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 Formulations and advantages

pill

15 mg

45 mg

Chronic myeloid leukemia

Suitable for patients in the chronic phase (CP) of chronic myeloid leukemia (CML) who are resistant or intolerant to at least 2 previous kinase inhibitors

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It is also suitable for accelerated phase (AP) or explosion phase (BP) CML without indication of other kinase inhibitors, and T315I positive CML (CP, AP, BP)

CP-CML

Initial 45 mg PO qDay

When reaching ≤1% BCR-ABL1IS, reduce q to 15 mg PO daily

Patients who fail to respond will re-raise the dose to the previously tolerated 30 mg or 45 mg PO qDay dose

Continue until the dose is raised again, the reaction disappears or unacceptable toxicity occurs

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AP-CML or BP-CML

The optimal dose has not been determined

45 mg PO qday

AP CML

Consider reducing the dose of AP CML in patients who have already achieved a major cytogenetic response

Continue treatment until loss of response or unacceptable toxicity

If there is no response after 3 months, please consider discontinuing treatment

Acute lymphocytic leukemia

Suitable for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) patients without other kinase inhibitors

Also suitable for T315I positive Ph + ALL, the optimal dose has not been determined

Initial 45 mg PO qDay

Continue treatment until loss of response or unacceptable toxicity

If there is no response after 3 months, please consider discontinuing treatment

Dosage modification

Reduce the dose of adverse reactions

CP-CML H5

First reduction: 30 mg PO per day

Second reduction: 15 mg PO qDay

Third reduction: 10 mg PO qDay

Cannot tolerate 10 mg/day: permanent withdrawal

AP-CML, BP-CML and Ph + ALL H5

First reduction: 30 mg PO per day

Second reduction: 15 mg PO qDay

Cannot tolerate 15 mg/day: permanent withdrawal

Arterial occlusion event (cardiovascular or cerebrovascular)

Level 1: Interrupt treatment until resolved, then resume with the same dose

Level 2: Interrupt treatment until it is below level 1, then resume with the next lower dose

Grade 2 recurrence or Grade 3 or 4: stop the drug

Arterial occlusion events (peripheral vascular and other or venous thromboembolism [VTE])

Grade 1 or 2: Interrupt treatment until resolved, then resume with the same dose

Grade 2 recurrence or Grade 3: Interrupt treatment until ≤ Grade 1, then resume with the next lower dose

Relapse in 3rd grade or 4th grade: stop the drug

heart failure

Grade 2 or 3: Interrupt treatment until ≤ Grade 1, then restart at the next lower dose

Grade 2 or 3 recurrence or Grade 4: withdrawal

Liver toxicity

AST or ALT> 3 times the upper limit of normal (ULN): Interrupt treatment until ≤≤1 grade, then resume with the next lower dose

AST or ALT ≥ 3 times the upper limit of normal value, bilirubin> 2 times the upper limit of normal value, alkaline phosphatase <2 times the upper limit of normal value: withdrawal

Pancreatitis and elevated lipase

Serum lipase> 1 to 1.5 times the upper limit of normal (ULN): consider interrupting treatment until resolution, and then resume with the same dose

Serum lipase> 1.5 to 2 times the upper limit of normal, 2 to 5 times the upper limit of normal, and asymptomatic or asymptomatic radiation pancreatitis: Interrupt treatment until ≤ Grade 1 (defined as <1.5 times the upper limit of normal), then compare the following Low-dose recovery

Serum lipase> 2 to 5 times ULN and symptomatic, symptomatic grade 3 pancreatitis, or serum lipase> 5 times ULN and asymptomatic: Interrupt treatment until the symptoms are completely relieved, and the lipase rises to ≤1 Recover after grade, then lower the dose again

Symptomatic pancreatitis and serum lipase> 5 times the upper limit of normal: interrupt treatment

Bone marrow suppression

ANC <1 x 109/L or platelets <50 x 109/L: Interrupt treatment until ANC is at least 1.5 x 109/L and platelets are at least 75 x 109/L, then resume at the same dose

If it recurs, interrupt treatment until resolved, then resume with the next lower dose

Other non-hematological adverse reactions

Level 1: Interrupt treatment until resolved, then resume with the same dose

Level 2: Interrupt treatment until it is below level 1, then resume with the same dose

Grade 2 or Grade 3 or 4 recurrence: Interrupt treatment until ≤ Grade 1, then resume with the next lower dose

Grade 3 or 4 recurrence: stop the drug

Strong CYP3A4 inhibitor H4

Avoid co-administration with strong CYP3A inhibitors

If it is unavoidable, please reduce the dose as recommended

After discontinuing the strong CYP3A inhibitor for 3-5 elimination half-lives, resume the tolerated dose before starting the strong CYP3A

Recommended co-administration dose of strong CYP3A inhibitor

The current ponatinib dose is 45 mg qDay: reduce ponatinib to 30 mg qDay

The current ponatinib dose is 30 mg qDay: reduce ponatinib to 15 mg qDay

The current ponatinib dose is 15 mg qDay: reduce ponatinib to 10 mg qDay

The current ponatinib dose is 10 mg q days: avoid co-administration

Renal insufficiency

Mild to moderate (CrCl 30-89 mL/min): No need to adjust the dose

Severe (CrCl <30 mL/min): Not studied

Liver insufficiency

Pre-existing liver insufficiency (Child-Pugh A, B, or C): reduce the starting dose from 45 mg qDay to 30 mg qDay

Dosage considerations

Verify the pregnancy status of women of reproductive potential before starting

Use restrictions

For newly diagnosed CP-CML patients, it is not recommended to use, not recommended

Gastrointestinal stromal tumor (orphan)

Orphan designation for the treatment of gastrointestinal stromal tumors (GIST)

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