Carac

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.

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.

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not apply a double dose of this medication.

• It is used to treat a precancerous skin problem called actinic keratosis.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Carac Cream should be applied once a day to the skin where actinic keratosis lesions appear, using enough to cover the entire area with a thin film. Carac Cream should not be applied near the eyes, nostrils, or mouth. Carac Cream should be applied 10 minutes after thoroughly washing, rinsing, and drying the entire area. Carac Cream may be applied using the fingertips. Immediately after application, the hands should be thoroughly washed. Carac Cream should be applied up to 4 weeks as tolerated. Continued treatment up to 4 weeks results in greater lesion reduction. Local irritation is not markedly increased by extending treatment from 2 to 4 weeks, and is generally resolved within 2 weeks of cessation of treatment.

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence, but the duration of abstinence is not clear.

UK: Contraindicated AU, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -If this drug is used during breastfeeding, complete blood count and differential should be monitored in the infant.