5.1 Embryo-Fetal Toxicity
5.2 QTc Interval Prolongation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are
not listed.
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FULL PRESCRIBING INFORMATION
WARNING: EMBRYO-FETAL TOXICITY
DAURISMO can cause embryo-fetal death or severe birth defects when administered to apregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals [see
Warnings and Precautions (5.1), Use in Specific Populations (8.1)].
Conduct pregnancy testing in females of reproductive potential prior to initiation ofDAURISMO treatment. Advise females of reproductive potential to use effective
contraception during treatment with DAURISMO and for at least 30 days after the last dose[see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
Advise males of the potential risk of DAURISMO exposure through semen and to usecondoms with a pregnant partner or a female partner of reproductive potential during
treatment with DAURISMO and for at least 30 days after the last dose to avoid potentialdrug exposure [see Warnings and Precautions (5.1), Use in Specific Populations (8.3)].
1 INDICATIONS AND USAGE
DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acutemyeloid leukemia (AML) in adult patients who are >75 years old or who have comorbidities that preclude useof intensive induction chemotherapy.
Limitation of Use: DAURISMO has not been studied in patients with the comorbidities of severe renalimpairment or moderate-to-severe hepatic impairment.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose and Schedule
The recommended dose of DAURISMO is 100 mg orally once daily on days 1 to 28 in combination withcytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle in the absence ofunacceptable toxicity or loss of disease control. For patients without unacceptable toxicity, treat for a minimumof 6 cycles to allow time for clinical response.
Administer DAURISMO with or without food. Do not split or crush DAURISMO tablets.
AdministerDAURISMO about the same time each day. If a dose of DAURISMO is vomited, do not administer areplacement dose; wait until the next scheduled dose is due. If a dose of DAURISMO is missed or not takenat the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose.
Return to the normal schedule the following day. Do not administer 2 doses of DAURISMO within 12 hours.
2.2 Monitoring and Dose Modifications
Assess complete blood counts, electrolytes, renal, and hepatic function prior to the initiation of DAURISMOand at least once weekly for the first month. Monitor electrolytes and renal function once monthly for the duration of therapy. Obtain serum creatine kinase levels prior to initiating DAURISMO |
