5 Flucel Injection

Fluorouracil is indicated for the treatment of patients with: Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with - Adenocarcinoma of the Colon and Rectum - Adenocarcinoma of the Breast - Gastric Adenocarcinoma - Pancreatic Adenocarcinoma

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Increased Risk of Serious or Fatal Adverse Reactions in Patients with Low or Absent Dipyrimidine Dehydrogenase Activity: Withhold or permanently discontinue Fluorouracil in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of dipyrimidine dehydrogenase (DPD) activity. No Fluorouracil dose has been proven safe in patients with absent DPD activity. - Cardiotoxicity: Fluorouracil can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure. Withhold Fluorouracil for cardiac toxicity. - Hyperammonemic Encephalopathy: Altered mental status, confusion, disorientation, coma, or ataxia with elevated serum ammonia level can occur within 72 hours of initiation of Fluorouracil. Withhold Fluorouracil and initiate ammonia-lowering therapy. - Neurologic Toxicity: Fluorouracil can cause acute cerebellar syndrome, confusion, disorientation, ataxia, or visual disturbances. Withhold Fluorouracil for neurologic toxicity. - Diarrhea: Fluorouracil can cause severe diarrhea. Withhold Fluorouracil for severe diarrhea until resolved. - Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome): Fluorouracil can cause hand-foot syndrome. If severe, discontinue Fluorouracil until resolved or decreased to Grade 1, then resume at a reduced dose. - Myelosuppression: Fluorouracil can cause severe and fatal myelosuppression. Withhold Fluorouracil until severe myelosuppression resolves, then resume at a reduced dose. - Mucositis: Fluorouracil can cause severe mucositis. Discontinue Fluorouracil until resolved or decreased to Grade 1, then resume at a reduced dose. - Increased Risk of Elevated INR with Warfarin: Concurrent administration with warfarin can result in clinically significant increases in coagulation parameters: Closely monitor INR and prothrombin time. - Embryofetal Toxicity: Fluorouracil can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus. Increased Risk of Serious or Fatal Adverse Reactions in Patients with Low or Absent Dipyrimidine Dehydrogenase (DPD) Activity Based on postmarketing reports, patients with certain homozygous or certain compound heterozygous mutations in the DPD gene that result in complete or near complete absence of DPD activity are at increased risk for acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by Fluorouracil (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity). Patients with partial DPD activity may also have increased risk of severe, life-threatening, or fatal adverse reactions caused by Fluorouracil. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are discussed in more detail in other sections of the labeling: - Increased risk of serious or fatal adverse reactions in patients with low or absent dipyrimidine dehydrogenase activity - Cardiotoxicity - Hyperammonemic encephalopathy - Neurologic toxicity - Diarrhea - Palmar-plantar erythrodysesthesia (hand-foot syndrome) - Myelosuppression - Mucositis - Increased risk of elevated INR when administrated with warfarin Postmarketing Experience The following adverse reactions have been identified during postapproval use of Fluorouracil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hematologic: pancytopenia Gastrointestinal: gastrointestinal ulceration, nausea, vomiting Allergic Reactions: anaphylaxis and generalized allergic reactions Neurologic: nystagmus, headache Dermatologic: dry skin; fissuring; photosensitivity, as manifested by erythema or increased pigmentation of the skin; vein pigmentation Ophthalmic: lacrimal duct stenosis, visual changes, lacrimation, photophobia Psychiatric: euphoria Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails) Postmarketing Experience The following adverse reactions have been identified during postapproval use of Fluorouracil. fissuring; vein pigmentation Ophthalmic: lacrimal duct stenosis, visual changes, lacrimation, photophobia Psychiatric: euphoria Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails)

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.