CANDIN® (Candida albicans Skin Test Antigen For Cellular Hypersensitivity)                                                                          
The only FDA-approved delayed-type hypersensitivity (DTH) Candida albicans extract-based skin test antigen available to assess cell-mediated immunity.
CANDIN should not be used to diagnose or treat Type 1 allergy to Candida albicans.
                                             
      Full Prescribing Information                                                                                               

SPHERUSOL® (Coccidioides immitis Spherule-Derived Skin Test Antigen)
The only FDA-approved skin test antigen to assess cell-mediated immunity to Coccidioides,
the causative agent of Valley Fever (coccidioidomycosis).  Commonly referred to as the "Valley Fever Skin Test".
The use of SPHERUSOL to detect delayed-type hypersensitivity response in a general population with unknown exposure to Coccidioides has not been evaluated
Persons with acute or disseminated coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL
Persons with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL

     Full Prescribing Information 

CANDIN

INDICATION AND USAGE

CANDIN is a skin test antigen to assess cellular hypersensitivity to Candida albicans.  CANDIN should not be used to diagnose or treat Type 1 allergy to Candida albicans.

IMPORTANT SAFETY INFORMATION FOR CANDIN: 

WARNING:

The expected response to CANDIN is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication.

Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 20 minutes following the administration of a skin test.

CANDIN should never be given intravenously.

Contraindication:

CANDIN should not be used after a previous unacceptable adverse reaction to this antigen or to a similar product, i.e., extreme hypersensitivity/allergy.

Warnings and Precautions:

The antigen must be injected intradermally. Do not inject intravenously.

As has been observed with other, unstandardized, antigens used for DTH skin testing, it is possible that some patients may have exquisite immediate hypersensitivity to CANDIN.

Physicians using this product must have facilities, equipment and medication necessary to treat potential side effects. Epinephrine and oxygen must be immediately available in the event of a serious systemic response.

Adverse Reactions:

Immediate hypersensitivity local reactions can include itching, swelling, pain and blistering at the test site occurring 15-20 minutes after administration. Necrosis is possible.

Systemic reactions to CANDIN have not been observed, however all foreign antigens have the remote possibility of causing Type 1 anaphylaxis and even death when injected intradermally.

Drug Interactions:

Pharmacologic doses of corticosteroids may variably suppress the DTH skin test response after two weeks of therapy.

Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine, in the event that epinephrine is required to control an adverse allergic reaction

Use in Specific Populations:

It is not known whether CANDIN can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. CANDIN should be given to pregnant women only if clearly needed.

It is not known whether CANDIN is excreted in human milk. Caution should be exercised when administered to a nursing woman.

Use in pediatric populations has not been established.

Geriatric populations may have a diminished response to the skin test.This Important Safety Information does not contain all the information needed to use CANDIN safely and effective. Please see Full Prescribing Information for additional information.

 

SPHERUSOL

INDICATION AND USAGE

SPHERUSOL is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a history of pulmonary coccidioidomycosis.  SPHERUSOL is approved for use in individuals 18-64 years of age.

The use of SPHERUSOL to detect delayed-type hypersensitivity response in a general population with unknown exposure to C. immitis has not been evaluated.

Persons with acute or disseminated coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL.

Persons with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response to SPHERUSOL.

 IMPORTANT SAFETY INFORMATION FOR SPHERUSOL: 

 WARNING:

The expected response to SPHERUSOL is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication.

Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 20 minutes following the administration of a skin test.

SPHERUSOL should never be given intravenously.

Contraindication:

Severe allergic reaction (e.g., anaphylaxis) to SPHERUSOL, or any component of SPHERUSOL or other coccidioidin products.  

Warnings and Precautions:

Acute hypersensitivity reactions and anaphylaxis have occurred following the administration of other skin test antigens and may occur in individuals following the administration of SPHERUSOL.

Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine in cases of hypersensitivity.

Any condition or agent that impairs or attenuates delayed-type hypersensitivity reactions, including infections and use of immunosuppressive drugs, can potentially cause a false negative reaction to SPHERUSOL. 

Adverse Reactions:

The most commonly reported local adverse reactions were itching and swelling (>75%) and pain (>15%) within 7 days of administration.

Drug Interactions:

Corticosteroids and immunosuppressive agents may suppress the response to the skin test.

Use in Specific Populations:

The safety and effectiveness of SPHERUSOL have not been established in pregnant and nursing women, the pediatric population, or individuals > 65 years of age.

This Important Safety Information does not contain all the information needed to use SPHERUSOL safely and effective. Please see Full Prescribing Information for additional information.

You Are About to Leave NielsenBio.com (Nielsen BioSciences.com)

The following third-party website was provided for your convenience, and Nielsen BioSciences, Inc. does not endorse, verify, or otherwise support the information contained in these websites. You are subject to the legal terms and conditions of use for third-party websites.

The following information is intended for licensed health care providers.

By continuing on to the following pages, you are agreeing that you are licensed in your state as a physician or other health care provider.