Sonrotoclax
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
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 ] .
Dosing in liver impairment
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 ] .
Preparation and administration
Administration Take BEQALZI tablets with a meal once a day at the same approximate time. Swallow tablets whole with a glass of water. Do not break, chew, or crush the tablets. Missed Dose If a dose of BEQALZI is missed within 8 hours of when it is usually taken, instruct the patient to take the missed dose as soon as possible with a meal and resume the normal daily dosing schedule.
If a dose is missed by more than 8 hours, instruct the patient to not take the missed dose, and resume the usual dosing schedule the next day. If the patient vomits following a dose, instruct the patient to not take an additional dose that day, and resume the usual dosing schedule the next day.
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Sonrotoclax
Label text (3 paragraphs)
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.
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for sonrotoclax. Check the label's hepatic warnings.
Pregnancy and lactation
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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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