ETOPOPHOS- etoposide phosphate injection, powder, lyophilized, for solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

etoposide phosphate (UNII: 528XYJ8L1N) (etoposide - UNII:6PLQ3CP4P3)

Verfügbar ab:

E.R. Squibb & Sons, L.L.C.

INN (Internationale Bezeichnung):

etoposide phosphate

Zusammensetzung:

etoposide 100 mg

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer. ETOPOPHOS is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products [see Warnings and Precautions (5.3)] . Risk Summary Based on animal data and its mechanism of action, ETOPOPHOS can cause fetal harm when administered to a pregnant woman. Etoposide, the active moiety of etoposide phosphate is teratogenic in mice and rats (see Data) . Advise pregnant women of the potential hazard to a fetus. Advise women of childbearing potential to avoid becoming pregnant. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In rats, an intravenous etoposide dose of 0.4 m

Produktbesonderheiten:

How Supplied/Storage ETOPOPHOS is supplied as a single-dose vial containing etoposide phosphate equivalent to 100 mg etoposide as a lyophilized powder for reconstitution, individually packaged in a carton: NDC 0015-3404-20 Store unopened vials at 2° to 8°C (36°-46°F). Keep vial in outer carton to protect from light. Handling ETOPOPHOS is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Berechtigungsstatus:

New Drug Application

Fachinformation

ETOPOPHOS- ETOPOSIDE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
E.R. SQUIBB & SONS, L.L.C.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ETOPOPHOS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ETOPOPHOS.
ETOPOPHOS
(ETOPOSIDE PHOSPHATE) FOR INJECTION,
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of
patients with:
Refractory testicular tumors, in combination with other
chemotherapeutic drugs. (1)
Small cell lung cancer, in combination with cisplatin, as first-line
treatment. (1)
DOSAGE AND ADMINISTRATION
Refractory testicular tumors: 50 to 100 mg/m per day administered
intravenously over 5 minutes to 3.5 hours on days
1 through 5, or 100 mg/m administered intravenously over 5 minutes to
3.5 hours on days 1, 3, and 5. (2.1)
Small cell lung cancer: 35 mg/m per day administered intravenously
over 5 minutes to 3.5 hours for 4 days or 50
mg/m per day administered intravenously over 5 minutes to 3.5 hours
for 5 days. (2.2)
Do not give by bolus injection. (2.4)
Renal impairment: Reduce the recommended dose to 75% in patients with
creatinine clearance 15 to 50 mL/min. (2.3)
DOSAGE FORMS AND STRENGTHS
For injection: 114 mg etoposide phosphate (equivalent to 100 mg
etoposide), white to off-white, lyophilized powder in
single-dose vial for reconstitution. (3, 11)
CONTRAINDICATIONS
Hypersensitivity to etoposide products. (4, 5.3)
WARNINGS AND PRECAUTIONS
Myelosuppression: Obtain complete blood counts prior to each cycle and
more frequently as clinically indicated. (5.1)
Secondary leukemias: Can occur with long-term use. (5.2)
Hypersensitivity reactions: Hypersensitivity reactions including
anaphylaxis may occur. (5.3)
Embryo-fetal toxicity: ETOPOPHOS can cause fetal harm. Advise females
of potential risk to the fetus and to use
effective contraception during treatment with ETOPOPHOS and for 6
months after final dose. Advise males to use
effec