Efudex

Efudex cream and topical solution are prescription medications used to treat a skin condition on the face and front part of the scalp known as actinic keratosis (also called solar keratosis). Actinic keratosis is a precancerous condition marked by scaly, crusty patches of skin. It is caused by long term exposure to the sun. Efudex 5% strength topical formulations are also useful in the treatment of superficial basal cell carcinomas. This is a slow-growing form of skin cancer.

Efudex is in a class of drugs known as antimetabolites. It interferes with DNA and RNA production, causing fast-growing cells (like cancer cells or cells in actinic keratoses) to die.

This medication is available as a cream and topical solution that are applied directly to the affected areas of the skin. It is usually used once a day for 2 to 4 weeks.

Injectable:

Fluorouracil is a prescription medication used in combination with other medications to treat colon cancer or rectal cancer (cancer that begins in the large intestine) that has gotten worse or spread to other parts of the body. Fluorouracil is used in combination with other medications to treat certain types of breast cancer after surgery to remove the tumor or radiation therapy. Fluorouracil is also used to treat cancer of the pancreas and stomach cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Topical:

Fluorouracil cream and topical solution are prescription medications used to treat a skin condition on the face and front part of the scalp known as actinic keratosis (also called solar keratosis). Actinic keratosis is a precancerous condition marked by scaly, crusty patches of skin.  It is caused by long term exposure to the sun.

The 5% strength topical formulations are also useful in the treatment of superficial basal cell carcinomas. This is a slow-growing form of skin cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Quality Care Pharmaceuticals

• Valeant Pharmaceuticals International

• Valeant Pharmaceuticals North America LLC

Injectable:

Common side effects of fluorouracil injectable include

• inflammation and ulceration of the mouth and throat
• nausea
• vomiting
• loss of appetite
• diarrhea
• hair loss
• skin inflammation

Topical:

Common side effects of fluorouracil cream and topical solution include

• redness
• dryness
• burning
• pain
• erosion (loss of the upper layer of skin)
• swelling
• Irritation may continue for two or more weeks after treatment is over. The treated area may become unsightly during therapy.
• Some patients get eye irritation. Eye irritation might consist of burning, sensitivity, itching, stinging, and watering. If you are concerned about side effects, talk to your doctor.
• A few patients have reported side effects such as stomach pain, diarrhea, vomiting, fever, or chills, possibly due to the lack of a specific enzyme, DPD, in their body. If you experience any of these symptoms, discontinue therapy immediately, and contact your doctor.

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• leucovorin (Fusilev)
• chemotherapy medications such as bendamustine (Treanda), busulfan (Myerlan, Busulfex), carmustine (BiCNU, Gliadel Wafer), cyclophosphamide (Cytoxan), chlorambucil (Leukeran), ifosfamide (Ifex), lomustine (CeeNU), melphalan (Alkeran), procarbazine (Mutalane), or temozolomide (Temodar)
• medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf)

This is not a complete list of fluorouracil drug interactions. Ask your doctor or pharmacist for more information.

Injectable:

Serious side effects of fluorouracil injection include

• hand-foot syndrome. Symptoms include a tingling sensation of hands and feet which may progress over the next few days to pain when holding objects or walking. The palms and soles become swollen, red and tender. Desquamation, or skin peeling, may also occur.
• stomatitis (mouth inflammation and ulceration)
• esophagopharyngitis (throat and feeding tube inflammation and ulceration)
• a rapidly falling white blood count, which increases your chance of infection
• stomach and intestinal ulceration and bleeding
• low platelet counts, which increases your chance of bleeding

Plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Fluorouracil may make your skin sensitive to sunlight.

Do not use fluorouracil injectable if you:

• are in poor nutritional state
• have depressed bone marrow function
• have a serious infections
• have a known hypersensitivity to fluorouracil

Topical:

Do not use fluorouracil cream or topical solution if you:

• have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. Fluorouracil, can cause serious side effects in patients who are DPD enzyme deficient. If you have DPD enzyme deficiency and use medications containing fluorouracil, you may develop serious side effects such as stomach pain, bloody diarrhea, vomiting, fever, or chills.
• are allergic to the ingredients in fluorouracil
• are under 18 years of age. Fluorouracil should not be used in children.
• are pregnant or breastfeeding

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fluorouracil, there are no specific foods that you must exclude from your diet.

Before using fluorouracil, tell your doctor about all of your medical conditions including if you:

• are allergic to any ingredient in fluorouracil or any other medications
• have or have ever had dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
• are less than 18 years of age
• have an infection. Your doctor may not want you to receive fluorouracil injection.
• have previously received radiation (x-ray) therapy or treatment with other chemotherapy medications
• have or have ever had kidney or liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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.

Injectable:

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Topical:

• Cream
  • Use fluorouracil once a day as instructed by your doctor. Use it only on your skin.
    • Clean the area where you will apply fluorouracil. Rinse well and dry the area with a towel and wait 10 minutes before applying fluorouracil.
    • Use enough to cover the affected area of skin.
    • Avoid contact with your eyes, nostrils, and mouth.
    • Wash your hands as soon as you finish putting the fluorouracil on your skin.
    • Do not use any other skin products including creams, lotions, medications or cosmetics unless instructed by your doctor.
• Topical solution
  • Apply solution preferably with a nonmetal applicator or suitable glove. If applied with the fingers, the hands should be washed immediately afterward.
• What you should avoid while using fluorouracil cream or topical solution:
  • Avoid sunlight or other ultraviolet light (such as tanning booths) as much as possible while using fluorouracil. Sunlight may increase your side effects. When exposed to sunlight, wear a hat and use sunscreen.
  • Do not cover the treated skin with a dressing.
  • Do not breast feed or become pregnant while using fluorouracil. If you do become pregnant, stop using fluorouracil and tell your doctor right away.

Injectable:

• The starting dose is typically 12 mg/kg are given intravenously (into the vein) once daily for 4 successive days. The daily dose should not exceed 800 mg.
  • If no toxicity is observed, 6 mg/kg are given on the 6th, 8th, 10th and 12th days unless toxicity occurs.
  • No therapy is given on the 5th, 7th, 9th or 11th days.
  • Therapy is to be discontinued at the end of the 12th day, even if no toxicity has become apparent.
• In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:
  • Repeat dosage of first course every 30 days after the last day of the previous course.
  • When toxic effects from the first course of therapy have subsided, maintenance dosage of 10 to 15 mg/kg/week as a single dose is recommended. Do not exceed 1 gram per week.
• Dose and duration of use may be adjusted if you are in poorer health or if you experience certain toxic side effects.

Topical:

• Cream
  • Refer to your specific cream product and your doctor's prescribed directions for use. There are different cream formulations with different directions.
• Topical solution
  • Apply topical solution twice daily in an amount sufficient to cover the lesions.
  • The usual duration of therapy is from 2 to 4 weeks if treating for actinic or solar keratoses.
  • The usual duration of therapy is from 3 to 6 weeks if treating for basal cell carcinoma. Therapy may be required for as long as 10 to 12 weeks.

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.

Injectable:

• Store at room temperature 15° to 30°C (59° to 86°F).
• Protect from light.
• Retain in carton until time of use.

Topical:

• Keep this medicine at room temperature (68–77° F/ 20–25° C). Throw away unused medicine.
• Keep this medicine out of the reach of children.
• Medicines are sometimes prescribed for conditions that are not described in patient information leaflets. Do not use it for a condition for which it was not prescribed. This medicine is for your use only. Never give it to other people. It may harm them even if their skin problem appears to be the same as yours. Do not use Carac after the expiration date on the tube.

It is recommended that fluorouracil Injection be given only by or under the supervision of a qualified physician who is experienced in cancer chemotherapy and who is well versed in the use of potent antimetabolites. Because of the possibility of severe toxic reactions, it is recommended that patients be hospitalized at least during the initial course of therapy.

These instructions should be thoroughly reviewed before administration of fluorouracil.