Temobenz 20 Capsules

Temobenz 20/100/250

Generic Name: Temozolomide

Drug Class: Antineoplastic; Alkylating agent

Temozolomide is an oral alkylating agent which has shown promise in treating malignant gliomas and other difficult-to-treat tumors. It has been approved by FDA for the treatment of adult patients with refractory anaplastic astrocytoma and newly diagnosed glioblastoma. It acts by methylating guanine residues in DNA strand, which results in single and double strand breaks, thus causing cell cycle arrest and ultimately cell death.

Dosage and Administration

  • Recommended dose in newly diagnosed GBM: 75 mg/m2 for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m2 once daily for days 1-5 of a 28-day cycle of temozolomide for 6 cycles
  • Recommended dose in refractory anaplastic astrocytoma: 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle

Dosage Form and Strength

  • Supplied as capsules for oral use
  • Available in 20mg, 100mg and 250 mg strength
Category:

Description

Temobenz 20/100/250 (Temozolomide capsules) is an oral chemotherapy drug, available in various strengths. It easily enters the cerebrospinal fluid and do not require hepatic metabolism for activation, thus providing 100% bioavailability. With enhanced bioavailability, it also provides ease of administration and improves patient compliance rates.

Indications & Usage

Temozolomide is indicated for treatment of adult patients with:

  • Newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment>
  • Refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine

Limitations of Use

  • Temozolomide is minimally effective for brain metastases from systemic cancers

Clinical Efficacy

  • Exhibits higher efficacy and an acceptable safety profile in the treatment of patients with newly diagnosed and recurrent malignant gliomas
  • Delays time of progression and improves quality of life in patients with recurrent glioblastoma when compared with standard chemotherapy
  • Shows a response rate of 35%, and a 6-month progression-free survival of 46% in patients with recurrent anaplastic astrocytomas
  • Prolongs survival and health related quality of life scores when added to standard radiotherapy in patients with GBM, newly diagnosed and recurrent anaplastic astrocytoma

Safety Information

Adverse Reactions

  • The most common adverse reactions are alopecia, fatigue, fever, dizziness, nausea, vomiting, headache, constipation, diarrhea, anorexia, convulsions, asthenia, rash, allergic reactions, viral infection, amnesia, and insomnia
  • Other hematologic abnormalities that can develop during treatment with temozolomide are lymphopenia, thrombocytopenia, neutropenia, and leukopenia

Contraindications

  • It is contraindicated in patients with a known hypersensitivity to temozolomide or dacarbazine

Special Precautions

  • Monitor absolute neutrophil and platelet count prior to dosing and throughout treatment to determine the risk and complications caused due to myelosuppression
  • Pneumocystis – pneumonia prophylaxis is required for all patients receiving concomitant temozolomide and radiotherapy for the treatment of newly diagnosed GBM
  • Patients receiving steroids should be observed closely for the development of lymphopenia and PCP
  • Liver function tests should be performed at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately 2-4 weeks after the last dose of temozolomide to evaluate risk of hepatotoxicity
  • Caution should be used while treating patients with severe renal or hepatic impairment
  • Women are advised to use effective contraceptives to avoid pregnancy while receiving temozolomide
  • Temozolomide cause harm to fetus, therefore it is not recommended for use in pregnant and breastfeeding mothers

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