TEMOZOLOMIDE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)

Tilgængelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

TEMOZOLOMIDE

Sammensætning:

TEMOZOLOMIDE 5 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TEMOZOLOMIDE- TEMOZOLOMIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
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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
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Temozolomide capsules is an alkylating drug indicated for the
treatment of adult patients with:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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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)
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 to 5 of a 28-day cycle of
temozolomide capsules for 6 cycles. (2.1)
2
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Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m once daily
for 5 consecutive days per 28-day treatment
cycle. (2.1)
2
The recommended dose for temozolomide capsules as an intravenous
infusion over 90 minutes is the same as the
dose for the oral capsule formulation. Bioequivalence has been
established only when temozolomide for injection was
given over 90 minutes. (2.1, 12.3)
5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg capsules. (3)
Known hypersensitivity to any temozolomide capsules component or to
dacarbazine (DTIC). (4.1)
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 _pneumonia (PCP)-PCP prophylaxis required