Adrucil (fluorouracil)

Indications and Usage

Parenteral

Palliative management of colon, rectum, breast, gastric, and pancreatic carcinoma.

Topical Carac , Efudex , Fluoroplex

Multiple actinic or solar keratoses. Carac is only indicated for the face and anterior scalp areas.

Efudex 5%

Superficial basal cell carcinoma.

Unlabeled Uses

Condylomata acuminata (topical).

Contraindications

Hypersensitivity to any component of the product.

Parenteral

Depressed bone marrow function; poor nutritional status; potentially serious infections.

Topical

Pregnancy; dihydropyrimidine dehydrogenase enzyme deficiency (except for 1% cream).

Dosage and Administration

Colon, Rectum, Breast, Gastric, and Pancreatic Carcinomas
Adults

IV Individualize dosage based on actual body weight. Use lean body weight if patient is obese or has abnormal fluid retention.

Initial dose

12 mg/kg/day for 4 days. Do not exceed 800 mg/day. If no toxicity is observed, give 6 mg/kg on days 6, 8, 10, and 12. Give no therapy on days 5, 7, 9, or 11. Discontinue at end of day 12, even with no apparent toxicity.

In poor-risk patients and those with inadequate nutritional status

6 mg/kg/day for 3 days. If no toxicity is observed, give 3 mg/kg on days 5, 7, and 9. Give no therapy on days 4, 6, or 8. Do not exceed 400 mg/day.

Maintenance therapy

Start maintenance therapy 30 days after the last dose. If no toxicity is observed with the first course of therapy, repeat that dose of fluorouracil at 30-day intervals. If toxicity is observed with the first course of therapy, after the patient has recovered from initial toxicity, use a single weekly dose of 10 to 15 mg/kg. Do not exceed a weekly maintenance dose of 1,000 mg. Poor-risk patients may require a reduced maintenance dose.

Multiple Actinic or Solar Keratosis
Adults

Topical

Carac

Apply amount sufficient to cover the lesions once daily for up to 4 wk as tolerated. Healing generally occurs within 2 wk after therapy is stopped. The 0.5% cream is only indicated for the face and anterior scalp areas. Using fingertips, apply every day to cover lesions with a thin film. Do not apply near eyes, nostrils, or mouth. Apply 10 min after thoroughly washing, rinsing, and drying the entire area. After application, wash hands thoroughly. Continued treatment up to 4 wk results in greater lesion reduction.

Efudex

Apply amount sufficient to cover the lesions twice daily for 2 to 4 wk. Complete healing may not occur until 1 to 2 mo after therapy is stopped.

Fluoroplex

Apply amount sufficient to cover the entire face or other affected areas twice daily for 2 to 6 wk. When the inflammatory reaction reaches the erosion, ulceration, and necrosis stages, terminate use.

Superficial Basal Cell Carcinoma (5% Strength Only)
Adults

Topical Apply a sufficient amount to cover the lesions twice daily for 3 to 6 wk. Treatment may be required for 10 to 12 wk.

General Advice

• If a precipitate occurs in the injectable product because of exposure to low temperature, resolubilize by heating to 140°F and shaking vigorously; allow to cool to body temperature before using.

Storage/Stability

Injection

Store at 68° to 77°F.

Carac

Store at 68° to 77°F.

Efudex

Store at 59° to 86°F.

Fluoroplex

Store at 59° to 86°F. Avoid freezing.