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This safety and warning information is intended to inform you about the potential risks and necessary precautions associated with the use of fluorouracil (Efudex) topical. It is important to review this information carefully and discuss any concerns with your healthcare provider.

• Application Precautions: Avoid applying fluorouracil (Efudex) topical to sensitive areas of skin, or near mucous membranes such as the eyes, mouth, or nose, to prevent skin damage.

• Post-Application Care: Do not cover treated skin areas with bandages or dressings, as this may increase medication absorption and lead to more pronounced skin side effects.

• UV Exposure Warning: Exposure to ultraviolet (UV) light while using fluorouracil (Efudex) topical can result in severe skin reactions, including painful peeling or blistering. Avoid sunbathing, sunlamps, and tanning beds, and minimize sun exposure. Consult your dermatologist about using sunscreen and wearing protective clothing, like hats and long sleeves, when outdoor activity is unavoidable.

• Pregnancy Alert: The use of fluorouracil (Efudex) topical during pregnancy can harm an unborn baby, leading to birth defects or miscarriage. Inform your dermatologist if you are pregnant or planning to become pregnant. This warning is particularly important for females of childbearing age.

• Rare Toxic Reaction: In rare cases, individuals with a deficiency in dihydropyrimidine dehydrogenase (DPD) may experience toxicity symptoms such as stomach pain, bloody diarrhea, vomiting, and fever. These symptoms may indicate inflammation and sores in the mouth, stomach, and bowels.

Contraindications:

• Do not use fluorouracil (Efudex) topical if you are currently pregnant or have a known DPD deficiency, as it could pose significant health risks.

Please consult your healthcare provider if you have any conditions or factors that may contraindicate the use of this medication.

Common side effects:

• skin irritation
• burning
• redness
• dryness
• stinging
• itchiness
• soreness
• scarring at the application site

Less common but important to monitor:

• crusting
• tenderness
• changes in skin color, such as darkening
• blistering
• rash
• swelling

Serious side effects:

• severe stomach or abdominal pain
• bloody diarrhea
• vomiting
• signs of infection like persistent sore throat or fever
• painful mouth sores
• severe dizziness
• rash
• itching
• swelling, especially of the face, tongue, or throat
• trouble breathing

Fluorouracil (5-FU) is a chemotherapy medication used to treat various cancers. When taking fluorouracil, it's important to be aware of potential interactions with other medications and substances, as these can affect its effectiveness and safety.

Folic Acid and Leucovorin: Combining fluorouracil with folic acid or leucovorin can enhance the drug's effects, which may increase the risk of severe side effects such as anemia, bleeding problems, infections, and nerve damage. Patients should inform their healthcare provider about any vitamins or supplements they are taking to avoid unintended interactions.

Blood Pressure Medications: Fluorouracil can interact with certain blood pressure medications, such as Losartan. This combination may reduce the effectiveness of the blood pressure medication, potentially leading to increased blood pressure. Patients on such medications should have their blood pressure monitored closely and consult their healthcare provider for appropriate adjustments.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Using NSAIDs like Ibuprofen or Aspirin alongside fluorouracil can increase the risk of bleeding. This is due to the combined effects of both drugs on blood clotting. Patients should discuss the use of NSAIDs with their healthcare provider to ensure safe management of pain or inflammation.

Live Vaccines: Patients receiving fluorouracil should avoid live vaccines, as the chemotherapy can weaken the immune system, increasing the risk of infection from the vaccine. It's advisable to complete any necessary vaccinations at least two weeks before starting fluorouracil therapy.

Dihydropyrimidine Dehydrogenase (DPD) Deficiency: Some individuals have a genetic deficiency in DPD, an enzyme responsible for breaking down fluorouracil. This deficiency can lead to severe toxicity when taking fluorouracil. Patients may be tested for DPD deficiency before starting treatment to determine the appropriate dosage or consider alternative therapies.

Other Medications: Fluorouracil can interact with a wide range of other drugs, including certain antibiotics, antifungals, and medications metabolized by the liver enzyme CYP2C9. These interactions can alter the levels of fluorouracil or the other medications, leading to increased side effects or reduced effectiveness. Patients should provide a complete list of all medications and supplements they are taking to their healthcare provider to assess for potential interactions.

It's crucial for patients undergoing fluorouracil treatment to maintain open communication with their healthcare team and report any new medications, supplements, or health changes to ensure safe and effective treatment.