LuciDasa Dasatinib Tablets

Dasatinib: Detailed Product Information

I. Basic Drug Information

Generic Name: Dasatinib Tablets

Brand Name: Sprycel

English Name: Dasatinib Tablets

Specifications: 20 mg × 60 tablets/box; 50 mg × 60 tablets/box; 70 mg × 60 tablets/box

Manufacturer: Lucius Pharmaceutical (Laos) Co., Ltd.

II. Indications

1. Adult Patients:

Chronic Myeloid Leukemia (CML):

Chronic Phase: For Philadelphia chromosome-positive (Ph+) patients who are resistant to or intolerant of imatinib mesylate.

Accelerated Phase / Blast Phase (Myeloid or Lymphoid Blast Crisis): For patients with disease progression or those who have failed other therapies.

Ph+ Acute Lymphoblastic Leukemia (ALL): For adult patients who are resistant to or intolerant of other therapies.

2. Pediatric Patients (Ages 1 and Older):

Ph+ CML (Chronic Phase) and newly diagnosed Ph+ ALL (in combination with chemotherapy).

III. Dosage and Administration

1. Recommended Dosage for Adults:

Chronic Phase CML: 100 mg orally once daily; may be increased to 140 mg once daily.

Accelerated Phase / Blast Phase CML or Ph+ ALL: 70 mg twice daily (morning/evening); may be increased to 90 mg twice daily.

2. Method of Administration:

Swallow tablets whole; do not crush or cut them. Take the medication at a consistent time each day (morning or evening).

May be taken with or without food; however, avoid grapefruit or grapefruit juice (as they affect metabolism).

IV. Adverse Reactions

1. Common Adverse Reactions (Incidence ≥ 10%):

Fluid Retention: Pleural effusion, peripheral edema, ascites, etc.

Gastrointestinal Reactions: Diarrhea, nausea, vomiting, abdominal pain.

Hematologic Toxicity: Anemia, neutropenia, thrombocytopenia.

Others: Headache, rash, musculoskeletal pain, fatigue, dyspnea, etc. 2. Serious Adverse Reactions:

Pulmonary Arterial Hypertension: Discontinuation of the drug and monitoring of cardiopulmonary function are required.

QT Interval Prolongation: Use with caution in patients with hypokalemia or those taking other medications known to prolong the QT interval.

Hemorrhagic Events: Central nervous system hemorrhage (incidence approximately 1%); platelet counts must be monitored.

V. Precautions

1. Management of Myelosuppression:

Monitor complete blood counts regularly; adjust the dosage based on neutrophil and platelet counts (see Table 1).

In cases of severe neutropenia (ANC <0.5×10^9/L) or thrombocytopenia (<50×10^9/L), suspend drug administration.

2. Management of Fluid Retention:

For pleural effusion, diuretics or a short course of corticosteroids may be used; reduce the dosage or discontinue the drug if necessary.

3. Monitoring of Hepatic Function:

Use with caution in patients with hepatic impairment; for mild to severe hepatic impairment, no adjustment to the starting dose is required, but close monitoring is necessary.

VI. Drug Interactions

1. CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, erythromycin): May increase dasatinib plasma concentrations; monitor closely for toxicity.

2. CYP3A4 Inducers (e.g., rifampin, phenytoin): May reduce therapeutic efficacy; avoid concomitant use.

3. Antacids / H2 Receptor Antagonists:

Antacids should be taken at least 2 hours before or 2 hours after the administration of dasatinib.

Proton Pump Inhibitors (e.g., omeprazole) may reduce therapeutic efficacy; concomitant use is not recommended.

VII. Use in Specific Populations

1. Pregnancy / Lactation:

Pregnant Women: Contraindicated; animal studies have demonstrated reproductive toxicity.

Lactating Women: Discontinue breastfeeding.

2. Children: May be used in patients aged 1 year and older, provided that indications and dosage guidelines are strictly followed.

3. Elderly Patients (≥65 years): More susceptible to fluid retention and dyspnea; enhanced monitoring is required.

VIII. Storage

Store in a tightly sealed container in a cool, dry place; protect from high temperatures and light. Summary

Dasatinib is a second-generation tyrosine kinase inhibitor that effectively treats imatinib-resistant Ph+ leukemia by selectively inhibiting BCR-ABL and SRC-family kinases. In clinical practice, dosages must be adjusted based on disease stage, genetic status, and patient tolerability; clinicians must also remain vigilant for adverse reactions such as myelosuppression and fluid retention. Specific treatment regimens should be evaluated and formulated by a hematologist.