Through the Diflucan® Partnership Program, Pfizer’s antifungal medicine Diflucan® (fluconazole) is made available free of charge for the treatment of cryptococcal meningitis and esophageal candidiasis, two opportunistic infections associated with HIV/AIDS, to governments and nongovernmental organizations in developing countries. Countries with HIV/AIDS prevalence greater than 1 percent are given priority.
The prescription and use of Diflucan® requires the donated product to be registered in the country of use. If these dosage forms and indications of Diflucan® are not registered, the applying organization must secure a special import license, waiver, or other documentation required by the government of the country to receive the donation.
The Diflucan® Partnership offers Diflucan® free of charge and will cover the shipping costs up to the point of entry in the country. The recipient is responsible for all other charges, including costs of handling, taxes and duties, and distribution in the country.
Diflucan Partnership Program Distribution Map
In celebration of World AIDS Day 2012, Direct Relief released the Diflucan Partnership Program Map, an interactive map that highlights the significant achievements made by Diflucan Partnership Program since 2000. The map illustrates the nearly 90 million defined daily doses of Diflucan that have been distributed to people living with HIV in 60 countries in sub-Saharan Africa, Asia, and Latin America.
About the Partners
Pfizer Inc, a worldwide biopharmaceutical company, manufactures Diflucan® and donates it to Direct Relief. A nonprofit medical aid organization, Direct Relief processes the applications, maintains databases, and monitors re-ordering for the applicant organizations.
Diflucan® (fluconazole) is included in the World Health Organization (WHO) List of Essential Drugs as a treatment for fungal infections. This 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 percent 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 to 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 to 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
For additional treatment information on these fungal opportunistic infections from the World Health Organization (WHO), please click here. If the WHO guidelines are in any respect different than the prescribing information and the donation recipient elects to follow the WHO guidelines for the use of Diflucan®, 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 must secure either a waiver, a special import license or whatever documentation is required 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 exfoliative 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 17 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 the package insert for Diflucan® for donation programs (91K Adobe Acrobat document) and/or the prescribing information for South Africa (38K Adobe Acrobat document).
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