Active Substance: Temozolomide .
Overview
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This medicine contains an important and useful components, as it consists of
Temozolomide
is available in the market in concentration
Temozolomide Hydrochloride
Severe hepatic and renal impairment. Elderly >70 yr, children. Women of child bearing potential should avoid becoming pregnant during therapy. Males should be advised not to father a child up to 6 mth after treatment and to consider cryoconservation of sperms due to possibility of irreversible infertility. May impair ability to drive or operate machinery. Monitor CBC wkly during concomitant therapy and on day 22 of each 28 day treatment cycle, followed by wkly blood count until recovery. Hepatitis screening and prophylactic therapy with antiviral agents as clinically indicated to be considered. Prophylaxis for Pneumocystis jiroveci (or Pneumocystis carinii) pneumonia (PCP) needed for all patients receiving concomitant temozolomide and radiation therapy for the 42-day regimen; if patients experience lymphocytopenia during the concomitant phase of therapy, PCP prophylaxis should be continued until recovery from lymphocytopenia. Monitor closely for PCP development in all patients. Anti-emetic prophylaxis recommended. Lactation: Unknown if distributed into breastmilk, discontinue nursing due to potential risk.
Glioblastoma multiforme, Malignant gliomas, Metastatic melanoma
Hypersensitivity to dacarbazine. Severe myelosupression. Pregnancy.
>10% Alopecia (55-69%),Lymphopenia (55%),Nausea (53%),Vomiting (42%),Headache (41%),Fatigue (34%),Constipation (33%),Anorexia (9-27%),Convulsions (23%),Thrombocytopenia (19%),Rash (8-19%),Hemiparesis (18%),Diarrhea (16%),Neutropenia (14%),Fever (13%),Asthenia (13%),Dizziness (12%),Peripheral edema (11%),Viral infections (11%) 1-10% (selected) Amnesia (10%),Insomnia (10%),Abdominal pain (5-9%),Ataxia (8%),Back pain (8%),Paresis (8%),URI (8%),Urinary incontinence (8%),UTI (8%),Abnormal vision (5-8%),Pruritus (5-8%),Breast pain (6%),Depression (6%),Confusion (5%),Myalgia (5%),Weight gain (5%),Anemia (4%),Erythema (1%)
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Temozolomide, a triazene, is an inactive prodrug. It is chemically hydrolysed to 3-methyl-(triazen-1-yl) imidazole-4-carboxamide (MTIC), the active metabolite of dacarbazine. The cytotoxicity of MTIC is believed to be due alkylation of DNA, mainly at the O6 and N7 positions of guanine.
Valproic acid, other myelosuppressive agents.
Information not available