Bee venom extracts

PRODUCT AND SCOPE: this entry reproduces the UK SPC for ONE product only - ALUTARD SQ Bee (honey bee venom, Apis mellifera, adsorbed to aluminium hydroxide), dosed in SQ-U (biological-activity units). Vials (SPC section 2, Table 1): vial 1 (grey) 100 SQ-U/ml; vial 2 (green) 1 000 SQ-U/ml; vial 3 (orange) 10 000 SQ-U/ml; vial 4 (red) 100 000 SQ-U/ml. SPC: 'ALUTARD SQ Bee is not interchangeable with other venom immunotherapy products'; if available on the market, Aquagen SQ Apis mellifera (ALK manufacturing) can be used in the up-dosing phase before switching to ALUTARD SQ Bee for the maintenance phase. The page lists the brand Pharmalgen Bee Venom, which is NOT the product covered here - other allergen products, units and schedules are not covered. The SPC states the up-dosing tables 'are to be considered as a guidance' and that dosing 'must always be adjusted according to the allergenic anamnesis and the patient's sensitivity'. UP-DOSING SCHEDULES AS PRINTED (volume of the stated vial strength = dose in SQ-U): Table 3, 15-week conventional: weeks 1-3 vial 1 (100 SQ-U/ml) 0.2 / 0.4 / 0.8 ml = 20 / 40 / 80 SQ-U; weeks 4-6 vial 2 (1 000 SQ-U/ml) 0.2 / 0.4 / 0.8 ml = 200 / 400 / 800 SQ-U; weeks 7-9 vial 3 (10 000 SQ-U/ml) 0.2 / 0.4 / 0.8 ml = 2 000 / 4 000 / 8 000 SQ-U; weeks 10-15 vial 4 (100 000 SQ-U/ml) 0.1 / 0.2 / 0.4 / 0.6 / 0.8 / 1.0 ml = 10 000 / 20 000 / 40 000 / 60 000 / 80 000 / 100 000 SQ-U. Table 4, 25-week extended conventional (sensitive patients): weeks 1-3 vial 1 0.2 / 0.4 / 0.8 ml = 20 / 40 / 80 SQ-U; weeks 4-6 vial 2 0.2 / 0.4 / 0.8 ml = 200 / 400 / 800 SQ-U; weeks 7-15 vial 3 0.1 to 0.9 ml in 0.1 ml steps = 1 000 to 9 000 SQ-U in 1 000 steps; weeks 16-25 vial 4 0.1 to 1.0 ml in 0.1 ml steps = 10 000 to 100 000 SQ-U in 10 000 steps. The SPC also gives a cluster up-dosing schedule (Table 2) that is not reproduced here - see the SPC. MISSED OR EARLY/LATE VISITS: Table 5 (up-dosing) - up to 2 weeks between visits: continue up-dosing; 2-3 weeks: repeat previous dose; 3-4 weeks: reduce to 50 % of previous dose; 4 weeks or more: restart up-dosing according to Table 2, 3 or 4. Table 6 (maintenance) - up to 8 weeks: continue with the maintenance dose; 8-10 weeks: reduce to 75 % of previous dose; 10-12 weeks: reduce to 50 %; 12-14 weeks: reduce to 25 %; 14-16 weeks: reduce to 10 %; 16 weeks or more: restart up-dosing according to Table 2, 3 or 4. After a maintenance dose reduction the patient must be carefully observed, then up-dosed per Table 2, 3 or 4 until the maximal maintenance dose is reached. DOSE REDUCTION FOR LOCAL REACTIONS (if an injection-site reaction persists for more than 6 hours; Table 7, maximum diameter of swelling, children / adults): <5 cm / <8 cm continue up-ward titration; 5-7 cm / 8-12 cm repeat dose last given; 7-12 cm / 12-20 cm reduce to the dose given the time before last; 12-17 cm / >20 cm reduce to the dose given 2 times before last; >17 cm / - reduce to the dose given 3 times before last. SYSTEMIC REACTIONS: if a serious systemic reaction occurs after injection, treatment should only be continued after careful consideration; if continued, 'the following dose should be reduced to 10% of the dose provoking the reaction'; the reduced dose can be split into two injections given 30 minutes apart, then up-dose per Table 2, 3 or 4 until the maximal tolerated dose or 100 000 SQ-U is reached. ADMINISTRATION: observe the patient for at least 30 minutes after each injection; on the day of injection avoid physical exercise, hot baths and alcohol; vials are turned slowly upside down 10-20 times before use; avoid intravascular injection by careful aspiration, repeated for every 0.2 ml, and inject slowly; an anaphylactic emergency kit must be available. If more than one allergen is given concomitantly, inject in different locations on the arm, 30 minutes apart. Postpone the injection if fever or other signs of chronic or acute infection, exacerbated atopic dermatitis, or an allergic reaction in the previous 3-4 days; after other vaccinations wait at least a week before continuing, and do not give other vaccinations earlier than a week after an ALUTARD SQ injection. Pre-treatment with H1 antihistamines should be considered in the up-dosing phase for patients with large local or systemic allergic reactions. SPECIAL POPULATIONS: Elderly - no additional dose adjustment required. Paediatric - SPC: 'No additional dose adjustment is required in the paediatric population'; special care in the risk-benefit assessment for children younger than 5 years, and a risk-benefit assessment is also recommended for children 5 years or older (SPC 4.4). The SPC prints no separate paediatric dose, so none is given here. LIMITS OF THIS EXTRACT: SPC section 4.8 was truncated at the source-fetch limit, so the side-effect list is partial; section 6.6 (handling) was not retrieved.