ETOPOSIDE- etoposide injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETOPOSIDE (UNII: 6PLQ3CP4P3) (ETOPOSIDE - UNII:6PLQ3CP4P3)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

ETOPOSIDE

Composition:

ETOPOSIDE 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Etoposide Injection, USP is indicated in the management of the following neoplasms: Etoposide Injection, USP in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Adequate data on the use of etoposide capsules in the treatment of testicular cancer are not available. Etoposide Injection, USP and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. Etoposide Injection, USP is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

Product summary:

Etoposide Injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ETOPOSIDE - ETOPOSIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
ETOPOSIDE INJECTION, USP
Rx only
Must be diluted before intravenous infusion.
WARNINGS
ETOPOSIDE SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A QUALIFIED
PHYSICIAN EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPEUTIC AGENTS.
SEVERE MYELOSUPPRESSION WITH RESULTING INFECTION OR BLEEDING MAY
OCCUR.
DESCRIPTION:
Etoposide (also commonly known as VP-16) is a semisynthetic derivative
of
podophyllotoxin used in the treatment of certain neoplastic diseases.
It is 4’-
demethylepipodophyllotoxin
9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very
soluble in methanol and chloroform, slightly soluble in ethanol, and
sparingly soluble in
water and ether. It is made more miscible with water by means of
organic solvents.
Etoposide Injection, USP is available for intravenous use as a 20
mg/mL solution
in 100 mg (5 mL), 500 mg (25 mL), or 1 gram (50 mL) sterile, multiple
dose vials. The
pH of the clear, nearly colorless to yellow liquid is 3 to 4. Each mL
contains 20 mg
etoposide, 2 mg citric acid, 30 mg benzyl alcohol, 80 mg polysorbate
80/tween 80, 650
mg polyethylene glycol 300, and 30.5 percent (v/v) alcohol. Vial
headspace contains
nitrogen. The structural formula is:
C
H
O M.W.
588.56
CLINICAL PHARMACOLOGY:
Etoposide has been shown to cause metaphase arrest in chick
fibroblasts. Its main
effect, however, appears to be at the G
portion of the cell cycle in mammalian cells.
Two different dose-dependent responses are seen. At high
concentrations (10 mcg/mL
or more), lysis of cells entering mitosis is observed. At low
concentrations (0.3 to 10
mcg/mL), cells are inhibited from entering prophase. It does not
interfere with
microtubular assembly. The predominant macromolecular effect of
etoposide appears
to be the induction of DNA strand breaks by an interaction with DNA
topoisomerase II or
the formation of free radicals.
_PHARMACOKINETICS_
On intravenous administration, the disposition of etoposide is best
described as a
biphasic process with a