All Names: Sprycel、Dasatinib、Spryce、Dasanix、达沙替尼、施达赛、依尼舒
Indications:Suitable for newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase chronic myeloid leukemia (CML) adult patients, Ph+CML (chronic phase, accelerated phase, myeloid or lymphocytic leukemia) adult patients with resistance or intolerance to previous treatments (including imatinib), and Ph+acute lymphoblastic leukemia (ALL) adult patients, as well as Ph+chronic phase CML pediatric patients aged 1 year and above and newly diagnosed Ph+ALL pediatric patients aged 1 year and above who require combination chemotherapy.
Manufacturer:LUCIUS PHARMACEUTICAL (LAOS) CO., LTD
Customs Clearance Procedure:If the customs requires the package for customs clearance, please pay the customs clearance fee according to the content of EMS SMS and customs regulations.
Dasatinib is an oral tyrosine kinase inhibitor that exerts its effects by targeting the inhibition of BCR-ABL fusion protein and SRC family kinases (including SRC, LCK, YES, FYN) and other kinase activities.
1、 Drug name
1. Common name: Dasatinib
2. Product Name: SPRYCEL ®
2、 Indications
1. Adult patients:
Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) chronic phase.
Chronic, accelerated, or rapidly changing Ph+CML that is resistant or intolerant to previous treatments (including imatinib).
Phz+acute lymphoblastic leukemia (ALL) that is resistant or intolerant to previous treatments.
2. Pediatric patients (1 year and older):
Ph+chronic phase of CML.
Newly diagnosed Ph+ALL (combination chemotherapy).
3、 Specifications and characteristics
1. Specifications: 20mg, 50mg, 70mg tablets.
2. Appearance: Thin film coated sheet.
4、 Main components
1. Active ingredient: Dasatinib monohydrate.
2. Accessories: lactose monohydrate, microcrystalline cellulose, cross-linked carboxymethyl cellulose sodium, hydroxypropyl cellulose, magnesium stearate.
5、 Usage and dosage
1. Adults:
Chronic phase CML: 100mg once daily.
CML or Ph+ALL in accelerated/rapid phase: 140mg once daily.
Usage: Swallow the whole tablet, do not crush, cut or chew.
Dosage: Can be taken in the morning or evening, with food or on an empty stomach.
2. Pediatrics:
Administer according to body weight: 10-<20kg (40mg), 20-<30kg (60mg), 30-<45kg (70mg), ≥ 45kg (100mg).
6、 Dose adjustment
1. Bone marrow suppression adjustment:
When the chronic phase of CML in adults is less than 0.5 × 10 ⁹/L or when the platelet count is less than 50 × 10 ⁹/L, medication should be suspended. After recovery, the original dose or reduced dosage should be administered.
2. Non hematological toxicity:
Suspend medication when serious adverse reactions occur, and reduce dosage as appropriate after recovery.
3. Drug interaction adjustment:
Strong CYP3A4 inhibitor: Consider reducing dosage (e.g. 140mg to 40mg).
Strong CYP3A4 inducer: Consider increment.
7、 Medication precautions
1. Omission treatment: Take the next dose at the scheduled time and do not take two doses at the same time.
2. Vomiting treatment: If vomiting occurs after taking medication, there is no need to take the next dose according to the original plan.
8、 Medication for special populations
2. Pregnancy: May cause fetal damage, contraindicated.
2. Breastfeeding period: Avoid breastfeeding during treatment and for 2 weeks after the last dose.
3. Children: Monitor bone growth and development.
4. Elderly individuals: closely monitor cardiovascular events.
9、 Adverse reactions
1. Common adverse reactions (≥ 15%):
Myelosuppression, fluid retention events, diarrhea, headache, rash, bleeding, dyspnea, fatigue, nausea, musculoskeletal pain.
2. Common adverse reactions (≥ 30%) during combination chemotherapy in pediatric patients:
Mucosal inflammation, febrile neutropenia, fever, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infection.
10、 Contraindications
none
11、 Drug interactions
1. Strong CYP3A4 inhibitor: increase the concentration of dasatinib.
2. Strong CYP3A4 inducer: reduces the concentration of dasatinib.
3. Antacids: Avoid taking them simultaneously
4. H2 antagonists and proton pump inhibitors: avoid combination.
12、 Storage method
Storage conditions: 20-25 ° C, allowing fluctuations within the range of 15-30 ° C.
Dasatinibinformation