Alutard Sq

Leaflet attached to the packaging: patient information

ALUTARD SQ

suspension for injection
basic treatment: 100 SQ-U/ml, 1000 SQ-U/ml, 10 000 SQ-U/ml, 100 000 SQ-U/ml
maintenance treatment: 100 000 SQ-U/ml

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is ALUTARD SQ and what is it used for
• 2. Important information before using ALUTARD SQ
• 3. How to use ALUTARD SQ
• 4. Possible side effects
• 5. How to store ALUTARD SQ
• 6. Contents of the packaging and other information

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

ALUTARD SQ is intended for the treatment of allergic diseases dependent on specific immunoglobulin E (IgE).

2. Important information before using ALUTARD SQ

When not to use ALUTARD SQ

• if the patient is allergic to any of the other ingredients of this medicine (listed in section 6).
• if the patient has an immune system disorder, is taking immunosuppressive drugs or has cancer.
• if the patient has recently had an asthma attack and/or asthma symptoms have worsened recently, e.g. increased daily symptoms, nocturnal awakenings, increased need for medication and/or restriction of daily activities.

Consult a doctor, even if the above warnings refer to past situations.

Warnings and precautions

Before starting treatment with ALUTARD SQ, consult a doctor, pharmacist or nurse.
On the day of injection, avoid strenuous physical activity, hot baths and alcohol consumption.
Before starting treatment with ALUTARD SQ, tell your doctor if:

• There has been any adverse reaction at the site of the last injection.
• The patient is being treated with tricyclic antidepressants.
• The patient is being treated with monoamine oxidase inhibitors (MAO) for depression or catechol-O-methyltransferase inhibitors (COMT) for Parkinson's disease.
• The patient has chronic heart or lung disease or kidney disease.
• The patient is taking ACE inhibitors, e.g. for high blood pressure,
• The patient is taking beta-blockers, e.g. to lower blood pressure.
• The patient has a fever or other signs of infection.
• The patient has experienced symptoms of an allergic reaction, such as fever, asthma or rash in the last few days before injection.

After injecting ALUTARD SQ:

• The patient must remain under medical supervision for 30 minutes after the injection.
• If severe allergic reaction symptoms occur, such as hives, difficulty swallowing or breathing, voice changes, low blood pressure or a feeling of a foreign body in the throat, seek medical help immediately.
• If there is a significant worsening of asthma symptoms, seek medical help immediately.
• Before each allergen injection, the doctor should check the volume and date of the previous injection (interval between doses).
• If an allergic reaction occurred after the last injection, inform the doctor, as this may indicate the need to use a smaller dose (dose reduction).
• Avoid taking other aluminum-containing medications during treatment with ALUTARD SQ, such as some antacids.
• If the patient has an increased blood tryptase level and/or mastocytosis, the risk of adverse reactions and their severity may be higher.
• If the patient has mastocytosis, the effectiveness of ALUTARD SQ may be lower than in the general population of patients with insect venom allergy.

Children and adolescents

Children aged 5 and over: information on the efficacy of treatment in children is limited, however, safety data do not indicate a higher risk than in adults.
Children under 5 years: the doctor will carefully assess the need for treatment.
The dose of the injected medicine should be changed or the injection should be postponed if:

• A fever or other signs of infection occur.
• Allergic symptoms occur within 3-4 days.
• Previous adverse reactions (local or generalized) occur.
• Atopic dermatitis worsens.
• Another vaccine is administered.

ALUTARD SQ and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor about taking antiallergic medicines, such as antihistamines or corticosteroids, as they may have an adverse effect on treatment.
In such cases, the doctor may consider it necessary to adjust the dose of ALUTARD SQ.
In the case of other vaccinations, e.g. protective, a break of at least one week should be maintained before and after injecting ALUTARD SQ.
In the case of concurrent treatment with other allergens than ALUTARD SQ, injections should be administered sequentially in each arm. Wait at least 30 minutes between injections.
During treatment with ALUTARD SQ, avoid taking large doses of other aluminum-containing medications, such as some antacids.
Some medications may affect the action of adrenaline. Adrenaline is used to treat severe allergic reactions. Therefore, tell your doctor or medical staff about taking any of the following medications: beta-blockers, used to lower blood pressure, ACE inhibitors, used to treat high blood pressure, monoamine oxidase inhibitors (MAO), used to treat depression or catechol-O-methyltransferase inhibitors (COMT), used to treat Parkinson's disease.

ALUTARD SQ with food and drink

On the day of injection, avoid consuming alcohol, as the risk of severe allergic reactions may be higher.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult a doctor or pharmacist before using this medicine.
Do not start treatment during pregnancy. Women who become pregnant during treatment with this medicine may continue to use the medicine after the doctor has assessed their overall condition and reaction to previous doses.

Breastfeeding

It is not known whether ALUTARD SQ passes into breast milk. If you are breastfeeding, consult a doctor before starting treatment.

Driving and using machines

Treatment with ALUTARD SQ has no effect or negligible effect on the patient's ability to drive or operate machines.

ALUTARD SQ contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use ALUTARD SQ

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Method of administration
Before administering ALUTARD SQ, slowly turn the vial upside down 10-20 times. The medicine is injected subcutaneously into the upper arm or forearm.
Dosing:
ALUTARD SQ may only be administered in medical facilities under the control of a doctor experienced in specific immunotherapy and in medical facilities where appropriate medications and equipment are available to treat potential anaphylactic reactions.
The patient must remain in the medical facility for at least 30 minutes after each injection.
Treatment is divided into two phases: the dose increase phase (the dose is gradually increased) and the maintenance phase (a constant dose is used).
Dosing in both phases is individually determined by the doctor, depending on the patient's tolerance and sensitivity to the allergen.
Dose increase phase
During the initial phase, the allergen dose is increased to achieve the maximum tolerated dose. This dose is the maintenance dose.
During the initial phase, one injection is given once a week for 13 weeks to achieve the maintenance dose.
Maintenance phase (maintenance treatment)
After achieving the maintenance dose, the interval between injections is gradually increased from 1 to 2, 4 and 6 weeks. Then, treatment is continued for 3 years, with injections given every 6 weeks ± 2 weeks.
Dose reduction:
Maximum swelling diameter
Children
Adults
Recommended dose reduction
<5 cm
<8 cm
Continue to increase the dose according to the dosing schedule.
5–7 cm
8–12 cm
Repeat the last administered dose.
7–12 cm
12–20 cm
Reduce the dose to the previously administered dose.
12-17 cm
> 20 cm
Reduce the dose to the dose administered two periods earlier than the last one.
>17 cm

• Reduce the dose to the dose administered three periods earlier than the last one.

The doctor should adjust the dose of ALUTARD SQ in the following situations:

• if more time has passed since the last visit than recommended,
• in the event of a severe reaction at the injection site, lasting more than 6 hours after the injection. Such a reaction should be reported to the doctor,
• in the event of a severe, generalized reaction to the medicine, the doctor will consider whether to continue treatment. If treatment is continued, the next dose will be reduced to 10% of the dose that caused the reaction.

Using a higher than recommended dose of ALUTARD SQ

In the event of accidental administration of too high a dose of ALUTARD SQ, there is an increased risk of allergic reactions. Therefore, remain in the medical facility for at least 30 minutes after the injection. If necessary, treatment for potential adverse reactions will be administered.
If you have any further doubts about the use of this medicine, consult a doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ask your doctor what to do if you experience any side effects.
Immediately contact your doctor if you experience a severe side effect.
Side effects may be an allergic response to the administered allergen, which the patient is being treated for.
Symptoms of side effects may occur within the first 30 minutes after injection, although they may also appear up to 24 hours after the injection.
Most side effects are mild or moderate in severity, and if necessary, can be treated symptomatically with antihistamines.
Immediately contact your doctorif you experience any of the following symptoms, which may be symptoms of an anaphylactic reaction:

• Sudden swelling of the face, lips or throat
• Difficulty swallowing
• Difficulty breathing
• Hives
• Voice changes
• Worsening of existing asthma
• Nausea, abdominal pain and cramps, vomiting and diarrhea
• Feeling of severe discomfort

Other possible side effects:

Very common side effects (occurring in more than 1 in 10 people)

• Headache

Common side effects (occurring in more than 1 in 100 people but less than 1 in 10 people)

• Dizziness
• Feeling of tingling on the skin
• Inflammation or itching of the eyes
• Wheezing
• Asthma symptoms, shortness of breath, constriction of the lower airways, coughing or sneezing
• Feeling of irritation in the throat
• Feeling of a blocked nose
• Heartburn
• Redness or itching of the skin
• Rash
• Hot flashes
• Back pain, pain or swelling of the joints
• Itching at the injection site
• Feeling of fatigue

Uncommon side effects (occurring in more than 1 in 1000 people but less than 1 in 100 people)

• Feeling of rapid, irregular heartbeat
• Redness at the injection site
• Feeling of discomfort in the chest

Side effects with unknown frequency

• Allergic reactions, including anaphylactic shock
• Swelling of the eyelids
• Rapid heartbeat
• Low blood pressure
• Pallor
• Feeling of discomfort in the nose, feeling of a blocked nose or runny nose
• Feeling of pressure in the throat
• Pain when swallowing or difficulty swallowing
• Feeling of a foreign body in the throat
• Swelling, hives, discoloration of the skin, nodules, pain, excessive hair growth and bruising at the injection site
• Feeling of heat
• Swelling of tissues (usually lower limbs)

Tell your doctor if you experience any side effects. This is important information for your doctor to choose the optimal dose of the medicine for you.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, consult a doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store ALUTARD SQ

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Store the vials in the outer packaging to protect from light.
After opening the vial, the medicine can be used for a maximum of 6 months if stored as recommended, i.e. in a refrigerator (2°C - 8°C); after this time, the medicine should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What ALUTARD SQ contains

Insect venom extracts:
801 Bee venom
802 Wasp venom
basic treatment: 100 SQ-U/ml, 1000 SQ-U/ml, 10 000 SQ-U/ml, 100 000 SQ-U/ml
maintenance treatment: 100 000 SQ-U/ml
suspension for injection
Excipients:
801 Bee venom: aluminum hydroxide, hydrated, sodium chloride, sodium bicarbonate, phenol, sodium hydroxide - to adjust pH, human albumin, water for injection.
802 Wasp venom: aluminum hydroxide, hydrated, sodium chloride, sodium bicarbonate, phenol, sodium hydroxide - to adjust pH, water for injection.

What ALUTARD SQ looks like and contents of the packaging

The basic treatment set contains 4 vials of 5 ml each (from 100 SQ-U/ml to 100 000 SQ-U/ml).
The maintenance treatment set contains 1 vial of 5 ml (100 000 SQ-U/ml).
The vials are made of type I glass with laminated bromobutyl rubber stoppers and aluminum caps (different color for each concentration: gray - 100 SQ-U/ml, green - 1 000 SQ-U/ml, gold - 10 000 SQ-U/ml, red - 100 000 SQ-U/ml).
ALUTARD SQ should be administered by a qualified person (e.g. doctor, nurse).
It is recommended to store ALUTARD SQ in a medical facility.

Marketing authorization holder and manufacturer

ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm, Denmark

Manufacturer

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

Date of last update of the leaflet: 06/2025

Information intended only for healthcare professionals:

Treatment with ALUTARD SQ should only be carried out by a doctor experienced in specific immunotherapy. The patient should be monitored for at least 30 minutes after each injection.
During storage, the appearance of a sediment and a clear liquid may be observed in the medicinal product. This is a normal phenomenon. The sediment may be white to light brown or greenish in color.
Before use, the vial should be slowly turned upside down 10-20 times to obtain a homogeneous suspension. Before administration, the suspension should be inspected for solid particles. If solid particles are visible in the suspension, the product should be discarded.
ALUTARD SQ is administered subcutaneously. The product is injected either into the side of the distal part of the arm or into the dorsal part of the proximal forearm.
ALUTARD SQ should never be administered intravenously under any circumstances.
Avoid intravenous administration by performing careful aspiration before injecting the suspension. Aspiration should be repeated every 0.2 ml during injection of the product.
The injection must be administered slowly.
When using ALUTARD SQ, appropriate equipment and medications for the treatment of anaphylactic reactions must be available.
Since compatibility studies have not been performed, this medicine should not be mixed with other medicines.