Floxuridine
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-145Floxuridine is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Floxuridine is 63323-145. This drug is available in dosage form of Injection, Powder, Lyophilized, For Solution. The names of the active, medicinal ingredients in Floxuridine drug includes Floxuridine - 500 mg/5mL . The currest status of Floxuridine drug is Active.
Drug Information:
| Drug NDC: | 63323-145 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Floxuridine |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Floxuridine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fresenius Kabi Usa, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Powder, Lyophilized, For Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | FLOXURIDINE - 500 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRA-ARTERIAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 Mar, 2001 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA075837 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Fresenius Kabi USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310351
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000180853
M0006020
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 039LU44I5M
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Antimetabolite [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Deoxyuridine [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Antimetabolite [EPC]
Deoxyuridine [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63323-145-07 | 1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIAL | 15 Mar, 2001 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Floxuridine floxuridine floxuridine floxuridine
Indications and Usage:
Indications and usage: 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.
Warnings:
Warnings: because of the possibility of severe toxic reactions, all patients should be hospitalized for the first course of therapy. floxuridine should be used with extreme caution in poor risk patients with impaired hepatic or renal function or a history of high-dose pelvic irradiation or previous use of alkylating agents. the drug is not intended as an adjuvant to surgery. floxuridine may cause fetal harm when administered to a pregnant woman. it has been shown to be teratogenic in the chick embryo, mouse (at doses of 2.5 to 100 mg/kg) and rat (at doses of 75 to 150 mg/kg). malformations included cleft palates; skeletal defects; and deformed appendages, paws and tails. the dosages which were teratogenic in animals are 4.2 to 125 times the recommended human therapeutic dose. there are no adequate and well-controlled studies with floxuridine in pregnant women. if this drug is used during pregnancy or if the patient becomes pregnant while taking (receiving) this drug, the patient should
Read more... be apprised of the potential hazard to the fetus. women of childbearing potential should be advised to avoid becoming pregnant. combination therapy any form of therapy which adds to the stress of the patient, interferes with nutrition or depresses bone marrow function will increase the toxicity of floxuridine.
Dosage and Administration:
Dosage and administration: each vial must be reconstituted with 5 ml of sterile water for injection to yield a solution containing approximately 100 mg of floxuridine/ml. the calculated daily dose(s) of the drug is then diluted with 5% dextrose or 0.9% sodium chloride injection to a volume appropriate for the infusion apparatus to be used. the administration of floxuridine is best achieved with the use of an appropriate pump to overcome pressure in large arteries and to ensure a uniform rate of infusion. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. the recommended therapeutic dosage schedule of floxuridine by continuous arterial infusion is 0.1 to 0.6 mg/kg/day. the higher dosage ranges (0.4 to 0.6 mg) are usually employed for hepatic artery infusion because the liver metabolizes the drug, thus reducing the potential for systemic toxicity. therapy can be given until adverse
Read more... reactions appear. (see precautions ). when these side effects have subsided, therapy may be resumed. the patients should be maintained on therapy as long as response to floxuridine continues. procedures for proper handling and disposal of anticancer drugs should be considered. several guidelines on this subject have been published. 1-7 there is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Contraindications:
Contraindications: floxuridine therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function or those with potentially serious infections.
Adverse Reactions:
Adverse reactions: adverse reactions to the arterial infusion of floxuridine are generally related to the procedural complications of regional arterial infusion. the more common adverse reactions to the drug are nausea, vomiting, diarrhea, enteritis, stomatitis and localized erythema. the more common laboratory abnormalities are anemia, leukopenia, thrombocytopenia and elevations of alkaline phosphatase, serum transaminase, serum bilirubin and lactic dehydrogenase. other adverse reactions are: gastrointestinal: duodenal ulcer, duodenitis, gastritis, bleeding, gastroenteritis, glossitis, pharyngitis, anorexia, cramps, abdominal pain; possible intra- and extrahepatic biliary sclerosis, as well as acalculous cholecystitis. dermatologic: alopecia, dermatitis, nonspecific skin toxicity, rash. cardiovascular: myocardial ischemia. miscellaneous clinical reactions: fever, lethargy, malaise, weakness. laboratory abnormalities: bsp, prothrombin, total proteins, sedimentation rate and thrombopeni
Read more...a. procedural complications of regional arterial infusion: arterial aneurysm; arterial ischemia; arterial thrombosis; embolism; fibromyositis; thrombophlebitis; hepatic necrosis; abscesses; infection at catheter site; bleeding at catheter site; catheter blocked, displaced or leaking. the following adverse reactions have not been reported with floxuridine but have been noted following the administration of 5-fluorouracil. while the possibility of these occurring following floxuridine therapy is remote because of its regional administration, one should be alert for these reactions following the administration of floxuridine because of the pharmacological similarity of these two drugs: pancytopenia, agranulocytosis, myocardial ischemia, angina, anaphylaxis, generalized allergic reactions, acute cerebellar syndrome, nystagmus, headache, dry skin, fissuring, photosensitivity, pruritic maculopapular rash, increased pigmentation of the skin, vein pigmentation, lacrimal duct stenosis, visual changes, lacrimation, photophobia, disorientation, confusion, euphoria, epistaxis and nail changes, including loss of nails.
Overdosage:
Overdosage: the possibility of overdosage with floxuridine is unlikely in view of the mode of administration. nevertheless, the anticipated manifestations would be nausea, vomiting, diarrhea, gastrointestinal ulceration and bleeding, bone marrow depression (including thrombocytopenia, leukopenia and agranulocytosis). no specific antidotal therapy exists. patients who have been exposed to an overdosage of floxuridine should be monitored hematologically for at least 4 weeks. should abnormalities appear, appropriate therapy should be utilized. the acute intravenous toxicity of floxuridine is as follows: species ld 50 (mg/kg ± s.e.) mouse 880 ± 51 rat 670 ± 73 rabbit 94 ± 19.6 dog 157 ± 46
Description:
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 2â-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: floxuridine-structure
Clinical Pharmacology:
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 in the urine; it is also expired as respiratory carbon dioxide. pharmacokinetic data on intra-arterial infusion of floxuridine are not available.
How Supplied:
How supplied: product no. ndc no. 104507 63323-145-07 floxuridine for injection, usp, 500 mg floxuridine powder in a 5 ml vial, packaged individually. this is to be reconstituted with 5 ml sterile water for injection. 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.
Package Label Principal Display Panel:
Package label - principal display - floxuridine 500 mg vial label floxuridine for injection, usp 500 mg per vial for intra-arterial use only. powder for reconstitution of parenteral solutions. rx only package label - principal display - floxuridine 500 mg vial carton panel floxuridine for injection, usp 500 mg per vial for intra-arterial use only. powder for reconstitution of parenteral solutions. rx only vial carton