Alutard Vespula

Package leaflet: Information for the user

Allergen from Wasp Venom ( Vespula spp. )
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet:

1. What ALUTARD Vespula is and what it is used for
2. What you need to know before using ALUTARD Vespula
3. How to use ALUTARD Vespula
4. Possible side effects
5. How to store ALUTARD Vespula
6. Contents of the pack and other information

1. What ALUTARD Vespula is and what it is used for

ALUTARD Vespula contains allergens (the substance that causes the allergic reaction) derived from wasp venom and is used as preventive treatment for allergies triggered by wasp stings.
This treatment is intended for patients known to have severe 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 using ALUTARD Vespula

Do not use ALUTARD Vespula

• if you are allergic to any of the other ingredients of this medicine (listed in section 6)
• if you have a disease affecting the immune system
• if you have recently had an asthma attack and/or have recently experienced worsening of asthma symptoms, such as increased daily symptoms, nocturnal awakenings, increased need for medication, and/or limitations in normal daily activities
• if you suffer from severe heart or circulatory diseases.

Warnings and precautions
Talk to your doctor before using ALUTARD Vespula if:

• you have experienced any adverse reaction after the last injection of ALUTARD Vespula
• you have chronic heart disease
• you know you have reduced kidney function, as there may be a risk of aluminium accumulation in your body
• you have an autoimmune disease
• you have cancer
• you have fever or any other signs of infection
• you have experienced allergic symptoms such as hay fever in the last 3 to 4 days
• you have had a worsening of eczema
• you know you have elevated levels of tryptase protein in the blood
• you know you have mastocytosis or any other condition causing an increased number of cells called "mast cells" in the blood
• you suffer from asthma

If you experience any of the conditions listed above, it is important to discuss them with your doctor. This is to reduce the risk of allergic reactions associated with treatment with ALUTARD Vespula (see section 4 “Possible side effects”).

Children and adolescents
Children aged 5 years and older: information on the effects of treatment in children is limited. Safety data have not shown any increased risk in children compared to adults. It is recommended that the doctor assess the risk-benefit ratio for each child.
Children under 5 years of age: the doctor must carefully evaluate the risk-benefit ratio of treatment for each individual child.

Other medicines and ALUTARD Vespula
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or nurse if:

• you are taking any other medication for the treatment of allergy, such as antihistamines or corticosteroids, as these may increase tolerance to ALUTARD Vespula. Your doctor may need to adjust the dosage
• you are taking medicines containing high amounts of aluminium, such as certain antacids (used to treat heartburn). Since ALUTARD Vespula also contains aluminium, there may be a risk of aluminium accumulation in your body
• you have recently received other vaccinations, for example tetanus vaccine. At least one week should elapse between the injection of ALUTARD Vespula and another vaccination
• you are taking beta-blockers or ACE inhibitors for the treatment of hypertension or heart disease, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) for depression, or catechol-O-methyltransferase inhibitors (COMT) for Parkinson's disease. These medicines may increase the risk of and/or affect the response to treatment of any allergic reactions when using ALUTARD Vespula.

ALUTARD Vespula and alcohol
Alcohol should be avoided on the day of the injection, as it may increase the risk of a severe allergic reaction (anaphylaxis).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before receiving this medicine.
The dose-increase phase (initiation phase) with ALUTARD Vespula should not be started during pregnancy. If you become pregnant during maintenance treatment, you should discuss with your doctor the risks related to continuing maintenance treatment.
It is not known whether ALUTARD Vespula passes into breast milk; if you are breastfeeding, you should consult your doctor before starting treatment.

Driving and using machines
ALUTARD Vespula may in some cases affect the ability to drive or use machinery, as dizziness may occur after treatment.

ALUTARD Vespula contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to use ALUTARD Vespula

Treatment with ALUTARD Vespula is administered by injection. The injections are
normally given in your arm, subcutaneously. Injections must always be
administered by a doctor or nurse.
You must remain under observation at the doctor's office for at least 30 minutes after the injection,
in order to detect and treat any potential allergic reaction.
On the day of the injection, you should avoid: strenuous physical activity, hot baths, and alcohol consumption.
The treatment consists of two phases: the initial phase and the maintenance phase.
Initial phase:
Treatment is started according to an injection schedule designed by your
doctor. During the initial phase, injections are normally given once a week.
The initial phase lasts from 7 to 25 weeks.
The aim is to gradually increase the dose until reaching the highest dose you can tolerate or the recommended maximum maintenance dose. If a reaction at the injection site occurs and persists for more than 6 hours after the injection, your doctor may adjust the dose according to the extent of your skin reaction. Your doctor may administer an antihistamine before the injection.
Maintenance phase:
Once the maintenance dose has been reached, the interval between injections will be gradually increased. Subsequently, injections will be given every 6–8 weeks for 3–5 years.
Treatment with more than one allergen simultaneously
If you are receiving treatment with more than one allergen at the same time, the injections must be administered at least 30 minutes apart.
If you use more ALUTARD Vespula than you should
Treatment with ALUTARD Vespula is administered by the doctor.
In case of overdose, you will be monitored and treated by a doctor.
If you miss a dose of ALUTARD Vespula
Consult your doctor if you think you have missed a dose. If the interval between two injections is too long,
your doctor will reduce the dose to prevent the occurrence of an allergic reaction.
If you stop treatment with ALUTARD Vespula
To achieve the best outcome from your treatment, injections should be administered for a period of 3–5 years.
Talk to your doctor if you have any questions regarding your treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects may represent an allergic reaction to the allergen being administered. Local reactions such as itching, redness, and swelling may occur at the injection site after each injection. Side effects usually occur within 30 minutes after the injection. However, delayed reactions may appear up to 24 hours after the injection.
Seek immediate medical help if your asthma worsens suddenly or if you experience any of the following symptoms, which could be signs of an anaphylactic reaction (frequency cannot be estimated from available data):

• Rapid swelling of the face or throat
• Difficulty swallowing
• Difficulty breathing
• Hives
• Skin redness
• Worsening of pre-existing asthma
• Nausea, stomach pain, vomiting, and diarrhea
• Severe general malaise

Other possible side effects (frequency cannot be estimated from available data):

• Injection site reactions: swelling, skin discoloration, nodules, pain, itching, redness, bruising, increased hair growth
• Headache
• Dizziness
• Skin tingling sensation
• Eyelid swelling
• Itchy eyes
• Rapid heartbeat
• Sensation of strong, fast, or irregular heartbeat
• Low blood pressure
• Pallor
• Tightness or irritation sensation in the throat
• Wheezing
• Asthma symptoms, shortness of breath, or cough
• Skin rash
• Joint pain or joint swelling
• Feeling of warmth
• Sensation of something stuck in the throat
• Tissue swelling (usually in the lower limbs)
• Chest pain
• Fatigue
• Feeling of general discomfort

If you experience any allergic reaction, you must contact your doctor immediately to receive appropriate treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You may also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ALUTARD Vespula

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 the word EXP.
The expiry date refers to the last day of that month. The vial must be used within
6 months after opening when used for a single patient and stored in the refrigerator (2 °C - 8 °C).
Store in the refrigerator (2°C - 8°C). Do not freeze. Keep in the original packaging to
protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ALUTARD Vespula contains
The active substance is allergens derived from wasp venom (Vespula spp.). The wasp species
included in the mixture are: Vespula germanica, Vespula alascensis, Vespula maculifrons, Vespula
flavopilosa, Vespula pensylvanica and Vespula squamosa.
The other excipients are aluminium hydroxide (hydrate), sodium chloride, sodium bicarbonate, phenol,
sodium hydroxide, human albumin solution and water for injections.

Description of the appearance of ALUTARD Vespula and contents of the pack
ALUTARD Vespula is an injectable suspension. The suspension ranges from white to slightly brown
or green.
The product is available in two different pack sizes: a starter pack containing 4 concentrations and a maintenance pack containing the 100,000 SQ-U/ml concentration. The vials are colour-coded to distinguish between the different concentrations.
Not all pack sizes may be marketed.
Concentration is expressed in SQ-U/ml units.
The concentration per 1 ml of injectable suspension is:

| Vial / Vial Code | Vial 1 | Vial 2 | Vial 3 | Vial 4 |
|------------------|--------|--------|--------|--------|
| Colour | Grey | Green | Orange | Red |
| Concentration | 100 SQ-U/ml | 1,000 SQ-U/ml | 10,000 SQ-U/ml | 100,000 SQ-U/ml |
| Aluminium content in the adjuvant | 0.00113 mg/ml | 0.0113 mg/ml | 0.113 mg/ml | 1.13 mg/ml |

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ALK-Abelló A/S
Bøge Allé 6-8
2970 Hørsholm
Denmark

Manufacturer:
ALK-Abelló S.A.
Miguel Fleta 19
E-28037 Madrid
Spain

Selling Agent:
ALK-Abelló S.p.A
Via Nino Bixio 31
20129 Milano (MI)
Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

The following information is intended exclusively for healthcare professionals:
Treatment with ALUTARD Vespula must be carried out under the supervision of a physician experienced
in specific immunotherapy. After each injection, the patient must remain under observation for at least
30 minutes.
During storage, a precipitate and clear liquid may be observed. This is normal for a suspension and does
not indicate deterioration in product quality. The precipitate may range in color from white to slightly
brown or green. Vials should be inverted slowly 10–20 times to obtain a homogeneous suspension before
use. Visually inspect the suspension for particulate matter prior to administration. Discard the product if
visible particles are present.
ALUTARD Vespula is administered by subcutaneous injection. The injection should be given laterally in
the distal part of the upper arm or dorsally in the proximal part of the forearm. Intravascular injection
must be avoided by careful aspiration before injection. Aspiration should be repeated every 0.2 mL
injected, and the injection should be administered slowly. An emergency kit for the treatment of
anaphylactic reactions must be available whenever ALUTARD Vespula is used.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.