País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)
Nivagen Pharmaceuticals, Inc.
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 capsules, USP is contraindicated in patients with a history of hypersensitivity reactions to: - temozolomide or any other ingredients in Temozolomide capsules, USP; 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 postmarke
Temozolomide is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Temozolomide capsules, USP Temozolomide capsules, USP are supplied in HDPE bottle with child-resistant Polypropylene closure containing the following capsule strengths: 5 mg : white opaque bodies with green opaque caps. The capsule body is imprinted with “5 mg”. The cap is imprinted with “NIV-132”. They are supplied as follows: 5-count – NDC 75834-132-05 14-count – NDC 75834-132-14 20 mg : white opaque bodies with rich yellow opaque caps. The capsule body is imprinted with “20 mg”. The cap is imprinted with “NIV-142”. They are supplied as follows: 5-count – NDC 75834-142-05 14-count – NDC 75834-142-14 100 mg : buff opaque bodies with peach opaque caps. The capsule body is imprinted with “100 mg”. The cap is imprinted with “NIV-143”. They are supplied as follows: 5-count – NDC 75834-143-05 14-count – NDC 75834-143-14 140 mg : white opaque bodies with blue opaque caps. The capsule body is imprinted with “140 mg”. The cap is imprinted with “NIV-144”. They are supplied as follows: 5-count – NDC 75834-144-05 14-count – NDC 75834-144-14 180 mg : white opaque bodies with red opaque caps. The capsule body is imprinted with “180 mg”. The cap is imprinted with “NIV-145”. They are supplied as follows: 5-count – NDC 75834-145-05 14-count – NDC 75834-145-14 250 mg : white opaque bodies with white opaque caps. The capsule body is imprinted with “250 mg”. The cap is imprinted with “NIV-146”. They are supplied as follows: 5-count – NDC 75834-146-05 Store Temozolomide capsules, USP 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 NIVAGEN PHARMACEUTICALS, INC. ---------- 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, USP FOR ORAL USE INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Warnings and Precautions (5.5) 11/2019 INDICATIONS AND USAGE Temozolomide capsules, USP is 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 orally. Newly Diagnosed Glioblastoma: 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) 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 • Capsules: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg (3) CONTRAINDICATIONS History of hypersensitivity to temozolomide or any other ingredients in Temozolomide capsules, USP and dacarbazine. (4.1) 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 patien Llegiu el document complet