Drugs of porcine origin—A risk for patients with α-gal syndrome?

Tolerance of porcine pancreatic enzymes despite positive skin testing in alpha-gal allergy

“…Serologic evaluation at the time of initial consultation in 2018 was alpha-gal sIgE > 100 kU/L, beef sIgE = kU/L, lamb sIgE = 16.5 kU/L, pork sIgE = 16.5 kU/L, and porcine gelatin sIgE = 0.9 kU/L, reference all tests <0.35 kU/L. Skin prick testing was positive to Creon™ 3K lipase unit capsule contents (4mm wheal and 20mm flare) and Zenpep™ (5mm wheal and 25mm flare) prepared as per the protocol described by Swiontek et al 5 with appropriate positive and negative controls. A gelatin skin prick test was negative.…”

“…We have previously reported that a subset of alpha-gal allergic patients will react to the parenteral administration of alpha-gal contained in gelatin and gelatin containing vaccines. [2][3][4] A recent report by Swiontek et al 5 identified a group of 17 AGS patients who demonstrated positive skin prick and ex vivo testing to porcine derived pancreatic enzyme replacement. Since these patients had no need for pancreatic enzyme replacement they were not orally challenged to confirm reactivity versus tolerance.…”

“…Their report, therefore, highlights the further need to determine the safety of porcine pancreatic replacement in AGS patients. 5,6 To assess the safety of porcine pancreatic enzyme replacement in AGS patients, we evaluated two patients (Table 1) with a history of AGS and an indication for treatment with this class of medication. Skin prick testing to different commercially available porcine pancreatic enzymes was followed by oral ingestion challenge to determine tolerance.…”

“…At that time, she was avoiding all mammalian meats with alpha-gal sIgE = 1.24 kU/L, total IgE = 21.0 kU/L and porcine gelatin sIgE = <0.10 kU/L, reference all tests <0.10 kU/L. Skin prick testing was performed to FDA approved porcine derived pancreatic enzyme replacement products using a protocol similar to Swiontek et al 5 Testing was negative to pancrelipase (Creon™) 24K lipase unit capsule contents (no wheal and flare < 3mm) and positive to three other porcine derived formulations of pancrelipase: Viokase™ (10mm wheal and 15 mm flare), Zenpep™ (8mm wheal and 10 mm flare), and Pertyze™ (6mm wheal and 8mm flare).…”

DRUG ALLERGIES DUE TO IgE SENSITIZATION TO α-GAL

“…Although α-Gal is not present on heparin molecules, being derived from porcine intestinal mucosa there is a potential of contamination with this epitope in the manufacturing process, with a theoretical risk in patients with α-Gal allergy [27]. The α-Gal carrying proteins were instead recently detected by immunoblot technique in porcinederived oral medications, such as gastro-resistant capsules with porcine pancreatin (amylase, lipase, protease) microspheres, used in the therapy of exocrine pancreatic insufficiency in chronic pancreatitis, pancreatic cancer, cystic fibrosis or post-pancreatectomy, and gastro-resistant coated tablets with porcine pepsin as supportive medication for gastrointestinal malfunction [49].…”