TOPOTECAN HYDROCHLORIDE injection, powder, lyophilized, for solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Topotecan Hydrochloride (UNII: 956S425ZCY) (Topotecan - UNII:7M7YKX2N15)

Disponibil de la:

Bedford Laboratories

INN (nume internaţional):

Topotecan Hydrochloride

Compoziție:

Topotecan 4 mg in 4 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Topotecan hydrochloride for injection is indicated for the treatment of:  - Small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies (14) ].  - Topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of: stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.  Topotecan hydrochloride for injection is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. Topotecan hydrochloride for injection should not be used in patients with severe bone marrow depression.  Pregnancy Category D [see

Rezumat produs:

Topotecan hydrochloride for injection is supplied in 4 mg (free base) single-dose vials packaged in a carton containing 1vial NDC 55390-370-10 Storage: Store the vials protected from light in the original cartons at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TOPOTECAN HYDROCHLORIDE - TOPOTECAN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
BEDFORD LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
(TOPOTECAN HYDROCHLORIDE FOR INJECTION)
SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR (TOPOTECAN HYDROCHLORIDE FOR
INJECTION).
TOPOTECAN HYDROCHLORIDE FOR INJECTION
INITIAL U.S. APPROVAL: 1996
WARNING: BONE MARROW SUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DO NOT GIVE TOPOTECAN HYDROCHLORIDE FOR INJECTION TO PATIENTS WITH
BASELINE NEUTROPHIL COUNTS LESS THAN
1,500 CELLS/MM3. IN ORDER TO MONITOR THE OCCURRENCE OF BONE MARROW
SUPPRESSION, PRIMARILY NEUTROPENIA,
WHICH MAY BE SEVERE AND RESULT IN INFECTION AND DEATH, MONITOR
PERIPHERAL BLOOD CELL COUNTS FREQUENTLY
ON ALL PATIENTS RECEIVING TOPOTECAN HYDROCHLORIDE FOR INJECTION. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2) 02/2014
INDICATIONS AND USAGE
Topotecan hydrochloride for injection is a topoisomerase inhibitor
indicated for:
Small cell lung cancer sensitive disease after failure of first-line
chemotherapy. (1)
Combination therapy with cisplatin for stage IV-B, recurrent, or
persistent carcinoma of the cervix which is not
amenable to curative treatment with surgery and/or radiation therapy.
(1)
DOSAGE AND ADMINISTRATION
Small cell lung cancer: 1.5mg/m by intravenous infusion over 30
minutes daily for 5 consecutive days, starting on day
one of a 21-day course. (2.1)
Cervical cancer: 0.75mg/m by intravenous infusion over 30 minutes on
days 1, 2, and 3 followed by cisplatin 50mg/m
by intravenous infusion on day 1 repeated every 21 days. (2.2)
See Dosage Modification Guidelines for patients with neutropenia or
reduced platelets. (2.1, 2.2) See Dosage
Adjustment in Renal Impairment. (2.3)
DOSAGE FORMS AND STRENGTHS
4 mg (free base) single-dose vial. (3)
CONTRAINDICATIONS
History of severe hypersensitivity reactions (e.g., anaphylactoid
reactions) to topotecan or any of its ingredie