TEMOZOLOMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Nivagen Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temozolomide capsules, USP is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. Temozolomide capsules, USP is 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 capsules, USP is contraindicated in patients with a history of hypersensitivity reactions to: - temozolomide or any other ingredients in Temozolomide capsules, USP; 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 postmarke

Product summary:

Temozolomide is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Temozolomide capsules, USP Temozolomide capsules, USP are supplied in HDPE bottle with child-resistant Polypropylene closure containing the following capsule strengths: 5 mg : white opaque bodies with green opaque caps. The capsule body is imprinted with “5 mg”. The cap is imprinted with “NIV-132”. They are supplied as follows: 5-count – NDC 75834-132-05 14-count – NDC 75834-132-14 20 mg : white opaque bodies with rich yellow opaque caps. The capsule body is imprinted with “20 mg”. The cap is imprinted with “NIV-142”. They are supplied as follows: 5-count – NDC 75834-142-05 14-count – NDC 75834-142-14  100 mg : buff opaque bodies with peach opaque caps. The capsule body is imprinted with “100 mg”. The cap is imprinted with “NIV-143”. They are supplied as follows: 5-count – NDC 75834-143-05 14-count – NDC 75834-143-14 140 mg : white opaque bodies with blue opaque caps. The capsule body is imprinted with “140 mg”. The cap is imprinted with “NIV-144”. They are supplied as follows: 5-count – NDC 75834-144-05 14-count – NDC 75834-144-14  180 mg : white opaque bodies with red opaque caps. The capsule body is imprinted with “180 mg”. The cap is imprinted with “NIV-145”. They are supplied as follows: 5-count – NDC 75834-145-05 14-count – NDC 75834-145-14 250 mg : white opaque bodies with white opaque caps. The capsule body is imprinted with “250 mg”. The cap is imprinted with “NIV-146”. They are supplied as follows: 5-count – NDC 75834-146-05 Store Temozolomide capsules, USP at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TEMOZOLOMIDE - TEMOZOLOMIDE CAPSULE
NIVAGEN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TEMOZOLOMIDE CAPSULES,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TEMOZOLOMIDE CAPSULES,
USP.
TEMOZOLOMIDE CAPSULES, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions
(5.5) 11/2019
INDICATIONS AND USAGE
Temozolomide capsules, USP is 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 – 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, USP and
dacarbazine. (4.1)
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 patien