Tolerability Profile

Carac® is the only topical 5-FU AK treatment of the face and anterior scalp with once-a-day dosing

  • In the clinical trials
    • Mean irritation severity declined below baseline at 2 weeks post-treatment regardless of treatment duration1
      • Application site reaction in patients treated with Carac® occurred in 94.6% of patients, eye irritation occurred in 5.4% of patients
      • Irritation generally began on day 4 and persisted for the remainder of treatment
  • Severity of facial irritation at the last treatment visit was1
    • Slightly below baseline for the vehicle group
    • Mild to moderate for the 1-week active treatment group
    • Moderate for the 2- and 4-week active treatment groups
    • 12% of Carac® -treated patients discontinued early due to facial irritation
  • Carac® should be used up to 4 weeks as tolerated
  • Irritation is predominantly localized to the site of application1
  • Individual results may vary

The Carac® Clearing Cycle

clearing cycle

Mean irritation severity declined below baseline at 2 weeks post-treatment regardless of treatment duration1

  • Application site reaction in patients treated with Carac® occurred in 94.6% of patients, eye irritation occurred in 5.4% of patients
  • Irritation generally began on day 4 and persisted for the remainder of treatment

The most commonly reported application site adverse events were erythema (93.4%), dryness (83.3%), and burning (74.7%)

Reference: 1. Carac® Prescribing Information. Dermik Laboratories, 2009.

Indication

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

For more information, please see Full Prescribing Information for Carac®.

Important Treatment Considerations for Carac®

  • Carac® is for external use only.
  • Patients should avoid contact with eyes, eyelids, nostrils, and mouth.
  • Patients should cleanse affected area and wait 10 minutes before applying Carac®.
  • Patients should wash hands immediately after applying Carac®.
  • Patients should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment, as the intensity of the reaction may be increased.
  • Most patients using Carac® get skin reactions where the medicine is used. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling. Irritation at the application site may persist for two or more weeks after therapy is discontinued. Treated areas may be unsightly during and after therapy.
  • If patients develop abdominal pain, bloody diarrhea, vomiting, fever, or chills while on Carac® therapy, stop the medication and contact your physician and/or pharmacist.
  • Patients should report any side effects to the physician and/or pharmacist.

Important Safety Information for Carac®

Carac® is contraindicated in women who are nursing, pregnant or may become pregnant as fluorouracil may cause fetal harm. Carac® is also contraindicated in patients with DPD enzyme deficiency. Carac® should be discontinued if abdominal pain, diarrhea, vomiting, fever, or chills develop when using the product. Carac® should not be used in patients with known hypersensitivity to any of its components.

There is a potential for a delayed hypersensitivity reaction to fluorouracil. Patch testing to determine hypersensitivity may be inconclusive. Applications to mucous membranes should be avoided due to the possibility of local inflammation and ulceration.

In clinical trials, the most common drug-related adverse event was application site reaction (94.6%), which included: erythema, dryness, burning, erosion, pain, and edema. Skin irritation generally began on day 4 and persisted for up to two weeks after treatment discontinuation. Some patients also experienced eye irritation (5.4%), including stinging and burning.

Healthcare Professionals

This information is intended for U.S. Healthcare Professionals only.

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