Spherusol label

Spherusol

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Uses

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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History

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Other Information

Spherusol ® is a sterile aqueous solution of extracts of C. immitis spherules. The multi-dose vial contains 0.9% sodium chloride and 0.014% sodium borate with 0.4% phenol as a preservative. Residual thimerosal from the manufacturing process is present at a concentration of ≤0.0001% (<0.05 mcg mercury/0.1 mL dose). Each 0.1 mL dose contains 1.27 mcg of spherule-derived antigen.

The potency of each lot of Spherusol ® is determined in sensitized guinea pigs.

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Spherusol Manufacturers

  • Nielsen Biosciences, Inc.
    Spherusol | Nielsen Biosciences, Inc.
    No Recall

    Spherusol | Nielsen Biosciences, Inc.

    Spherusol | Nielsen Biosciences, Inc.

    2.1 Preparation for Administration

    Spherusol ® is a clear, colorless sterile solution for intradermal administration.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exists, the skin test antigen should not be administered.

    2.2 Administration:

    Spherusol ® is administered as a 0.1 mL dose by intradermal injection to the volar surface of the forearm using a tuberculin syringe (0.5 or 1.0 mL) and a ½ inch 26-27 gauge needle. The needle should be inserted bevel side up in the skin at a 15-20 degree angle. Intradermal injection of 0.1 mL Spherusol ® will result in a bleb 5-10 mm in diameter at the injection site.

    2.3 Skin Test Assessment

    The injection site should be assessed for induration at 48 hours (±4 hours) following administration. The response to the skin test should be measured by taking the mean of the orthogonal diameters of the area of induration. A mean induration of ≥ 5 mm is considered a positive delayed-type hypersensitivity response to Spherusol ®.

    Repeat administration of Spherusol ® has not been evaluated.

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