Benzylpenicilloyl polylysine

What Benzylpenicilloyl polylysine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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 …

— FDA label: Pre-Pen, Alk-Abello, Inc., effective January 12, 2024. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, intradermal), Pre-Pen, Alk-Abello, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Benzylpenicilloyl polylysine side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

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.

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The patient should be kept under observation for several hours.

— FDA label: Pre-Pen, Alk-Abello, Inc., effective January 12, 2024. Read the full label on DailyMed →

Benzylpenicilloyl polylysine dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

SKIN TESTING DOSAGE AND TECHNIQUE Skin testing responses can be attenuated by interfering drugs (e.g. H1-antihistamines 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.

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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 PRE-PEN solution using a sterile 22-28 gauge needle. The same needle can then be used to make a single shallow puncture of the epidermis through the drop of PRE-PEN. 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 PRE-PEN 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.

— FDA label: Pre-Pen, Alk-Abello, Inc., effective January 12, 2024. This is part of the section. Read the full label on DailyMed →

Benzylpenicilloyl polylysine in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

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.

— FDA label: Pre-Pen, Alk-Abello, Inc., effective January 12, 2024. Read the full label on DailyMed →

When Benzylpenicilloyl polylysine should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

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.

— FDA label: Pre-Pen, Alk-Abello, Inc., effective January 12, 2024. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• ALK-Abello, Inc.1 product

FDA approval history

• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Pre-Pen, Alk-Abello, Inc., effective January 12, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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