Penicillin allergy skin testing with PRE-PEN® (benzylpenicilloyl polylysine injection USP) can provide critical information to support patient care and advance your AMS efforts
Penicillin allergy is the most frequently reported drug allergy in the United States, yet the diagnosis may not always be accurate1-3
Penicillin allergy testing can improve patient care while supporting your institution’s AMS efforts.EXPLORE THE BENEFITS
Testing for penicillin allergy can keep your therapeutic options open and may improve patient outcomes.4
Get support with implementing penicillin allergy skin testing at your institution.LEARN HOW
It all starts with PRE-PEN®—the only FDA-approved skin test antigen reagent for the diagnosis of penicillin allergy.5,6
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References: 1. Pongdee T, Li JT. Evaluation and management of penicillin allergy. Mayo Clin Proc. 2018;93(1):101-107. doi:10.1016/j.mayocp.2017.09.020 2. Evaluation and diagnosis of penicillin allergy for healthcare professionals. Centers for Disease Control and Prevention. Updated October 31, 2017. Accessed October 3, 2021. https://www.cdc.gov/antibiotic-use/clinicians/penicillin-allergy.html 3. Penicillin allergy. Mayo Clinic. Published December 5, 2019. Accessed October 3, 2021. https://www.mayoclinic.org/diseases-conditions/penicillin-allergy/symptoms-causes/syc-20376222 4. Heil EL, Bork JT, Schmalzle SA, et al. Implementation of an infectious disease fellow–managed penicillin allergy skin testing service. Open Forum Infect Dis. 2016;3(3):ofw155. doi:10.1093/ofid/ofw155 5. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. Accessed October 3, 2021. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm 6. PRE-PEN. Prescribing information. ALK-Abelló, Inc.; 2013.
PRE-PEN 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 PRE-PEN 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 PRE-PEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PRE-PEN 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 PRE-PEN and/or minor penicillin determinants.
The risk of sensitization to repeated skin testing with PRE-PEN is not established. Rarely, a systemic allergic reaction including anaphylaxis (see below) may follow a skin test with PRE-PEN. 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.
PRE-PEN 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.
No reagent, test, or combination of tests will completely assure that a reaction to penicillin therapy will not occur. The value of the PRE-PEN 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:
In addition, the clinical value of PRE-PEN 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 PRE-PEN skin tests alone in determining the risk of administering semisynthetic penicillins (phenoxymethylpenicillin, ampicillin, carbenicillin, dicloxacillin, methicillin, nafcillin, oxacillin, amoxicillin), cephalosporin-derived antibiotics, and penem antibiotics is not known.
In addition to the results of the PRE-PEN 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:
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.
Pregnancy Category C: Animal reproduction studies have not been conducted with PRE-PEN. It is not known whether PRE-PEN 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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information for additional Important Safety Information.