Coccidioides Immitis Spherule

In individuals with a history of pulmonary coccidioidomycosis Spherusol ® is thought to elicit a cellular immune reaction to C. immitis , as evidenced by a delayed-type hypersensitivity (DTH) response to Coccidioidin (1,2,3,4) .

• 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.

• A severe allergic reaction (e.g., anaphylaxis) to Spherusol ® , or any component of Spherusol ® or other coccidioidin products is a contraindication to administration. Severe allergic reaction (e.g., anaphylaxis) to Spherusol ® , or any component of Spherusol ® or other coccidioidin products.contraindicated

A single 0.1 mL intradermal injection. Induration at injection site to be evaluated 48 hours after administration. ( 2.1 , 2.3 ) 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.

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 ® . ( 5.1 ) Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine in cases of hypersensitivity. ( 5.2 ) 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 ® . ( 5.3 ) 5.1 Prevention and Management of Acute Hypersensitivity Reactions Prior to administration, the healthcare provider should review the medical history for possible skin test sensitivity and previous skin test related adverse reactions to assess the risks and benefits. Immediate hypersensitivity, to include severe systemic reactions, may occur following administration of skin test antigens. Medications and equipment to manage possible anaphylactic reactions should be available for immediate use. Patients should be observed for a minimum of 30 minutes following administration to assess for adverse reactions. 5.2 Patients on Beta Blockers Patients receiving beta blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. 5.3 Immunosuppression 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 ® .

The most commonly reported local adverse reactions were itching and swelling (>75%) and pain (>15%) within 7 days of administration.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Nielsen Biosciences, Inc. at (855) 855-1212 or Food and Drug Administration (FDA) at 1-800-332-1088 or www.vaers.hhs.gov . ( 6.3 ) 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a skin test antigen cannot be directly compared to rates in the clinical trials of another skin test antigen, and may not reflect the rates observed in practice. As with any skin test antigen, there is the possibility that broad use of Spherusol ® could reveal adverse reactions not observed in clinical trials. In a double-blinded placebo-controlled clinical trial conducted in areas of the U.S. endemic for C. immitis (Bakersfield, CA and Tucson, AZ), 54 adults (23-64 years of age) with a history of pulmonary coccidioidomycosis of at least 45 days duration, diagnosed by clinical findings, radiography and serological and/or mycological evidence of the disease, received a single dose of Spherusol ® concomitantly with two licensed skin test extracts (Candin ® and Trichophyton) and two controls (product diluent [thimerosal ≤0.0001%] and saline). Each intradermal injection of 0.1 mL of reagent was given at pre-determined sites on the right and left forearms. Solicited local adverse reactions and systemic adverse events occurring within 7 days after injection were recorded by study subjects via diary card.

The safety and effectiveness of Spherusol ® in pregnant and nursing women have not been established. ( 8.1 , 8.3 ) 8.1 Pregnancy The safety and effectiveness of Spherusol ® in pregnant women have not been established. Pregnancy Category C Animal reproduction studies have not been conducted with Spherusol ® . It is also not known whether Spherusol ® can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Spherusol ® should be given to a pregnant woman only if clearly needed. 8.2 Labor and Delivery No information is available to assess the effects of Spherusol ® on childbirth. 8.3 Nursing Mothers The safety and effectiveness of Spherusol ® in nursing women have not been established. It is not known whether Spherusol ® is excreted in human milk. However, because the potential exists for Spherusol ® to be excreted in human milk, caution should be exercised when administering Spherusol ® to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of Spherusol ® in the pediatric population have not been established. 8.5 Geriatric Use The safety and effectiveness of Spherusol ® have not been established in individuals >65 years of age.

The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Coccidioides Immitis Spherule as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Multi-center Study of Spherule-Derived Coccidioidin
  Completed · Phase 3 · Interventional · 113 enrolled · Nielsen BioSciences, Inc.
  NCT00690092updated 2013-10-29

Frequently asked questions

How does Coccidioides Immitis Spherule work?

In individuals with a history of pulmonary coccidioidomycosis Spherusol ® is thought to elicit a cellular immune reaction to C. immitis , as evidenced by a delayed-type hypersensitivity (DTH) response to Coccidioidin (1,2,3,4) .

What is Coccidioides Immitis Spherule used for?

According to FDA labeling, Coccidioides Immitis Spherule carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Coccidioides Immitis Spherule?

Coccidioides Immitis Spherule is classified as Skin Test Antigen, Cell-mediated Immunity.

What are the brand names for Coccidioides Immitis Spherule?

Coccidioides Immitis Spherule is marketed under brand names including Spherusol.

What are the contraindications for Coccidioides Immitis Spherule?

Coccidioides Immitis Spherule labeling lists contraindications including: A severe allergic reaction (e.g., anaphylaxis) to Spherusol ® , or any component of Spherusol ® or other coccidioidin products is a contraindication to administration. Severe allergic reaction (e.g., anaphylaxis) to Spherusol ® , or any component of Spherusol ® or other coccidioidin products.. Always consult the full prescribing information and a clinician.