TOPOTECAN HYDROCHLORIDE injection powder lyophilized for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

topotecan hydrochloride (UNII: 956S425ZCY) (topotecan - UNII:7M7YKX2N15)

Available from:

Sagent Pharmaceuticals

INN (International Name):

topotecan hydrochloride

Composition:

topotecan hydrochloride 4 mg in 4 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TOPOTECAN HYDROCHLORIDE- TOPOTECAN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
SAGENT PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPOTECAN HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPOTECAN
HYDROCHLORIDE.
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 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. (5.1)
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: 1.5 mg/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: 0.75 mg/m by intravenous infusion over 30 minutes on
days 1, 2, and 3 followed by cisplatin 50
mg/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 ingredients (4)
Severe bone marrow depression (4)
WARNINGS AND PRECAUTIONS
Bone marrow suppression: Administer topotecan hy