TEMODAR- temozolomide capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Temozolomide (UNII: YF1K15M17Y) (Temozolomide - UNII:YF1K15M17Y)

제공처:

Physicians Total Care, Inc.

INN (국제 이름):

Temozolomide

구성:

Temozolomide 5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

TEMODAR® (temozolomide) is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. TEMODAR is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. TEMODAR (temozolomide) is contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and Stevens-Johnson syndrome) to any of its components. TEMODAR is also contraindicated in patients who have a history of hypersensitivity to DTIC, since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). Pregnancy Category D. See Warnings and Precautions section. TEMODAR can cause fetal harm when administered to a pregnant woman. Five consecutive days of oral temozolomide administration of 0.38

제품 요약:

Care should be exercised in the handling and preparation of TEMODAR. Vials and capsules should not be opened. If vials or capsules are accidentally opened or damaged, rigorous precautions should be taken with the contents to avoid inhalation or contact with the skin or mucous membranes. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or capsules. Procedures for proper handling and disposal of anticancer drugs should be considered1–4 . Several guidelines on this subject have been published. TEMODAR Capsules: TEMODAR (temozolomide) Capsules are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths: TEMODAR Capsules 5 mg: have opaque white bodies with green caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR". They are supplied as follows:   5-count - NDC 54868-5348-1 TEMODAR Capsules 20 mg: have opaque white bodies with yellow caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR". They are supplied as follows:   5-count - NDC 54868-4142-0   10-count - NDC 54868-4142-2   20-count - NDC 54868-4142-6   30-count - NDC 54868-4142-5   40-count - NDC 54868-4142-4   60-count - NDC 54868-4142-3 TEMODAR Capsules 100 mg: have opaque white bodies with pink caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR". They are supplied as follows:   5-count - NDC 54868-5350-2   10-count - NDC 54868-5350-3   15-count - NDC 54868-5350-0   30-count - NDC 54868-5350-4 TEMODAR Capsules 180 mg: have opaque white bodies with orange caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR". They are supplied as follows:   14-count - NDC 54868-5980-0 TEMODAR Capsules 250 mg: have opaque white bodies with white caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR". They are supplied as follows:   5-count - NDC 54868-5354-0 Store TEMODAR Capsules at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Store TEMODAR for Injection refrigerated at 2°–8°C (36°–46°F). After reconstitution, store reconstituted product at room temperature (25°C [77°F]). Reconstituted product must be used within 14 hours, including infusion time.

승인 상태:

New Drug Application

제품 특성 요약

TEMODAR - TEMOZOLOMIDE CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TEMODAR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TEMODAR.
TEMODAR (TEMOZOLOMIDE) CAPSULES
TEMODAR (TEMOZOLOMIDE) FOR INJECTION ADMINISTERED VIA INTRAVENOUS
INFUSION
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
DOSAGE AND ADMINISTRATION, PREPARATION AND ADMINISTRATION (2.2)
[02/2011]
INDICATIONS AND USAGE
TEMODAR is an alkylating drug indicated for the treatment of adult
patients with:
Newly diagnosed glioblastoma multiforme (GBM) concomitantly with
radiotherapy and then as maintenance treatment.
(1.1)
Refractory anaplastic astrocytoma patients who have experienced
disease progression on a drug regimen containing
nitrosourea and procarbazine. (1.2)
DOSAGE AND ADMINISTRATION
Newly Diagnosed GBM: 75 mg/m for 42 days concomitant with focal
radiotherapy followed by initial maintenance dose
of 150 mg/m once daily for Days 1–5 of a 28-day cycle of TEMODAR for
6 cycles. (2.1)
Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m once daily
for 5 consecutive days per 28-day treatment
cycle. (2.1)
The recommended dose for TEMODAR as an intravenous infusion over 90
minutes is the same as the dose for the oral
capsule formulation. Bioequivalence has been established only when
TEMODAR for Injection was given over 90
minutes. (2.1, 12.3)
DOSAGE FORMS AND STRENGTHS
5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg capsules. (3)
100-mg powder for injection. (3)
CONTRAINDICATIONS
Known hypersensitivity to any TEMODAR component or to dacarbazine
(DTIC). (4.1)
WARNINGS AND PRECAUTIONS
Myelosuppression - monitor Absolute Neutrophil Count (ANC) and
platelet count prior to dosing and throughout
treatment. Geriatric patients and women have a higher risk of
developing myelosuppression. (5.1)
Cases of myelodysplastic syndrome and secondary malignancies,
including myeloid leukemia, have been observed.
(5.2)
_Pneumocystis carinii_ pneumonia (