Glasdegib Film-Coated Tablets are a type of Smoothened (SMO) inhibitor. In 2018, they were approved by the U.S. FDA for combination use with low-dose cytarabine in the treatment of newly diagnosed acute myeloid leukemia (AML).

What Are the Side Effects of Glasdegib Film-Coated Tablets?

Common Side Effects

Hematological system: Anemia (43%), bleeding (41%), thrombocytopenia (31%), febrile neutropenia (36%).

Systemic symptoms: Fatigue (31%), edema (30%), fever (30%).

Musculoskeletal system: Muscle pain (30%), muscle spasms (15%).

Digestive system: Nausea (29%), constipation (20%), diarrhea (18%), vomiting (18%).

Others: Dyspnea (23%), decreased appetite (21%), dysgeusia (21%), oral mucositis (20%), rash (20%).

Serious Side Effects Requiring Vigilance for Glasdegib Film-Coated Tablets

Embryo-Fetal Toxicity

Risk: Glasdegib can cause embryonic death or severe birth defects. Animal studies have shown that it has embryotoxicity and teratogenicity.

Measures: Women of childbearing potential must confirm a negative pregnancy test before taking the drug, and take effective contraceptive measures during treatment and within 30 days after discontinuing the drug; men must use condoms to avoid exposure through semen.

QTc Interval Prolongation

Data: 5% of patients had a QTc interval > 500 ms, and 4% of patients had a QTc interval prolongation > 60 ms compared with the baseline.

Monitoring: Electrocardiograms (ECG) and electrolytes should be checked regularly before and during treatment, and concurrent use of other drugs that prolong the QTc interval should be avoided.

Severe Infections and Bleeding

Pneumonia: Occurred in 23% of patients, and 6% of cases led to permanent drug discontinuation.

Bleeding: 12% of cases were severe events, including intracranial hemorrhage, gastrointestinal bleeding, etc.

Precautions for Taking Glasdegib Film-Coated Tablets

Contraindications

There are no absolute contraindications, but patients with severe hepatic or renal impairment should use the drug with caution (due to insufficient research data).

Medication in High-Risk Populations

Pregnancy/lactation: Contraindicated in pregnant women; breastfeeding is prohibited during treatment and within 30 days after drug discontinuation.

Male patients: Must use condoms to avoid semen exposure, and sperm donation is prohibited within 30 days after drug discontinuation.

Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole): May increase the blood concentration of glasdegib, so adverse reactions need to be monitored.

Strong CYP3A4 inducers (e.g., rifampicin): Concurrent use should be avoided, as it may reduce the efficacy of glasdegib.