TEMODAR- temozolomide capsule TEMODAR- temozolomide injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merck Sharp & Dohme LLC

INN (International Name):

Temozolomide

Composition:

Temozolomide 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. TEMODAR is indicated for the: - adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; - treatment of adults with refractory anaplastic astrocytoma. TEMODAR is contraindicated in patients with a history of serious hypersensitivity reactions to: - temozolomide or any other ingredients in TEMODAR; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. Reactions to TEMODAR have included anaphylaxis [see Adverse Reactions (6.2)]. Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)] , TEMODAR can cause fetal harm when administered to a pregnant woman. Available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with cen

Product summary:

TEMODAR is a hazardous drug. Follow applicable special handling and disposal procedures.1 TEMODAR capsules TEMODAR capsules are supplied in child-resistant sachets containing the following capsule strengths: 5 mg: opaque white bodies with green caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with “TEMODAR”. They are supplied as follows: 20 mg: opaque white bodies with yellow caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with “TEMODAR”. They are supplied as follows: 100 mg: opaque white bodies with pink caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with “TEMODAR”. They are supplied as follows: 140 mg: opaque white bodies with blue caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with “TEMODAR”. They are supplied as follows: 180 mg: opaque white bodies with orange caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with “TEMODAR”. They are supplied as follows: 250 mg: opaque white bodies with white caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with “TEMODAR”. They are supplied as follows: Store TEMODAR Capsules at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. TEMODAR for injection TEMODAR for injection is supplied in single-dose glass vials containing 100 mg temozolomide. The lyophilized powder is white to light tan or light pink. Store TEMODAR for injection refrigerated at 2°C to 8°C (36°F to 46°F).

Authorization status:

New Drug Application

Summary of Product characteristics

TEMODAR- TEMOZOLOMIDE CAPSULE
TEMODAR- TEMOZOLOMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TEMODAR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TEMODAR.
TEMODAR (TEMOZOLOMIDE) CAPSULES, FOR ORAL USE
TEMODAR (TEMOZOLOMIDE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage (1.2)
9/2023
Dosage and Administration (2.1, 2.2, 2.3, 2.4)
9/2023
Contraindications (4)
9/2023
Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.6)
9/2023
INDICATIONS AND USAGE
TEMODAR is an alkylating drug indicated for the treatment of adults
with:
Newly diagnosed glioblastoma concomitantly with radiotherapy and then
as maintenance treatment.
(1.1)
Anaplastic astrocytoma. (1.2)
Adjuvant treatment of adults with newly diagnosed anaplastic
astrocytoma. (1.2)
Treatment of adults with refractory anaplastic astrocytoma. (1.2)
DOSAGE AND ADMINISTRATION
Administer either orally or intravenously. (2.4)
Newly Diagnosed Glioblastoma:
75 mg/m once daily for 42 to 49 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)
Adjuvant Treatment of Newly Diagnosed Anaplastic Astrocytoma:
Beginning 4 weeks after the end of
radiotherapy, administer TEMODAR orally in a single dose on days 1-5
of a 28-day cycle for 12 cycles.
The recommended dosage for Cycle 1 is 150 mg/m per day and for Cycles
2 to 12 is 200 mg/m if
patient experienced no or minimal toxicity in Cycle 1. (2.2)
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 STREN