Pre-pen
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Questions & Answers
Side Effects & Adverse Reactions
The risk of sensitization to repeated skin testing with PREPEN is not established. Rarely, a systemic allergic reaction including anaphylaxis (see below) 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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:
Sources
Pre-pen Manufacturers
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Allerquest Llc
![Pre-pen (Benzylpenicilloyl Polylysine) Injection [Allerquest Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pre-pen | Allerquest Llc
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.
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