TOPOTECAN- topotecan hydrochloride injection, powder, lyophilized, for solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Meitheal Pharmaceuticals Inc.

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 av

Proizvod sažetak:

Topotecan Hydrochloride for Injection is supplied as a lyophilized, buffered, light yellow to greenish powder for reconstitution as follows:

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

TOPOTECAN- TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MEITHEAL PHARMACEUTICALS INC.
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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).
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 (2.1, 2.2)
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 (2.3)
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 single-dose vial
(3)
CONTRAINDICATIONS
History of severe hypersensitivity reactions to topotecan (4)
WARNINGS AND PRECAUTIONS
Interstitial Lung Disease (ILD): Fatal case