TEMOZOLOMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. Temozolomide capsules are 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 capsules; 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 spon

Product summary:

Temozolomide Capsules, USP are supplied in amber glass bottles with plastic child-resistant caps containing the following capsule strengths:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TEMOZOLOMIDE - TEMOZOLOMIDE CAPSULE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET 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 are 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 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)
CONTRAINDICATIONS
History of hypersensitivity to temozolomide or any other ingredients
in temozolomide capsules 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 _Pneumonia (PCP): Closely monitor all patients,
particularly those receiving steroids, for
the development of ly