TEMOZOLOMIDE- temozolomide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Temozolomide (UNII: YF1K15M17Y) (Temozolomide - UNII:YF1K15M17Y)

Available from:

Chemi Pharma LLC

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 and preparation of Temozolomide. 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 amber glass bottles with child-resistant caps containing the following capsule strengths: Temozolomide capsules 5 mg: have opaque white bodies with green caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: 5-count – NDC 42737-101-05 14-count – NDC 42737-101-14 Temozolomide capsules 20 mg: have opaque white bodies with yellow caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: 5-count – NDC 42737-102-05 14-count – NDC 42737-102-14 Temozolomide capsules 100 mg: have opaque white bodies with pink caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: 5-count – NDC 42737-103-05 14-count – NDC 42737-103-14 Temozolomide capsules 140 mg: have opaque white bodies with blue caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: 5-count – NDC 42737-104-05 14-count – NDC 42737-104-14 Temozolomide capsules 180 mg: have opaque white bodies with orange caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: 5-count – NDC 42737-105-05 14-count – NDC 42737-105-14 Temozolomide capsules 250 mg: have opaque white bodies with white caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: 5-count – NDC 42737-106-05 Store Temozolomide capsules at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TEMOZOLOMIDE- TEMOZOLOMIDE CAPSULE
CHEMI PHARMA LLC
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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 1-5 of a 28-day cycle of Temozolomide
Capsules 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)
The recommended dose for temozolomide 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)
DOSAGE FORMS AND STRENGTHS
5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg capsules. (3)
100-mg powder for injection. (3)
CONTRAINDICATIONS
Known hypersensitivity to any temozolomide 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