Imatinib Mesylate (Page 2 of 11)

2.14 Dose Adjustment for Hematologic Adverse Reactions

Dose reduction or treatment interruptions for severe neutropenia and thrombocytopenia are recommended as indicated in Table 1.

Table 1: Dose Adjustments for Neutropenia and Thrombocytopenia

ASM associated with eosinophilia (starting dose 100 mg)

ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L

1.
Stop imatinib mesylate tablets until ANC greater than or equal to 1.5 x 10 9 /L and platelets greater than or equal to 75 x 10 9 /L
2.
Resume treatment with imatinib mesylate tablets at previous dose (i.e., dose before severe adverse reaction)

HES/CEL with FIP1L1-PDGFRα fusion kinase (starting dose 100 mg)

ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L

1.
Stop imatinib mesylate tablets until ANC greater than or equal to 1.5 x 10 9 /L and platelets greater than or equal to 75 x 10 9 /L
2.
Resume treatment with imatinib mesylate tablets at previous dose (i.e., dose before severe adverse reaction)

Chronic Phase CML (starting dose 400 mg) MDS/MPD, ASM and HES/CEL (starting dose 400 mg)

ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L

1.
Stop imatinib mesylate tablets until ANC greater than or equal to 1.5 x 10 9 /L and platelets greater than or equal to 75 x 10 9 /L
2.
Resume treatment with imatinib mesylate tablets at the original starting dose of 400 mg
3.
If recurrence of ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L, repeat step 1 and resume imatinib mesylate tablets at a reduced dose of 300 mg

Ph+ CML: Accelerated Phase and Blast Crisis (starting dose 600 mg) Ph+ ALL (starting dose 600 mg)

ANC less than 0.5 x 10 9 /L and/or platelets less than 10 x 10 9 /L

1.
Check if cytopenia is related to leukemia (marrow aspirate or biopsy)
2.
If cytopenia is unrelated to leukemia, reduce dose of imatinib mesylate tablets to 400 mg
3.
If cytopenia persists 2 weeks, reduce further to 300 mg
4.
If cytopenia persists 4 weeks and is still unrelated to leukemia, stop imatinib mesylate tablets until ANC greater than or equal to 1 x 10 9 /L and platelets greater than or equal to 20 x 10 9 /L and then resume treatment at 300 mg

DFSP (starting dose 800 mg)

ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L

1.
Stop imatinib mesylate tablets until ANC greater than or equal to 1.5 x 10 9 /L and platelets greater than or equal to 75 x 10 9 /L
2.
Resume treatment with imatinib mesylate tablets at 600 mg
3.
In the event of recurrence of ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L, repeat step 1 and resume imatinib mesylate tablets at reduced dose of 400 mg.

Pediatric newly diagnosed chronic phase CML (starting dose 340 mg/m 2)

ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L

1.
Stop imatinib mesylate tablets until ANC greater than or equal to 1.5 x 10 9 /L and platelets greater than or equal to 75 x 10 9 /L
2.
Resume treatment with imatinib mesylate tablets at previous dose (i.e., dose before severe adverse reaction)
3.
In the event of recurrence of ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L, repeat step 1 and resume imatinib mesylate tablets at reduced dose of 260 mg/m 2

Abbreviations: ANC, absolute neutrophil count; ASM, aggressive systemic mastocytosis; CEL, chronic eosinophilic leukemia; CML, chronic myeloid leukemia; DFSP, dermatofibrosarcoma protuberans; HES, hypereosinophilic syndrome; MDS/MPD, myelodysplastic/myeloproliferative diseases; PDGFR, plateletderived growth factor receptor; Ph+ CML, Philadelphia chromosome positive chronic myeloid leukemia; Ph+ ALL, Philadelphia chromosome positive acute lymphoblastic leukemia.

3 DOSAGE FORMS AND STRENGTHS

100 mg film-coated tablets

Yellow, circular, biconvex, film coated tablet debossed with “472” on one side and breakline on the other side.

400 mg film-coated tablets

Yellow, ovaloid shaped, biconvex, film coated tablet debossed with “475” on one side and breakline on the other side.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Fluid Retention and Edema

Imatinib mesylate is often associated with edema and occasionally serious fluid retention [ see Adverse Reactions ( 6.1) ]. Weigh and monitor patients regularly for signs and symptoms of fluid retention. Investigate unexpected rapid weight gain carefully and provide appropriate treatment. The probability of edema was increased with higher imatinib mesylate dose and age greater than 65 years in the CML studies. Severe superficial edema was reported in 1.5% of newly diagnosed CML patients taking imatinib mesylate tablets, and in 2% to 6% of other adult CML patients taking imatinib mesylate tablets. In addition, other severe fluid retention (e.g., pleural effusion, pericardial effusion, pulmonary edema, and ascites) reactions were reported in 1.3% of newly diagnosed CML patients taking imatinib mesylate tablets, and in 2% to 6% of other adult CML patients taking imatinib mesylate tablets. In a randomized trial in patients with newly diagnosed Ph+CML in chronic phase comparing imatinib mesylate and nilotinib, severe (Grade 3 or 4) fluid retention occurred in 2.5% of patients receiving imatinib mesylate and in 3.9% of patients receiving nilotinib 300 mg twice daily. Effusions (including pleural effusion, pericardial effusion, ascites) or pulmonary edema were observed in 2.1% (none were Grade 3 or 4) of patients in the imatinib mesylate arm and 2.2% (0.7% Grade 3 or 4) of patients in the nilotinib 300 mg twice daily arm.

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