Version May 2024
The expected response to Coccidioides immitis skin test 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.
Coccidioides immitis skin test should never be given intravenously.
To report SUSPECTED ADVERSE REACTIONS contact the manufacturer at (855) 855-1212 or MEDWATCH, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852, Telephone: (800) 332-1088 or www.vaers.hhs.gov.
Coccidioides immitis skin test antigen: Intradermal: 0.1 mL; repeat administration has not been evaluated.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported following concomitant injections with other skin test extracts, product diluent, and saline; frequencies may not be specific to the Coccidioides immitis antigen.
>10%: Local: Itching at injection site (85%), swelling at injection site (79%), pain at injection site (17%)
1% to 10%:
Cardiovascular: Increased heart rate (4%)
Central nervous system: Dizziness (2%) , fatigue (2%)
Dermatologic: Skin ulceration at injection site (including necrosis, 4%)
Gastrointestinal: Gastrointestinal symptoms (nausea/cramps, 2%)
Local: Erythema at injection site (2%), injection site reaction (sensitivity, 2%)
Neuromuscular & skeletal: Weakness (6%), arthralgia (2%)
Respiratory: Flu-like symptoms (7%), cough (2%)
Severe allergic reaction (eg, anaphylaxis) to Coccidioides immitis skin test, or any component of the formulation, or other coccidioidin products.
Concerns related to adverse effects:
• Hypersensitivity reactions: [US Boxed Warning]: Systemic reactions can occur with skin test antigens and may be life-threatening (some fatal). Observe patients for at least 30 minutes after an injection in case an immediate hypersensitivity reaction occurs; resuscitative equipment and medications to manage anaphylactic reactions should be available.
• 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.
Other warnings/precautions:
• Appropriate use: [US Boxed Warning]: Do not administer intravenously. The use of Coccidioides immitis skin test to detect delayed-type hypersensitivity response in the general population with unknown exposure to Coccidioides immitis has not been evaluated.
• Skin test response: [US Boxed Warning]: The expected response is local inflammation at the site of the skin test. This reaction is usually a dime to quarter in 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. Individuals with acute or disseminated coccidioidomycosis or individuals with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intradermal:
Spherusol: 127 mcg/0.1 mL (1 mL) [contains phenol, thimerosal (thiomersal)]
No
Solution (Spherusol Intradermal)
127 mcg/0.1 mL (per mL): $1,380.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Intradermal: Inject intradermally in the volar surface of forearm using a tuberculin syringe (0.5 or 1 mL) and a 1/2" 26- or 27-gauge needle.
Positive reaction: Induration of 5 mm or more (usually 5 to 10 mm in diameter and dime to quarter in size); assess for induration at 48 hours following administration. An immediate reaction (15 minutes to 1 hour following administration and persisting for up to 24 hours) may occur in some patients; however, these wheals do not represent a positive reaction (Wack 2015).
Coccidioides immitis skin test antigen: For detection of delayed-type hypersensitivity to Coccidioides immitis in individuals 18 to 64 years of age with a history of pulmonary coccidioidomycosis.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Corticosteroids (Systemic): May diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing systemic corticosteroids (dosed at 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks) several weeks prior to coccidioides immitis skin antigen testing. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
Methotrexate: May diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing methotrexate several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
Animal reproduction studies have not been conducted.
It is not known if Coccidioides immitis antigen is excreted in breast milk. The manufacturer recommends that caution be exercised when administering to a nursing women.
Hypersensitivity reactions (30 minutes after injection)
Elicits a cellular immune reaction to Coccidioides immitis, as evidenced by a delayed-type hypersensitivity (DTH) response to coccidioidin based on the interaction of antigen with CD4 and CD8 lymphocytes followed by the secretion of interleukins and other lymphokines from macrophage cells. The release of effector molecules causes endothelial cells lining the blood vessels to become permeable and allows fibrinogen to escape into the surrounding tissue where it is converted to fibrin. The deposition of fibrin and the accumulation of T-cells and monocytes within the extracellular spaces cause the tissue to swell and become indurated.
Time to peak: 48 hours
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