About Diflucan® for the Diflucan Partnership Program

Diflucan® (fluconazole) is included in the World Health Organization List of Essential Drugs as a treatment for fungal infections.

How is Diflucan used in this program ?
The program provides Diflucan® for the indications of Cryptococcal meningitis and Esophageal candidiasis.

About Diflucan® and Fungal Opportunistic Infections

Cryptococcal meningitis and other serious fungal infections are common complications in patients infected with human immunodeficiency virus (HIV). Diflucan ® is one of the WHO's recommended treatments for Cryptococcal meningitis and Esophageal candidiasis.

Cryptococcal Meningitis

• Cryptococcal meningitis is a life-threatening opportunistic infection of the brain caused by the yeast Cryptococcus neoformans. The infection invades the fluid surrounding the brain and spinal cord and causes damage to the central nervous system.
  
  
• Studies conducted in the United States suggest that between 6 and 10 percent of patients with AIDS, and in parts of Africa up to 30 percent, will develop Cryptococcal meningitis[1]. If left untreated, the prognosis is extremely poor. Relapse rates are as high as 50-60 percent, therefore, ongoing treatment is required for life [2].
  
  
• The onset of Cryptococcal meningitis is gradual and insidious, causing fatigue, fever, and weight loss followed by headache, nausea, vomiting, confusion, drowsiness, photophobia, and blurred vision [3].
  
  
• Definitive diagnosis of Cryptococcal meningitis can only be made by lumbar puncture (spinal tap), a medical procedure that must be performed in an appropriate medical facility.

Esophageal candidiasis

• Esophageal candidiasis is a fungal infection of the esophagus predominantly caused by Candida albicans [4]. In HIV-positive patients, this infection may be the first manifestation of AIDS [5].
  
  
• It is reported anecdotally in 20-40 percent of all patients with HIV/AIDS.
  
  
• The mortality rates are considerably lower for patients suffering Esophageal candidiasis than for those with Cryptococcal meningitis. However, Esophageal candidiasis frequently prevents patients from swallowing food and can lead to overall physical deterioration.
  
• The most common symptoms of Esophageal candidiasis include painful swallowing and chest pain. Nausea, vomiting and bleeding can also occur.
  
  
• Diagnosis of Esophageal candidiasis is made through clinical and microbiological assessment of the patient.

Prescribing Information

Diflucan® for the Diflucan® Partnership Program is registered in South Africa and other countries. To download Diflucan® prescribing information (South Africa) for Cryptococcal meningitis and Esophageal candidiasis, please click here (38K Adobe Acrobat document). To download U.S. product information for all approved Diflucan® indications, please click here (85K Adobe Acrobat document).

For additional treatment information on these fungal opportunistic infections from the World Health Organization (WHO), please click here. To the extent the WHO guidelines provide for the use of Diflucan® that is in any respect different from the prescribing information provided for the donated product, and the donation recipient and/or treating physicians elect to follow the WHO Guidelines, the donation recipient and/or the treating physician shall be responsible for such election.

References

1 - Powderly, WG. 1992. Therapy for Cryptococcal meningitis in patients with AIDS. Clin Infect Dis 14(suppl 1):S54-59.
2 - Powderly, William et al. 1992. A controlled trial of fluconazole or amphotericin B to prevent relapse of Cryptococcal meningitis in patients with acquired immunodeficiency syndrome. New England Journal of Medicine 326: 793-798
3 - Dismukes, William. 1989. Cryptococcal meningitis in patients with AIDS. The Journal of Infectious Diseases 157: 624-628.
4 - Vasquez, Jose. 2000. Therapeutic options for the management of Oropharyngeal and Esophageal candidiasis in HIV/AIDS patients. HIV Clinical Trials 1:47-59.
5 - Ibid. 52.

Note: The prescription and use of Diflucan® requires the product to be registered in the country of use. It is important to verify that Diflucan® is registered locally featuring the indications of Cryptococcal meningitis and Esophageal candidiasis. If Diflucan® is not registered, the applying institution needs to apply for a special import license for the donation from the local government.

DIFLUCAN® (FLUCONAZOLE) The product information provided in this site is intended only for non-United States residents. The products discussed herein may have different product labeling in different countries. Important Product Information Systemic In more than 4,000 patients, who received multiple doses of Diflucan® , the most common adverse events were nausea (3.7%), headache (1.9%), skin rash (1.8%), vomiting (1.7%), abdominal pain (1.7%), and diarrhea (1.5%). Diflucan® has been associated with rare cases of serious hepatic toxicity, including fatalities, primarily in patients with serious underlying medical conditions. Patients who develop abnormal liver function tests should be monitored for the development of more severe hepatic injury. Patients have rarely developed exfoliataive skin disorders during treatment with Diflucan®. Coadministration of terfenadine is contraindicated in patients receiving Diflucan® at multiple daily doses of 400 mg (equivalent to 12 mg/kg pediatric doses or higher) or higher. Coadministration of cisapride is contraindicated in patients receiving Diflucan®. Pediatric In 577 children, ages one day to seventeen years, who received Diflucan® , the most common treatment-related side effects were vomiting (5.4%), abdominal pain (2.8%), nausea (2.3%), and diarrhea (2.1%). For additional information, please see Diflucan® prescribing information for the U.S. (38K Adobe Acrobat document) and for South Africa (85K Adobe Acrobat document).