Benzylpenicilloyl polylysine
Benzylpenicilloyl polylysine is used as a skin-testing reagent to detect immunoglobulin E antibodies in people with a history of penicillin allergy. The quantitation of in vitro IgE antibodies to the benzylpenicilloyl determinant is a useful tool for evaluating allergic subjects
Mechanism of effect
Benzylpenicilloyl polylysine, a conjugate of the benzylpenicilloyl structural group (hapten) and the poly-l-lysine carrier (protein), is an antigen which reacts with benzylpenicilloyl IgE antibodies to elicit the release of chemical mediators, thereby producing type I (immediate or accelerated) urticarial reactions in patients hypersensitive to penicillins
Drug indications
Adjunct in assessing the risk of administering penicillin (penicillin G or benzylpenicillin) in patients suspected of clinical penicillin hypersensitivity
Dosage
Dosing: Adult
Diagnostic aid for detection of penicillin allergy
Note: Benzylpenicilloyl polylysine should always be applied first via the puncture technique. Do not administer intradermally to patients who have a positive reaction to the puncture test
Puncture test: Apply a small drop of the skin test solution using a 22- to 28-gauge needle and make a single shallow puncture of the epidermis through the drop of solution. A positive reaction consists of a pale wheal surrounding the puncture site which develops within 10 minutes and ranges from 5-15 mm or more in diameter (wheal may be surrounded by erythema and variable degrees of itching). If a positive response is evident, the solution should be wiped off immediately. If the puncture test is negative or equivocal (<5 mm wheal, with little or no erythema and no itching) 15 minutes following the puncture test, an intradermal test may be performed
Intradermal test: Using a 0.5-1 mL tuberculin syringe with a 3/8 to 5/8 inch, 26- to 30-gauge short bevel needle, inject a volume of skin test solution sufficient to raise a small intradermal bleb ~3 mm in diameter intradermally, in duplicate at least 2 cm apart. A control of 0.9% sodium chloride or allergen-diluting solution should be injected at least 5 cm from the antigen test site. Most skin responses to the intradermal test will develop within 5-15 minutes. A response to the skin test is read at 20 minutes
Interpretation of intradermal test
Negative: No increase in size of original bleb or no greater reaction compared to the control site
Ambiguous: Wheal only slightly larger than original bleb with or without erythematous flare and slightly larger than control site; OR discordance between duplicate test sites
Positive: Itching and marked increase in size of original bleb to ≥5 mm. Wheal may exhibit pseudopods and be >20 mm in diameter
Control site should be reactionless. If wheal >2-3 mm develops at control site, repeat the test. If same reaction occurs, consultation is necessary
Dosing: Geriatric
Refer to adult dosing
Dosing: Pediatric
Diagnostic aid for detection of penicillin allergy (penicillin G and benzylpenicillin): Limited data available for assessment of other beta-lactams and cephalosporins allergy: Children and Adolescents
Note: Benzylpenicilloyl polylysine should always be applied first via the puncture technique. Do not administer intradermally to patients who have positive reactions to a puncture test
Puncture scratch test: Apply a small drop of the skin test solution using a 22- to 28-gauge needle and make a single shallow puncture of the epidermis through the drop of solution. A positive reaction consists of a pale wheal surrounding the puncture site which develops within 10 minutes and ranges from 5 to 15 mm or more in diameter (wheal may be surrounded by erythema and variable degrees of itching). If a positive response is evident, the solution should be wiped off immediately. If the puncture test is negative or equivocal (<5 mm wheal, with little or no erythema and no itching) 15 minutes following the puncture test, an intradermal test may be performed
Intradermal test: Using a 0.5 to 1 mL tuberculin syringe with a 3/8- to 5/8-inch, 26- to 30-gauge short bevel needle; inject a volume of skin test solution sufficient to raise a small intradermal bleb ~3 mm in diameter intradermally and duplicate at least 2 cm apart. A control of 0.9% sodium chloride or allergen-diluting solution should be injected at least 5 cm from the antigen test site. Most skin responses to the intradermal test will develop within 5 to 15 minutes. A response to the skin test is read at 20 minutes
Interpretation of intradermal test
Negative: No increase in size of original bleb or no greater reaction compared to the control site
Ambiguous: Wheal only slightly larger than original bleb with or without erythematous flare and slightly larger than control site; or discordance between duplicate test sites
Positive: Itching and marked increase in size of original bleb to ≥5 mm. Wheal may exhibit pseudopods and be >20 mm in diameter
Control site should be reactionless. If wheal >2 to 3 mm develops at control site, repeat the test. If same reaction occurs, consultation is necessary
Diagnostic aid for detection of penicillin allergy
Note: Benzylpenicilloyl polylysine should always be applied first via the puncture technique. Do not administer intradermally to patients who have a positive reaction to the puncture test
Puncture test: Apply a small drop of the skin test solution using a 22- to 28-gauge needle and make a single shallow puncture of the epidermis through the drop of solution. A positive reaction consists of a pale wheal surrounding the puncture site which develops within 10 minutes and ranges from 5-15 mm or more in diameter (wheal may be surrounded by erythema and variable degrees of itching). If a positive response is evident, the solution should be wiped off immediately. If the puncture test is negative or equivocal (<5 mm wheal, with little or no erythema and no itching) 15 minutes following the puncture test, an intradermal test may be performed
Intradermal test: Using a 0.5-1 mL tuberculin syringe with a 3/8 to 5/8 inch, 26- to 30-gauge short bevel needle, inject a volume of skin test solution sufficient to raise a small intradermal bleb ~3 mm in diameter intradermally, in duplicate at least 2 cm apart. A control of 0.9% sodium chloride or allergen-diluting solution should be injected at least 5 cm from the antigen test site. Most skin responses to the intradermal test will develop within 5-15 minutes. A response to the skin test is read at 20 minutes
Interpretation of intradermal test
Negative: No increase in size of original bleb or no greater reaction compared to the control site
Ambiguous: Wheal only slightly larger than original bleb with or without erythematous flare and slightly larger than control site; OR discordance between duplicate test sites
Positive: Itching and marked increase in size of original bleb to ≥5 mm. Wheal may exhibit pseudopods and be >20 mm in diameter
Control site should be reactionless. If wheal >2-3 mm develops at control site, repeat the test. If same reaction occurs, consultation is necessary
Dosing: Geriatric
Refer to adult dosing
Dosing: Pediatric
Diagnostic aid for detection of penicillin allergy (penicillin G and benzylpenicillin): Limited data available for assessment of other beta-lactams and cephalosporins allergy: Children and Adolescents
Note: Benzylpenicilloyl polylysine should always be applied first via the puncture technique. Do not administer intradermally to patients who have positive reactions to a puncture test
Puncture scratch test: Apply a small drop of the skin test solution using a 22- to 28-gauge needle and make a single shallow puncture of the epidermis through the drop of solution. A positive reaction consists of a pale wheal surrounding the puncture site which develops within 10 minutes and ranges from 5 to 15 mm or more in diameter (wheal may be surrounded by erythema and variable degrees of itching). If a positive response is evident, the solution should be wiped off immediately. If the puncture test is negative or equivocal (<5 mm wheal, with little or no erythema and no itching) 15 minutes following the puncture test, an intradermal test may be performed
Intradermal test: Using a 0.5 to 1 mL tuberculin syringe with a 3/8- to 5/8-inch, 26- to 30-gauge short bevel needle; inject a volume of skin test solution sufficient to raise a small intradermal bleb ~3 mm in diameter intradermally and duplicate at least 2 cm apart. A control of 0.9% sodium chloride or allergen-diluting solution should be injected at least 5 cm from the antigen test site. Most skin responses to the intradermal test will develop within 5 to 15 minutes. A response to the skin test is read at 20 minutes
Interpretation of intradermal test
Negative: No increase in size of original bleb or no greater reaction compared to the control site
Ambiguous: Wheal only slightly larger than original bleb with or without erythematous flare and slightly larger than control site; or discordance between duplicate test sites
Positive: Itching and marked increase in size of original bleb to ≥5 mm. Wheal may exhibit pseudopods and be >20 mm in diameter
Control site should be reactionless. If wheal >2 to 3 mm develops at control site, repeat the test. If same reaction occurs, consultation is necessary
Drug contraindications
Systemic or marked local reaction to a previous administration of benzylpenicilloyl polylysine skin test; patients with a known severe hypersensitivity to penicillin should not be tested
Side effects
Immunologic
Rare (less than 0.1%): Systemic allergic reaction
Frequency not defined
Cardiovascular: Hypotension
Dermatologic: Erythema, pruritus, urticaria (including local reaction at skin test site
Hypersensitivity: Angioedema, hypersensitivity reaction (including anaphylaxis; rare
Local: Local inflammation (intense; at skin test site
Respiratory: Dyspnea
Rare (less than 0.1%): Systemic allergic reaction
Frequency not defined
Cardiovascular: Hypotension
Dermatologic: Erythema, pruritus, urticaria (including local reaction at skin test site
Hypersensitivity: Angioedema, hypersensitivity reaction (including anaphylaxis; rare
Local: Local inflammation (intense; at skin test site
Respiratory: Dyspnea
Interactions
Alpha-/Beta-Agonists, Alpha1-Agonists, Antihistamines
Alerts
Safety and efficacy have not been established in patients younger than 18 years
Rare systemic allergic reactions, including anaphylaxis, have been associated with penicillin skin testing. Penicillin skin testing should only be performed by skilled medical personnel under direct supervision of a physician, and testing should be performed only in an appropriate healthcare setting prepared for the immediate treatment with epinephrine. To decrease the risk of a systemic allergic reaction, the manufacturer recommends puncture skin testing prior to intradermal testing
Patients with a reliable history of a severe life-threatening penicillin allergy, including Stevens-Johnson syndrome or TEN, should NOT receive penicillin skin testing
Rare systemic allergic reactions, including anaphylaxis, have been associated with penicillin skin testing. Penicillin skin testing should only be performed by skilled medical personnel under direct supervision of a physician, and testing should be performed only in an appropriate healthcare setting prepared for the immediate treatment with epinephrine. To decrease the risk of a systemic allergic reaction, the manufacturer recommends puncture skin testing prior to intradermal testing
Patients with a reliable history of a severe life-threatening penicillin allergy, including Stevens-Johnson syndrome or TEN, should NOT receive penicillin skin testing
Points of recommendation
Do not administer the intradermally test to patients who have a positive reaction to the puncture test
Skin test responses can be attenuated by interfering drugs (e.g., H1 antihistamines and vasopressors); use of this drug product should be delayed until the effects of such drugs have dissipated OR a separate skin test with histamine can be used to evaluate persistent antihistamine effects in vivo
Each ampule of this drug is for single patient use only and contains 0.25 mL, which is sufficient for both puncture and intradermal testing in duplicate in one patient; unused portions should be discarded
This drug product should be inspected visually for particulate matter and discoloration prior to administration
Optimal storage is under refrigeration (2 to 8 Celsius). This drug product should be discarded if subjected to ambient temperatures for more than 24 hours or if particulate matter and/or discoloration are present
Skin test responses can be attenuated by interfering drugs (e.g., H1 antihistamines and vasopressors); use of this drug product should be delayed until the effects of such drugs have dissipated OR a separate skin test with histamine can be used to evaluate persistent antihistamine effects in vivo
Each ampule of this drug is for single patient use only and contains 0.25 mL, which is sufficient for both puncture and intradermal testing in duplicate in one patient; unused portions should be discarded
This drug product should be inspected visually for particulate matter and discoloration prior to administration
Optimal storage is under refrigeration (2 to 8 Celsius). This drug product should be discarded if subjected to ambient temperatures for more than 24 hours or if particulate matter and/or discoloration are present
Pregnancy level
C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Safety has not been established during pregnancy; this drug product should not be used
unless the benefit outweighs the risk
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Safety has not been established during pregnancy; this drug product should not be used
unless the benefit outweighs the risk
Breast feeding warning
The manufacturer makes no recommendation regarding use during lactation
Drug forms
Pre-Pen
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