] . 5.4 Embryo-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) ] .
Side effects
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. 6.1 Clinical 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. 12 1.7 General Disorders Fatigue Includes fatigue and asthenia. 16 0.9 Edema Includes edema peripheral, generalized edema, and other related terms. 14 0 Pyrexia 10 0.9 Gastrointestinal Disorders Diarrhea 14 1.7 Constipation 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 patients with a baseline value and at least one post-treatment value. BEQALZI 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
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 ) 7.1 Effects 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
Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy 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. 8.2 Lactation 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. 8.3 Females 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) ] . 8.4 Pediatric Use The safety and effectiveness of BEQALZI in pediatric patients have not been established. 8.5 Geriatric 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. 8.6 Renal 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) ] . 8.7 Hepatic 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 studied in patients with severe hepatic impairment (bilirubin >3 × ULN and any AST) [see Clinical Pharmacology (12.3) ] .
Pregnancy
8.1 Pregnancy 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
8.4 Pediatric Use The safety and effectiveness of BEQALZI in pediatric patients have not been established.
Geriatric use
8.5 Geriatric 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.
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
Mechanism of action
12.1 Mechanism 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
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
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.
Patient 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 healthcare provider before restarting BEQALZI after stopping treatment. Advise patients that: Their healthcare provider will determine the correct dose based on their previous dose and how long they were off treatment. Depending on how long they were off treatment, they may resume at the same dose where they left off, or they may need to restart at a lower dose. If needed, individual restart packs are available outside of the starter pack for restart dosing as prescribed by their healthcare provider. They may be instructed to resume dosing on Day 1 or Day 4 of the restart pack depending on their prescribed restart dose. If instructed to start on Day 4, they will not use all tablets in the blister pack and should remove and dispose of tablets from Days 1 through 3 in order to avoid confusion or accidental use. They should not use leftover packs from previous treatment without consulting their healthcare provider.
Label text from the FDA structured product label by BeOne Medicines USA, Inc. (revised Jul 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sonrotoclax in 4 products
Beqalzi NDC products (5)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 72579-015 | Kit | BeOne Medicines USA, Inc. | NDA |
| 72579-017 | Sonrotoclax 5 mg/1 Tablet, Film Coated | BeOne Medicines USA, Inc. | NDA |
| 72579-020 | Sonrotoclax 1 mg/1 Tablet, Film Coated | BeOne Medicines USA, Inc. | NDA |
| 72579-022 | Sonrotoclax 80 mg/1 Tablet, Film Coated | BeOne Medicines USA, Inc. | NDA |
| 72579-025 | Sonrotoclax 20 mg/1 Tablet, Film Coated | BeOne Medicines USA, Inc. | NDA |
Frequently asked questions
What is Beqalzi used for?
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…
What are the side effects of Beqalzi?
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… See the full label for the complete list.
Who makes Beqalzi?
Beqalzi is listed by 1 labeler in the FDA NDC directory, including BeOne Medicines USA, Inc..