DARZALEX FASPRO - Use in Patients with Bee Venom Allergy

SUMMARY

• Johnson & Johnson does not recommend the use of DARZALEX FASPRO in a manner that is inconsistent with the approved labeling.
• Hyaluronidase increases permeability of the subcutaneous tissue by depolymerizing hyaluronan. In the doses administered, hyaluronidase in DARZALEX FASPRO acts locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.¹
• There is no systematically collected data to define the potential for cross-reactivity between bee venom allergy and DARZALEX FASPRO. Clinical judgement should be exercised when administering DARZALEX FASPRO to patients with an allergy to bee venom.

BACKGROUND

• Hyaluronidase in the venom of bees, wasps, and hornets (Hymenoptera) may trigger allergic reactions, including anaphylactic shock. Honeybee venom contains multiple allergenic proteins, including Api m 2 (hyaluronidase), which is considered one of the major bee venom allergens and is recognized by IgE antibodies in approximately 50% of individuals with honeybee venom allergy. Due to the similarity of the structures of bee and wasp hyaluronidase, this allergen is the main cause of cross-reactions with specific IgE antibodies directed against the venom of both insects.³
• In a study of 90 patients with a history of anaphylactic reactions to bee venom (n=73), wasp venom (n=14), or both (n=3), 5 patients had a positive skin prick test (SPT) for medical hyaluronidase. All 5 patients had a history of anaphylaxis to wasp stings only. These 5 patients had no history of prior venom-specific immunotherapy (SIT), suggesting that patients with an untreated allergy to bee or wasp venom should consult an allergy specialist prior to receiving medical hyaluronidase.⁴
• Contraindications to hyaluronidase include hypersensitivity to hyaluronidase or any other ingredient in the formulation.²
• Allergic reactions to hyaluronidase have been reported in less than 0.1% of patients.²

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 15 July 2026.