Temodal 100 mg Tablet

Benefits

• Convenient oral therapy: Simplifies administration compared to intravenous options.

• Synergistic with radiotherapy: Demonstrated improved survival in newly diagnosed glioblastoma.

• Versatile usage: Effective for both first-line and recurrent brain tumor settings.

Indications and Usage

• Newly diagnosed glioblastoma multiforme: Administered concurrently with radiotherapy, followed by maintenance temozolomide.

• Recurrent malignant glioma (glioblastoma multiforme or anaplastic astrocytoma) in adults and children,≥3 years after prior treatments have failed.

• Used off-label for other brain/spine tumors or metastatic melanoma per physician discretion.

How it Works

Temozolomide is converted in the body to MTIC, which methylates DNA at guanine bases, resulting in tumor cell death. Its lipophilicity enables effective crossing of the blood-brain barrier, making it ideal for central nervous system tumors.

Dosage & Administration

• Concomitant regimen: 75 mg/m² orally daily during a 6-week radiotherapy course.

• Maintenance dosing: 150–200 mg/m² once daily for 5 days, repeated every 28-day cycle.

• Recurrent disease: Same 5-day/28-day cycle at 150–200 mg/m².

• Administration tips: Capsules should be swallowed whole, preferably on an empty stomach or 1 hour before meals. Hydration and routine anti-emetics can support tolerability.

Side Effects

Very Common (≥50%):

• Fatigue, nausea/vomiting, loss of appetite, constipation, headache, hair thinning/loss

Standard (25–49%):

• Diarrhea, fever, cough, weakness, oral sores, seizures, dizziness

Hematologic toxicities:

• Neutropenia, thrombocytopenia, and anemia — dose-limiting effects. Requires periodic CBC monitoring.

Severe (1–10% / rare):

• Pneumocystis jirovecii pneumonia (PCP)—consider prophylaxis in combined radiotherapy regimens.

• Hepatotoxicity, including elevated transaminases and rare liver failure.

• Severe skin reactions (eg, Stevens–Johnson syndrome), interstitial pneumonitis, secondary leukemias. 

Warning and Precaution

• Blood counts: Monitor CBC before each cycle; withhold treatment for severe cytopenias.

• Liver & kidney: Assess organ function regularly; monitor patients with hepatic or renal impairment.

• Infection control: Screen for hepatitis B; consider PCP prophylaxis during radio-temozolomide therapy.

• Reproductive safety: Contraindicated in pregnancy; men and women must avoid conception during and for 6 months post-treatment due to genotoxic and teratogenic risks.

• Handling caution: Capsule content can be absorbed through the skin or lungs. Pregnant caregivers should avoid handling.

Patient Guidance

• Storage: Store capsules at 20–25°C (68–77°F) in a dry place, out of the reach of children.

• Handling: Avoid opening capsules. If contents come into contact with the skin or eyes, do not inhale; wash thoroughly with water.

• Maintain hydration, manage nausea proactively, and report fever or bleeding immediately.

• Pregnancy risks: Use effective contraception during and for 6 months after treatment. Paternity caution: Men should not conceive during and for 3 months after therapy.

Clinical Trial & Approvals

• EORTC-NCIC study: Temozolomide plus radiotherapy followed by monotherapy significantly improved survival in newly diagnosed glioblastoma compared to radiotherapy alone.

• Recurrence trials: Several phase II/III studies demonstrated temozolomide’s effectiveness in recurrent malignant gliomas, both as a single agent and compared to procarbazine.

• Regulatory approvals:

  • FDA: First approved in August 1999 (capsules) and February 2009 (IV formulation)

  • EMA: Approved January 1999; pediatric indication added later