Instructions for Use of SPHERUSOL® (See Full Prescribing Information for all instructions)


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.



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.


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

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.


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