Temozolomide

Temozolomide capsules are is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

TEMODAL® (temozolomide) is indicated for:  treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.  treatment of adult patients with glioblastoma multiforme or anaplastic astrocytoma and documented evidence of recurrence or progression after standard therapy.

1 Pediatrics Pediatrics (<18 years and >3 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of TEMODAL® in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

2 Geriatrics Geriatrics (≥70 years old): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. (see 7 WARNINGS AND PRECAUTIONS)

Temodal is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

1 INDICATIONS AND USAGE TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 1 ) Anaplastic astrocytoma. 2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.

2 ) Treatment of adults with refractory anaplastic astrocytoma. 1 Newly Diagnosed Glioblastoma TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.

2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.