HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DAURISMO safely and effectively. See full prescribing information for DAURISMO.
DAURISMO™ (glasdegib) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning.
- DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals. (5.1, 8.1)
- Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment. Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose. (5.1, 8.1, 8.3)
- Advise males of the potential risk of exposure through semen and to use condoms 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 potential drug exposure. (5.1, 8.3)
RECENT MAJOR CHANGES
|Dosage and Administration, Dosage Modification for Concomitant Use with Moderate CYP3A4 Inducers (2.3)||3/2020|
INDICATIONS AND USAGE
DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. (1)
DOSAGE AND ADMINISTRATION
Recommended dosage: 100 mg orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 25 mg. (3)
WARNINGS AND PRECAUTIONS
- Blood Donation: Advise patients not to donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose. (5.1)
- QTc Interval Prolongation: Monitor electrocardiograms and electrolytes. If QTc prolongation occurs, interrupt treatment with DAURISMO. (2.2, 5.2)
Most common adverse reactions (incidence ≥20%) are anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Strong CYP3A4 Inhibitors: Consider alternative therapies that are not strong CYP3A4 inhibitors or monitor for increased risk of adverse reactions, including QTc interval prolongation. (7)
- Strong CYP3A4 Inducers: Avoid concomitant use with DAURISMO. (7)
- Moderate CYP3A4 Inducers: Avoid concomitant use with DAURISMO. If, concomitant use cannot be avoided, increase the dose of DAURISMO (2.3, 7).
- QTc Prolonging Drugs: Avoid co-administration with DAURISMO. If co-administration is unavoidable, monitor for increased risk of QTc interval prolongation. (7)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.