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Ponatinib is a tyrosine kinase inhibitor that inhibits tumor cell proliferation by targeting the activity of BCR-ABL fusion protein (including T315I mutant) and various other kinases (such as VEGFR, PDGFR, FGFR, etc.), blocking abnormal signaling.
1. Trade name: ICLUSIG
2. Generic name: Ponatinib )
1. For the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant or intolerant to previous tyrosine kinase inhibitor therapy.
2. For the treatment of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who are resistant or intolerant to previous tyrosine kinase inhibitor therapy.
1. Specifications: 15mg and 45mg.
2. Characteristics: Tablets.
Active ingredient: ponatinib (ponatinib), which exists in the form of ponatinibhydrochloride.
Recommended dosage: 45 mg once a day, orally, with or without food.
1. Adjust the dose according to the toxic reaction. If bone marrow suppression occurs, interrupt the administration when it occurs for the first time and reduce the dose to 30mg after recovery; reduce the dosage to 15mg when it occurs for the second time; consider discontinuing the drug when it occurs for the third time.
2. For non-hematological adverse reactions, adjust the dose or interrupt treatment according to the severity.
3. When used in combination with strong CYP3A inhibitors, the recommended dose is reduced to 30 mg once daily.
1. Before and after meals: It can be taken with or without food.
2. Missed dose: If a dose is missed, the patient should not take two doses at the same time to make up for the missed dose, but should continue to take the next dose at the regular time.
3. Vomiting: If vomiting occurs after taking the medicine, you should not take the next dose immediately, but continue to take the next dose at the regular time.
1. Pregnant women: It may cause harm to the fetus and is contraindicated for pregnant women.
2. Breastfeeding women: It is unclear whether ponatinib is secreted into human milk. The importance of breastfeeding should be weighed against the mother's drug needs.
3. Children: The safety and effectiveness in patients under 18 years of age have not been determined.
4. The elderly: Patients aged 65 and above may be more susceptible to adverse reactions, so dose selection should be cautious.
5. Patients with hepatic and renal insufficiency: This product has not been studied in patients with hepatic and renal insufficiency and should be used with caution.
1. Common non-hematological adverse reactions (≥20%): High blood pressure, 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, impaired wound healing and gastrointestinal perforation.
No specific contraindications are mentioned.
1. When combined with strong CYP3A inhibitors, the plasma concentration of ponatinib will increase, and it is recommended to use it at a reduced dose.
2. When combined with strong CYP3A inducers, the plasma concentration of ponatinib may be reduced, and combined use should be avoided.
3. When combined with drugs that increase gastric pH, the bioavailability of ponatinib may be reduced, and combined use should be avoided.
4. Ponatinib is an inhibitor of P-gp and ABCG2 transport systems. When used in combination with other sensitive substrates, it may affect the exposure of these substrates.
1. Store at 20°C to 25°C (68°F to 77°F), and the allowable range is 15°C to 30°C (59°F to 86°F).
2. Keep out of reach of children.