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:

Cerona Therapeutics, Inc.

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:

Floxuridine for Injection, USP, 500 mg, lyophilized, in a 5 mL vial, is supplied in individual cartons. NDC 81643-9270-1. This is to be reconstituted with 5 mL sterile water for injection. 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. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLOXURIDINE- FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CERONA THERAPEUTICS, INC.
----------
FLOXURIDINE FOR INJECTION USP
FOR INTRA-ARTERIAL INFUSION ONLY
RX ONLY
WARNING
It is recommended that floxuridine 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 section).
Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is
2'-Deoxy-5-fluorouridine,
with a molecular formula of C H
FN O . 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 molecular
weight of
floxuridine is 246.20 and the structural formula is:
CLINICAL PHARMACOLOGY
When floxuridine is given by rapid intra-arterial injection it is
apparently rapidly
9
11
2
5
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