em/Organ Class All Reactions Grade 3/4
Adverse Reaction
* These various tumors included the following: PNET-medulloblastoma, glioblastoma, low grade astrocytoma, brain stem tumor, ependymoma, mixed glioma, oligodendroglioma, neuroblastoma, Ewing's sarcoma, pineoblastoma, alveolar soft part sarcoma, neurofibrosarcoma, optic glioma, and osteosarcoma.
Subjects Reporting an AE 107 (88) 69 (57)
Body as a Whole
Central and Peripheral Nervous System
Central cerebral CNS cortex 22 (18) 13 (11)
Gastrointestinal System
Nausea 56 (46) 5 (4)
Vomiting 62 (51) 4 (3)
Platelet, Bleeding and Clotting
Thrombocytopenia 71 (58) 31 (25)
Red Blood Cell Disorders
Decreased Hemoglobin 62 (51) 7 (6)
White Cell and RES Disorders
Decreased WBC 71 (58) 21 (17)
Lymphopenia 73 (60) 48 (39)
Neutropenia 62 (51) 24 (20)
These various tumors included the following: PNET-medulloblastoma, glioblastoma, low grade astrocytoma, brain stem tumor, ependymoma, mixed glioma, oligodendroglioma, neuroblastoma, Ewing's sarcoma, pineoblastoma, alveolar soft part sarcoma, neurofibrosarcoma, optic glioma, and osteosarcoma.
8.5 Geriatric UseadvertisementClinical studies of temozolomide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
In the anaplastic astrocytoma study population, patients 70 years of age or older had a higher incidence of Grade 4 neutropenia and Grade 4 thrombocytopenia (2/8; 25%, P =0.31 and 2/10; 20%, P =0.09, respectively) in the first cycle of therapy than patients under 70 years of age [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
In newly diagnosed patients with glioblastoma multiforme, the adverse reaction profile was similar in younger patients (<65 years) vs. older (≥65 years).
8.6 Renal ImpairmentCaution should be exercised when TEMODAR is administered to patients with severe renal impairment [see Clinical Pharmacology (12.3)].
8.7 Hepatic ImpairmentCaution should be exercised when TEMODAR is administered to patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].
10 OVERDOSAGEDoses of 500, 750, 1000, and 1250 mg/m2 (total dose per cycle over 5 days) have been eva luated clinically in patients. Dose-limiting toxicity was hematologic and was reported with any dose but is expected to be more severe at higher doses. An overdose of 2000 mg per day for 5 days was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure, and death. There are reports of patients who have taken more than 5 days of treatment (up to 64 days), with adverse reactions reported including bone marrow suppression, which in some cases was severe and prolonged, and infections and resulted in death. In the event of an overdose, hematologic eva luation is needed. Supportive measures should be provided as necessary.
11 DESCRIPTIONTEMODAR contains temozolomi |