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:

  • Adjunct in the assessment of hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins) to determine the safety of penicillin in patients with a history of reaction to cephalosporins

Penicilloyl-polylysine (Pre-Pen) Dose in Adults

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

Note:

• Benzylpenicilloyl polylysine should always be applied initially via the puncture technique.
• Do not inject intradermally to patients who have a positive reaction to the puncture test.

• Puncture test:

  • 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 5-15 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 0.5-1 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, in duplicate at least 2 cm apart.
    • A control of 0.9% sodium chloride or allergen-diluting solution should be injected at least 5 cm from the antigen test site.
    • Most skin responses to the intradermal test will develop within 5-15 minutes.
    • A response to the skin test is read at 20 minutes.

• Interpretation of intradermal test:

  • (-) Negative:

    • No increase in the size of an original bleb or no greater reaction compared to the control site

  • (±) Ambiguous:

    • Wheal only slightly larger than original bleb with or without erythematous flare and slightly larger than control site; OR discordance between 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:

  • Benzylpenicilloyl polylysine should always be administered first via the puncture technique.
  • Do not inject intradermally to patients who have positive reactions to a puncture test.

• 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.
  • Control of 0.9% sodium chloride or allergen-diluting solution should be injected at least 5 cm from the antigen test site.
  • Most skin responses to the intradermal test will develop within 5 to 15 minutes.
  • A response to the skin test is read at 20 minutes.

• Interpretation of the intradermal test:

  • (-) Negative:

    • No increase in the size of an original bleb or no greater reaction compared to the control site.

  • (±) Ambiguous:

    • Wheal is only slightly larger than original bleb with or without erythematous flare and slightly larger than the control site, or discordance between duplicate test sites.

  • (+) 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

• Studies on animal reproduction have not been conducted with benzylpenicilloyl-polylysine.
• The Centers for Disease Control and Prevention states that penicillin skin testing can help to determine if a pregnant patient with syphilis is susceptible to penicillin hypersensitivity. Penicillin is the only proven alternative in this population.

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:

  • Penicillin skin testing should not be performed on patients with a history of severe penicillin allergy.

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.