The expected response to Candida albicans skin test antigen is a local area of inflammation at the site of the skin test. The size of reaction depends on the sensitivity of the person receiving the test, but 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 as well as personnel trained in their use should be immediately available in the event of a life-threatening reaction. Patients should be observed for at least 20 minutes following the administration of a skin test.
C. albicans skin test antigen should never be given intravenously (IV).
Serious adverse reactions to C. albicans skin test antigen should be reported to Nielsen Biosciences, Inc. at (855) 855-1212 or Medwatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9782, (800) 332-1088 or www.vaers.hhs.gov.
Anergy testing: Intradermal: 0.1 mL; concurrent use of other licensed cell-mediated hypersensitivity skin test antigens is recommended. Note: Examine reaction site in 48 hours; induration ≥5 mm in diameter is a positive reaction.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Dermatologic: Localized vesiculation
Hypersensitivity: Type I hypersensitivity reaction
Local: Local pruritus, local swelling
Hypersensitivity or other previous unacceptable adverse reaction to C. albicans skin test antigen, similar products, or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: [US Boxed Warning]: Systemic reactions, possibly fatal, can occur; observe patients for ≥20 minutes following administration. Emergency care as well as trained personnel should be immediately available in the event of a life-threatening reaction. Expected response is a local area of inflammation at the administration site; size of reaction depends on the sensitivity of the patient (usually dime to quarter size reaching maximum diameter between 24 and 48 hours). Larger accelerated reactions (eg, itching, swelling, pain, blistering) can occur and may require treatment (eg, local cold compresses, anti-inflammatory medication).
Disease-related concerns:
• Bleeding disorders: Bruising and nonspecific induration may occur because of the trauma of skin test administration trauma in patients with bleeding tendencies.
Special populations:
• Older adult: Delayed-type hypersensitivity response may be diminished.
Other warnings/precautions:
• Administration: [US Boxed Warning]: Should never be given intravenously; must be injected intradermally as superficially as possible.
• Adverse event reporting: [US Boxed Warning]: Serious adverse reactions to Candida albicans skin test antigen should be reported to the manufacturer or the FDA.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection:
Generic: 1:10 (5 mL)
Solution, Intradermal:
Candin: (1 mL) [contains albumin human, phenol, polysorbate 80]
Generic: (5 mL)
Yes
Solution (Candida Albicans Skn Tst Antgn Injection)
1:10 (per mL): $30.00
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Intradermal: Administer intradermally on the volar surface of forearm or on the outer aspect of the upper arm; do not administer IV or subcutaneously. Injection should be as superficial as possible, resulting in a sharply defined bleb at the skin test site. Examine reaction site in 48 hours; induration ≥5 mm in diameter is a positive reaction.
Anergy testing: Use as a recall antigen for detecting cell-mediated hypersensitivity by intracutaneous (intradermal) testing; may be useful in evaluating the cellular immune response in patients suspected of having reduced cellular hypersensitivity. Concurrent use of other licensed cell-mediated hypersensitivity skin test antigens is recommended.
Limitations of use: Should not be used to diagnose or treat Type 1 allergy to C. albicans.
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted. Anergy testing is not expected to be influenced by pregnancy (Jackson 2001).
It is not known if C. albicans is present in breast milk. The manufacturer recommends that caution be exercised when administering C. albicans to breastfeeding women.
Cellular hypersensitivity or delayed-type hypersensitivity (DTH) can be assessed by intracutaneous testing with C. albicans antigens to which most healthy persons are sensitized. A positive skin test denotes prior antigenic exposure, T-cell competency, and an intact inflammatory response.
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