TOPOTECAN injection, solution, concentrate

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:

Mylan Institutional LLC

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Topotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see Adverse Reactions (6.2)] . Risk Summary Based on animal data and its mechanism of action, Topotecan Injection can cause fetal harm when administered to a pregnant woman. There are no available clinical data on the use of topotecan in pregnancy. Topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose (see Data). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data An

Rezumat produs:

Topotecan Injection is supplied in 4 mg/4 mL (1 mg/mL, topotecan free base) single-dose vials. Each vial contains 4 mL of the sterile, clear, yellow to yellow-green solution. NDC 67457-662-05 (Package of 1 single-dose vial) Store refrigerated between 2° and 8°C (36° and 46°F) in the original carton to protect from light. Discard unused portion. Topotecan Injection is a cytotoxic drug. Follow applicable handling and disposal procedures.1

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TOPOTECAN- TOPOTECAN INJECTION, SOLUTION, CONCENTRATE
MYLAN INSTITUTIONAL LLC
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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.
TOPOTECAN INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
WARNING: MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TOPOTECAN CAN CAUSE SEVERE MYELOSUPPRESSION. ADMINISTER FIRST CYCLE
ONLY TO PATIENTS WITH BASELINE
NEUTROPHIL COUNTS GREATER THAN OR EQUAL TO 1,500/MM AND PLATELET COUNT
GREATER THAN OR EQUAL TO
100,000/MM . MONITOR BLOOD CELL COUNTS. (2.2, 5.1)
INDICATIONS AND USAGE
Topotecan Injection is a topoisomerase inhibitor indicated for
treatment of small cell lung cancer (SCLC) platinum-
sensitive disease in patients who progressed at least 60 days after
initiation of first-line chemotherapy. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/4 mL (1 mg/mL topotecan free base) solution in
single-dose vial. (3)
CONTRAINDICATIONS
History of severe hypersensitivity reactions to topotecan. (4)
WARNINGS AND PRECAUTIONS
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•
•
ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-INFO-RX) OR FDA AT
1-800-FDA-1088 OR www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: MYELOSUPPRESSION
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3
3
Recommended dosage: 1.5 mg/m by intravenous infusion over 30 minutes
daily for 5 consecutive days, starting on
Day 1 of a 21-day cycle. (2.2)
2
Renal impairment: Reduce dose for creatinine clearance (CLcr) of 20 to
39 mL/min. (2.4)
Interstitial lung disease (ILD): Fatal cases have occurred.
Permanently discontinue if ILD confirmed. (5.2)
Extravasation and tissue injury: Severe cases have occurred. If
extravasation occ