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.
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| DFSP (starting dose 800 mg) | ANC less than 1 x 10 9 /L and/or platelets less than 50 x 10 9 /L |
|
| 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 |
|
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.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/imatinib-mesylate-6/page/2/