Find answers to the most frequently asked questions about PRE-PEN below.

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Which patients are good candidates for penicillin allergy skin testing?
  • Any patient with a history of a reaction to a penicillin antibiotic that may have been IgE-mediated
  • Any patient who is currently denied access to beta-lactam antibiotics out of concern for such reactions
  • 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.
Who can administer the test?

Physicians and staff who are qualified to conduct skin testing may perform penicillin skin testing, under the direction of a supervising physician, include:

  • Pharmacists (check with your state board to confirm your eligibility)
  • Licensed Practical Nurses
  • Medical Assistants
  • Nurse Practitioners
  • Physicians
  • Physician Assistants
  • Registered Nurses
How long does the test  take?

The skin test takes approximately one hour and may be followed by an optional ingestion challenge.

Which health system departments may benefit from offering penicillin allergy skin testing?

Numerous departments may benefit from offering penicillin allergy skin testing, so it’s important to educate prescribing physicians on the availability and benefits of testing. The following are some of the most common departments that offer penicillin allergy skin testing:

  • Infectious Disease
  • Allergy
  • Oncology
  • Anesthesiology
  • Medical/Inpatient Ward
  • Out-patient Clinic or Infusion Center
  • Preoperative and Surgical
  • Intensive Care Unit
  • Emergency Department
Where can I find support  for implementation?

ALK is committed to providing you with the resources and tools you need to successfully implement penicillin allergy skin testing with PRE-PEN. We offer onsite or virtual training, resources on our website, and you can reach out to us at with any questions.

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Contact ALK to learn how we can help you impact antibiotic treatment through penicillin allergy skin testing




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:

  • Adult patients who give no history of clinical penicillin hypersensitivity.
  • Pediatric patients.

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:

  • A serious allergic reaction to therapeutic penicillin may occur in a patient with a negative skin test to PRE-PEN.
  • It is possible for a patient to have an anaphylactic reaction to therapeutic penicillin in the presence of a negative PRE-PEN 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.

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 or call 1-800-FDA-1088. Please see full Prescribing Information for additional Important Safety Information.