22nd May 2017
Lactation Safety Information
No published evidence of safety
Components of the venom unlikely to enter breast milk
No adverse effects reported in breastfed infants
22nd May 2017
Alutard SQ Bee · IgE-mediated allergy to honey bee venom
Alutard SQ Bee
Development and Regulatory status
Sep 19 · Alutard SQ Bee is licensed for Allergy immunotherapy for patients with a documented history of generalised and/or systemic IgE-mediated allergic reactions due to sensitisation to honey bee venom (Apis mellifera), confirmed by skin prick test and/or intradermal test and/or specific IgE test .
Sep 19 · Launched in the UK. Price - initial kit 4 x 5mL vials and maintenance kit 1 x 5mL vial = £462.61 .
May 19 · Alutard has been available for about 20 years in Germany and the Nordic countries, and ALK-Abello has now decided to bring this product to the UK .
Mar 19 · Approved in the UK by the MHRA .
Dec 18 · Has previously been approved in the EU via the mutual recognition procedure [1,4].
Honey bee venom adsorbed onto aluminium hydroxide
Insects of the order Hymenoptera include bees, wasps and ants; most relevant in the UK are wasp (Vespula vulgaris) and honey bee (Apis mellifera). Large local reactions (LLRs) occur in 26% of people and systemic reactions in up to 7.5% of people who are stung. Likelihood of anaphylaxis from a future sting following an LLR is around 5%. With a history of anaphylaxis from a previous sting & a positive skin tests to venom, >60% of adults & 20-32% of children will have anaphylaxis again .
IgE-mediated allergy to honey bee venom
Trial or other data
Feb 93 · Prospective 3-yr study published in Allergy. It investigated the safety, immunogenicity, and effectiveness of immunotherapy (IT) with aluminum hydroxide adsorbed insect venom extracts (Alutard SQ, ALK Laboratories) in patients with previous, severe, systemic, IgE-mediated, anaphylactic reactions to Hymenoptera stings. Seventeen patients were treated with honeybee venom (BV), 13 with yellow-jacket venom (YJV - a type of wasp), and 5 with both. No severe reactions to IT were noted. Only 3 BV-allergic patients experienced mild systemic reactions of grades I or II (1 per 139 injections) during the increase phase. As for the immunologic data, there was a significant decrease in specific IgE antibodies after 1 year, and a significant increase in specific IgG and IgG4 antibodies on reaching the maintenance dose, with a further rise after 1, 2, and 3 years. Moreover, a significant decrease in anti-IgE autoantibodies was observed in the BV group. Out of the 11 patients that were occasionally restung by the relevant insect (totaling 19 stings in all), only one patient developed mild systemic allergic symptoms after a third sting .