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Efudex (Fluorouracil Topical) - Summary

 
 



EFUDEX SUMMARY

Efudex Solutions and Cream are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. Efudex Solution consists of 2% or 5% fluorouracil on a weight/weight basis, compounded with propylene glycol, tris (hydroxymethyl) aminomethane, hydroxypropyl cellulose, parabens (methyl and propyl) and disodium edetate. Efudex Cream contains 5% fluorouracil in a vanishing cream base consisting of white petrolatum, stearyl alcohol, propylene glycol, polysorbate 60 and parabens (methyl and propyl).

Efudex is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.

The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Efudex Cream and Solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.


See all Efudex indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Efudex (Fluorouracil Topical)

Irsogladine maleate reduces the incidence of fluorouracil-based chemotherapy-induced oral mucositis. [2013]
mucositis through a double-blind, placebo controlled trial... CONCLUSION: IM significantly reduced the incidence and maximum severity of oral

Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in combination with salicylic acid treating actinic keratoses. [2012]
practicability... CONCLUSIONS: Topical 0.5% 5-FU/SA demonstrated superior sustained clinical

A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. [2012]
maintenance therapy for metastatic colorectal cancer (MCRC)... CONCLUSIONS: Enzastaurin combined with bevacizumab-based therapy is tolerable,

Comparison of the efficacy of intralesional triamcinolone acetonide and 5-fluorouracil tattooing for the treatment of keloids. [2012]
for treatment of keloids... CONCLUSION: 5-FU tattooing was more effective than intralesional TAC for the

Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced hepatocellular carcinoma with portal venous invasion. [2011.11.09]
BACKGROUND: The prognosis of advanced hepatocellular carcinoma (HCC) remains poor, particularly among patients with portal vein tumor thrombosis (PVTT). This study evaluated the efficacy of combined 5-fluorouracil and pegylated interferon (PEG-IFN) alpha-2b in patients with advanced HCC... CONCLUSIONS: Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-fluorouracil and PEG-IFNalpha-2b, this new combination therapy may be useful for patients with advanced HCC. Cancer 2011;. (c) 2011 American Cancer Society. Copyright (c) 2011 American Cancer Society.

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Clinical Trials Related to Efudex (Fluorouracil Topical)

Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients [Enrolling by invitation]
The primary objective of this study is to evaluate whether the management of colorectal cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU related toxicities and improves outcomes compared to the current standard of care. A secondary objective is to characterize the variability of 5-FU levels among CRC patients managed with 5-FU exposure optimization testing and the impact of such management on 5-FU plasma levels and drug doses during the course of chemotherapy.

Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients [Completed]
Phase I Objectives Primary: 1. The primary objective of this study is to determine the maximum tolerated dose (MTD) of Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated, locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ). Secondary: 1. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination. Phase II Objectives Primary: 1. To assess time to cancer progression to D-FOX treatment regimen. Secondary: 1. To assess response rate to D-FOX treatment regimen. 2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination treatment regimen. 3. Determine overall survival. 4. Perform an exploratory investigation into the effect of D-FOX on phenotypic abnormalities in blood.

Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab [Completed]
The goal of this clinical research study is to find the best combination of oxaliplatin, bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with advanced cancer that has spread to the liver. Different combinations of these drugs will be used, and the safety of all drug combinations will also be studied.

Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis [Completed]
Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy. Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial AKs. Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.

Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) [Active, not recruiting]
The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.

more trials >>

Reports of Suspected Efudex (Fluorouracil Topical) Side Effects

Abdominal Pain Upper (6)Blood Urine Present (5)Vomiting (5)Diffuse Large B-Cell Lymphoma (4)Incorrect Route of Drug Administration (2)Pain (2)Death (2)Disseminated Intravascular Coagulation (1)Drug Administration Error (1)Rash Generalised (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Efudex has an overall score of 7.33. The effectiveness score is 8.67 and the side effect score is 6.67. The scores are on ten point scale: 10 - best, 1 - worst.
 

Efudex review by 54 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Skin cancers
Dosage & duration:   Topical Cream (dosage frequency: twice a day) for the period of 3 to 4 weeks
Other conditions:   Solar keratosis basal cell squasanoma
Other drugs taken:   none
  
Reported Results
Benefits:   It removes boyh visible a nd unseen sun damage from the skin
Side effects:   There seem to beno side effects it produces ulceration of the skin where there are changed cells but this is how the drug works
Comments:   Topically applied cream that ulcerates the changed or damaged skin cells that are considered precanerous it creates red welts that take antwhere from two to 6 weeks to develop then when you stop using the cream it takes to 14 days to heal any flake off leaving very clear clean skin.

 

Efudex review by 41 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   actinic keratoses
Dosage & duration:   .05 (dosage frequency: every day) for the period of 1 month
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   hopefully it got rid of many actinic keratoses permanently, but hard to say. I think it made my skin look better, though.
Side effects:   extremely red, irritated, sore skin, extreme sun sentitivity. One are even blistered, eventually so badly that my dr. said stop using it.
Comments:   applied to face and chest sparingly daily after washing. My face and chest both became very red, and my face especially got so bad it looked like hamburger meat. My chest had many small red spots. One area under my eye blistered and then became infected. I did not even want to see sunlight, I became so sun sensitive. After I stopped using the medication it took at least a week to feel anything like normal. a horrible experience. but I do think it made my skin look better.

 

Efudex review by 41 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   actinic keratoses
Dosage & duration:   .05 (dosage frequency: every day) for the period of 1 month
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   hopefully it got rid of many actinic keratoses permanently, but hard to say. I think it made my skin look better, though.
Side effects:   extremely red, irritated, sore skin, extreme sun sentitivity. One are even blistered, eventually so badly that my dr. said stop using it.
Comments:   applied to face and chest sparingly daily after washing. My face and chest both became very red, and my face especially got so bad it looked like hamburger meat. My chest had many small red spots. One area under my eye blistered and then became infected. I did not even want to see sunlight, I became so sun sensitive. After I stopped using the medication it took at least a week to feel anything like normal. a horrible experience. but I do think it made my skin look better.

See all Efudex reviews / ratings >>

Page last updated: 2014-11-30

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