TEMOZOLOMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA 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 concomitantly with radiotherapy and then as maintenance treatment. Temozolomide capsules are 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 is contraindicated in patients with a history of 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-(3methyltriazen-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 postmarketing reports describe

Product summary:

Temozolomide is a cytotoxic drug. Follow applicable special handling and disposal procedures.1   Temozolomide capsules are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths: Temozolomide Capsules, 5 mg have white to off-white to light-pink/light-tan granular powder filled in size '5' hard gelatin capsules with green colored cap and white colored body. The capsule bodies are imprinted with "751" in black and are supplied as follows: NDC 68382-751-96 in bottle of 5 capsules with child-resistant closure NDC 68382-751-67 in bottle of 14 capsules with child-resistant closure Temozolomide Capsules, 20 mg have white to off-white to light-pink/light-tan granular powder filled in size '5' hard gelatin capsules with yellow colored cap and white colored body. The capsule bodies are imprinted with "752" in black and are supplied as follows: NDC 68382-752-96 in bottle of 5 capsules with child-resistant closure NDC 68382-752-67 in bottle of 14 capsules with child-resistant closure Temozolomide Capsules, 100 mg have white to off-white to light-pink/light-tan granular powder filled in size '3' hard gelatin capsules with pink colored cap and white colored body. The capsule bodies are imprinted with "753" in black and are supplied as follows: NDC 68382-753-96 in bottle of 5 capsules with child-resistant closure NDC 68382-753-67 in bottle of 14 capsules with child-resistant closure Temozolomide Capsules, 140 mg have white to off-white to light-pink/light-tan granular powder filled in size '2' hard gelatin capsules with blue colored cap and white colored body. The capsule bodies are imprinted with "754" in black and are supplied as follows: NDC 68382-754-96 in bottle of 5 capsules with child-resistant closure NDC 68382-754-67 in bottle of 14 capsules with child-resistant closure Temozolomide Capsules, 180 mg have white to off-white to light-pink/light-tan granular powder filled in Size '0' hard gelatin capsules with orange colored cap and white colored body. The capsule bodies are imprinted with "755" in black and are supplied as follows: NDC 68382-755-96 in bottle of 5 capsules with child-resistant closure NDC 68382-755-67 in bottle of 14 capsules with child-resistant closure Temozolomide Capsules, 250 mg capsules have white to off-white to light-pink/light-tan granular powder filled in Size '00' hard gelatin capsules with white colored cap and white colored body. The capsule bodies are imprinted with "756" in black and are supplied as follows: NDC 68382-756-96 in bottle of 5 capsules with child-resistant closure NDC 68382-756-67 in bottle of 14 capsules with child-resistant closure 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
ZYDUS PHARMACEUTICALS USA 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: 1996
RECENT MAJOR CHANGES
Warnings and Precautions (5.5)11/2019
INDICATIONS AND USAGE
Temozolomide is an alkylating drug indicated for the treatment of
adult patients with: (1)
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 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) (5)
_MYELODYSPLASTIC SYNDROME AND SECONDARY MALIGNANCIES_ , including
myeloid leukemia, have
been observed. (5.2)
_PNEUMOCYSTIS PNEUMONIA (PCP)_
Closely monitor all patients, particularly those receivin