TEMOZOLOMIDE- temozolomide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

TEMOZOLOMIDE

Composition:

TEMOZOLOMIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Temozolomide capsules are 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. 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. Temozolomide is also contraindicated in patients who have a history of hypersensitivity to dacarbazine (DTIC), since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). Pregnancy Category D. See Warnings and Precautions section. Temozolomide can cause fetal harm when administered to a pregnant woman. Five consecutive days of oral temozolom

Product summary:

Care should be exercised in the handling of temozolomide, USP. Capsules should not be opened. If 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 capsules. Procedures for proper handling and disposal of anticancer drugs should be considered {1-4}. Several guidelines on this subject have been published. Temozolomide Capsules: Temozolomide Capsules are supplied in plastic, white, opaque bottles with plastic, green child-resistant caps containing the following capsule strengths: 5 mg: Two-piece hard gelatin capsule with off-white opaque cap and off-white opaque body filled with white to off-white powder. Imprinted in green ink stylized barr over 5 mg on one piece and 1078 on the other piece. Available in bottles of 5 (NDC 0093-7599-57) and 14 (NDC 0093-7599-41). 20 mg: Two-piece hard gelatin capsule with off-white opaque cap and off-white opaque body filled with white to off-white powder. Imprinted in brown ink stylized barr over 20 mg on one piece and 1077 on the other piece. Available in bottles of 5 (NDC 0093-7600-57) and 14 (NDC 0093-7600-41). 100 mg: Two-piece hard gelatin capsule with off-white opaque cap and off-white opaque body filled with off-white or light tan/light pink powder. Imprinted in blue ink stylized barr over 100 mg on one piece and 1076 on the other piece. Available in bottles of 5 (NDC 0093-7601-57) and 14 (NDC 0093-7601-41). 140 mg: Two-piece hard gelatin capsule with blue opaque cap and off-white opaque body filled with off-white or light tan/light pink powder. Imprinted in black ink stylized barr over 140 mg on one piece and 1159 on the other piece. Available in bottles of 5 (NDC 0093-7638-57) and 14 (NDC 0093-7638-41). 180 mg: Two-piece hard gelatin capsule with dark orange opaque cap and off-white opaque body filled with off-white or light tan/light pink powder. Imprinted in black ink stylized barr over 180 mg on one piece and 1160 on the other piece. Available in bottles of 5 (NDC 0093-7639-57) and 14 (NDC 0093-7639-41). 250 mg: Two-piece hard gelatin capsule with off-white opaque cap and off-white opaque body filled with off-white or light tan/light pink powder. Imprinted in black ink stylized barr over 250 mg on one piece and 1075 on the other piece. Available in bottles of 5 (NDC 0093-7602-57). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original container. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TEMOZOLOMIDE- TEMOZOLOMIDE CAPSULE
TEVA PHARMACEUTICALS USA, 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 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 to 5 of a 28-day cycle of
temozolomide 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)
DOSAGE FORMS AND STRENGTHS
5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg capsules. (3)
CONTRAINDICATIONS
Known hypersensitivity to any temozolomide capsules 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 _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 lymphopenia and
PCP. (5.4)
Complete blood counts should be obtained throughout the