TOPOTECAN HYDROCHLORIDE- 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:

Fresenius Kabi USA, LLC

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, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. Topotecan hydrochloride for injection, as a single agent, 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 hydrochloride for injection in combination with cisplatin is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment. Topotecan hydrochloride 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 hydrochloride can cause fetal harm when administered to a pregnant woman. There are no ava

Rezumat produs:

Topotecan hydrochloride for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder. Topotecan hydrochloride for injection is supplied as follows: The container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light; product is light-sensitive. Retain in carton. Handle and dispose of topotecan hydrochloride for injection consistent with recommendations for the handling and disposal of hazardous drugs1 .

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TOPOTECAN HYDROCHLORIDE - TOPOTECAN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
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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, FOR INTRAVENOUS USE INITIAL
U.S. APPROVAL: 1996
WARNING: MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TOPOTECAN HYDROCHLORIDE CAN CAUSE SEVERE MYELOSUPPRESSION. ADMINISTER
FIRST CYCLE
ONLY TO PATIENTS WITH BASELINE NEUTROPHIL COUNTS GREATER THAN OR EQUAL
TO 1,500/MM
AND PLATELET COUNTS GREATER THAN OR EQUAL TO 100,000/MM . MONITOR
BLOOD CELL COUNTS.
(2.4, 5.1)
RECENT MAJOR CHANGES
Boxed Warning
06/2020
Contraindications (4)
06/2020
Warnings and Precautions (5.1, 5.2, 5.3)
06/2020
INDICATIONS AND USAGE
Topotecan hydrochloride for injection is a topoisomerase inhibitor
indicated for treatment of:
Patients with metastatic ovarian cancer after disease progression on
or after initial or subsequent
chemotherapy, as a single agent. (1.1)
Patients with small cell lung cancer (SCLC) platinum-sensitive disease
who progressed at least 60 days
after initiation of first-line chemotherapy, as a single agent. (1.2)
Patients with Stage IV-B, recurrent, or persistent cervical cancer
which is not amenable to curative
treatment, in combination with cisplatin. (1.3)
DOSAGE AND ADMINISTRATION
Ovarian cancer and small cell lung cancer: 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, 2.3)
Cervical cancer: 0.75 mg/m by intravenous infusion over 30 minutes on
Days 1, 2, and 3 with cisplatin
50 mg/m on Day 1, of a 21-day cycle. (2.4)
Renal impairment: Reduce dose if creatinine clearance (CLcr) 20 to 39
mL/min. (2.6)
DOSAGE FORMS AND STRENGTHS
For injection: 4 mg (free base) lyophilized powder in a single-dose
vial. (3)
CONTRAIND