Benzylpenicilloyl Polylysine: Difference between revisions
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|genericName=Benzylpenicilloyl Polylysine | |genericName=Benzylpenicilloyl Polylysine | ||
|aOrAn=a | |aOrAn=a | ||
|drugClass=Diagnostic Agent | |drugClass=[[Diagnosis|Diagnostic Agent]] | ||
|indicationType=diagnosis | |indicationType=diagnosis | ||
|indication=sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity | |indication=[[sensitization]] to [[penicillin]] ([[benzylpenicillin]] or [[penicillin G]]) in patients suspected to have clinical [[penicillin]] [[hypersensitivity]] | ||
|adverseReactions=allergic reaction, local inflammatory response | |adverseReactions=[[allergic reaction]], [[Inflammation|local inflammatory response]] | ||
| Line 19: | Line 19: | ||
<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult=====Indications==== | |fdaLIADAdult=====Indications==== | ||
* PREPEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PREPEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PREPEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PREPEN predicts a lower risk of anaphylaxis is not established. Similarly, when deciding the risk of proposed penicillin treatment, there are not enough data at present to permit relative weighing in individual cases of a history of clinical penicillin hypersensitivity as compared to positive skin tests to PREPEN and/or minor penicillin determinants. | * PREPEN is indicated for the assessment of [[sensitization]] to [[penicillin]] ([[benzylpenicillin]] or [[penicillin G]]) in patients suspected to have clinical [[penicillin]] [[hypersensitivity]]. A negative skin test to PREPEN is associated with an incidence of immediate [[allergic reactions]] of less than 5% after the administration of therapeutic [[penicillin]], whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PREPEN. These [[allergic reactions]] are predominantly [[dermatologic]]. Whether a negative skin test to PREPEN predicts a lower risk of [[anaphylaxis]] is not established. Similarly, when deciding the risk of proposed [[penicillin]] treatment, there are not enough data at present to permit relative weighing in individual cases of a history of clinical [[penicillin]] [[hypersensitivity]] as compared to positive skin tests to PREPEN and/or minor [[penicillin]] determinants. | ||
====Dosage==== | ====Dosage==== | ||
SKIN TESTING DOSAGE AND TECHNIQUE | =====SKIN TESTING DOSAGE AND TECHNIQUE===== | ||
Skin testing responses can be attenuated by interfering drugs (e.g. H1antihistamines and vasopressors). Skin testing should be delayed until the effects of such drugs have dissipated, or a separate skin test with histamine can be used to evaluate persistent antihistaminic effects in vivo. Due to the risk of potential systemic allergic reactions, skin testing should be performed in an appropriate healthcare setting under direct medical supervision. | * Skin testing responses can be attenuated by interfering drugs (e.g. [[H1antihistamines]] and [[vasopressors]]). Skin testing 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|antihistaminic]] effects in vivo. Due to the risk of potential systemic [[allergic reactions]], skin testing should be performed in an appropriate healthcare setting under direct medical supervision. | ||
Puncture Testing: | =====Puncture Testing:===== | ||
Skin testing is usually performed on the inner volar aspect of the forearm. The skin test antigen should always be applied first by the puncture technique. After preparing the skin surface, apply a small drop of PREPEN solution using a sterile 2228 gauge needle. The same needle can then be used to make a single shallow puncture of the epidermis through the drop of PREPEN. Very little pressure is required to break the epidermal continuity. Observe for the appearance of a wheal, erythema, and the occurrence of itching at the test site during the succeeding 15 minutes at which time the solution over the puncture site is wiped off. A positive reaction consists of the development within 10 minutes of a pale wheal, sometimes with pseudopods, surrounding the puncture site and varying in diameter from 5 to 15 mm (or more). This wheal may be surrounded by a variable diameter of erythema, and accompanied by a variable degree of itching. The most sensitive individuals develop itching quickly, and the wheal and erythema are prompt in their appearance. As soon as a positive response as defined above is clearly evident, the solution over the scratch should be immediately wiped off. If the puncture test is either negative or equivocally positive (less than 5 mm wheal with little or no erythema and no itching), an intradermal test may be performed. | * Skin testing is usually performed on the inner volar aspect of the forearm. The skin test antigen should always be applied first by the puncture technique. After preparing the skin surface, apply a small drop of PREPEN solution using a sterile 2228 gauge needle. The same needle can then be used to make a single shallow puncture of the epidermis through the drop of PREPEN. Very little pressure is required to break the epidermal continuity. Observe for the appearance of a wheal, erythema, and the occurrence of itching at the test site during the succeeding 15 minutes at which time the solution over the puncture site is wiped off. A positive reaction consists of the development within 10 minutes of a pale wheal, sometimes with [[pseudopods]], surrounding the puncture site and varying in diameter from 5 to 15 mm (or more). This wheal may be surrounded by a variable diameter of [[erythema]], and accompanied by a variable degree of itching. The most sensitive individuals develop itching quickly, and the wheal and [[erythema]] are prompt in their appearance. As soon as a positive response as defined above is clearly evident, the solution over the scratch should be immediately wiped off. If the puncture test is either negative or equivocally positive (less than 5 mm wheal with little or no [[erythema]] and no itching), an [[intradermal]] test may be performed. | ||
The lntradermal Test: | =====The lntradermal Test:===== | ||
Using a 0.5 to 1.0 cc syringe with a 3/8” to 5/8”long, 26 to 30 gauge, short bevel needle, withdraw the contents of the ampule. Prepare with an alcohol swab a skin test area on the upper, outer arm, sufficiently below the deltoid muscle to permit proximal application of a tourniquet later, if necessary. Be sure to eject all air from the syringe through the needle, then insert the needle, bevel up immediately below the skin surface. Inject an amount of PREPEN sufficient to raise a small intradermal bleb of about 3 mm in diameter, in duplicate at least 2 cm apart. Using a separate syringe and needle, inject a like amount of saline or allergen diluting solution as a control at least 5 cm removed from the antigen test sites. Most skin reactions will develop within 5-15 minutes and response to the skin test is read at 20 minutes as follows: | * Using a 0.5 to 1.0 cc syringe with a 3/8” to 5/8”long, 26 to 30 gauge, short bevel needle, withdraw the contents of the ampule. Prepare with an [[alcohol]] swab a skin test area on the upper, outer arm, sufficiently below the [[deltoid]] muscle to permit proximal application of a tourniquet later, if necessary. Be sure to eject all air from the syringe through the needle, then insert the needle, bevel up immediately below the skin surface. Inject an amount of PREPEN sufficient to raise a small [[intradermal]] bleb of about 3 mm in diameter, in duplicate at least 2 cm apart. Using a separate syringe and needle, inject a like amount of saline or allergen diluting solution as a control at least 5 cm removed from the antigen test sites. Most skin reactions will develop within 5-15 minutes and response to the skin test is read at 20 minutes as follows: | ||
Negative response — no increase in size of original bleb and no greater reaction than the control site. | * Negative response — no increase in size of original [[bleb]] and no greater reaction than the control site. | ||
Ambiguous response — wheal only slightly larger than initial injection bleb, with or without accompanying erythematous flare and slightly larger than the control site; OR discordance between duplicates. | * Ambiguous response — wheal only slightly larger than initial injection [[bleb]], with or without accompanying [[Erythema|erythematous]] flare and slightly larger than the control site; OR discordance between duplicates. | ||
Positive response — itching and significant increase in size of original blebs to at least 5 mm. Wheal may exceed 20 mm in diameter and exhibit pseudopods. | * Positive response — itching and significant increase in size of original blebs to at least 5 mm. Wheal may exceed 20 mm in diameter and exhibit [[pseudopods]]. | ||
If the control site exhibits a wheal greater than 23 mm, repeat the test, and if the same reaction is observed, a physician experienced with allergy skin testing should be consulted. | * If the control site exhibits a wheal greater than 23 mm, repeat the test, and if the same reaction is observed, a physician experienced with allergy skin testing should be consulted. | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
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<!--Contraindications--> | <!--Contraindications--> | ||
|contraindications=* PREPEN is contraindicated in those patients who have exhibited either a systemic or marked local reaction to its previous administration. Patients known to be extremely hypersensitive to penicillin should not be skin tested. | |contraindications=* PREPEN is contraindicated in those patients who have exhibited either a systemic or marked local reaction to its previous administration. Patients known to be extremely hypersensitive to [[penicillin]] should not be skin tested. | ||
<!--Warnings--> | <!--Warnings--> | ||
|warnings=* The risk of sensitization to repeated skin testing with PREPEN is not established. Rarely, a systemic allergic reaction including anaphylaxis | |warnings=* The risk of sensitization to repeated skin testing with PREPEN is not established. Rarely, a systemic allergic reaction including [[anaphylaxis]] may follow a skin test with PREPEN. To decrease the risk of a systemic allergic reaction, puncture skin testing should be performed first. [[Intradermal]] skin testing should be performed only if the puncture test is entirely negative. | ||
====Precautions==== | ====Precautions==== | ||
General | =====General===== | ||
No reagent, test, or combination of tests will completely assure that a reaction to penicillin therapy will not occur. | * No reagent, test, or combination of tests will completely assure that a reaction to penicillin therapy will not occur. | ||
The value of the PREPEN skin test alone as a means of assessing the risk of administering therapeutic penicillin (when penicillin is the preferred drug of choice) in the following situations is not established: | * The value of the PREPEN skin test alone as a means of assessing the risk of administering therapeutic [[penicillin]] (when [[penicillin]] is the preferred drug of choice) in the following situations is not established: | ||
Adult patients who give no history of clinical penicillin hypersensitivity. | * Adult patients who give no history of clinical [[penicillin]] [[hypersensitivity]]. | ||
Pediatric patients. | Pediatric patients. | ||
In addition, the clinical value of PREPEN where exposure to penicillin is suspected as a cause of a current drug reaction or in patients who are undergoing routine allergy evaluation is not known. Likewise, the clinical value of PREPEN skin tests alone in determining the risk of administering semi-synthetic penicillins (phenoxymethyl penicillin, ampicillin, carbenicillin, dicloxacillin, methicillin, nafcillin, oxacillin, amoxicillin), cephalosporin-derived antibiotics, and penem antibiotics is not known. | * In addition, the clinical value of PREPEN where exposure to [[penicillin]] is suspected as a cause of a current drug reaction or in patients who are undergoing routine allergy evaluation is not known. Likewise, the clinical value of PREPEN skin tests alone in determining the risk of administering semi-synthetic [[penicillins]] (phenoxymethyl penicillin, [[ampicillin]], [[carbenicillin]], [[dicloxacillin]], [[methicillin]], [[nafcillin]], [[oxacillin]], [[amoxicillin]]), [[cephalosporin]]-derived antibiotics, and penem antibiotics is not known. | ||
In addition to the results of the PREPEN skin test, the decision to administer or not administer penicillin should take into account individual patient factors. Healthcare professionals should keep in mind the following: | * In addition to the results of the PREPEN skin test, the decision to administer or not administer [[penicillin]] should take into account individual patient factors. Healthcare professionals should keep in mind the following: | ||
A serious allergic reaction to therapeutic penicillin may occur in a patient with a negative skin test to PREPEN. | * A serious [[allergic reaction]] to therapeutic [[penicillin]] may occur in a patient with a negative skin test to PREPEN. | ||
It is possible for a patient to have an anaphylactic reaction to therapeutic penicillin in the presence of a negative PREPEN skin test and a negative history of clinical penicillin hypersensitivity. | * It is possible for a patient to have an [[anaphylactic reaction]] to therapeutic [[penicillin]] in the presence of a negative PREPEN skin test and a negative history of clinical [[penicillin]] hypersensitivity. | ||
If penicillin is the drug of choice for a life-threatening infection, successful desensitization with therapeutic penicillin may be possible irrespective of a positive skin test and/or a positive history of clinical penicillin hypersensitivity. | * If [[penicillin]] is the drug of choice for a life-threatening infection, successful [[desensitization]] with therapeutic [[penicillin]] may be possible irrespective of a positive skin test and/or a positive history of clinical penicillin hypersensitivity. | ||
<!--Adverse Reactions--> | <!--Adverse Reactions--> | ||
<!--Clinical Trials Experience--> | <!--Clinical Trials Experience--> | ||
|clinicalTrials=Occasionally, patients may develop an intense local inflammatory response at the skin test site. Rarely, patients will develop a systemic allergic reaction, manifested by generalized erythema, pruritus, angioedema, urticaria, dyspnea, hypotension, and anaphylaxis. The usual methods of treating a skin test antigen-induced reaction — the applications of a venous occlusion tourniquet proximal to the skin test site and administration of epinephrine are recommended. The patient should be kept under observation for several hours. | |clinicalTrials=* Occasionally, patients may develop an intense [[Inflammation|local inflammatory response]] at the skin test site. Rarely, patients will develop a systemic [[allergic reaction]], manifested by generalized [[erythema]], [[pruritus]], [[angioedema]], [[urticaria]], [[dyspnea]], [[hypotension]], and [[anaphylaxis]]. The usual methods of treating a skin test antigen-induced reaction — the applications of a [[venous occlusion]] tourniquet proximal to the skin test site and administration of [[epinephrine]] are recommended. The patient should be kept under observation for several hours. | ||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | ||
| Line 159: | Line 109: | ||
<!--Administration and Monitoring--> | <!--Administration and Monitoring--> | ||
|administration=* Intradermal | |administration=* [[Intradermal]] | ||
* Intraepidermal | * [[Intraepidermal]] | ||
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | ||
| Line 255: | Line 205: | ||
<!--Mechanism of Action--> | <!--Mechanism of Action--> | ||
|mechAction=* PRE-PEN is a skin test antigen reagent that reacts specifically with benzylpenicilloyl IgE antibodies initiating the release of chemical mediators which produce an immediate wheal and flare reaction at a skin test site. All individuals exhibiting a positive skin test to PRE-PEN possess IgE against the benzylpenicilloyl structural group which is a hapten. A hapten is a low molecular weight chemical that conjugates with a carrier (e.g. poly-l-lysine) resulting in the formation of an antigen with the hapten’s specificity. The benzylpenicilloyl hapten is the major antigenic determinant in penicillin-allergic individuals. However, many individuals reacting positively to PRE-PEN will not develop a systemic allergic reaction on subsequent exposure to therapeutic penicillin, especially among those who have not reacted to penicillins in the past. Thus, the PRE-PEN skin test determines the presence of penicilloyl IgE antibodies which are necessary but not sufficient for acute allergic reactions due to the major penicilloyl determinant. | |mechAction=* PRE-PEN is a skin test antigen reagent that reacts specifically with benzylpenicilloyl [[IgE antibodies]] initiating the release of chemical mediators which produce an immediate wheal and flare reaction at a skin test site. All individuals exhibiting a positive skin test to PRE-PEN possess IgE against the benzylpenicilloyl structural group which is a [[hapten]]. A [[hapten]] is a low molecular weight chemical that conjugates with a carrier (e.g. poly-l-lysine) resulting in the formation of an antigen with the hapten’s specificity. The benzylpenicilloyl hapten is the major antigenic determinant in penicillin-allergic individuals. However, many individuals reacting positively to PRE-PEN will not develop a systemic allergic reaction on subsequent exposure to therapeutic penicillin, especially among those who have not reacted to [[penicillins]] in the past. Thus, the PRE-PEN skin test determines the presence of penicilloyl IgE antibodies which are necessary but not sufficient for acute allergic reactions due to the major penicilloyl determinant. | ||
Non-benzylpenicilloyl haptens are designated as minor determinants, since they less frequently elicit an immune response in penicillin treated individuals. The minor determinants may nevertheless be associated with significant clinical hypersensitivity. PRE-PEN does not react with IgE antibodies directed against non-benzylpenicilloyl haptens. | * Non-benzylpenicilloyl haptens are designated as minor determinants, since they less frequently elicit an immune response in penicillin treated individuals. The minor determinants may nevertheless be associated with significant clinical hypersensitivity. PRE-PEN does not react with IgE antibodies directed against non-benzylpenicilloyl haptens. | ||
<!--Structure--> | <!--Structure--> | ||
|structure=* PRE-PEN® (benzylpenicilloyl polylysine injection USP) is a sterile solution of benzylpenicilloyl polylysine in a concentration of 6.0X10-5M (benzylpenicilloyl) in 0.01 M phosphate buffer and 0.15 M sodium chloride. The benzylpenicilloyl polylysine in PRE-PEN is a derivative of poly-l-lysine, where the epsilon amino groups are substituted with benzylpenicilloyl groups (50-70%) forming benzylpenicilloyl alpha amide. Each single dose ampule contains 0.25 mL of PRE-PEN. | |structure=* PRE-PEN® (benzylpenicilloyl polylysine injection USP) is a sterile solution of benzylpenicilloyl polylysine in a concentration of 6.0X10-5M (benzylpenicilloyl) in 0.01 M phosphate buffer and 0.15 M sodium chloride. The benzylpenicilloyl polylysine in PRE-PEN is a derivative of poly-l-lysine, where the epsilon amino groups are substituted with benzylpenicilloyl groups (50-70%) forming benzylpenicilloyl alpha amide. Each single dose ampule contains 0.25 mL of PRE-PEN. | ||
PRE-PEN has the following structure: | * PRE-PEN has the following structure: | ||
: [[File:Benzylpenicilloyl Str.png|thumb|none|600px|This image is provided by the National Library of Medicine.]] | : [[File:Benzylpenicilloyl Str.png|thumb|none|600px|This image is provided by the National Library of Medicine.]] | ||
| Line 281: | Line 231: | ||
|howSupplied=* PREPEN® (benzylpenicilloyl polylysine injection USP) is a clear, colorless, sterile solution supplied in ampules containing 0.25 mL. | |howSupplied=* PREPEN® (benzylpenicilloyl polylysine injection USP) is a clear, colorless, sterile solution supplied in ampules containing 0.25 mL. | ||
Box of 5 single dose ampules. Ampules are opened by snapping the neck of the ampule using two forefingers of each hand. Visually inspect for glass chards before use. Each ampule is for single patient use only. Discard any unused portion. | * Box of 5 single dose ampules. Ampules are opened by snapping the neck of the ampule using two forefingers of each hand. Visually inspect for glass chards before use. Each ampule is for single patient use only. Discard any unused portion. | ||
|storage=* PREPEN is optimally stored under refrigeration (28° C). PREPEN subjected to ambient temperatures for more than 24 hours should be discarded. As with all parenteral drug products, PREPEN should be inspected visually for particulate matter and discoloration prior to administration. | |storage=* PREPEN is optimally stored under refrigeration (28° C). PREPEN subjected to ambient temperatures for more than 24 hours should be discarded. As with all parenteral drug products, PREPEN should be inspected visually for particulate matter and discoloration prior to administration. | ||
|packLabel=====PACKAGE/LABEL PRINCIPAL DISPLAY PANEL==== | |packLabel=====PACKAGE/LABEL PRINCIPAL DISPLAY PANEL==== | ||
| Line 301: | Line 251: | ||
|drugShortage= | |drugShortage= | ||
}} | }} | ||
Latest revision as of 18:03, 18 August 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Benzylpenicilloyl Polylysine is a Diagnostic Agent that is FDA approved for the diagnosis of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. Common adverse reactions include allergic reaction, local inflammatory response.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- PREPEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PREPEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PREPEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PREPEN predicts a lower risk of anaphylaxis is not established. Similarly, when deciding the risk of proposed penicillin treatment, there are not enough data at present to permit relative weighing in individual cases of a history of clinical penicillin hypersensitivity as compared to positive skin tests to PREPEN and/or minor penicillin determinants.
Dosage
SKIN TESTING DOSAGE AND TECHNIQUE
- Skin testing responses can be attenuated by interfering drugs (e.g. H1antihistamines and vasopressors). Skin testing should be delayed until the effects of such drugs have dissipated, or a separate skin test with histamine can be used to evaluate persistent antihistaminic effects in vivo. Due to the risk of potential systemic allergic reactions, skin testing should be performed in an appropriate healthcare setting under direct medical supervision.
Puncture Testing:
- Skin testing is usually performed on the inner volar aspect of the forearm. The skin test antigen should always be applied first by the puncture technique. After preparing the skin surface, apply a small drop of PREPEN solution using a sterile 2228 gauge needle. The same needle can then be used to make a single shallow puncture of the epidermis through the drop of PREPEN. Very little pressure is required to break the epidermal continuity. Observe for the appearance of a wheal, erythema, and the occurrence of itching at the test site during the succeeding 15 minutes at which time the solution over the puncture site is wiped off. A positive reaction consists of the development within 10 minutes of a pale wheal, sometimes with pseudopods, surrounding the puncture site and varying in diameter from 5 to 15 mm (or more). This wheal may be surrounded by a variable diameter of erythema, and accompanied by a variable degree of itching. The most sensitive individuals develop itching quickly, and the wheal and erythema are prompt in their appearance. As soon as a positive response as defined above is clearly evident, the solution over the scratch should be immediately wiped off. If the puncture test is either negative or equivocally positive (less than 5 mm wheal with little or no erythema and no itching), an intradermal test may be performed.
The lntradermal Test:
- Using a 0.5 to 1.0 cc syringe with a 3/8” to 5/8”long, 26 to 30 gauge, short bevel needle, withdraw the contents of the ampule. Prepare with an alcohol swab a skin test area on the upper, outer arm, sufficiently below the deltoid muscle to permit proximal application of a tourniquet later, if necessary. Be sure to eject all air from the syringe through the needle, then insert the needle, bevel up immediately below the skin surface. Inject an amount of PREPEN sufficient to raise a small intradermal bleb of about 3 mm in diameter, in duplicate at least 2 cm apart. Using a separate syringe and needle, inject a like amount of saline or allergen diluting solution as a control at least 5 cm removed from the antigen test sites. Most skin reactions will develop within 5-15 minutes and response to the skin test is read at 20 minutes as follows:
- Negative response — no increase in size of original bleb and no greater reaction than the control site.
- Ambiguous response — wheal only slightly larger than initial injection bleb, with or without accompanying erythematous flare and slightly larger than the control site; OR discordance between duplicates.
- Positive response — itching and significant increase in size of original blebs to at least 5 mm. Wheal may exceed 20 mm in diameter and exhibit pseudopods.
- If the control site exhibits a wheal greater than 23 mm, repeat the test, and if the same reaction is observed, a physician experienced with allergy skin testing should be consulted.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Benzylpenicilloyl Polylysine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzylpenicilloyl Polylysine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Benzylpenicilloyl Polylysine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Benzylpenicilloyl Polylysine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzylpenicilloyl Polylysine in pediatric patients.
Contraindications
- PREPEN is contraindicated in those patients who have exhibited either a systemic or marked local reaction to its previous administration. Patients known to be extremely hypersensitive to penicillin should not be skin tested.
Warnings
- The risk of sensitization to repeated skin testing with PREPEN is not established. Rarely, a systemic allergic reaction including anaphylaxis may follow a skin test with PREPEN. To decrease the risk of a systemic allergic reaction, puncture skin testing should be performed first. Intradermal skin testing should be performed only if the puncture test is entirely negative.
Precautions
General
- No reagent, test, or combination of tests will completely assure that a reaction to penicillin therapy will not occur.
- The value of the PREPEN skin test alone as a means of assessing the risk of administering therapeutic penicillin (when penicillin is the preferred drug of choice) in the following situations is not established:
- Adult patients who give no history of clinical penicillin hypersensitivity.
Pediatric patients.
- In addition, the clinical value of PREPEN where exposure to penicillin is suspected as a cause of a current drug reaction or in patients who are undergoing routine allergy evaluation is not known. Likewise, the clinical value of PREPEN skin tests alone in determining the risk of administering semi-synthetic penicillins (phenoxymethyl penicillin, ampicillin, carbenicillin, dicloxacillin, methicillin, nafcillin, oxacillin, amoxicillin), cephalosporin-derived antibiotics, and penem antibiotics is not known.
- In addition to the results of the PREPEN skin test, the decision to administer or not administer penicillin should take into account individual patient factors. Healthcare professionals should keep in mind the following:
- A serious allergic reaction to therapeutic penicillin may occur in a patient with a negative skin test to PREPEN.
- It is possible for a patient to have an anaphylactic reaction to therapeutic penicillin in the presence of a negative PREPEN skin test and a negative history of clinical penicillin hypersensitivity.
- If penicillin is the drug of choice for a life-threatening infection, successful desensitization with therapeutic penicillin may be possible irrespective of a positive skin test and/or a positive history of clinical penicillin hypersensitivity.
Adverse Reactions
Clinical Trials Experience
- Occasionally, patients may develop an intense local inflammatory response at the skin test site. Rarely, patients will develop a systemic allergic reaction, manifested by generalized erythema, pruritus, angioedema, urticaria, dyspnea, hypotension, and anaphylaxis. The usual methods of treating a skin test antigen-induced reaction — the applications of a venous occlusion tourniquet proximal to the skin test site and administration of epinephrine are recommended. The patient should be kept under observation for several hours.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Benzylpenicilloyl Polylysine in the drug label.
Drug Interactions
There is limited information regarding Benzylpenicilloyl Polylysine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- Animal reproduction studies have not been conducted with PREPEN. It is not known whether PREPEN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The hazards of skin testing in such patients should be weighed against the hazard of penicillin therapy without skin testing.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Benzylpenicilloyl Polylysine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Benzylpenicilloyl Polylysine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Benzylpenicilloyl Polylysine with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Benzylpenicilloyl Polylysine with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Benzylpenicilloyl Polylysine with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Benzylpenicilloyl Polylysine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Benzylpenicilloyl Polylysine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Benzylpenicilloyl Polylysine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Benzylpenicilloyl Polylysine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Benzylpenicilloyl Polylysine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Benzylpenicilloyl Polylysine in patients who are immunocompromised.
Administration and Monitoring
Administration
Monitoring
There is limited information regarding Monitoring of Benzylpenicilloyl Polylysine in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Benzylpenicilloyl Polylysine in the drug label.
Overdosage
There is limited information regarding Overdose of Benzylpenicilloyl Polylysine in the drug label.
Pharmacology
| |
Benzylpenicilloyl Polylysine
| |
| Systematic (IUPAC) name | |
| [2S-(2α,5α,6β)]-3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate : L-Lysine homopolymer | |
| Identifiers | |
| CAS number | |
| ATC code | none |
| PubChem | ? |
| DrugBank | |
| Chemical data | |
| Formula | ? |
| Mol. mass | ? |
| Synonyms | Pre-Pen |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Licence data |
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| Pregnancy cat. |
? |
| Legal status | |
| Routes | Liquid intradermal |
Mechanism of Action
- PRE-PEN is a skin test antigen reagent that reacts specifically with benzylpenicilloyl IgE antibodies initiating the release of chemical mediators which produce an immediate wheal and flare reaction at a skin test site. All individuals exhibiting a positive skin test to PRE-PEN possess IgE against the benzylpenicilloyl structural group which is a hapten. A hapten is a low molecular weight chemical that conjugates with a carrier (e.g. poly-l-lysine) resulting in the formation of an antigen with the hapten’s specificity. The benzylpenicilloyl hapten is the major antigenic determinant in penicillin-allergic individuals. However, many individuals reacting positively to PRE-PEN will not develop a systemic allergic reaction on subsequent exposure to therapeutic penicillin, especially among those who have not reacted to penicillins in the past. Thus, the PRE-PEN skin test determines the presence of penicilloyl IgE antibodies which are necessary but not sufficient for acute allergic reactions due to the major penicilloyl determinant.
- Non-benzylpenicilloyl haptens are designated as minor determinants, since they less frequently elicit an immune response in penicillin treated individuals. The minor determinants may nevertheless be associated with significant clinical hypersensitivity. PRE-PEN does not react with IgE antibodies directed against non-benzylpenicilloyl haptens.
Structure
- PRE-PEN® (benzylpenicilloyl polylysine injection USP) is a sterile solution of benzylpenicilloyl polylysine in a concentration of 6.0X10-5M (benzylpenicilloyl) in 0.01 M phosphate buffer and 0.15 M sodium chloride. The benzylpenicilloyl polylysine in PRE-PEN is a derivative of poly-l-lysine, where the epsilon amino groups are substituted with benzylpenicilloyl groups (50-70%) forming benzylpenicilloyl alpha amide. Each single dose ampule contains 0.25 mL of PRE-PEN.
- PRE-PEN has the following structure:
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Pharmacodynamics
There is limited information regarding Pharmacodynamics of Benzylpenicilloyl Polylysine in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Benzylpenicilloyl Polylysine in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Benzylpenicilloyl Polylysine in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Benzylpenicilloyl Polylysine in the drug label.
How Supplied
- PREPEN® (benzylpenicilloyl polylysine injection USP) is a clear, colorless, sterile solution supplied in ampules containing 0.25 mL.
- Box of 5 single dose ampules. Ampules are opened by snapping the neck of the ampule using two forefingers of each hand. Visually inspect for glass chards before use. Each ampule is for single patient use only. Discard any unused portion.
Storage
- PREPEN is optimally stored under refrigeration (28° C). PREPEN subjected to ambient temperatures for more than 24 hours should be discarded. As with all parenteral drug products, PREPEN should be inspected visually for particulate matter and discoloration prior to administration.
Images
Drug Images
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Package and Label Display Panel
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
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Ingredients and Appearance
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Benzylpenicilloyl Polylysine in the drug label.
Precautions with Alcohol
Alcohol-Benzylpenicilloyl Polylysine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- PRE-PEN®[1]
Look-Alike Drug Names
There is limited information regarding Benzylpenicilloyl Polylysine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.