TEMOZOLOMIDE

Other

Brand names: TEMODAR

Oral, Intravenous

Mechanism of Action

12.1 Mechanism of Action Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to DNA alkylation, mainly at the O 6 and N 7 positions of guanine, which causes DNA double strand breaks and results in programmed cell death.

Indications

concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma

treatment of adults with refractory anaplastic astrocytoma.

Contraindications

• 4 CONTRAINDICATIONS TEMODAR is contraindicated in patients with a history of serious hypersensitivity reactions to: temozolomide or any other ingredients in TEMODAR
• and dacarbazine

FDA Warnings

5 WARNINGS AND PRECAUTIONS Myelosuppression : Monitor absolute neutrophil count (ANC) and platelet count prior to each cycle and during treatment
Geriatric patients and women have a higher risk of developing myelosuppression
5 ) Hepatotoxicity : Fatal and severe hepatotoxicity have been reported
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception

Known Side Effects

6 documented side effects by frequency

Nausea

1-10%

Drug Not Working

1-10%

Fatigue

1-10%

Vomiting

1-10%

Diarrhea

0.1-1%

Weakness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral, Intravenous