"The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
For Injection USP
FOR INTRA-ARTERIAL INFUSION ONLY
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.
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 C9H11FN2O5. 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:
What are the possible side effects of floxuridine (FUDR)?
If you experience any of the following serious side effects from floxuridine, contact your doctor immediately:
- an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
- severe vomiting;
- diarrhea, frequent bowel movements or watery stools; or
- sores in the mouth or throat; or
- stomach pain or heartburn or black,...
What are the precautions when taking floxuridine (Floxuridine)?
Before using floxuridine, tell your doctor or pharmacist if you are allergic to it; or to fluorouracil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: poor nutrition, decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia), a serious infection.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, past high-dose radiation treatment of the pelvis.
Do not have...
Last reviewed on RxList: 11/13/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Floxuridine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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