SCEMBLIX (asciminib hydrochloride)

Asciminib steady-state exposure (AUC and C max ) increase slightly more than dose proportional across the dose range of 10 to 200 mg (0.25 to 5 times the recommended 80 mg daily dosage) administered once or twice daily. Pharmacokinetic parameters are presented as geometric mean (CV%) unless otherwise stated. The steady state C max and AUC tau of asciminib at recommended dosages are listed in Table 9.

Table 9Steady State a Asciminib Exposure at Recommended Dosages a Steady state is achieved wit...

14.1 Newly Diagnosed Ph+ CML-CP The efficacy of SCEMBLIX in the treatment of patients with newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) was evaluated in the multi-center, randomized, active-controlled, and open-label study ASC4FIRST (NCT04971226). In this study, a total of 405 patients were randomized in a 1:1 ratio to receive either SCEMBLIX or investigator selected tyrosine kinase inhibitors (IS-TKIs). Prior to randomization, the investigator selected the TKI (imatinib, nilotinib, dasatinib, or bosutinib) to be used in the event of randomization to the comparator arm, based on patie...

The following clinically significant adverse reactions can occur with SCEMBLIX and are discussed in greater detail in other sections of the labeling: Myelosuppression [see Warnings and Precautions (5.1)] Pancreatic Toxicity [see Warnings and Precautions (5.2)] Hypertension [see Warnings and Precautions (5.3)] Hypersensitivity [see Warnings and Precautions (5.4)] Cardiovascular Toxicity [see Warnings and Precautions (5.5)] Most common adverse reactions (≥ 20%) are musculoskeletal pain, rash, fati...

None. None. ( 4 )

Myelosuppression: Severe thrombocytopenia and neutropenia events may occur. Monitor complete blood counts regularly during therapy and manage by treatment interruption or dose reduction. ( 2.4 , 5.1 ) Pancreatic Toxicity: Monitor serum lipase and amylase. Interrupt, then resume at reduced dose or discontinue SCEMBLIX based on severity. Evaluate for pancreatitis when lipase elevation is accompanied by abdominal symptoms. ( 2.4 , 5.2 ) Hypertension: Monitor blood pressure and manage hypertension a...

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Closely monitor for adverse reactions during concomitant use of SCEMBLIX at 200 mg twice daily. ( 7.1 ) Itraconazole Oral Solution Containing Hydroxypropyl-β-cyclodextrin: Avoid concomitant use of SCEMBLIX at all recommended doses. ( 7.1 ) Certain Substrates of CYP3A4: Closely monitor for adverse reactions during concomitant use of SCEMBLIX at 80 mg to...