Frequently Asked Questions About CANDIN®

What Is CANDIN®?
CANDIN® (Candida albicans Skin Test Antigen to Assess Cellular Hypersensitivity) is prepared and extracted from cultures of key strains of the yeast Candida albicans grown in a chemically-defined media. The potency is controlled by clinical testing in normal subjects with pre-determined enrollment criteria. It is packaged as a sterile, ready-to-use aqueous solution in a multi-dose vial (10 tests/vial).

How Does CANDIN® Work?
The antigens present in CANDIN® elicit a response of the cellular immunity system when injected intradermally. The response, known as delayed-type hypersensitivity (DTH), demonstrates cellular immunity to Candida and the ability of the cellular immune system to produce DTH. Not all people with intact cellular immunity react to Candida extracts, so the response to CANDIN® is not 100%. Clinical studies have shown about 80% of subjects without immunocompromised status produce a positive (>5mm) response to CANDIN.

How Is CANDIN Administered?
CANDIN is used according to the Mantoux Method. It is administered by an intradermal injection of 0.1 mL (cc) to the volar surface of the forearm or outer aspect of the upper arm. Caution must be exercised to avoid subcutaneous or intravenous injections. The injection site is evaluated by a trained health care professional approximately 48 hours after injection. The site is evaluated for the diameter of observed induration (swelling). A positive response to CANDIN® is an area of induration of ≥5 mm.

CANDIN is intended for use by physicians who are experienced in the intradermal administration of a skin test antigen. Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life threatening or cause death. Patients should be observed for at least 20 minutes following the administration of a skin test. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life-threatening reaction."

This is not all of the information needed for dosage and administration of CANDIN®. See Full Prescribing Information. For additional information, see Mantoux Method.

How Can CANDIN Aid Tuberculin Skin Testing?
The tuberculin skin test (TST) is a standard method of determining whether a person is infected with Mycobacterium tuberculosis. The TST is performed by injecting 0.1 mL of tuberculin purified protein derivative (PPD) into the inner surface of the forearm by intradermal injection. Some persons may not react to TST even though they are infected with M. tuberculosis. The reasons for these false-negative reactions may include the following:

Anergic patients may not react properly to TSTs. Concurrent testing with CANDIN® can help assess a patient’s state of anergy, contributing to interpretation of TST. For more information, see Tuberculin Skin Testing.

What is Anergy?

Anergy, in regard to skin testing, is a state of altered cellular immune function that prevents the body from developing a DTH response. Anergy can arise from a variety of causes:

INDICATION AND USAGE

CANDIN is a skin test antigen to assess cellular hypersensitivity to Candida albicans.  CANDIN should not be used to diagnose or treat Type 1 allergy to Candida albicans.

IMPORTANT SAFETY INFORMATION FOR CANDIN: 

 WARNING:

The expected response to CANDIN 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.

CANDIN should never be given intravenously.

Contraindication:

CANDIN should not be used after a previous unacceptable adverse reaction to this antigen or to a similar product, i.e., extreme hypersensitivity/allergy.

Warnings and Precautions:

The antigen must be injected intradermally. Do not inject intravenously.

As has been observed with other, unstandardized, antigens used for DTH skin testing, it is possible that some patients may have exquisite immediate hypersensitivity to CANDIN.

Physicians using this product must have facilities, equipment and medication necessary to treat potential side effects. Epinephrine and oxygen must be immediately available in the event of a serious systemic response.

Adverse Reactions:

Immediate hypersensitivity local reactions can include itching, swelling, pain and blistering at the test site occurring 15-20 minutes after administration. Necrosis is possible.

Systemic reactions to CANDIN have not been observed, however all foreign antigens have the remote possibility of causing Type 1 anaphylaxis and even death when injected intradermally.

Drug Interactions:

Pharmacologic doses of corticosteroids may variably suppress the DTH skin test response after two weeks of therapy.

Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine, in the event that epinephrine is required to control an adverse allergic reaction

Use in Specific Populations:

It is not known whether CANDIN can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. CANDIN should be given to pregnant women only if clearly needed.

It is not known whether CANDIN is excreted in human milk. Caution should be exercised when administered to a nursing woman.

Use in pediatric populations has not been established.

Geriatric populations may have a diminished response to the skin test.This Important Safety Information does not contain all the information needed to use CANDIN safely and effective. Please see Full Prescribing Information for additional information.

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