Diflucan Frequently Asked Questions

This section addresses many common issues. If your question is not addressed here, please contact Direct Relief International.

Diflucan® (fluconazole)

  • Is Diflucan® a cure for AIDS?
  • Is this a clinical trial?
  • Can anyone living with HIV/AIDS use Diflucan®?
  • Will Diflucan® be provided free for vaginal candidiasis (thrush) for HIV-infected people?
  • Are there risks associated with the use of Diflucan®?

The Diflucan® Partnership Program

  • Who is eligible?
  • What are the costs involved?
  • Who is involved?

The Application Process

  • How do I apply?
  • Who is my contact?
  • What are the review criteria?
  • How long does the review process take?
  • How will I know if my application is approved?
  • What are the logistics for receiving the donation?
  • Do I have to complete the entire application if I want to request a repeat donation?

Privacy

  • Who sees my information?

Technical Issues

  • How do I read the application and/or documents in Adobe Acrobat® (PDF) format?
  • What if I have a problem with the forms?

 

 

Diflucan®

  • Is Diflucan® a cure for AIDS?
    No, Diflucan® does not treat HIV/AIDS, but as an antifungal medicine it treats life-threatening opportunistic infections. In this program, Diflucan® is being donated to treat two fungal infections, cryptococcal meningitis and esophageal candidiasis, that are associated with HIV/AIDS. Diagnosis is made by a health care professional.
  • Is this a clinical trial?
    No. Diflucan® was approved in 1994 in the United States and has a proven record of safety and efficacy. The Diflucan® Partnership Program is a donation program.
  • Can anyone living with HIV/AIDS use Diflucan®?
    No. Only people who have been diagnosed with cryptococcal meningitis or esophageal candidiasis by a health care professional should be treated with Diflucan®.
  • Will Diflucan® be provided free for vaginal candidiasis (thrush) for HIV-infected people?
    No. Diflucan® provided by the Diflucan® Partnership Program is only for the treatment of cryptococcal meningitis and esophageal candidiasis.
  • Are there risks associated with the use of Diflucan®?
    There are risks associated with use of any medicine. However, it is important to understand that the Diflucan® Partnership Program is not a clinical trial. Diflucan® has been approved and has been used for over 14 years for the treatment of cryptococcal meningitis and esophageal candidiasis, and other indications. For additional information, please see the package insert for Diflucan® for donation programs (91K Adobe Acrobat document) or the prescribing information for South Africa (38K Adobe Acrobat document ) and/or the summary below:

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®. Co-administration 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. Co-administration 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).

The Diflucan® Partnership Program

  • Who is eligible?
    The Diflucan® Partnership Program is open to governments and nongovernmental organizations in all developing countries. Countries with HIV/AIDS prevalence greater than 1 percent will be given priority. The donated medicine is to be used only for HIV/AIDS patients suffering from cryptococcal meningitis and/or esophageal candidiasis.
  • What are the costs involved?
    The Diflucan® Partnership Program offers Diflucan® for free and will cover the shipping costs up to the airport of entry into the recipient country. All other costs including costs of the handling, taxes and duties, and distribution in the country will be the responsibility of the applicant. Diflucan® must be provided free of charge to the patient.
  • Who is involved?
    Pfizer Inc provides Diflucan® to Direct Relief International, which reviews and approves the applications and provides the medicine to successful applicant organizations. Direct Relief manages the application as well as the resupply processes.

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The Application Process

  • How do I apply?
    Organizations interested in receiving Diflucan® must complete an application. The application is reviewed by Direct Relief, which guides the applicant through the process.
  • Who is my contact?
    Direct Relief is the primary contact: DiflucanPartnership@directrelief.orgDiflucan® Partnership Program
    Direct Relief International
    27 South La Patera Lane
    Santa Barbara, California 93117In the U.S.: Tel: +1 805 964 4767 • Fax: +1 805 681 4838
    In South Africa: +27 11 351 1287
  • What are the review criteria?
    Click here to read the review criteria.
  • How long does the review process take?
    Within five business days of submitting your application, Direct Relief will contact you with feedback about your application. Direct Relief will work with you to clarify or amend your application if necessary. Once it meets the requirements outlined in the review criteria, Direct Relief will recommend that it be considered for approval.
  • How will I know if my application is approved?
    Following the review process, Direct Relief will confirm by email the approval of your application and quantity of Diflucan® to be shipped. Details concerning shipping procedures will be defined with the responsible institution.
  • What are the logistics for receiving the donation?
    The institution must provide the exact shipping address and other information required to send the drug to the country. After complete shipping instructions have been received by Direct Relief, the organization will be notified of the shipment schedule. The freight forwarder or the International Dispensary Association may contact the person responsible for shipping to obtain information.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 and provide to Direct Relief a special import license, waiver or any other documentation required by the government of the country to receive this donation of medicine.The Diflucan® Partnership Program will offer Diflucan® for free and will cover the shipping costs up to the port of entry into the recipient country. All other costs will be the responsibility of the recipient organization including costs of handling, taxes and duties, and distribution in the country.
  • How do I request a resupply donation?
    Prior to resupply of Diflucan®, each organization is required to submit a progress report describing how the previous donation was used. Following submission of the progress report, each organization will be able to submit a resupply request. The Diflucan® Partnership Program reserves the right to amend this request based on information collected on the organization’s program.

Privacy

  • Who sees my information?
    Only the application manager has access to your information and will keep it confidential. For more information, please see our privacy policy.

Technical Issues

  • How do I read the application and/or documents in Adobe Acrobat® (PDF) format?
    You need the Acrobat Reader program. You can download it from Adobe’s Web site.
  • What if I have a problem with the forms?
    If you have trouble viewing the forms or have a technical problem with this Web site, please send an e-mail to DiflucanPartnership@directrelief.org, detailing your problem, the page and the circumstances under which you encountered it. Direct Relief will respond to your question in five working days.

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