Country: United States
Language: English
Source: NLM (National Library of Medicine)
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)
Ascend Laboratories, LLC
TEMOZOLOMIDE
TEMOZOLOMIDE 5 mg
ORAL
PRESCRIPTION DRUG
TEMOZOLOMIDE Capsules, USP is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. TEMOZOLOMIDE Capsules, USP is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. TEMOZOLOMIDE is contraindicated in patients with a history of hypersensitivity reactions to: • temozolomide or any other ingredients in TEMOZOLOMIDE; and • dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. Reactions to TEMOZOLOMIDE have included anaphylaxis [see Adverse Reactions ( 6.2 )]. Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1)] and findings from animal studies, TEMOZOLOMIDE can cause fetal harm when administered to a pregnant woman. Available postmarketing reports describ
TEMOZOLOMIDE is a cytotoxic drug. Follow applicable special handling and disposal procedures. TEMOZOLOMIDE Capsules, USP are supplied in amber glass bottles, with child-resistant polypropylene caps (not supplied in sachets) containing the following capsule strengths: Store TEMOZOLOMIDE Capsules at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
TEMOZOLOMIDE - TEMOZOLOMIDE CAPSULE ASCEND LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TEMOZOLOMIDE CAPSULES, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE CAPSULES FOR ORAL USE INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE TEMOZOLOMIDE Capsules, USP are an alkylating drug indicated for the treatment of adult patients with: • Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1) • Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2) DOSAGE AND ADMINISTRATION Administer either orally or intravenously. Newly Diagnosed Glioblastoma: o 75 mg/m once daily for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m once daily for Days 1 to 5 of each 28-day cycle for 6 cycles. May increase maintenance dose to 200 mg/ m for cycles 2 – 6 based on toxicity. (2.1) o Provide Pneumocystis pneumonia (PCP) prophylaxis during concomitant phase and continue in patients who develop lymphopenia until resolution to grade 1 or less. (2.1) Refractory Anaplastic Astrocytoma: Initial dose of 150 mg/m once daily on Days 1 to 5 of each 28-day cycle. (2.2) DOSAGE FORMS AND STRENGTHS · 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg capsules. (3) CONTRAINDICATIONS History of hypersensitivity to temozolomide or any other ingredients in TEMOZOLOMIDE capsules, USP and dacarbazine. (4) 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. (5.1) Myelodysplastic Syndrome and Secondary Malignancies, including myeloid leukemia, have been observed. (5.2) Pneumocystis Pneumonia (PCP): Closely monitor all patients, particularly those receiving steroids, for t Read the complete document