Alutard Apis mellifera

Package leaflet: Information for the user

ALUTARD Apis mellifera

100 SQ-U/ml, 1,000 SQ-U/ml, 10,000 SQ-U/ml and 100,000 SQ-U/ml, injectable suspension
Starter pack
ALUTARD Apis mellifera
100,000 SQ-U/ml, injectable suspension
Allergen derived from Bee Venom ( Apis mellifera )
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What ALUTARD Apis mellifera is and what it is used for

ALUTARD Apis mellifera contains allergens (the substance that causes the allergic reaction)
derived from bee venom and is used as a preventive treatment for allergies triggered
by bee stings.
This treatment is used in patients known to experience severe allergic reactions to
bee 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 bee venom.

2. What you should know before using ALUTARD Apis mellifica

Do not use ALUTARD Apis mellifera

• 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, nighttime awakenings, increased need for medication, and/or limitations in normal daily activities
• if you suffer from severe heart or circulatory diseases.

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

• you have experienced any adverse reaction after the last injection of ALUTARD Apis mellifera
• 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 show any other signs of infection
• you have experienced allergic symptoms such as hay fever within the last 3 to 4 days
• you have experienced a worsening of eczema
• you know you have elevated levels of tryptase protein in your blood
• you know you have mastocytosis or any other condition causing an increased number of cells called "mast cells" in your blood
• you suffer from asthma

If you experience any of the conditions listed above, it is important that you discuss them with your doctor. This is to reduce the risk of allergic reactions associated with treatment with ALUTARD Apis mellifera (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 an increased risk in children compared to adults. It is recommended that the doctor evaluates the individual 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 Apis mellifera
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 Apis mellifera. Your doctor may need to adjust the dosage
• you are taking medications containing high amounts of aluminium, such as certain antacids (used to treat heartburn). Since ALUTARD Apis mellifera 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 Apis mellifera and another vaccination
• you are taking beta-blockers or ACE inhibitors for hypertension or heart disease, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) for depression, or catechol-O-methyltransferase (COMT) inhibitors 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 Apis mellifera.

ALUTARD Apis mellifera and alcohol
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Alcohol should be avoided on the day of 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, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before receiving this medicine.
The dose-increase phase (initiation phase) with ALUTARD Apis mellifera should not be started during pregnancy. If you become pregnant during maintenance treatment, you should discuss with your doctor the risks associated with continuing maintenance treatment.
It is not known whether ALUTARD Apis mellifera passes into breast milk; if you are breastfeeding, you should consult your doctor before starting treatment.
Driving and using machines
ALUTARD Apis mellifera may, in some cases, affect your ability to drive or operate machinery, as dizziness may occur after treatment.
ALUTARD Apis mellifera contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.

3. How to use ALUTARD Apis mellifera

Treatment with ALUTARD Apis mellifera is administered by injection. The injections are usually given in your arm, subcutaneously. Injections must always be administered by a doctor or nurse.

You must remain under medical observation in the doctor's office for at least 30 minutes after the injection, so that any potential allergic reaction can be detected and treated.

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 established by your doctor. During the initial phase, injections are usually 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 a period of 3–5 years.

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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 Apis mellifera than you should
Treatment with ALUTARD Apis mellifera is administered by your doctor.
In case of overdose, you will be monitored and treated by a doctor.

If you miss a dose of ALUTARD Apis mellifera
Consult your doctor if you think you have missed a dose. If the interval between two injections is too long, your doctor may reduce the dose to prevent the occurrence of an allergic reaction.

If you stop treatment with ALUTARD Apis mellifera
To achieve the best outcome from your treatment, injections should be continued for a period of 3–5 years.

Talk to your doctor if you have any questions about your treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects may represent an allergic reaction to the allergen with which you are 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, delayed reactions may appear up to 24 hours after the injection.
Seek immediate medical attention if your asthma worsens suddenly or if you experience any of the following symptoms, which may 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, nodules, pain, itching, redness, increased hair growth
• Headache
• Dizziness
• Skin tingling sensation
• Swelling of the eyelids
• Inflammation or itching of the eyes
• Rapid heart rate
• Sensation of strong, fast, or irregular heartbeat 4/7
• Low blood pressure
• Pallor
• Stuffy nose
• 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
• General feeling of malaise

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 the website
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 Apis mellifera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ALUTARD Apis mellifica contains
The active substance is allergens derived from Bee venom (Apis mellifera).
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 Apis mellifera and contents of the pack
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ALUTARD Apis mellifera is an injectable suspension. The suspension is white to slightly brown or green.
The product is available in two different pack types: one pack for the initiation phase containing 4 concentrations, and a maintenance pack containing the 100,000 SQ-U/ml concentration. The vials are colour-coded to distinguish the different concentrations. Not all pack sizes may be marketed.
The concentration is expressed in SQ-U/ml.
The concentration in 1 ml of injection suspension is:

| Vial | Vial 1 | Vial 2 | Vial 3 | Vial 4 |
|------|--------|--------|--------|--------|
| Colour code | Grey | Green | Orange | Red |
| Concentration | 100 SQ-U | 1,000 SQ-U | 10,000 SQ-U | 100,000 SQ-U |
| Aluminium content from 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
28037 Madrid
Spain

Sole Distributor for Sales:
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:

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The following information is intended for healthcare professionals only:
Treatment with ALUTARD Apis mellifera 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 a deterioration in the quality of the product. The precipitate may range in color from white to slightly brown or green. Vials should be slowly inverted 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 Apis mellifera is administered by subcutaneous injection.
The injection should be administered 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 anaphylactic reactions must be available whenever ALUTARD Apis mellifera is used.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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