TOPOTECAN- topotecan injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

TOPOTECAN HYDROCHLORIDE

Composition:

TOPOTECAN HYDROCHLORIDE 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topotecan 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 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 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 Injection should not be used in patients with severe bone marrow depression. Pregnancy Category D [see Warnings and Precautions (5.4) ]. Topotecan Injection can cause fetal harm

Product summary:

Topotecan Injection is supplied in the following: 1 mg/mL Multiple Dose Vial NDC 66758-051-01 (package of 1) 3 mg/3 mL (1 mg/mL) Multiple Dose Vial NDC 66758-051-03 (package of 1) 4 mg/4 mL (1 mg/mL) Multiple Dose Vial NDC 66758-051-05 (package of 1) Unopened vials of Topotecan Injection are stable until the date indicated on the package when stored between 2ºC and 8°C (36°F and 46°F) and protected from light in the original package. Topotecan Injection is supplied as a multiple dose vial. Studies have shown the product is stable for 28 days after initial puncture when stored under refrigerated conditions. Topotecan Injection diluted for infusion is stable for 4 hours at room temperature or 24 hours at refrigerated temperature in ambient lighting conditions.

Authorization status:

New Drug Application

Summary of Product characteristics

TOPOTECAN- TOPOTECAN INJECTION
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPOTECAN INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR TOPOTECAN INJECTION. MUST BE
DILUTED BEFORE INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 1996
WARNING: BONE MARROW SUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
DO NOT GIVE TOPOTECAN 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 INJECTION. (5.1)
INDICATIONS AND USAGE
Topotecan 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: 1.5 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) (2)
See Dosage Adjustment in Renal Impairment. (2.3) (2)
DOSAGE FORMS AND STRENGTHS
1 mg/mL Multiple Dose Vial
3 mg/3 mL (1 mg/mL) Multiple Dose Vial
4 mg/4 mL (1 mg/mL) Multiple Dose Vial
Each mL contains topotecan hydrochloride equivalent to 1 mg of
topotecan free base. (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 m