Brand Name
Spherusol
Generic Name
immitis Spherule-Derived
View Brand Information FDA approval date: July 29, 2011
Classification: Skin Test Antigen
Form: Injection
What is Spherusol (immitis Spherule-Derived)?
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 responses 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 ®. 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 responses 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 ®.
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Brand Information
Spherusol (Coccidioides immitis Spherule-Derived Skin Test Antigen)
WARNING
- The expected response to Spherusol
- 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
- To report SUSPECTED ADVERSE REACTIONS, contact Nielsen BioSciences, Inc. at (855) 855-1212 or MEDWATCH, Food and Drug Administration (FDA), 5600 Fishers Lane, Rockville, MD 20852-9782. Telephone: (800) 332-1088 or
1INDICATIONS AND USAGE
Spherusol
- The use of Spherusol
- 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
2DOSAGE FORMS AND STRENGTHS
Spherusol
3CONTRAINDICATIONS
A severe allergic reaction (e.g., anaphylaxis) to Spherusol
4DESCRIPTION
Spherusol
The potency of each lot of Spherusol
5CLINICAL STUDIES
The delayed-type hypersensitivity response following administration of Spherusol
The use of Spherusol
6REFERENCES
- Edwards, PQ and Palmer CE. Prevalence of sensitivity to coccodioidin, with special reference to specific and nonspecific reactions to coccidioidin. Dis Chest. 31:35. 35-60, 1957.
- Emmons, C.W., Binford, C. H., Ulz, J.P. Kwon-Chung, K.J. Medical Mycology, Leanne Febiger, Philadelphia, Chapter 17, 230, 1977.
- Emmons CW and Olson BJ. Studies of the role of fungi in pulmonary disease. I. Cross-reactions with histoplasmin. Pub Health Rep. 60(47):1383, 1945.
- Levine HB, Restrepon A, Eyck DR, and Stevens DA. Spherulin and coccidioidin: cross-reactions in dermal sensitivity to histoplasmin and paracoccidioidin. Am J Epidemiol. 101(6):512, 1975.
- Zweiman, B. Cell-mediated immunity in health and disease. Allergy Principles and Practices, Mosby, Saint Louis, Chapter 50: 696, 1998.
7HOW SUPPLIED/STORAGE AND HANDLING
Spherusol
NDC# 59584-140-01: multi-dose vial.
Store refrigerated at 2° to 8°C (35° to 46°F). Do not freeze. Discard if frozen.
Do not use after expiration date.
8PATIENT COUNSELING INFORMATION
Patients should be:
- Informed of the potential benefits and risks of skin testing with Spherusol
- Instructed to report any adverse events to their healthcare provider.