Fluorouracil

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using fluorouracil, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Tell your doctor about all other cancer medications you are receiving, especially leucovorin.

Other drugs may interact with fluorouracil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Carac (fluorouracil) is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.

1-10%

Loss of appetite

Headache

Nausea

Vomiting

Diarrhea

Mucositis

Myelosuppression

Alopecia

Photosensitivity

Hand-foot syndrome

Maculopapular eruption (pruritic)

Frequency Not Defined

Angina

Coronary arteriosclerosis

Thrombophlebitis

Darkening of veins

Gastrointestinal ulcer

Increased alkaline phosphatase

Increased LFTs

Hyperbilirubinemia

Hypercholesterolemia (increased LDH)

Anaphylaxis

Nystagmus

Ophthalmic findings

Black Box Warnings

The drug 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

Contraindications

Hypersensitivity

Poor nutritional status

Myelosuppression

Serious infection

Recent serious surgery

Dihydropyrimidine Dehydrogenase (DPD) deficiency

Cautions

Discontinue in case of stomatitis, esophagopharyngitis, leukopenia, thrombocytopenia, intractable vomiting, GI bleeding, hemorrhage, diarrhea

Prior alkylating agent use, CAD, hepatic/renal impairment

Avoid pregnancy

Cardiotoxicity, usually ischemic in nature, has been seen with highdose infusions

Case reports of cardiomyopathy and acute decreases in LVEF Cardiotoxicity is more common with IV 5FU compared to oral capecitabine

There have been no reports of overdosage with Efudex.

The oral LD50 for the 5% topical cream was 234 mg/kg in rats and 39 mg/kg in dogs. These doses represented 11.7 and 1.95 mg/kg of fluorouracil, respectively. Studies with a 5% topical solution yielded an oral LD50 of 214 mg/kg in rats and 28.5 mg/kg in dogs, corresponding to 10.7 and 1.43 mg/kg of fluorouracil, respectively. The topical application of the 5% cream to rats yielded an LD50 of greater than 500 mg/kg.

Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with the treatment or increase irritation of the skin.

Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.

Your pharmacist has additional information about fluorouracil topical written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Fluorouracil may be found in some form under the following brand names:

• Adrucil

• Carac

• Efudex

• Fluoroplex

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if fluorouracil is excreted in human breast milk or if it will harm your nursing baby.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.