candida albicans extract

Action and Spectrum

Actions and Spectrum: 

Actions: 

The only skin testing antigen based on an extract from Candida albicans that has been approved by the FDA for intradermal injection to determine cell-mediated hypersensitivity to Candida albicans is CANDIN. It is not recommended to diagnose or treat Type 1 Candida albicans allergies using CANDIN. 

Spectrum: 

Dermatologists have employed intralesional injection immunotherapy for verruca vulgaris and plantar warts using Candida albicans allergenic extract 1:1000 (CAE). Despite its effectiveness, the precise mechanism of action remains incompletely understood. Toll-like receptors (TLRs), recognized as pattern recognition receptors that identify microbial pathogens, constitute a crucial component of the innate immune system’s initial defense. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Local reactions in immediate hypersensitivity may manifest as swelling, itching,  pain, and blistering at the test site within 15-20 minutes post-administration. The occurrence of necrosis is a potential outcome. 

Although systemic reactions have not been documented, it is crucial to acknowledge the remote possibility of any foreign antigens, including the potential for inducing Type 1 anaphylaxis and, in extreme cases, death when administered intradermally. 

Black Box Warning

Black Box Warning: 

The anticipated response to the candida albicans skin test antigen involves localized inflammation at the test site. The reaction size is contingent on the individual’s sensitivity, typically ranging from dime to quarter size, with the maximum diameter occurring between 24 and 48 hours. Occasionally, larger accelerated reactions may occur, necessitating treatment with local cold compresses and anti-inflammatory medication. 

Skin test antigens can induce systemic reactions, and in specific cases, these reactions may pose a life-threatening risk or result in death. Immediate access to emergency measures and trained personnel is crucial in the event of a life-threatening reaction. Patients should be under observation for at least 20 minutes following the skin test administration. It is essential to never administer Candida albicans skin test antigen intravenously. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 

Cautions 

• Renal impairment 
• Hepatic impairment 
• Drug interactions 
• Pregnancy  
• Breastfeeding 
• Unexpected larger reactions can occur after administering a skin test, as indicated in the Boxed Warning. 
• There is a risk of life-threatening or fatal systemic reactions. Any severe adverse reactions should be reported to the manufacturer or the FDA. 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

Intracutaneous testing with viral, bacterial,  and fungal antigens, to which the majority of healthy individuals are sensitized, can evaluate cellular hypersensitivity or delayed-type hypersensitivity (DTH). A positive skin test indicates prior exposure to the antigen, T-cell competency, and an intact inflammatory response. The typical manifestation of this reaction is induration at the test site, reaching its peak between 24 and 48 hours after introducing the antigen into the skin. 

Pharmacodynamics: 

The inflammatory response linked to the delayed-type hypersensitivity (DTH) reaction is marked by the infiltration of lymphocytes and macrophages at the location where the antigen is deposited. Key cell types implicated in the DTH response include CD4+ and CD8+ T lymphocytes, which exit the recirculating lymphocyte pool in reaction to external antigens. Both CD4+ and CD8+ lymphocytes have been identified in DTH reactions induced by Candida antigen. 

Pharmacokinetics: 

N/A 

Adminstartion

Administration: 

Administer via intradermal route; refrain from intravenous injection. Exercise caution to prevent inadvertent injection into a blood vessel. Conduct intradermal injections on the volar surface of the forearm or the outer aspect of the upper arm.

Ensure superficial administration, creating a distinct and sharply defined bleb. Injecting the product subcutaneously may yield an unreliable reaction. Prior to the skin test, cleanse the skin with 70% alcohol. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: candida albicans extract 

Pronounced: Can-di-duh al-bi-kanz ek-strakt 

Why do we use candida albicans extract? 

It is suggested for use as a recall antigen in intracutaneous (intradermal) testing to detect cell-mediated hypersensitivity. It is a valuable tool for the cellular immune response evaluation in patients suspected of having reduced cellular hypersensitivity.

It’s noteworthy that not all individuals with normal cellular immunity demonstrate hypersensitivity to Candida, so an expected response rate of less than 100% to the antigen is common in normal individuals. Therefore, it is recommended to use other licensed skin test antigens simultaneously to assess cell-mediated hypersensitivity.