TEMOZOLOMIDE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Sandoz Inc.

INN (International ime):

Temozolomide

Sastav:

Temozolomide 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. Temozolomide 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 describe cases of spontaneous abortions and congeni

Proizvod sažetak:

Temozolomide is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Temozolomide capsules Temozolomide capsules are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths: 5 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 20 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 100 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 140 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 180 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 250 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 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]. Store temozolomide for injection refrigerated at 2°C to 8°C (36°F to 46°F).

Status autorizacije:

New Drug Application Authorized Generic

Svojstava lijeka

TEMOZOLOMIDE- TEMOZOLOMIDE CAPSULE
SANDOZ INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TEMOZOLOMIDE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TEMOZOLOMIDE CAPSULES.
TEMOZOLOMIDE CAPSULES, FOR ORAL USE
TEMOZOLOMIDE FOR INJECTION MARKETED AS TEMODAR , FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Temozolomide 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 either orally or intravenously.
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 to 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)
For injection: 100 mg as a lyophilized powder in single-dose vial for
reconstitution. (3)
CONTRAINDICATIONS
History of hypersensitivity to temozolomide or any other ingredients
in temozolomide and dacarbazine.
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_