TOPOTECAN HYDROCHLORIDE injection powder lyophilized for solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

TOPOTECAN HYDROCHLORIDE (UNII: 956S425ZCY) (TOPOTECAN - UNII:7M7YKX2N15)

Beschikbaar vanaf:

Pfizer Laboratories Div Pfizer Inc.

INN (Algemene Internationale Benaming):

TOPOTECAN HYDROCHLORIDE

Samenstelling:

TOPOTECAN 4 mg in 4 mL

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

TOPOTECAN HYDROCHLORIDE- TOPOTECAN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
PFIZER LABORATORIES DIV PFIZER INC.
----------
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.
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/MM . 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)
INDICATIONS AND USAGE
Topotecan Hydrochloride for Injection is a topoisomerase inhibitor
indicated for: (1)
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) (2)
See Dosage Adjustment in Renal Impairment. (2.3) (2)
DOSAGE FORMS AND STRENGTHS
4- mg (free base) single-dose vial.(3) (3)
CONTRAINDICATIONS
History of severe hypersensitivity reactions (e.g., anaphylactoid
reactions) to topotecan or any of its ingredients (4)
Severe bone marrow depression (4)
WARNINGS AND PRECAUTIONS
Bone