Glasdegib film is a targeted drug used to treat newly diagnosed acute myeloid leukemia (AML), which requires combination with low-dose cytarabine. The standard usage is 100mg orally per day, and common side effects include skeletal muscle pain, taste changes, etc. At the same time, attention should be paid to adverse reactions such as severe bleeding and cardiovascular events that require emergency medical treatment.

1. Indications

Glasgib film tablets are suitable for combination therapy with low-dose cytarabine in adult patients with newly diagnosed acute myeloid leukemia (AML).

2. Usage and dosage

(1) Standard dose

The recommended dosage is 100mg orally, once daily, for 28 consecutive days, combined with 20mg subcutaneous injection of cytarabine (twice daily from the 1st to the 10th day of each 28 day cycle).

(2) Medication requirements

The whole tablet should be swallowed and cannot be divided. It can be taken with or without food. Administer the medication at a fixed time every day, do not take it again after vomiting, and if missed, take it again 12 hours before the next administration.

(3) Treatment cycle

At least 6 cycles of treatment, if there is no unacceptable toxicity, medication should be continued until disease progression.

3. Common side effects

(1) Can alleviate the reaction on its own

Including skeletal muscle pain, taste changes, constipation, decreased appetite, diarrhea, rash, and hair loss, which usually alleviate with treatment adaptation.

(2) Medical intervention response is required

Serious side effects require immediate discontinuation of medication and medical attention: bleeding tendency (black stool/hematuria), difficulty breathing, arrhythmia, neurological symptoms (blurred consciousness/epilepsy), oliguria or severe infection symptoms.

4. Medication for special populations

(1) Pregnant women and lactation period

Pregnant women are prohibited from using it, and a pregnancy test is required before medication; Breastfeeding is prohibited for lactating women during treatment and within 30 days after the last dose.

(2) Renal insufficiency

Mild to severe kidney damage does not require dose adjustment, but severe kidney damage (eGFR15-29mL/min) requires close monitoring of adverse reactions such as QTc prolongation.

(3) Children and the elderly

The safety of children has not been established, and medication for elderly patients needs to be carefully evaluated.

5. Pharmacodynamics

The steady-state plasma concentration was reached after 8 days of daily administration, and the Cmax and AUC showed a linear increase within the dose range of 5-600mg, with a median cumulative ratio of 1.2-2.5.