Oncology Drug Reference Sheet: Glasdegib

March 26, 2019 by Barbara Lubejko RN, MS

In November 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo™) for use in combination with low-dose cytarabine for treatment of patients with newly diagnosed acute myeloid leukemia who are not eligible for intensive chemotherapy. Data from clinical trials indicated that the regimen is safe for older adults and those with significant comorbidities, such as cardiac disease, poor performance status, or elevated serum creatinine.

Category/Class

Targeted therapy/hedgehog pathway inhibitor

Indication

The FDA approval is for use in combination with low-dose cytarabine for treatment of newly diagnosed acute myeloid leukemia in people who are at least 75 years old or who have comorbidities preventing use of intensive induction therapy.  

Dosing

Administer 100 mg orally once daily in combination with cytarabine 20 mg subcutaneously twice daily on days 1–10 of each 28-day treatment cycle. Treatment should be continued for at least six cycles unless unacceptable toxicity or loss of disease control occurs. Glasdegib may need to be interrupted, dose reduced, or discontinued if patients experience QTc prolongation, cytopenias, or other grade 3 or 4 toxicities.                           

Administration

Instruct patients to take glasdegib orally, with or without food, at the same time each day.     

Adverse Reactions 

Clinically significant QTc prolongation and ventricular arrhythmias have occurred (5%), including ventricular fibrillation and ventricular tachycardia. Other common adverse reactions are anemia (41%), fatigue (36%), febrile neutropenia (31%), thrombocytopenia (30%), muscle pain or spasm (30%), edema (30%), nausea (29%), dyspnea (23%), decreased appetite (21%), mucositis (21%), rash (20%), constipation (20%), pneumonia (19%), renal insufficiency (19%), atrial arrhythmia (13%), and bleeding/hemorrhage (6%). Electrolyte imbalances, such as increased creatinine (96%), hyponatremia (54%), hypomagnesemia (33%), increased AST (28%), increased bilirubin (25%), and increased alkaline phosphatase (23%), also can occur

Nursing Considerations

Drug-Drug Interactions

Drugs that are strong CYP3A inhibitors and inducers should be avoided. Also avoid coadministration of QTc prolonging drugs, if possible, or monitor patients closely for QTc interval prolongation.   

Patient Education

Gero-Oncoloy Considerations

Glasdegib was found to be safe in older adults because 60% of people enrolled in clinical trials were at least 75 years old and almost all were at least 65 years old.

Safe Handling

Glasdegib is considered a hazardous drug because of its reproductive risk. Glasdegib has a black box warning that it can cause embryo-fetal death and must be avoided in pregnant women. Women of childbearing potential should have a pregnancy test before beginning treatment and must be advised to use effective contraception during and for 30 days after the last dose of glasdegib. Men must use condoms with sexual activity during and for 30 days after the last dose of glasdegib to decrease the risk of exposure to their partners. In addition, women receiving glasdegib should not breastfeed their children during treatment and for 30 days after their last dose.

Patient Assistance

Patient assistance may be available at pfizeroncologytogether.com. To find out which patients may qualify, call 877-744-5675.


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