TEMOZOLOMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Avera McKennan Hospital

INN (International Name):

TEMOZOLOMIDE

Composition:

TEMOZOLOMIDE 140 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TEMOZOLOMIDE- TEMOZOLOMIDE CAPSULE
AVERA MCKENNAN HOSPITAL
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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 are 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 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
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 for all
patients receiving concomitant temozolomide and
radiotherapy for the 42-day regimen for the treatment of newly
diagnosed glioblastoma multiforme. (5.3)
All patients, particularly those receiving steroids, should be
observed closely for the development of l