TEMOZOLOMIDE capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Lannett Company, Inc.

INN (Միջազգային անվանումը):

TEMOZOLOMIDE

Կազմը:

TEMOZOLOMIDE 5 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Temozolomide Capsules is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Temozolomide is 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 Capsules 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

Ապրանքի ամփոփագիր:

Care should be exercised in the handling and preparation of Temozolomide Capsules. 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 HDPE bottles with child-resistant polypropylene caps containing the following capsule strengths: Temozolomide Capsules 5 mg: have opaque white bodies with opaque green caps. The cap is imprinted with "KU" and the capsule body is imprinted with "5 mg" in black ink. They are supplied as follows: 5-count - NDC 62175-240-19 14-count - NDC 62175-240-24 Temozolomide Capsules 20 mg: have opaque white bodies with opaque yellow caps. The cap is imprinted with "KU" and the capsule body is imprinted with "20 mg" in black ink. They are supplied as follows: 5-count - NDC 62175-241-19 14-count - NDC 62175-241-24 Temozolomide Capsules 100 mg: have opaque white bodies with opaque purple caps. The cap is imprinted with "KU" and the capsule body is imprinted with "100 mg" in black ink. They are supplied as follows: 5-count - NDC 62175-242-19 14-count - NDC 62175-242-24 Temozolomide Capsules 140 mg: have opaque white bodies with opaque blue caps. The cap is imprinted with "KU" and the capsule body is imprinted with "140 mg" in black ink. They are supplied as follows: 5-count - NDC 62175-243-19 14-count - NDC 62175-243-24 Temozolomide Capsules 180 mg: have opaque white bodies with opaque orange caps. The cap is imprinted with "KU" and the capsule body is imprinted with "180 mg" in black ink. They are supplied as follows: 5-count - NDC 62175-244-19 14-count - NDC 62175-244-35 Temozolomide Capsules 250 mg: have opaque white bodies with opaque white caps. The cap is imprinted with "KU" and the capsule body is imprinted with "250 mg" in black ink. They are supplied as follows: 5-count - NDC 62175-245-19 14- count - NDC 62175-245-24 Store Temozolomide Capsules at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

TEMOZOLOMIDE- TEMOZOLOMIDE CAPSULE
LANNETT COMPANY, 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
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Temozolomide is 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 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)
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 42-day regimen for the treatment of newly
diagnosed glio