Treatment with ALUTARD SQ Wasp should be carried out under the supervision of a doctor experienced in specific immunotherapy. After each injection, the patient must be observed for at least 30 minutes.
Posology
The treatment is divided into two phases; an up-dosing phase and a maintenance phase. The aim is to gradually increase the dose until the highest tolerated maintenance dose is reached. The highest recommended maintenance dose is 1 ml of 100 000 SQ-U/ml (vial 4). The dosing of ALUTARD SQ Wasp must always be adjusted according to the allergenic anamnesis and the patient's sensitivity to the specific allergen (see 4.4).
Up-dosing phase:
Recommendations for up-dosing are given in table 2, 3 and 4. The recommendations given in the tables are to be considered as a guidance. The patient should be informed that local and general reactions may occur during the up-dosing phase (see section 4.8). The choice of up-dosing schedule depends on the patient's sensitivity since the risk of developing allergic reactions is reduced with a slow up-dosing.
Table 2: 7-week up-dosing (cluster) which is recommended in cases when there is a need for faster protection.
| Vial no | Strength SQ-U/ml | Week no | Injection no | Volume ml | Dosage SQ-U |
| 1 | 100 | 1 | 1 | 0.1 | 10 |
| 2 | 1 000 | | 2 | 0.1 | 100 |
| 3 | 10 000 | | 3 | 0.1 | 1 000 |
| | 10 000 | 2 | 4 | 0.2 | 2 000 |
| | 10 000 | | 5 | 0.2 | 2 000 |
| | 10 000 | 3 | 6 | 0.5 | 5 000 |
| | 10 000 | | 7 | 0.5 | 5 000 |
| 4 | 100 000 | 4 | 8 | 0.2 | 20 000 |
| | 100 000 | 5 | 9 | 0.4 | 40 000 |
| | 100 000 | 6 | 10 | 0.6 | 60 000 |
| | 100 000 | 7 | 11 | 1.0 | 100 000 |
Table 3: 15-week up-dosing (conventional) which is suitable for the majority of patients.
| Vial no | Strength SQ-U/ml | Week no | Injection no | Volume ml | Dosage SQ-U |
| 1 | 100 | 1 | 1 | 0.2 | 20 |
| | 100 | 2 | 2 | 0.4 | 40 |
| | 100 | 3 | 3 | 0.8 | 80 |
| 2 | 1 000 | 4 | 4 | 0.2 | 200 |
| | 1 000 | 5 | 5 | 0.4 | 400 |
| | 1 000 | 6 | 6 | 0.8 | 800 |
| 3 | 10 000 | 7 | 7 | 0.2 | 2 000 |
| | 10 000 | 8 | 8 | 0.4 | 4 000 |
| | 10 000 | 9 | 9 | 0.8 | 8 000 |
| 4 | 100 000 | 10 | 10 | 0.1 | 10 000 |
| | 100 000 | 11 | 11 | 0.2 | 20 000 |
| | 100 000 | 12 | 12 | 0.4 | 40 000 |
| | 100 000 | 13 | 13 | 0.6 | 60 000 |
| | 100 000 | 14 | 14 | 0.8 | 80 000 |
| | 100 000 | 15 | 15 | 1.0 | 100 000 |
Table 4: 25-week up-dosing (extended conventional) recommended for sensitive patients.
| Vial no | Strength SQ-U/ml | Week no | Injection no | Volume ml | Dosage SQ-U |
| 1 | 100 | 1 | 1 | 0.2 | 20 |
| | 100 | 2 | 2 | 0.4 | 40 |
| | 100 | 3 | 3 | 0.8 | 80 |
| 2 | 1 000 | 4 | 4 | 0.2 | 200 |
| | 1 000 | 5 | 5 | 0.4 | 400 |
| | 1 000 | 6 | 6 | 0.8 | 800 |
| 3 | 10 000 | 7 | 7 | 0.1 | 1 000 |
| | 10 000 | 8 | 8 | 0.2 | 2 000 |
| | 10 000 | 9 | 9 | 0.3 | 3 000 |
| | 10 000 | 10 | 10 | 0.4 | 4 000 |
| | 10 000 | 11 | 11 | 0.5 | 5 000 |
| | 10 000 | 12 | 12 | 0.6 | 6 000 |
| | 10 000 | 13 | 13 | 0.7 | 7 000 |
| | 10 000 | 14 | 14 | 0.8 | 8 000 |
| | 10 000 | 15 | 15 | 0.9 | 9 000 |
| 4 | 100 000 | 16 | 16 | 0.1 | 10 000 |
| | 100 000 | 17 | 17 | 0.2 | 20 000 |
| | 100 000 | 18 | 18 | 0.3 | 30 000 |
| | 100 000 | 19 | 19 | 0.4 | 40 000 |
| | 100 000 | 20 | 20 | 0.5 | 50 000 |
| | 100 000 | 21 | 21 | 0.6 | 60 000 |
| | 100 000 | 22 | 22 | 0.7 | 70 000 |
| | 100 000 | 23 | 23 | 0.8 | 80 000 |
| | 100 000 | 24 | 24 | 0.9 | 90 000 |
| | 100 000 | 25 | 25 | 1.0 | 100 000 |
Maintenance phase:
When the maintenance dose is reached, the interval between injections is gradually increased. The interval is increased from 1 to 2, 4 and 6 to 8 weeks. Subsequently, the injections are given every 6 to 8 weeks. The maintenance treatment is continued for 3-5 years.
If the patient responds with severe allergic reactions during the up-dosing phase, it is possible that the highest recommended dose of 100 000 SQ-U is not reached. A lower dose should then be considered as the maximal tolerated dose for the patient, and this will be the maintenance dose.
ALUTARD SQ Wasp is not interchangeable with other venom immunotherapy products, but, if available on the market, Aquagen SQ Vespula spp. (ALK manufacturing) can be used in the up-dosing phase before switching to ALUTARD SQ Wasp for the maintenance phase.
Exceeded time interval between two visits
If the recommended time interval between visits has been exceeded, the dosing of the following injection is handled according to the following recommendation:
Table 5: Exceeded time interval between two visits during the up-dosing phase
| Weeks between visits | Dosage |
| Up to 2 weeks | Continue up-dosing according to table 2, 3 or 4 |
| 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: Exceeded time interval between two visits during the maintenance phase
| Weeks between visits | Dosage |
| Up to 8 weeks | Continue with the maintenance dose |
| 8 - 10 weeks | Reduce to 75 % of previous dose |
| 10 - 12 weeks | Reduce to 50 % of previous dose |
| 12 – 14 weeks | Reduce to 25 % of previous dose |
| 14 - 16 weeks | Reduce to 10 % of previous dose |
| 16 weeks or more | Restart up-dosing according to table 2, 3 or 4 |
In case of a dose reduction in the maintenance phase, the patient must be carefully observed after the injection. Subsequently, up-dose according to the recommendations in table 2, 3 or 4 until the maximal maintenance dose is reached.
Concomitant treatment with more than one allergen
In case of treatment with more than one allergen concomitantly, the injections should be given in different locations on the arm. In order to evaluate possible allergic reactions caused by the specific allergen it is recommended to give the injections with a 30 minute interval.
Dose reduction in case of allergic reactions
Dose reductions in case of local reactions
If an injection site reaction persists for more than 6 hours after the injection, the following dose reduction is recommended depending on the size of the swelling:
Table 7: Recommended dose-reduction in case of local adverse events
| Maximum diameter of swelling | Recommended dose reduction |
| Children | Adults |
| < 5 cm | < 8 cm | Continue up-ward titration according to schedule (table 2, 3 or 4) |
| 5-7 cm | 8-12 cm | Repeat dose last given |
| 7-12 cm | 12-20 cm | Reduce dose to dose given the time before last |
| 12-17 cm | >20 cm | Reduce dose to dose given 2 times before last |
| >17 cm | - | Reduce dose to dose given 3 times before last |
Dose reduction in case of systemic reactions
If a serious systemic reaction (see section 4.8) occurs after injection, the treatment should only be continued after careful consideration. If the treatment is continued, the following dose should be reduced to 10% of the dose provoking the reaction.
The chosen reduced dose can be split into two injections given with a 30 minute interval. The patient should be observed after the injections. Subsequently, up-dose according to recommendations in table 2, 3 or 4 until the maximal tolerated dose or 100 000 SQ-U is reached.
Elderly population
No additional dose adjustment is required in the elderly population.
Paediatric population
No additional dose adjustment is required in the paediatric population. See section 4.4.
Method of administration
After each injection, the patient must be observed for at least 30 minutes. On the day of injection the patient must avoid physical exercise, hot baths and alcohol as these co-factors may potentially amplify an anaphylactic reaction.
ALUTARD SQ Wasp is administered subcutaneously. The vials must be turned slowly upside down 10 - 20 times before use. For instructions on the handling of ALUTARD SQ Wasp before administration, see section 6.6.
The injection is given either laterally in the distal part of the upper arm or dorsally in the proximal part of the forearm.
Avoid intravascular injection by careful aspiration before injection. Aspiration must be repeated for every 0.2 ml during the injection and the injection must be given slowly. An anaphylactic emergency kit must be available while using ALUTARD SQ Wasp. Please refer to section 4.4 for warnings and precaution in relation to treatment.
Precautions in relation to administrations
The injection should be postponed:
- If the patient has a fever or shows other clinical signs of a chronic or acute infection.
- If the patient has an atopic dermatitis that has exacerbated.
- If the patient has had an allergic reaction within the last 3-4 days prior to the injection.
- If other kinds of vaccinations have been given, wait at least a week before treatment with ALUTARD SQ is continued. Other vaccinations should not be given earlier than a week after an ALUTARD SQ injection.
Before injection:
- Double check the allergen, concentration, volume and previous injection date (dosing interval), prior to each injection.
- ALUTARD SQ Wasp is intended for subcutaneous injection. Intravenous administration must be avoided due to the increased risk of allergic reactions.
- Allergic reactions (both local and systemic) which occurred during the previous injections should be recorded and the dose should be assessed on the basis of this.
- Pre-treatment with H1 antihistamines should be considered in the up-dosing phase for patients who experience large local reactions or systemic allergic reactions.
- The patient's state of health and allergy status must be evaluated as well as any changes of other medication since the last administered injection (see section 4.4 and 4.5).
- The asthma status, in patients with a medical history of asthma, must be evaluated prior to injection (see section 4.4).
After injection:
- The patient must be advised to consult a doctor or emergency room immediately in case of severe systemic delayed reactions.
- The patient must be advised to observe any local or systemic reactions that may occur subsequently, and to inform the attending doctor at the next visit.
- Any allergic reactions (both local and systemic) should be recorded before the patient leaves the clinic.
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