Imatinib Instructions

1. Indications

Imatinib is a kinase inhibitor used to treat:

1.Adult and pediatric patients newly diagnosed with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) .

2.Philadelphia chromosome positiveChronic myeloid leukemia (CML)Patient, in blast crisis(BC), accelerated phase(AP), or chronic phase(CP) after failure of interferon-α treatment.

3.Adult patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

4.Adult patients with myelodysplasia/myeloproliferative diseases(MDS/MPD) whoseP DGFR (Platelet Derived Growth Factor Receptor)gene rearrangements are determined by FDAapproved tests.

5.Adult patients with aggressive systemic mastocytosis(ASM)who are FDA-approved and determined to be free of D816V c-Kitmutation, or c-Kitmutation status unknown.

6.Suffering from hypereosinophilic syndrome(HES)and/or chronic eosinophilic leukemia(CEL)Adult patients withFIP1L1-PDGFRαfusion kinase(CHIC2 Mutation analysis or FISHproven ),and patients with HES and / or CEL patients whose FIP1L1-PDGFRαFusion kinase negative or unknown.

7.Adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans(DFSP).

2. Dosage and usage

Adults withPh+chronic myelogenous leukemia(2.2): 400mg/day

Adults withPh+ CML AP or BC(2.2): 600mg/day

Ph+ CML CPPediatrics(2.3): 340mg/cubic meters2/days

Adults withPh+ ALL(2.4): 600mg/day

Adults withMDS/MPD(2.6): 400mg/day

Adults withASM(2.7): 100mg/day or 400mg/day

Adults withHES/CEL(2.8): 100mg/day or 400mg/day

Adults withDFSP(2.9)800mg/day

Patients with mild to moderate hepatic impairment(2.12): 400mg/day

Patients with severe liver function impairment(2.12): 300mg/day

All doses of imatinib mesylate tablets should be taken with a meal and a large glass of water. The 400 mg or 600mg dose should be given once daily, while the 800mg dose should be given twice daily. Imatinib mesylate tablets are soluble in water or apple juice and are used for patients with difficulty swallowing. Doses of 800mg daily and above should be completed using 400mg tablets to reduce iron exposure.

Three. Dosage form and strength

Tablets: 100mg and 400mg

Four. Contraindications

None

Five. Warnings and Precautions

1.Edema and severe fluid retention occur. Weigh patients regularly and manage unexpected rapid weight gain by interrupting medications and diuretics.

2.Cytopenia occurs, especially anemia, neutropenia and thrombocytopenia. Reduce or interrupt dose, or discontinue treatment. Complete blood counts were performed weekly for the first month, every two weeks for the second month, and periodically thereafter.

3.Severe congestive heart failure and left ventricular dysfunction have been reported, particularly in patients with comorbidities and risk factors. Monitor and treat patients with heart disease or risk factors for heart failure.

4.Severe liver toxicity, including death, may occur. Assess liver function before initiating treatment and monthly thereafter or as clinically indicated. Monitor liver function when used concomitantly with chemotherapy known to be associated with hepatic dysfunction.

5.Grade 3/4 hemorrhage has been reported in clinical studies in newly diagnosed CML patients.

6.Cardiogenic shock/Left ventricular dysfunction has been associated with initiation of imatinib mesylate in patients with disorders associated with high eosinophil levels (such as HES, MDS/MPD, and ASM).

7.Hypothyroidism occurs in thyroidectomy patients receiving levothyroxine replacement therapy. Closely monitor TSH levels in such patients.

8.Pregnant women taking this product may cause harm to the fetus. Inform women of the potential hazard to the fetus and to avoid becoming pregnant while taking imatinib mesylate tablets.

9.Growth retardation occurs in children and prepubertal children receiving imatinib mesylate. Close monitoring of growth in children receiving imatinib mesylate is recommended.

10.Motor vehicle accidents have been reported in patients receiving imatinib mesylate. Remind the patient to drive or operate machinery.

11.Nephrotoxicity. Patients receiving imatinib mesylate may experience a decrease in renal function. Assess renal function at baseline and during treatment and note risk factors for renal dysfunction.

6. adverse reactions

Adverse reactions

The most commonly reported adverse reactions (greater than or equal to30%)are edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain.

7. drug interactions

CYP3A4Inducers may reduce imatinib mesylateCmaximum and area under the curve(AUC).

CYP3A4Inhibitors may increase the Cmaximum and AUC of imatinib mesylate.

Imatinib mesylate is the inhibitor of CYP3A4 and CYP2D6 with the greatest AUC of other drugs.

Patients requiring anticoagulation should receive low molecular weight or standard heparin rather than warfarin.

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