TEMOZOLOMIDE- temozolomide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Roxane Laboratories, 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 Capsules are 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 Capsules are also contraindicated in patients who have a history of hypersensitivity to dacarbazine, 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 o

Product summary:

Care should be exercised in the handling and preparation of Temozolomide Capsules. 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 are supplied as follows: 5 mg Capsule: Green Opaque/White Opaque capsule with "54 688" printed in black ink on the cap and body, containing a white to slightly pink powder. NDC 0054-0320-03 bottle of 5 capsules NDC 0054-0320-06 bottle of 14 capsules 20 mg Capsule: Yellow Opaque/White Opaque capsule with "54 349" printed in black ink on the cap and body, containing a white to slightly pink powder. NDC 0054-0321-03 bottle of 5 capsules NDC 0054-0321-06 bottle of 14 capsules 100 mg Capsule: Pink Opaque/White Opaque capsule with "54 025" printed in black ink on the cap and body, containing a white to slightly pink powder. NDC 0054-0322-03 bottle of 5 capsules NDC 0054-0322-06 bottle of 14 capsules 140 mg Capsule: Blue Opaque/White Opaque capsule with "54 987" printed in black in on the cap and body, containing a white to slightly pink powder. NDC 0054-0323-03 bottle of 5 capsules NDC 0054-0323-06 bottle of 14 capsules 180 mg Capsule: Light Carmel Opaque/White Opaque capsules with “54 793” printed in black ink on the cap and body, containing a white to slightly pink powder. NDC 0054-0324-03 bottle of 5 capsules NDC 0054-0324-06 bottle of 14 capsules 250 mg Capsule: White Opaque/White Opaque capsule with “54 108” printed in black ink on the cap and body, containing a white to slightly pink powder. NDC 0054-0325-03 bottle of 5 capsules Store Temozolomide Capsules at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TEMOZOLOMIDE- TEMOZOLOMIDE CAPSULE
ROXANE LABORATORIES, 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 (TEM-OH-ZOHL-OH-MIDE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Temozolomide 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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Warnings and Precautions, Hepatotoxicity (5.5) 05/2014
Newly diagnosed glioblastoma multiform (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)
New 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 1-5 of a 28-day cycle of temozolomide
for 6 cycles. (2.1)
2
2
Refractory Anaplastic Astroctoma: 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 component or to
dacarbazine. (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