Trichophyton mentagrophytes and trichophyton rubrum

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# Black Box Warning

# Overview
Trichophyton mentagrophytes and trichophyton rubrum is an antifungal agent that is FDA approved for the diagnosis of type I hypersensitivity (i.e. allergy) to  fungus. There is a Black Box Warning for this drug as shown here.  Common adverse reactions include anaphylaxis, fainting, pallor, bradycardia, hypotension,angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- Intradermal skin tests with Trichophyton extract are indicated for use in persons who are suspected of having Type I hypersensitivity (i.e. allergy) to the fungus.

# Dosage
- INTRADERMAL TEST The intradermal test is performed by administering 0.1 mL of extract into the skin. The injection should be given as superficially as possible creating a distinct bleb approximately 5 mm in diameter. The tests should be examined after 15 - 20 minutes and read as negative or positive. Test sites that show a wheal and flare response should be measured and reported in mm of edema and erythema or scored as 1+ to 4+ based on a mm reference scale. Induration after 24 - 48 hours can occur in some individuals and also may be recorded in mm.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Trichophyton mentagrophytes and trichophyton rubrum in adult patients.

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-Supported Use of Trichophyton mentagrophytes and trichophyton rubrum in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

# Indications
- Intradermal skin tests with Trichophyton extract are indicated for use in persons who are suspected of having Type I hypersensitivity (i.e. allergy) to the fungus.

# Dosage
- INTRADERMAL TEST The intradermal test is performed by administering 0.1 mL of extract into the skin. The injection should be given as superficially as possible creating a distinct bleb approximately 5 mm in diameter. The tests should be examined after 15 - 20 minutes and read as negative or positive. Test sites that show a wheal and flare response should be measured and reported in mm of edema and erythema or scored as 1+ to 4+ based on a mm reference scale. Induration after 24 - 48 hours can occur in some individuals and also may be recorded in mm.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Trichophyton mentagrophytes and trichophyton rubrum in pediatric patients.

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-Supported Use of Trichophyton mentagrophytes and trichophyton rubrum in pediatric patients.

# Contraindications
- Conditions under which the administration of allergenic extract may be contraindicated, depending upon individual circumstances, include: extreme sensitivity to an  allergen - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; myocardial infarction - Patients who have experienced a recent myocardial infarction may be less able to tolerate the life-threatening effects of a serious adverse reaction. Asthma - Patients with highly unstable asthma are at greater risk of fatal reactions from skin tests than are patients without asthma, especially during seasonal exacerbations of the disease. Also, the combination of unstable asthma and treatment with B-adrenergic blockers appears to increase this risk5. Allergenic extract should be temporarily withheld from patients if any of the following conditions exist: 1) severe symptoms of hay fever and/or asthma; 2) infection or flu accompanied by fever; and 3) exposure to excessive amounts of clinically relevant allergen(s) prior to skin testing.

# Warnings
- Physicians who use allergenic extracts should have a knowledge and practical understanding of allergy skin testing as described in the published literature6,7,8.
- Allergenic extracts are manufactured to assure high potency and therefore have the ability to cause serious local and systemic reactions, including death in highly sensitive patients5. Patients should be informed of the risks of skin testing and instructed in the recognition of symptoms of an adverse allergic reaction.
- Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to allergens to which he or she is sensitive.

# Adverse Reactions

## Clinical Trials Experience
- Local reactions large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral anti-histamines.
- Systemic reactions Allergenic extracts are highly potent and in highly sensitive individuals can cause systemic symptoms, including anaphylaxis. It cannot be overemphasized that anaphylactic shock is always a possibility under certain unpredictable combinations of circumstances. Other possible systemic reaction symptoms may include fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. Therefore, it is imperative that physicians administering skin tests understand and be prepared to treat severe allergic reactions.
- If a systemic or anaphylactic reaction occurs during or following skin testing, the patient should be treated with 1:1000 epinephrine hydrochloride. The recommended dose: infants to 2 years of age 0.05 to 0.1 mL, children 2 to 6 years, 0.15 mL, children 6 to 12 years, 0.2 mL, adults 0.3 - 0.5 mL. If necessary, treatment may be repeated up to three times every 10 - 15 minutes.
- After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Oxygen should be given by mask. Intravenous antihistamine, aminophylline, inhaled bronchodilators or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately. The physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment is of utmost importance14.
- Serious adverse reactions should be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Office Of The Center Director, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 5100, Rockville, MD 20852, Telephone (800) 332-1088.

## Postmarketing Experience
- There is limited information regarding Postmarketing Experience of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

# Drug Interactions
- Treatment with beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to control an adverse reaction11.
- Since drugs may affect the reactivity of the skin, patients should be instructed to avoid medications, particularly antihistamines and sympathomimetic drugs for at least 24 hours prior to skin testing. Non-sedating antihistamine suppresses the erythema/edema response for longer periods and should be withheld according to information included in the package insert. Adrenal corticosteroids and ACTH do not alter the immediate hypersensitivity reaction of the skin but do reduce delayed-type reactions associated with cellular hypersensitivity.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- PREGNANCY CATEGORY C Allergenic Extracts. Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed. Since studies indicate no increased risk to the fetus or to the mother who is treated cautiously with immunotherapy during a normal pregnancy, it is unlikely that extract administered by skin test will be harmful. However, on the basis of histamine's known ability to contract uterine muscle, extensive testing with its possibility of histamine release should be avoided during pregnancy. Also, immunologic suppressive action can occur during pregnancy and for this reason it is possible that the results of allergy skin tests may not accurately reflect the allergic state of the pregnant patient12.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
- There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trichophyton mentagrophytes and trichophyton rubrum in women who are pregnant.

### Labor and Delivery
- There is no FDA guidance on use of Trichophyton mentagrophytes and trichophyton rubrum during labor and delivery.

### Nursing Mothers
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extract is administered to a nursing woman.

### Pediatric Use
- The procedures and precautions that are observed in skin testing adults should be observed with children.

### Geriatic Use
- There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum with respect to geriatric patients.

### Gender
- There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum with respect to specific gender populations.

### Race
- There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum with respect to specific racial populations.

### Renal Impairment
- There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum in patients with renal impairment.

### Hepatic Impairment
- There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum in patients with hepatic impairment.

### Females of Reproductive Potential and Males
- There is no FDA guidance on the use of Trichophyton mentagrophytes and trichophyton rubrum in women of reproductive potentials and males.

### Immunocompromised Patients
- There is no FDA guidance one the use of Trichophyton mentagrophytes and trichophyton rubrum in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Dermal Patch
- Prior to administering skin tests, the skin should be cleaned with alcohol and allowed to dry completely. The tests should be placed on the volar surface of the forearm and four rows may be placed on the back.

### Monitoring
- There is limited information regarding Monitoring of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

# IV Compatibility
- There is limited information regarding IV Compatibility of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

# Overdosage
- The signs and symptoms of overdosage are the same as those listed under adverse reactions.
- The treatment of a systemic allergic reaction resulting from skin tests should include the following:
- The patient should be placed in the recumbent position to maintain blood flow to the head.
- Aqueous epinephrine 1:1,000 should be administered subcutaneously.
- Reassurance should be provided.
- The above steps should be performed nearly simultaneously and as soon as possible after the reaction begins. Persistent wheezing may necessitate treatment with intravenous aminophylline and inhaled bronchodilators. For profound shock and hypotension, intravenous fluids, vasopressors and oxygen also may be needed.
- Maintenance of an open airway is critical if upper airway obstruction is present. Corticosteroids may provide benefit if symptoms are prolonged or recurrent.

# Pharmacology

## Mechanism of Action
There is limited information regarding Mechanism of Action of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

## Structure
- Trichophyton extract for diagnostic skin testing is a sterile solution that is prepared by extracting allergenic source material of equal parts of Trichophyton mentagrophytes and Trichophyton rubrum with an aqueous solution of 0.25% sodium chloride, 0.125% sodium bicarbonate and 50% glycerol v/v. Phenol is added at 0.4% w/v as a preservative. Extract for intradermal administration is diluted with the above solution without glycerol.
- Weight by volume (W/V) Weight by volume refers to the weight of raw product added to a measured volume of extraction solution. A 1:500 w/v extract contains 1 gram of source material in 500 mL of solution. The w/v designation refers to concentration rather than potency. Extract labeled w/v has no U.S. Standard of Potency.

## Pharmacodynamics
- There is limited information regarding Pharmacodynamics of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

## Pharmacokinetics
- There is limited information regarding Pharmacokinetics of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

## Nonclinical Toxicology
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
- Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.

# Clinical Studies
- There is limited information regarding Clinical Studies of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

# How Supplied
- One mL of extract for intradermal skin testing is supplied in 2 mL sealed multidose vials. Each vial contains enough extract for 10 tests.

## Storage
- Extract should be stored at 2C to 8C, since higher temperatures may adversely affect the stability of allergens. Do not freeze.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- There is limited information regarding Patient Counseling Information of Trichophyton mentagrophytes and trichophyton rubrum in the drug label.

# Precautions with Alcohol
- Alcohol-Trichophyton mentagrophytes and trichophyton rubrum interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- TRICHOPHYTON FOR INTRADERMAL SKIN TESTING 

# Look-Alike Drug Names
- A  B

# Drug Shortage Status

# Price