ALUTARD SQ VESPULA SPP STARTER PACK (100 SQ-U/mL, 1000 SQ-U/mL, 10,000 SQ-U/mL and 100,000 SQ-U/mL) INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

Alutard SQ Vespula spp. starter kit (100 SQ-U/ml, 1,000 SQ-U/ml, 10,000 SQ-U/ml, and 100,000 SQ-U/ml), injectable suspension

Alutard SQ Vespula spp..100,000 SQ-U/ml injectable suspension

Wasp venom allergen (Vespula spp.)

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 further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Alutard SQ Vespula spp. is and what it is used for

Alutard SQ Vespula spp. contains the allergen (the substance that causes the allergic reaction) from wasp venom. It is used as preventive treatment for wasp sting allergy.

This treatment is used in patients with a history of severe allergic reactions to wasp stings. The goal of the treatment is to combat the underlying cause of the allergy. It works by gradually increasing immunological tolerance to wasp venom.

2. What you need to know before you use Alutard SQ Vespula spp.

Do not use Alutard SQ Vespula spp.

• if you are allergic to any of the other ingredients of this medicine (listed in section 6).
• if you have any disease that affects your immune system.
• if you have recently had an asthma attack and/or your asthma symptoms have worsened, for example, your symptoms have increased during the day, you have had nighttime awakenings, your need for medication has increased, and/or you have had limitations in your activity.
• if you have severe heart or vascular disease.

Warnings and precautions

Talk to your doctor before starting to use Alutard SQ Vespula spp. if:

• you have experienced any side effects after the last administration of Alutard SQ Vespula spp.
• you have chronic heart disease
• you know that your kidney function is reduced, as there may be a risk of aluminum accumulation in your body
• you have an autoimmune disease
• you have cancer
• you have a fever or show any other sign of infection
• in the last 3 or 4 days you have had allergic symptoms such as allergic rhinitis
• you have eczema that has worsened
• you know that you have a high level of tryptase protein in your blood
• you know that you have mastocytosis or any other disease that produces an increase in the number of mast cells in your body
• you have asthma

If you present any of the above cases, it is essential that you inform your doctor about it, to reduce the risk of allergic reactions related to treatment with Alutard SQ Vespula spp. (see section 4 "Possible side effects").

Children and adolescents

Children from 5 years old: The information on the effect of the treatment in children is limited. Safety data have not shown a higher risk in children than in adults. It is recommended that the doctor assess the risks and benefits in each child.

Children under 5 years old: The doctor should carefully assess the risks and benefits of treatment in each child.

Using Alutard SQ Vespula spp. with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor or nurse especially if

• you are taking any other medicine to treat your allergy, such as antihistamines or corticosteroids, as they may increase your tolerance to this treatment. The doctor may need to adjust the dose
• you are taking medicines that contain large amounts of aluminum, such as some antacids (used for heartburn). Since Alutard SQ Vespula spp. also contains aluminum, there may be a risk of aluminum accumulation in your body.
• you have been recently vaccinated, for example against tetanus. There should be at least one week between the injection of Alutard SQ Vespula spp. and that of the other vaccine
• you are taking beta-blockers or ACE inhibitors to treat high blood pressure or heart disease, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) for depression or COMT inhibitors for Parkinson's disease. These medicines may increase the risk of/or influence the treatment of any allergic reaction produced when using Alutard SQ Vespula spp.

Using Alutard SQ Vespula spp. with alcohol

You should avoid alcohol on the day of the injection as it may increase the risk of suffering a severe allergic reaction (anaphylaxis).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Initiation of treatment with Alutard SQ Vespula spp. should not be started during pregnancy. If you become pregnant during maintenance treatment, you should discuss the risks of continuing maintenance treatment with your doctor.

It is not known whether Alutard SQ Vespula spp. is excreted in breast milk. You should consult your doctor before starting treatment if you are breastfeeding.

Driving and using machines

Alutard SQ Vespula spp. may affect your ability to drive or use machines, as you may feel dizzy after receiving the treatment.

Alutard SQ Vespula spp. contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use Alutard SQ Vespula spp.

Treatment with Alutard SQ Vespula spp. is administered by injection. The injections will normally be given in your arm, under the skin. Your doctor or nurse will always give you the injections.

You should remain in the clinic for at least 30 minutes after the injection to detect and treat any potential allergic reaction.

On the day of the injection, you should avoid: intense physical exercise, hot baths, and alcohol.

The treatment is divided into two phases: initiation phase and maintenance phase.

Initiation phase:

Treatment will be started according to the schedule established by your doctor. In the initiation phase, it is usual for the injections to be given once a week. This phase usually lasts between 7 and 25 weeks.

The goal is to gradually increase the dose until the maximum dose that can be tolerated or the recommended maintenance dose is reached. If a reaction occurs at the injection site and lasts more than 6 hours after the injection, the doctor may adjust the dose based on the extent of your skin reaction. Your doctor may prescribe antihistamines before the injection.

Maintenance phase:

Once the maintenance dose is reached, the time between injections will be gradually increased, until they are administered every 6-8 weeks for 3-5 years.

Treatment with more than one allergen at the same time:

If you are being treated with more than one allergen at the same time, the time between injections should be at least 30 minutes.

If you use more Alutard SQ Vespula spp. than you should

A doctor will administer the treatment with Alutard SQ Vespula spp. In case of overdose, you will be monitored and treated by a doctor.

If you forget to use Alutard SQ Vespula spp.

Contact your doctor if you think you have missed a dose. If the time interval between 2 injections has been too long, the doctor will reduce the dose to avoid an allergic reaction.

If you stop using Alutard SQ Vespula spp.

To get the best result from your treatment, you will need to receive the injections for 3 to 5 years.

If you have any other questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may be an allergic reaction to the allergen being treated. 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, late reactions can occur up to 24 hours after the injection.

Seek medical attention immediatelyif your asthma suddenly worsens or if you experience any of the following symptoms, which may be a sign of an anaphylactic reaction (the frequency cannot be estimated from the available data):

• Rapid swelling of the face or throat
• Difficulty swallowing
• Difficulty breathing
• Hives
• Flushing
• Worsening of existing asthma
• Nausea, abdominal pain, vomiting, and diarrhea
• Severe discomfort

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

• Reactions at the injection site: swelling, discoloration, nodules, pain, itching, redness, hematoma, hair growth
• Headache
• Dizziness
• Itching sensation on the skin
• Swelling of the eyelids
• Itching in the eyes
• Rapid heartbeat
• Sensation of rapid and strong or irregular heartbeats
• Low blood pressure
• Pallor
• Feeling of oppression or irritation in the throat
• Wheezing
• Asthmatic symptoms, shortness of breath, or cough
• Rash
• Pain or swelling of the joints
• Feeling of heat
• Feeling of something stuck in the throat
• Swelling of the tissues (usually in the lower limbs)
• Chest discomfort
• Fatigue
• Feeling of discomfort

In case of any allergic reaction, you should contact your doctor immediately to receive the appropriate treatment.

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alutard SQ Vespula spp.

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 is the last day of the month shown. The vial should be used within 6 months after opening when used for a specific patient and stored in the refrigerator (between 2°C and 8°C).

Store in the refrigerator (between 2°C and 8°C). Do not freeze. Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Alutard SQ Vespula spp.

• The active substance is the allergen from wasp venom (Vespulaspp.). The wasp venom species included in the mixture are: Vespula germanica, Vespula alascensis, Vespula maculifrons, Vespula flavopilosa, Vespula pensylvanica, and Vespula squamosa.
• The other ingredients are aluminum hydroxide (hydrated), sodium chloride, sodium hydrogen carbonate, phenol, sodium hydroxide, and water for injections.

Appearance and packaging

Alutard SQ Vespula spp. is an injectable suspension. The suspension is white to slightly brown or green in color.

The product is available in two presentations: a starter kit with four concentrations and a maintenance kit with a concentration of 100,000 SQ-U/ml. The numbers on the vials are of different colors to distinguish between the different concentrations. Not all pack sizes may be marketed.

Activity is expressed in SQ-U/ml units.

Activity in 1 ml of injectable suspension is:

Marketing authorization holder and manufacturer

Marketing authorization holder

ALK-Abelló A/S

Bøge Allé 6-8

2970 Hørsholm

Denmark

Manufacturer

ALK-Abelló S.A.

Miguel Fleta 19

28037 Madrid

Spain

You can obtain more information about this medicine by contacting the local representative of the marketing authorization holder:

ALK-Abelló S.A.

C/ Miguel Fleta, 19

28037 – Madrid

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:11/2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended only for healthcare professionals:

Treatment with Alutard SQ Vespula spp. should be performed under the supervision of a doctor with experience in specific immunotherapy. After each injection, the patient should remain under observation for at least 30 minutes.

During storage, a precipitate and a clear liquid may be observed. This is normal in a suspension and does not constitute a sign of deterioration of the product. The precipitate may be white to slightly brown or green in color. The vials should be inverted slowly up and down 10-20 times to form a homogeneous suspension before use. Visually inspect the suspension for fine particles before administration. Discard the product if there are visible particles in it.

Alutard SQ Vespula spp. 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 aspirating carefully before injection. Aspiration should be repeated every 0.2 ml during the injection, and the injection should be administered slowly. During the use of Alutard SQ Vespula spp., an emergency kit should be available to treat anaphylaxis.

Due to the lack of compatibility studies, this medicine should not be mixed with others.