TEMOZOLOMIDE capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Sun Pharmaceutical Industries, Inc.

INN:

TEMOZOLOMIDE

composition:

TEMOZOLOMIDE 5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Temozolomide capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. Temozolomide capsules are indicated for the: • adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; • treatment of adults with refractory anaplastic astrocytoma. Temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; 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 findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], temozolomide can cause fetal harm when administered to a pregnant woman. Available postmarketing reports describe cases of spontaneous abortions and c

leaflet_short:

Temozolomide is a hazardous drug. Follow applicable special handling and disposal procedures.1 Temozolomide capsules, USP are supplied in amber glass bottles with child-resistant caps or child-resistant blister packs containing the following capsule strengths: 5 mg hard gelatin capsules have white opaque caps and bodies, imprinted with band and the dosage strength “5 mg” on body and “890” on cap in green ink, containing white to light tan/light pink powder and are supplied as: Bottles of 5 with Child Resistant Cap…….………..NDC 47335-890-80 Bottles of 14 with Child Resistant Cap………….....NDC 47335-890-21 Bottles of 20 with Child Resistant Cap…………….NDC 47335-890-87 Unit-dose blister pack of 5 (1 × 5).............................NDC 47335-890-74 Unit-dose blister pack of 15 (3 x 5)...........................NDC 47335-890-72 Unit-dose blister pack of 20 (4 × 5)...........................NDC 47335-890-75 20 mg hard gelatin capsules have white opaque caps and bodies, imprinted with band and the dosage strength “20 mg” on body and “891” on cap in yellow ink, containing white to light tan/light pink powder and are supplied as: Bottles of 5 with Child Resistant Cap…….………..NDC 47335-891-80 Bottles of 14 with Child Resistant Cap………….....NDC 47335-891-21 Bottles of 20 with Child Resistant Cap…………….NDC 47335-891-87 Unit-dose blister pack of 5 (1 × 5) ...........................NDC 47335-891-74 Unit-dose blister pack of 15 (3 x 5)..........................NDC 47335-891-72 Unit-dose blister pack of 20 (4 × 5) .........................NDC 47335-891-75 100 mg hard gelatin capsules have white opaque caps and bodies, imprinted with band and the dosage strength “100 mg” on body and “892” on cap in pink ink, containing white to light tan/light pink powder and are supplied as: Bottles of 5 with Child Resistant Cap…….………..NDC 47335-892-80 Bottles of 14 with Child Resistant Cap………….....NDC 47335-892-21 Bottles of 20 with Child Resistant Cap…………….NDC 47335-892-87 Unit-dose blister pack of 5 (1 × 5) ...........................NDC 47335-892-74 Unit-dose blister pack of 15 (3 x 5)..........................NDC 47335-892-72 Unit-dose blister pack of 20 (4 × 5)..........................NDC 47335-892-75 140 mg hard gelatin capsules have white opaque caps and bodies, imprinted with band and the dosage strength “140 mg” on body and “929” on cap in blue ink, containing white to light tan/light pink powder and are supplied as: Bottles of 5 with Child Resistant Cap…….………..NDC 47335-929-80 Bottles of 14 with Child Resistant Cap………….....NDC 47335-929-21 Bottles of 20 with Child Resistant Cap…………….NDC 47335-929-87 Unit-dose blister pack of 5 (1 × 5) ...........................NDC 47335-929-74 Unit-dose blister pack of 15 (3 x 5)..........................NDC 47335-929-72 Unit-dose blister pack of 20 (4 × 5)..........................NDC 47335-929-75 180 mg hard gelatin capsules have white opaque caps and bodies, imprinted with band and the dosage strength “180 mg” on body and “930” on cap in reddish brown ink, containing white to light tan/light pink powder and are supplied as: Bottles of 5 with Child Resistant Cap…….………..NDC 47335-930-80 Bottles of 14 with Child Resistant Cap………….... NDC 47335-930-21 Bottles of 20 with Child Resistant Cap…………….NDC 47335-930-87 Unit-dose blister pack of 5 (1 × 5) ...........................NDC 47335-930-74 Unit-dose blister pack of 15 (3 x 5)..........................NDC 47335-930-72 Unit-dose blister pack of 20 (4 × 5) .........................NDC 47335-930-75 250 mg hard gelatin capsules have white opaque caps and bodies, imprinted with band and the dosage strength “250 mg” on body and “893” on cap in black ink, containing white to light tan/light pink powder and are supplied as: Bottles of 5 with Child Resistant Cap……................NDC 47335-893-80 Bottles of 14 with Child Resistant Cap…………......NDC 47335-893-21 Bottles of 20 with Child Resistant Cap……………..NDC 47335-893-87 Unit-dose blister pack of 5 (1 × 5) ............................NDC 47335-893-74 Unit-dose blister pack of 20 (4 × 5)...........................NDC 47335-893-75 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in USP/NF or retain in original bottle.

authorization_status:

Abbreviated New Drug Application

SPC

TEMOZOLOMIDE- TEMOZOLOMIDE CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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
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
Temozolomide 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)
o Adjuvant treatment of adults with newly diagnosed anaplastic
astrocytoma. (1.2)
o Treatment of adults with refractory anaplastic astrocytoma. (1.2)
(1)
DOSAGE AND ADMINISTRATION
Administer orally. (2.4)
Newly Diagnosed Glioblastoma:
o 75 mg/m2 once daily for 42 to 49 days concomitant with focal
radiotherapy followed by initial
maintenance dose of 150 mg/m2 once daily for Days 1 to 5 of each
28-day cycle for 6 cycles. May
increase maintenance dose to 200 mg/m2 for Cycles 2 to 6 based on
toxicity. (2.1)
o 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 temozolomide orally in a single dose on days
1 to 5 of a 28-day cycle for 12
cycles. The recommended dosage for Cycle 1 is 150 mg/m2 per day and
for Cycles 2 to 12 is 200
mg/m2 if patient experienced no or minimal toxicity in Cycle 1. (2.2)
Refractory Anaplastic Astrocytoma: Initial dose of
150 mg/m2 o