Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Alutard Wasp Venom Initial
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Wasp venom may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
ALUTARD SQ Wasp contains allergen (the substance that cause the allergic reaction) from wasp venom and is used as preventive treatment for allergy against wasp stings. This treatment is used for patients who are known to have serious allergic reactions to wasp stings. The aim of the treatment is to address the underlying cause of the allergy. It works by gradually increasing the immune system's tolerance to wasp venom. 2.
What you need to know before you take it
e ALUTARD SQ Wasp
Do not use ALUTARD SQ Wasp if you are allergic to any of the other ingredients of this medicine (listed in section 6) if you have a disease which affects the immune system if you have recently had an asthma attack and/or have recently experienced worsening of your asthma symptoms e.g. increase in daytime symptoms, nightly wakening, increased need for medication and/or activity limitations if you suffer from severe heart or blood vessel disease Warnings and precautions Talk to your doctor before using ALUTARD SQ Wasp if:
- you experienced any side effects after the last treatment with ALUTARD SQ Wasp.
- you have a chronic heart disease
- you know that you suffer from reduced kidney function, as there may be a risk of aluminium accumulation in your body
- you have an autoimmune disease
- you have cancer 1
–
you have a fever or show any other signs of an infection you have suffered from allergic symptoms such as hay fever in the last 3 to 4 days you have eczema which has worsened you know that you have an increased level of the protein tryptase in your blood you know that you are suffering from mastocytosis or any other condition that causes you to have an increased number of mast cells in your body you have asthma
If any of the above applies to you it is important that you speak to your doctor about it. This is to minimise the risk of allergic reactions in connection with the treatment with ALUTARD SQ Wasp (see section 4 "Possible side effects") Children and adolescents Children from 5 years: information on the effect of treatment in children is limited. Safety data have not shown any increase in risk for children compared to adults. It is recommended that the doctor evaluates the risks and benefit of the individual child. Children under 5 years: the doctor must carefully evaluate the risks and benefit of the treatment for the individual child. Other medicines and ALUTARD SQ Wasp Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Particularly tell your doctor or nurse if you
- are taking any other medicines for treatment of allergy such as antihistamines or corticosteroids, as they may increase your tolerance to this treatment. The doctor may need to adjust the dosage. •
are taking medicines containing large amounts of aluminium, such as some antacids (used for heartburn). Since ALUTARD SQ Wasp also contains aluminium there may be a risk of aluminium accumulation in your body.
•
recently had another vaccination, such as Tetanus vaccination. There should be at least one week between injection with ALUTARD SQ Wasp and another vaccination
•
are taking beta blockers or ACE inhibitors to treat high blood pressure or heart disease, tricyclic antidepressants or mono amino oxidase inhibitors (MAOIs) for depression or COMT inhibitors for Parkinson ́s disease. These medicinal products may increase the risk for/or influence the treatment of any allergic reactions when you use ALUTARD SQ Wasp
ALUTARD SQ Wasp with alcohol Alcohol should be avoided on the day of injection as this might increase the risk of a severe allergic reaction (anaphylaxis). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before having this treatment. Up-dosing treatment with ALUTARD SQ Wasp should not be started during pregnancy. If you become pregnant during maintenance treatment you should speak to your doctor about the risks of continuing the maintenance treatment. It is not known whether ALUTARD SQ Wasp passes into breast milk. You should consult your doctor before starting treatment, if you are breast feeding. Driving and using machines 2
ALUTARD SQ Wasp may in some cases have an effect on driving or using machines, as you can feel dizzy after the treatment. ALUTARD SQ Wasp contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodiumfree'. 3.
How to take it
ALUTARD SQ Wasp
Treatment with ALUTARD SQ Wasp is given by injection. The injections are usually given in your arm, just under the skin. The injections are always given by a doctor or a nurse. You will need to stay at the clinic for at least 30 minutes following the injection in order to detect and treat any potential allergic reaction. On the day of your injection you should avoid: strenuous physical exercise, hot baths and alcohol. The treatment is divided into two phases: the up-dosing phase and the maintenance phase. Up-dosing Phase: Treatment is started according to a schedule that has been worked out by your doctor. During the updosing phase, the injections are usually given once a week. The up-dosing phase takes between 7 and 25 weeks. The aim is to gradually increase the dose until reaching the highest dose that you can tolerate or the highest recommended maintenance dose. If an injection site reaction occurs and it persists for more than 6 hours after the injection, the doctor may adapt the dose depending on the size of your skin reaction. Your doctor may provide you with an antihistamine before your injection. Maintenance Phase: When the maintenance dose is reached, the period between injections will be gradually increased. Thereafter injections are given every 6 – 8 weeks for 3 – 5 years. Treatment with more than one allergen at the same: If you receive treatment with multiple allergens at the same time the injections should be given 30 minutes apart. If you are given more ALUTARD SQ Wasp than you should Treatment with ALUTARD SQ Wasp is administered by a doctor. In the event of an overdose, you will be monitored and treated by a doctor. If you have missed a dose of ALUTARD SQ Wasp Ask your doctor if you think you have not been given a dose. If the interval between 2 injections is too long, the doctor will reduce the dose in order to prevent an allergic reaction. If you stop having ALUTARD SQ Wasp To achieve the best outcome from your treatment you will need to have the injections for 3 to 5 years. Talk to your doctor if you have any questions about your treatment
3
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects may be an allergic reaction to the allergen you are being treated with. Local reactions such as itching, redness and swelling may occur at the site of injection after each injection. The side effects usually occur within 30 minutes after the injection. However, late reactions can occur up to 24 hours after the injection. Get medical help immediately if your asthma suddenly becomes worse or if you experience the following symptoms which may be signs of an anaphylactic reaction (frequency cannot be estimated from the available data): − Rapid swelling of face or throat − Difficulties in swallowing − Difficulties in breathing − Hives − Flushing − Worsening of existing asthma − Nausea, stomach pain, vomiting and diarrhoea − Severe discomfort Other possible side effects (frequency cannot be estimated from the available data): –
Reactions at the injection site: swelling, discolouration, nodules, pain, itching, redness, bruise, hair growth Headache Dizziness Prickling sensation of the skin Swollen eyelids Itching of the eyes Fast heart rate Sensation of rapid forceful or irregular beating of the heart Low blood pressure Paleness Tightness or irritating sensation in the throat Wheezing breathing Asthma symptoms, shortness of breath or cough Rash Joint pain or joint swelling Feeling hot Sensation of something stuck in the throat Swelling of tissue (usually in the lower limbs) Chest discomfort Tiredness Feeling of discomfort
In the event of any allergic reactions, you should contact a doctor immediately in order to receive adequate treatment. Reporting of side effects In UK: If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for "MHRA Yellow Card" in the Google play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.
4
In Ireland: If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the HPRA via the HPRA Pharmacovigilance Website www.hpra.ie. By reporting side affects you can help provide more information on the safety of this medicine. 5.
How to store it
ALUTARD SQ Wasp
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. The vial should be used within 6 months after opening when used for one individual patient and when stored in a refrigerator (2°C – 8°C). Store in a refrigerator (2oC – 8oC). Do not freeze. Store in the original package, in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What ALUTARD SQ Wasp contains The active substance is allergen from wasp venom (Vespula spp.). The wasp venom species included in the mixture are: Vespula germanica, Vespula alascensis, Vespula maculifrons, Vespula flavopilosa, Vespula pensylvanica and Vespula Squamosa. Other ingredients are aluminium hydroxide (hydrated), sodium chloride, sodium hydrogen carbonate, phenol, sodium hydroxide, human albumin solution and water for injection. What the medicine looks like and contents of the pack ALUTARD SQ Wasp is a suspension for injection. The suspension is white to faintly brown or green. The product is available in two different packs. An up-dosing pack with four strengths for up-dosing and a maintenance pack with the strength 100 000 SQ-U/ml. The vial numbers are colour coded to distinguish between the different strengths. Not all pack sizes may be marketed. Activity is expressed in the unit SQ-U/ml. The activity in 1 ml of suspension for injection is: Vial/colour code Vial 1 Vial 2 Grey Green Strength 100 SQ-U 1 000 SQ-U Aluminium 0.00113 mg/ml 0.0113 mg/ml content in adjuvant Marketing Authorisation Holder ALK-Abelló A/S Bøge Allé 6-8 2970 Hørsholm Denmark Manufacturer ALK-Abelló S.A. 5
Vial 3 Orange 10 000 SQ-U 0.113 mg/ml
Vial 4 Red 100 000 SQ-U 1.13 mg/ml
Miguel Fleta 19 E-28037 Madrid Spain This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Belgium, Ireland, Luxemburg, United Kingdom ALUTARD SQ Wasp (Northern Ireland) Portugal, Spain ALUTARD SQ Vespula spp. Austria ALUTARD SQ Wespengift France ALUTARD VENIN DE GUEPE VESPULA SPP. Hungary ALUTARD SQ Darázs Italy ALUTARD Vespula Norway Alutard SQ Vepsegift Romania ALUTARD SQ venin de viespe Slovenia Osji strup ALUTARD SQ Sweden Alutard SQ Getinggift This leaflet was last revised in October 2025 The following information is intended for healthcare professionals only: 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. During storage, a precipitate and a clear liquid can be observed. This is normal for a suspension and does not constitute a sign of deterioration of the quality of the product. The precipitate might be white to faintly brown or green. The vials must be turned slowly upside down 10 – 20 times to make a homogeneous suspension prior to use. Inspect the suspension visually for particulate matter prior to administration. Discard the product if visible particles are present. ALUTARD SQ Wasp is administered subcutaneously. 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. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6
Frequently asked questions about Alutard Wasp Venom Initial
What is the active substance in Alutard Wasp Venom Initial?
The active substance in Alutard Wasp Venom Initial is wasp venom.
Are there equivalent medicines to Alutard Wasp Venom Initial?
Medicines with the same active substance, strength and form include: Alutard Wasp Venom Maintenance. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Alutard Wasp Venom Initial, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Alutard Wasp Venom Initial without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: wasp venom
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Allergy immunotherapy for patients with a documented history of generalised and/or systemic IgE-mediated allergic reactions due to sensitisation to wasp venom (Vespula spp.), confirmed by skin prick test and/or intradermal test and/or specific IgE test.
4.2. Posology and method of administration
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.
4.3. Contraindications
- Hypersensitivity to any of the excipients listed in section 6.1.
- Patients with active or poorly controlled systemic autoimmune diseases and immunodeficiency disorders.
- Patients with disorders or conditions where an induced anaphylactic reaction imply an unacceptable risk such as severe cardiovascular disease.
- Asthma patients at risk of exacerbation and/or with inadequate symptom control defined as the presence of:
loss of symptom control within the last four weeks (e.g. increase in daytime symptoms, nightly wakening, increased need of medication, activity limitations).
4.4. Special warnings and precautions for use
Severe systemic allergic reactions
Due to the risk of serious allergic reactions, immediate access to full resuscitation equipment and drugs must be available, including adrenaline for injection and staff trained in the use thereof. If symptoms of a systemic reaction, such as urticaria, angioedema or severe asthma occur, symptomatic treatment should be initiated immediately (see section 4.2 and 4.8).
Cardiovascular diseases
Patients with cardiac diseases may be at increased risk in case of systemic allergic reactions. Patients with cardiovascular diseases must be sufficiently treated for the underlying condition prior to the initiation of ALUTARD SQ Wasp treatment. In connection with the treatment with ALUTARD SQ Wasp special attention should be given. See section 4.3. Clinical experience in treatment with ALUTARD SQ Wasp of patients with cardiac diseases is limited.
Autoimmune diseases
There are no controlled studies on the influence of autoimmune disorders on the efficacy of allergy immunotherapy (AIT), or on autoimmune disorders as a predisposing factor for severe side effects during AIT. AIT may only be initiated in patients with autoimmune diseases in case of disease remission or well-adjusted therapy. ALUTARD SQ Wasp should therefore be prescribed with caution in these patients.
Malignant neoplastic diseases
There are no controlled studies on the influence of malignant neoplastic diseases on the efficacy of AIT, or on malignant neoplastic diseases as a predisposing factor for severe side effects during ALUTARD SQ Wasp immunotherapy. AIT may only be initiated when the malignant disease is stable. In case of aggravation treatment with ALUTARD SQ Wasp should be discontinued. ALUTARD SQ Wasp should therefore be prescribed with caution in these patients.
Mastocytosis
Patients with increased baseline serum tryptase and/or mastocytosis may be at an increased risk of developing systemic allergic reactions and the severity of these may be increased. Patients with mastocytosis should therefore be monitored carefully during treatment with ALUTARD SQ Wasp. Patients with mastocytosis may expect less efficacy of treatment compared with the general insect venom allergic population.
Treatment with ACE-inhibitors
Patients simultaneously treated with ACE inhibitors may be at higher risk of developing more severe anaphylactic reactions and should therefore be carefully monitored during the up-dosing phase. Temporarily interrupting the ACE inhibitor treatment (based on the half-life of the ACE inhibitor) should be considered carefully in relation to the advantages of immunotherapy in the individual patient. ACE inhibitors might reduce the effect of ALUTARD SQ Wasp.
Treatment with MAO-inhibitors, COMT- inhibitors or beta-blockers
One option for treating severe systemic allergic reactions is adrenaline. The effects of adrenaline may be potentiated in patients treated with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) and/or COMT inhibitors with possible fatal consequences. The effects of adrenaline may be reduced in patients treated with beta-blockers. In addition, the effects of adrenaline may exacerbate cardiovascular disease, e.g .cause cardiac arrhythmia. Patients in treatment with beta-blockers should be carefully monitored during the up-dosing phase.
Asthma
Asthma is a known risk factor for severe systemic allergic reactions. In patients with asthma, the asthma symptoms should be adequately controlled prior to the initiation of ALUTARD SQ Wasp treatment. In connection with the treatment with ALUTARD SQ Wasp special attention should be given. The patient´s asthma condition must be assessed prior to each injection (see section 4.3).
Patients must be informed of the need to seek medical attention immediately if their asthma suddenly deteriorates. Clinical experience in treatment with ALUTARD SQ Wasp of patients with asthma is limited.
Other populations (including patients with renal dysfunction)
As ALUTARD SQ Wasp contains aluminium, there is a theoretical risk of aluminium accumulation in patients at high risk (i.e. patients with renal dysfunction and patients concomitantly treated with other aluminium containing drugs (e.g. antacids)). This should be considered when initiating therapy with ALUTARD SQ Wasp.
Paediatric population
Special care should be given to the risk-benefit assessment with regard to the treatment of children younger than 5 years of age. For children ≥ 5 years of age clinical data of efficacy are sparse, however data on safety do not reveal a higher risk as for adults. A risk-benefit assessment with regard to the treatment of children ≥ 5 years of age is also recommended.
Co-administration with other AIT
No clinical experience on co-administration with other types of allergy immunotherapy is available.
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been conducted in humans and no potential drug interactions have been identified from any source. Concomitant treatment with symptomatic anti-allergy medications, e. g. antihistamines, corticosteroids and mast cell stabilisers may increase the patient's tolerance level towards the allergen injections. This should be considered at discontinuation of such medications.
For information considering concomitant use of ACE inhibitors, MAOIs, COMT inhibitors, beta-blockers and antacids see section 4.4.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is no clinical experience of the use of ALUTARD SQ Wasp during pregnancy. Up-dosing treatment should not be initiated during pregnancy. If pregnancy occurs during maintenance treatment, the maintenance treatment may continue after a careful evaluation of the patient's general condition and reactions to previous injections with ALUTARD SQ Wasp.
Breastfeeding
No clinical data is available on the use of ALUTARD SQ Wasp during breastfeeding. No effects on the breastfed infants are anticipated.
Fertility
There are no clinical data available related to the effect of ALUTARD SQ Wasp on fertility.
4.7. Effects on ability to drive and use machines
ALUTARD SQ Wasp may in some cases influence the ability to drive or use machines due to the side effect vertigo.
4.8. Undesirable effects
Summary of the safety profile
Generally, reactions appearing in connection with ALUTARD SQ Wasp treatment occur due to an immunological reaction (local and /or systemic) to wasp venom.
Symptoms of an immediate reaction appear within the first 30 minutes after the injection. Symptoms of a delayed reaction appear within the first 24 hours after the injection.
Commonly reported adverse reactions in patients treated with ALUTARD SQ Wasp are local reactions at the injection site.
The most serious adverse drug reaction occurring in patients treated with ALUTARD SQ Wasp is anaphylactic shock. As it is a life threatening condition, it demands immediate treatment.
Tabulated list of adverse reactions
Data from clinical trials with ALUTARD SQ Wasp are limited. Therefore, the following table is based on adverse drug reactions for the product reported spontaneously from the market. The frequency is not known (cannot be estimated from the available data).
System Organ Class
Adverse Drug Reaction
Frequency
Immune system disorders
Systemic allergic reactions including anaphylactic shock
Not known
Nervous system disorder
Headache, dizziness, paraesthesia
Not known
Eye disorders
Eyelid oedema, eye pruritus
Not known
Ear and labyrinth disorders
Vertigo
Not known
Cardiac disorders
Tachycardia, palpitations
Not known
Vascular disorders
Hypotension, pallor, flushing
Not known
Respiratory, thoracic and mediastinal disorders
Throat tightness, wheezing, cough, dyspnoea, asthma, throat irritation
Not known
Gastrointestinal disorders
Dysphagia, diarrhoea, vomiting, nausea, abdominal pain
Not known
Skin and subcutaneous tissue disorders
Urticaria, pruritus, rash, erythema, angioedema, swollen face
Not known
Musculoskeletal and connective tissue disorders
Arthralgia, Joint swelling
Not known
General disorders and administration site conditions
Injection site swelling, injection site urticaria, injection site discolouration, injection site nodule, injection site pain, injection site granuloma, injection site haematoma, injection site erythema, injection site pruritus, injection site hypertrichosis, feeling hot, sensation of foreign body, peripheral swelling, chest discomfort, fatigue, malaise
Not known
Local reactions
Literature reporting of local reactions associated with the use of ALUTARD SQ Wasp and/or ALUTARD SQ Bee varied from 6% to 79% in the up-dosing phase and from 0% to 47% in the maintenance phase.
Local reactions can be treated with symptomatic medication, e.g. antihistamines.
▪ Injection site reactions consist of one or several of the following symptoms: diffuse swelling, redness, pain, itching and injection site urticaria. These symptoms most often appear within 30 minutes and may also persist after 6 hours. Generalized pruritus may also occur.
▪ Subcutaneous nodules at the injection site have been observed after repeated injections.
The aluminium content may contribute to the occurrence of local adverse effects including positive skin patch test for aluminium.
Systemic allergic reactions
Mild to moderate systemic allergic reactions might occur and can be effectively treated with symptomatic medications, e.g. antihistamines. Literature reporting of systemic reactions associated with the use of ALUTARD SQ Wasp and/or ALUTARD SQ Bee varied from 0% to 25% in the up-dosing phase and from 0% to 16% in the maintenance phase.
Symptoms that may be associated with a systemic allergic reaction may include but are not limited to urticaria, angioedema, dyspnoea, cough, bronchospasm, rhinitis, wheezing, chest tightness, asthma, tachycardia and hypotension. Other symptoms of a systemic allergic reaction can be fatigue, general discomfort, headache, abdominal pain, vomiting, diarrhoea, flushing, rash, pruritus, conjunctivitis or sneezing.
A severe systemic allergic reaction is a potentially life-threatening reaction that usually occurs within a few minutes after the patient has been exposed to the allergen. A severe systemic allergic reaction requires immediate treatment with e.g. adrenalin and/or other anaphylactic treatment.
In case of large local reactions and systemic reactions an evaluation of the treatment must be performed (see section 4.2 and section 4.4).
Atopic dermatitis
Atopic dermatitis may be exacerbated during treatment.
Paediatric population
Limited data from clinical trials on the adverse events in children is available. Available safety data does not indicate additional risks related to the use of ALUTARD SQ in the paediatric population.
Other special populations
No data from clinical trials on the adverse events in other populations available.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
If a higher dose of ALUTARD SQ Wasp than intended is injected, the risk of side effects increases including the risk of developing a serious allergic reaction. The patient must be observed and any reaction must be treated with relevant symptomatic medication.
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