Penicilloyl-polylysine (Pre-Pen) is a reagent for penicillin allergy skin testing. It binds specifically to the IgE that is released in response to penicillins.

Penicilloyl-polylysine (Pre-Pen) Uses:

• Adjunct in assessing the risk of administering penicillin (penicillin G or benzylpenicillin) in suspected patients of clinical penicillin hypersensitivity

• Off Label Use of Penicilloyl-polylysine in Adults:

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Penicilloyl-polylysine (Pre-Pen) Dose in Adults

Penicilloyl-polylysine (Pre-Pen) Dose in the Diagnostic aid for the detection of penicillin allergy:

Note:

• Adjunct in the evaluation of cephalosporin and penicillin hypersensitivity to ascertain the safety of penicillin in individuals with a history of reactivity to cephalosporins.

• Puncture test:

  • A 22 to 28 gauge needle is used to apply a little drop of the skin test solution and produce a single shallow puncture in the epidermis.
  • A pale wheal that is at least 5 mm in diameter and forms around the puncture site within 10 minutes after the procedure indicates a positive reaction (wheal may be surrounded by erythema and variable degrees of itching).
  • The solution needs to be removed right away if a positive reaction is visible.
  • An intradermal test may be carried out if the puncture test is negative or equivocal (5 mm wheal, with little or no erythema and no itching) 15 minutes after the puncture test.

  • Intradermal test:

    • To raise a small intradermal bleb about 3 mm in diameter intradermally, inject a volume of skin test solution using a
    • 0.5-1 mL tuberculin syringe and a 3/8 to 5/8 inch, 26- to 30-gauge short bevel needle. Do this twice, at least 2 cm apart.
    • The antigen test site should be at least 5 cm away from the control injection of 0.9% sodium chloride or allergen-diluting solution.
    • The majority of skin reactions to the intradermal test manifest within 5–15 minutes.
    • At 20 minutes, the skin test result is read.

• Interpretation of intradermal test:

  • (-) Negative:

    • No enlargement of an initial bleb or more intense reaction than at the control site

  • (±) Ambiguous:

    • Wheal that is only marginally larger than the original bleb, whether or not there is an erythematous flare, and marginally larger than the control site; OR discrepancy between the duplicate test sites.

  • (+) Positive:

    • Itching and a marked increase in the size of original bleb to ≥5 mm. Wheal may exhibit pseudopods and be >20 mm in diameter.
  • Control site should be reactionless. If wheal of size >2-3 mm develops at the control site, repeat the test. If same reaction occurs, consultation is necessary.

Penicilloyl-polylysine (Pre-Pen) Dose in Childrens

Penicilloyl-polylysine (Pre-Pen) Dose in the Diagnostic aid for the detection of penicillin allergy (penicillin G and benzylpenicillin):

• Children and Adolescents:

• Note: 

  • The puncture technique should always be used to deliver benzylpenicilloyl polylysine first.
  • If a puncture test reveals a patient has a positive reaction, do not inject intradermally.

• Puncture scratch test:

  • A small drop of the skin test solution is applied by 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 about 3 mm in diameter intradermally and duplicate at least 2 cm apart.
  • The control injection should be done at least 5 cm away from the antigen test site and contain 0.9% sodium chloride or an allergen-diluting solution.
  • Most skin reactions to the intradermal test take 5 to 15 minutes to manifest.
  • A response to the skin test is read at 20 minutes.

• Interpretation of the intradermal test:

  • (-) Negative:

    • No bleb's original size increased, and there was no more reactivity than at the control site.

  • (±) Ambiguous:

    • Wheal is only slightly larger than the original bleb, whether it has an erythematous flare or not, and somewhat larger than the control site.

  • (+) Positive:

    • Itching and a marked increase in the size of the original bleb to ≥5 mm. Wheal may exhibit pseudopods and be >20 mm in diameter.
  • The control site should be reactionless. If wheal of size >2 to 3 mm develops at the control site, repeat the test. If the same reaction occurs, consultation is necessary.

Pregnancy Risk Factor C

• Benzylpenicilloyl-polylysine has not been studied in relation to animal reproduction.
• According to the Centers for Disease Control and Prevention, penicillin skin testing can assist identify whether a pregnant syphilis patient is prone to penicillin hypersensitivity.
• The only effective alternative in this demographic is penicillin.

Pre-Pen Dose in Kidney Disease:

• No dosage adjustment provided in the drug manufacturer’s labeling.

Pre-Pen Dose in Liver Disease:

• No dosage adjustment provided in the drug manufacturer’s labeling.

Side effects of Penicilloyl-polylysine (Pre-Pen):

• 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

Contraindications to Penicilloyl-polylysine:

• A previous skin test with benzylpenicilloylpolylysine showed a marked or systemic reaction;
• Penicillin hypersensitivity patients should not be tested again

Warnings & Precautions

• Allergy reactions

  • Penicillin skin testing has been linked to rare systemic allergic reactions (including anaphylaxis).
  • Penicillin skin testing should only be performed by qualified medical personnel under the supervision and direction of a doctor. Only use Epinephrine-ready healthcare facilities for testing.
  • To reduce allergic reactions, the manufacturer recommends that intradermal testing be done before puncture skin testing.

• Severe penicillin allergy:

  • Patients with a history of severe penicillin allergies shouldn't undergo penicillin skin testing.

Penicilloyl-polylysine: Drug Interaction

Monitoring Parameters:

None mentioned.

How to administer Penicilloyl-polylysine (Pre-Pen)?

• Puncture test:

  • Administer initially by puncture technique on the inner volar aspect of the forearm, followed by an intradermal injection only in patients with a negative reaction.

• Intradermal:

  • Do not administer intradermally to patients with a positive skin reaction (wheal of 5 to 15 mm or more in diameter) after skin puncture test.
  • Inject the intradermal test solution on the upper, outer arm, below the deltoid muscle in the event a severe hypersensitivity reaction occurs and a tourniquet needs to be applied.
  • During the skin test, immediate treatment with epinephrine should also be available.

Mechanism of action of (Pre-Pen) Penicilloyl-polylysine:

• 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 initiate the release of chemical mediators, thereby producing type I (immediate or accelerated) hypersensitivity/urticarial reactions in patients hypersensitive to penicillins.

International Brands of Penicilloyl-polylysine:

• Pre-Pen

Penicilloyl-polylysine Brand Names in Pakistan:

No Brands Available in Pakistan.