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Imitab®

Imatinib Mesylate BP Film Coated Tablet

Capcitab

Brand Name:

Imitab®100

Generic Name:

Imatinib Mesylate

Strength:

100mg

Description:

Beige colored, round shaped film coated tablet

Pack Size:

3 X 10 Tablets



Capcitab

Brand Name:

Imitab®400

Generic Name:

Imatinib Mesylate

Strength:

400mg

Description:

Light orange colored, capsule shaped film coated tablet

Pack Size:

3 X 10 Tablets



* Storage Conditions:  Store below 30 °C temperature. Keep away from light and wet place. Keep out of reach of children.

Approved Indications of Imitab



  • Philadelphia chromosome positive chronic myeloid leukemia (CML).

  • Philadelphia chromosome positive acute lymphoblastic leukemia (ALL).

  • Newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Follow-up is limited to 5 years

  • 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. There are no controlled trials in pediatric patients demonstrating a clinical benet, such as improvement in disease-related symptoms or increased survival.

  • 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 c-Kit mutational status unknown.

  • Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFR fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR fusion kinase negative or unknown.

  • Adult patients with unresectable, recurrent and/or metastatic dermatobrosarcoma protuberans (DFSP).

  • Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).


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