FLOXURIDINE- floxuridine injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLOXURIDINE (UNII: 039LU44I5M) (FLOXURIDINE - UNII:039LU44I5M)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

FLOXURIDINE

Composition:

FLOXURIDINE 500 mg in 5 mL

Administration route:

INTRA-ARTERIAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means.  Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents. Floxuridine therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function or those with potentially serious infections.

Product summary:

The container closure is not made with natural rubber latex. The sterile powder should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Reconstituted vials should be stored under refrigeration 2° to 8°C (36° to 46°F) for not more than 2 weeks.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLOXURIDINE - FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
FLOXURIDINE FOR INJECTION, USP
FOR INTRA-ARTERIAL INFUSION ONLY
WARNING
It is recommended that Floxuridine for Injection, USP be given only by
or under the supervision of a
qualified physician who is experienced in cancer chemotherapy and
intra-arterial drug therapy and is
well versed in the use of potent antimetabolites.
Because of the possibility of severe toxic reactions, all patients
should be hospitalized for initiation of
the first course of therapy.
DESCRIPTION:
Floxuridine for Injection, USP, an antineoplastic antimetabolite, is
available as a sterile, nonpyrogenic,
lyophilized powder for reconstitution. Each vial contains 500 mg of
floxuridine which is to be
reconstituted with 5 mL of sterile water for injection. An appropriate
amount of reconstituted solution
is then diluted with a parenteral solution for intra-arterial infusion
(see _DOSAGE AND_
_ADMINISTRATION_).
Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is
2’-deoxy-5-fluorouridine. It is a
white to off-white odorless solid which is freely soluble in water.
The 2% aqueous solution has a pH
of between 4.0 and 5.5.
The structural formula is:
CLINICAL PHARMACOLOGY:
When floxuridine is given by rapid intra-arterial injection it is
apparently rapidly catabolized to 5-
fluorouracil. Thus, rapid injection of floxuridine produces the same
toxic and antimetabolic effects as
does 5-fluorouracil. The primary effect is to interfere with the
synthesis of deoxyribonucleic acid
(DNA) and to a lesser extent inhibit the formation of ribonucleic acid
(RNA). However, when
floxuridine is given by continuous intra-arterial infusion its direct
anabolism to floxuridine-
monophosphate is enhanced, thus increasing the inhibition of DNA.
Floxuridine is metabolized in the liver. The drug is excreted intact
and as urea, fluorouracil, α-fluoro-
β-ureidopropionic acid, dihydrofluorouracil,
α-fluoro-β-guanidopropionic acid and α-fluoro-β-alanine
i