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Matibenz 400 Tablets

Generic Name- Imatinib mesylate

Drug Class- Antineoplastic agent

Imatinib a tyrosine kinase inhibitor, which was initially approved for the treatment of chronic myeloid leukemia. Its use has now extended to various other cancers and has achieved first-line position in cancers like Ph+ ALL, advanced dermatofibrosarcoma protuberans (DFPS), hypereosinophilic syndrome (HS), and systemic mastocytosis (SM). It blocks constitutive action of protein tyrosine kinase by working as a competitive inhibitor of the ATP binding cleft of ABL inducing apoptosis of leukemic cells.

Category

Product Description

Matibenz 400 (Imatinib mesylate) is an oral anti-cancer drug, available in tablet form.

Indications and Usage

Imatinib is indicated for treatment of:

  • Newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
  • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy Pediatric patients with Ph+ CML in chronic phase who are newly diagnosed or whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy
  • Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
  • Adult patients with myelodysplastic/ myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements
  • Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with cKit mutational status unknown
  • Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) 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 unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)

Dosage and Administration

  • Recommended dose for adults with Ph+ CML CP: 400 mg/day
  • Recommended dose for adults with Ph+ CML AP or BC: 600 mg/day
  • Recommended dose for pediatric patients with Ph+ CML: 340 mg/m2/day or 260 mg/m2/day
  • Recommended dose for adults with Ph+ ALL: 600 mg/day
  • Recommended dose for adults with MDS/MPD: 400 mg/day
  • Recommended dose for adults with ASM: 100 mg/day or 400 mg/day
  • Recommended dose for adults with HES/CEL: 100 mg/day or 400 mg/day
  • Recommended dose for adults with DFSP: 800 mg/day
  • Recommended dose for adults with GIST: 400 mg/day3

Dosage Form and Strengths

  • Supplied as tablets for oral use
  • Available as 400mg

Clinical Efficacy

  • Induces complete haematological response in 95.3% patients and complete cytogenetic response in 73.8% patients with CML2
  • Increases survival outcomes including overall survival, event-free survival, and relapse-free survival in patients with Ph+ ALL2
  • Effective in ASM patients carrying KIT mutations other than those involving KITD816V mutation or with KIT mutational status unknown2
  • Induces complete hematological remission within three months in 100% of patients with HES/CEL2
  • Produces an average tumor reduction of 50% after a median follow-up time of 24 months in DFSP patients2  
  • Shows a significantly superior progression free survival with a risk reduction of 61% in GIST patients2

Adverse Reactions

  • The most commonly reported adverse reactions events are edema, nausea, vomiting, diarrhea, abdominal pain, muscle cramps, musculoskeletal pain, rash, and fatigue

Contraindications

  • None

Special Precautions

  • Edema and severe fluid retention occurs with imatinib, so weigh patients regularly and manage unexpected rapid weight gain by drug interruption and diuretics
  • Perform regular blood counts weekly for the first month, biweekly for the second month, and periodically thereafter to determine cytopenias, particularly anemia, neutropenia, and thrombocytopenia
  • Monitor patients for the risk of cardiac failure and cardiac disease before administration of imatinib
  • Assess liver function before initiation of treatment and monthly thereafter to determine the risk of hepatotoxicity
  • Imatinib can cause grade 3/4 hemorrhage in patients with newly diagnosed CML and with GIST Gastrointestinal perforations and bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have been reported with the use of imatinib
  • Monitor TSH levels in thyroidectomy patients undergoing levothyroxine replacement, as imatinib can cause hypothyroidism in these patients
  • Consider potential toxicities, including, liver, kidney, and cardiac toxicity, and immunosuppression in patients receiving imatinib from long term
  • Women of child bearing potential should be advised of potential harm to fetus
  • It is not recommended for use in pregnant women
Chemotherapy Tablet Imatinib Mesylate 100/400mg Manufacturer