Gleevec (Imatinib Mesylate)
General Information:
Gleevec (imatinib mesylate) was developed in the late 1990s by Novartis and was approved by the FDA in 2001. The team developing the drug included Nicholas Lydon, Elizabeth Buchdunger, and Juerg Zimmerman. It was the first targeted drug therapy for CML. The story of Gleevec began in 1960 with the discovery of the Philadelphia chromosome, which is a chromosomal defect that leads to CML. Various scientific ventures in the next few decades, led to the generation of the compound that would become Gleevec in 1992. The first preliminary study on patients began in 1998 with miraculous results.
The recommended dose of Gleevec is 400 mg/day for adult patients in chronic phase CML and 600 mg/day for adult patients in accelerated phase or blast crisis. These doses may be increased by 200 mg/day if not response in observed. The recommended dose of Gleevec for children with newly diagnosed Ph+ CML is 340 mg/m2/day and is not to exceed 600 mg. Commonly reported side effects include nausea, vomiting, muscle and joint pains, skin rash, diarrhea, heartburn, headache, and water retention (edema.) Although some of the serious side effects occur less frequently, severe side effects include severe fluid retention (edema) liver toxicity, and the potential for bleeding (hemorrhage) especially in the elderly. Gleevec may increase or decrease blood levels of other drugs being taken simultaneously so one should speak to a doctor about possible dangers. Over dosage can cause regular side effects as well as low blood cell counts.
Gleevec (imatinib mesylate) was developed in the late 1990s by Novartis and was approved by the FDA in 2001. The team developing the drug included Nicholas Lydon, Elizabeth Buchdunger, and Juerg Zimmerman. It was the first targeted drug therapy for CML. The story of Gleevec began in 1960 with the discovery of the Philadelphia chromosome, which is a chromosomal defect that leads to CML. Various scientific ventures in the next few decades, led to the generation of the compound that would become Gleevec in 1992. The first preliminary study on patients began in 1998 with miraculous results.
The recommended dose of Gleevec is 400 mg/day for adult patients in chronic phase CML and 600 mg/day for adult patients in accelerated phase or blast crisis. These doses may be increased by 200 mg/day if not response in observed. The recommended dose of Gleevec for children with newly diagnosed Ph+ CML is 340 mg/m2/day and is not to exceed 600 mg. Commonly reported side effects include nausea, vomiting, muscle and joint pains, skin rash, diarrhea, heartburn, headache, and water retention (edema.) Although some of the serious side effects occur less frequently, severe side effects include severe fluid retention (edema) liver toxicity, and the potential for bleeding (hemorrhage) especially in the elderly. Gleevec may increase or decrease blood levels of other drugs being taken simultaneously so one should speak to a doctor about possible dangers. Over dosage can cause regular side effects as well as low blood cell counts.
Prescribed for:
(This is a very specific list but Gleevec is generally prescribed to CML patients)
(This is a very specific list but Gleevec is generally prescribed to CML patients)
- Newly diagnosed adult and pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase
- Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy
- Adult patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL)
- Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
- Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements
- Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-KIT mutation or with c-KIT mutational status unknown
- Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown
- Adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP)
- Patients with KIT(CD117)-positive gastrointestinal stromal tumors (GISTs) that are cancerous, cannot be surgically removed, and/or have spread to other parts of the body
- Adult patients after surgery who have had their KIT (CD117)-positive GISTs completely removed