TOPOTECAN- topotecan injection, solution, concentrate

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 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topotecan injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy. Topotecan injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan injection in combination with cisplatin is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment. Topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Risk Summary Based on animal data, topotecan can cause fetal harm when administered to a pregnant woman. Topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose [see Data]. There are

Product summary:

Topotecan Injection is supplied as follows: Topotecan injection is supplied in 4 mg per 4 mL (1 mg per mL, topotecan free base equivalent) single-dose vials. Each vial contains 4 mL of the sterile, clear, light yellow to greenish solution. Store refrigerated between 2°C and 8°C (36°F and 46°F). Handle and dispose of topotecan injection consistent with recommendations for the handling and disposal of hazardous drugs1 . Protect from light. Retain in carton until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.

Authorization status:

New Drug Application

Summary of Product characteristics

TOPOTECAN- TOPOTECAN INJECTION, SOLUTION, CONCENTRATE
SAGENT PHARMACEUTICALS
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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: BONE MARROW SUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TOPOTECAN CAN CAUSE SEVERE MYELOSUPPRESSION. ADMINISTER ONLY TO
PATIENTS WITH BASELINE NEUTROPHIL
COUNTS GREATER THAN OR EQUAL TO 1,500 CELLS/MM AND PLATELET COUNT
GREATER THAN OR EQUAL TO 100,000/MM .
MONITOR BLOOD CELL COUNTS. (5.1)
RECENT MAJOR CHANGES
Indications and Usage, Ovarian Cancer (1.1)
12/2017
Dosage and Administration, Ovarian Cancer (2.1)
12/2017
INDICATIONS AND USAGE
Topotecan injection is a topoisomerase inhibitor indicated for:
metastatic carcinoma of the ovary after disease progression on or
after initial or subsequent chemotherapy. (1.1)
small cell lung cancer platinum-sensitive disease in patients who
progressed after first-line chemotherapy. (1.2)
combination therapy with cisplatin for Stage IV-B, recurrent, or
persistent carcinoma of the cervix which is not
amenable to curative treatment. (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 course. (2.1, 2.2)
Cervical cancer: 0.75 mg/m by intravenous infusion over 30 minutes on
Days 1, 2, and 3 repeated every 21 days in
combination with cisplatin 50 mg/m on Day 1. (2.3)
Renal impairment: Dose reduce topotecan injection in patients with
moderate renal impairment (20 to 39 mL/min). (2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 4 mg per 4 mL (1 mg per mL, topotecan free base equivalent)
solution in single-dose vial (3)
CONTRAINDICATIONS
History of severe hypersensitivity reactions to topotecan. (4)
WARNINGS AND PRECAUTIONS
Bone marrow suppression: Administer topoteca