Frequently Asked Questions about SPHERUSOL®

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What Is SPHERUSOL?
SPHERUSOL (Coccidioides immitis Spherule Derived Skin Test Antigen) is prepared and extracted from laboratory cultures of Coccidioides immitis spherules. Spherules are the form of Coccidioides present when the fungus is growing in body tissues such as during coccidioidomycosis (i.e., Valley Fever). SPHERUSOL® is packaged as a sterile, ready-to-use aqueous solution in a multi-dose vial (10 tests/vial). SPHERUSOL® does not replace serological testing used by physicians to diagnose coccidioidomycosis.

How Does SPHERUSOL Work?
Most, but not all, people with a history of coccidioidomycosis have developed immunity to Coccidioides. The antigens present in SPHERUSOL elicit a response of the cellular immunity system when injected intradermally. The response, known as delayed-type hypersensitivity (DTH), demonstrates an individual’s immunity to Coccidioides and the ability of their cellular immune system to produce DTH. Not all people with intact cellular immunity react to coccidioidin preparations and other conditions such as bacterial or viral infections may also interfere; therefore the response to SPHERUSOL is not 100%. Additionally, people with acute or disseminating coccidioidomycosis may not react to SPHERUSOL. SPHERUSOL does not replace serological testing used by physicians to diagnose coccidioidomycosis.

How Is SPHERUSOL® Administered?
SPHERUSOL is used according to the Mantoux Method. It is administered by an intradermal injection of 0.1 mL (cc) to the volar surface of the forearm or outer aspect of the upper arm. Caution must be exercised to avoid subcutaneous or intravenous injections. The injection site is evaluated by a trained health care professional about 48 hours after injection. The site is evaluated for the diameter of observed induration (swelling) and not redness. A positive response to SPHERUSOL is an area of induration of ≥5 mm. 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-inflamatory 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. This is not all of the information needed for dosage and administration of SPHERUSOL. See Full Prescribing Information for additional details. For detailed information, see Mantoux Method.

For more information on coccidioidomycosis or Valley Fever:

Centers for Disease Control and Prevention at:
http://www.cdc.gov/fungal/diseases/coccidioidomycosis/index.html

Valley Fever Center for Excellence at:
https://www.vfce.arizona.edu/Default.aspx

Kern County Public Health Services at:
http://kerncountyvalleyfever.com/

Click here to download a copy of the SPHERUSOL Patient Information to provide to your patients.

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 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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