Ponatinib is a tyrosine kinase inhibitor that inhibits tumor cell proliferation by targeting the activity of BCR-ABL fusion proteins (including T315I mutant) and various other kinases (such as VEGFR, PDGFR, FGFR, etc.), blocking abnormal signal transduction.

1、 Drug name:

1. Product Name: ICLUSIG

2. Common name: Ponatinib

2、 Indications:

1. Used to treat adult chronic myeloid leukemia (CML) patients who are resistant or intolerant to previous tyrosine kinase inhibitor therapy in the chronic, accelerated, or acute phase.

2. Used to treat Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) patients who are resistant or intolerant to previous tyrosine kinase inhibitor therapy.

3、 Specifications and characteristics:

1. Specifications: 15mg and 45mg.

2. Appearance: Tablets.

4、 Main components:

Active ingredient: Ponatinib, which exists in the form of ponatinib hydrochloride.

5、 Usage and dosage:

Recommended dosage: once daily, 45mg each time, oral, can be taken with food or separately.

6、 Dose adjustment:

1. Adjust the dosage based on toxicity reactions. If bone marrow suppression occurs, discontinue administration for the first time and reduce to 30mg after recovery. For the second occurrence, reduce to 15mg. For the third occurrence, consider discontinuing the medication.

2. For non hematological adverse reactions, adjust the dosage or discontinue treatment according to the severity.

3. When combined with strong CYP3A inhibitors, it is recommended to reduce the dosage to 30mg once daily.

7、 Medication precautions:

1. Before and after meals: can be taken together or separately from food.

2. Missed dose: If missed once, patients should not take two doses at the same time to make up for the missed dose, but should continue taking the next dose at the regular time.

3. Vomiting: If vomiting occurs after taking medication, it should not be taken immediately, but the next dose should be continued at the regular time.

8、 Medication for special populations:

1. Pregnant women: May cause harm to the fetus, prohibited for pregnant women.

2. Breastfeeding women: It is not yet clear whether Punatinib is secreted into human milk, and the importance of breastfeeding and the medication needs of the mother should be balanced.

3. Children: The safety and efficacy of patients under 18 years old have not been determined.

4. Elderly people: Patients aged 65 and above may be more prone to adverse reactions, and dosage selection should be cautious.

5. Patients with liver and kidney dysfunction: Not studied in patients with liver and kidney dysfunction, should be used with caution.

9、 Adverse reactions:

1. Common non hematological adverse reactions (≥ 20%): hypertension, rash, abdominal pain, fatigue, headache, dry skin, constipation, joint pain, nausea, and fever.

2. Common hematological adverse reactions: thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.

3. Serious adverse reactions: arterial thrombosis, hepatotoxicity, heart failure, hypertension, pancreatitis, bleeding, fluid retention, arrhythmia, bone marrow suppression, tumor lysis syndrome, wound healing damage and gastrointestinal perforation.

10、 Contraindications:

No specific contraindications mentioned.

11、 Drug interactions:

1. When used in combination with strong CYP3A inhibitors, the plasma concentration of sunitinib increases, and it is recommended to reduce its dosage.

2. When used in combination with strong CYP3A inducers, it may reduce the plasma concentration of sunitinib and should be avoided.

3. When used in combination with drugs that increase gastric pH, it may reduce the bioavailability of sunitinib and should be avoided.

4. Punatinib is an inhibitor of the P-gp and ABCG2 transport systems, and its combination with other sensitive substrates may affect their exposure.

12、 Storage method:

1. Stored at 20 ° C to 25 ° C (68 ° F to 77 ° F), with a permissible range of 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Keep out of reach of children.

Ponatinibinformation