Bacrelba Special Precautions

Myelosuppression: Thrombocytopenia, neutropenia, and anemia occurred in patients receiving Asciminib (Bacrelba). Severe (NCI CTCAE grade 3 or 4) thrombocytopenia and neutropenia were reported during treatment with Asciminib (Bacrelba) (see Adverse Reactions). Myelosuppression was generally reversible and managed by temporarily withholding Asciminib (Bacrelba). Complete blood counts should be performed every two weeks for the first 3 months of treatment and monthly thereafter, or as clinically indicated. Patients should be monitored for signs and symptoms of myelosuppression.
Based on the severity of thrombocytopenia and/or neutropenia, the Asciminib (Bacrelba) dose should be reduced, temporarily withheld, or permanently discontinued as described in Table 4 (see Dosage & Administration).
Pancreatic toxicity: Pancreatitis occurred in 11 of 556 (2%) patients receiving Asciminib (Bacrelba), with grade 3 reactions occurring in 6 (1.1%) patients. Asciminib (Bacrelba) was permanently discontinued in 3 (0.5%) patients, while it was temporarily withheld in 6 (1.1%) patients due to pancreatitis. Asymptomatic elevation of serum lipase and amylase occurred in 107 of 556 (19.2%) patients receiving Asciminib (Bacrelba), with grade 3 and 4 reactions occurring in 41 (7.4%) and 11 (2%) of patients, respectively. Asciminib (Bacrelba) was permanently discontinued in 11 (2%) patients due to the asymptomatic elevation of serum lipase and amylase.
Serum lipase and amylase levels should be assessed monthly during treatment with Asciminib (Bacrelba), or as clinically indicated. Patients should be monitored for signs and symptoms of pancreatic toxicity. More frequent monitoring should be performed in patients with a history of pancreatitis. If serum lipase and amylase elevation are accompanied by abdominal symptoms, treatment should be temporarily withheld, and appropriate diagnostic tests should be considered to exclude pancreatitis (see Dosage & Administration).
Based on the severity of serum lipase and amylase elevation, the Asciminib (Bacrelba) dose should be reduced, temporarily withheld, or permanently discontinued as described in Table 4 (see Dosage & Administration).
QT prolongation: Electrocardiogram QT prolongation occurred in 5 of 556 (0.9%) patients receiving Asciminib (Bacrelba) (see Adverse Reactions). In the ASCEMBL clinical study, one patient had a prolonged QTcF greater than 500 ms together with more than 60 ms QTcF increase from baseline and one patient had prolonged QTcF with more than 60 ms QTcF increase from baseline.
It is recommended that an electrocardiogram is performed prior to the start of treatment with Asciminib (Bacrelba) and monitored during treatment as clinically indicated. Hypokalemia and hypomagnesemia should be corrected prior to Asciminib (Bacrelba) administration and monitored during treatment as clinically indicated.
Caution should be exercised when administering Asciminib (Bacrelba) at a total daily dose of 80 mg concomitantly with medicinal products with a known risk of torsades de pointes. Coadministration of Asciminib (Bacrelba) at 200 mg twice daily concomitantly with medicinal products with a known risk of torsades de pointes should be avoided (see Interactions and Pharmacology under Actions).
Hypertension: Hypertension occurred in 88 of 556 (15.8%) patients receiving Asciminib (Bacrelba), with grade 3 and 4 reactions reported in 47 (8.5%) and 1 (0.2%) patients, respectively. Among the patients with hypertension ≥grade 3, the median time to first occurrence of reactions was 21.29 weeks (range: 0.14 to 365 weeks). Asciminib (Bacrelba) was temporarily withheld in 5 (0.9%) patients due to hypertension.
Hypertension should be monitored and managed using standard antihypertensive therapy during treatment with Asciminib (Bacrelba) as clinically indicated.
Hypersensitivity: Hypersensitivity events occurred in 169 of 556 (30.4%) patients receiving Asciminib (Bacrelba), with ≥grade 3 events reported in 8 (1.4%) patients. Patients should be monitored for signs and symptoms of hypersensitivity and appropriate treatment should be initiated as clinically indicated.
Hepatitis B reactivation: Reactivation of hepatitis B virus (HBV) has occurred in patients who are chronic carriers of this virus following administration of other BCR::ABL1 tyrosine kinase inhibitors (TKIs). Patients should be tested for HBV infection before the start of treatment with Asciminib (Bacrelba). HBV carriers who require treatment with Asciminib (Bacrelba) should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Use in Pregnancy: Embryo-fetal toxicity: Based on findings from animal studies, Asciminib (Bacrelba) can cause fetal harm when administered to a pregnant woman. Pregnant women and females of reproductive potential should be advised of the potential risk to a fetus if Asciminib (Bacrelba) is used during pregnancy or if the patient becomes pregnant while taking Asciminib (Bacrelba). The pregnancy status of females of reproductive potential should be verified prior to starting treatment with Asciminib (Bacrelba). Sexually active females of reproductive potential should use effective contraception during treatment with Asciminib (Bacrelba) and for at least 3 days after the last dose (see Use in Pregnancy & Lactation).