Glasdegib

Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.

DAURISMO (glasdegib) is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients who are age ≥75 years or who are not eligible to receive intensive induction chemotherapy.

Distribution Restrictions DAURISMO is only available through a control distribution program called the DAURISMO Pregnancy Prevention Program (DPPP). Under this program, only prescribers and pharmacies registered with the program are able to prescribe and dispense the product, respectively.

In addition, DAURISMO can only be dispensed to patients who are registered and meet all the conditions of the DPPP. For more information, please contact the DPPP at 1 844 616-6888. 1 Pediatrics Pediatrics (˂18 years of age): The safety and efficacy of DAURISMO in the pediatric population have not been established.

Adverse changes in growing bone, including premature partial to complete closure of the epiphyseal plate were observed in non-clinical toxicity studies. DAURISMO is not indicated for use in the pediatric population. 2 Geriatrics Geriatrics (> 65 years of age): In the clinical studies of DAURISMO with low-dose cytarabine, 98% of the patients were age 65 years or older and 60% of the patients were age 75 years or older.

Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.