Fluorouracil

Fluorouracil is an antineoplastic (anticancer) antimetabolite effective in the palliative management of carcinoma (cancer) of the colon, breast, ovary, liver, pancreas, rectum, and stomach.

Other uses for fluorouracil include treatment of cervical, bladder, hepatic, prostate, endometrial, and head and neck carcinomas.

Fluorouracil is available under the following different brand names: Adrucil.

Dosage Forms and Strengths

Injectable solution

• 50 mg/mL

Dosage Considerations – Should be Given as Follows:

Cancers of Colon, Breast, Ovary, Liver, Pancreas, Rectum, Stomach

• Various protocols exist
• 500 mg/m2 intravenously (IV) on Days 1-5, OR
• 450-600 mg/ m2 IV weekly, OR
• 200-400 mg/ m2 IV continuous infusion once/day
• Not to exceed 800 mg/day

Other Information

• May use leucovorin concomitantly
• Monitor: Complete blood count (CBC)
• Pediatric: Safety and efficacy not established

Other Indications and Uses

• Off-label use for cervical, bladder, hepatic, prostate, endometrial, and head and neck carcinoma

Side effects of Fluorouracilinclude:

• Loss of appetite
• Headache
• Nausea
• Vomiting
• Diarrhea
• Mouth inflammation and sores
• Myelosuppression
• Hair loss
• Sensitivity of skin to sunlight (photosensitivity)
• Hand-foot syndrome
• Red, itchy skin rash
• Sore throat
• Inflammation of the esophagus
• Low white blood cell counts (leukopenia)

Other side effects of fluorouracil include:

• Chest pain (angina)
• Coronary arteriosclerosis
• Thrombophlebitis
• Darkening of veins
• Gastrointestinal ulcer
• Increased alkaline phosphatase
• Increased liver function tests (LFTs)
• Hyperbilirubinemia
• Hypercholesterolemia (increased LDH)
• Severe allergic reaction (anaphylaxis)
• Repetitive, involuntary eye movements
• Ophthalmic findings

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Fluorouracil has no known severe interactions with other drugs.
• Serious interactions of Fluorouracil include:
  • adenovirus types 4 and 7 live, oral
  • germanium
  • influenza virus vaccine trivalent, adjuvanted
  • palifermin
  • tofacitinib
• Fluorouracil has moderate interactions with at least 33 different drugs.
• Mild interactions of fluorouracil include:
  • maitake
  • taurine
  • vitamin A
  • vitamin E

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

• Fluorouracil should be administered under the supervision of an experienced cancer chemotherapy physician because of the possibility of severe toxic reactions
• Patient should be hospitalized for initiation of the therapy because of the risk for severe toxic reactions
• This medication contains fluorouracil. Do not take Adrucil if you are allergic to fluorouracil or any ingredients contained in this drug

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Poor nutritional status
• Myelosuppression
• Serious infection
• Recent serious surgery
• Dihydropyrimidine Dehydrogenase (DPD) deficiency

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Fluorouracil?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Fluorouracil?"

Cautions

• Discontinue in case of stomatitis, esophagopharyngitis, leukopenia, thrombocytopenia, intractable vomiting, gastrointestinal (GI) bleeding, hemorrhage, diarrhea
• Prior alkylating agent use, coronary artery disease (CAD), hepatic/renal impairment
• Avoid pregnancy
• Cardiotoxicity, usually ischemic in nature, has been seen with high dose infusions
• Case reports of cardiomyopathy and acute decreases in left ventricular ejection fraction (LVEF). Cardiotoxicity is more common with intravenous (IV) 5FU compared to oral capecitabine

Pregnancy and Lactation

• Use fluorouracil during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available
• There is positive evidence of human fetal risk
• Fluorouracil excretion in milk is unknown
• Do not nurse while using fluorouracil