Alutard sq

Package leaflet: Information for the patient

ALUTARD SQ
Injection suspension
Maintenance treatment: 100 000 SQ-U/ml
Please read carefully all the information in this leaflet before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor, pharmacist, or nurse if you have any questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Contents of the leaflet:

1. What ALUTARD SQ is and what it is 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 pack and other information

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

ALUTARD SQ is a medicine intended for the treatment of allergic diseases mediated by specific immunoglobulin E (IgE).

2. Important information before using ALUTARD SQ

After receiving an injection, the patient should remain at the medical facility for at least 30 minutes due to the risk of an allergic reaction.

When not to use ALUTARD SQ:

• if the patient has active autoimmune disease (poorly controlled) or any disease affecting the immune system,
• if the patient has malignant cancer,
• if the patient has impaired lung function (as assessed by the physician),
• if the patient with asthma has experienced worsening of asthma symptoms within the last 3 months (as assessed by the physician),
• if the patient is hypersensitive to any of the other components of this medicine (listed in section 6.1).

Consult your doctor, even if the above warnings refer to conditions from the past.

Warnings and precautions

On the day of injection, avoid strenuous physical activity, hot baths, and alcohol consumption.

Before each allergen injection, the physician should verify the volume and date of the previous injection (interval between doses).

Before starting treatment with ALUTARD SQ, inform your doctor if:

• An allergic reaction occurred after the last injection, as this may indicate the need for a reduced dose.
• The patient is being treated for depression with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), or is being treated for Parkinson's disease with catechol-O-methyltransferase (COMT) inhibitors.
• The patient has chronic heart, lung, or kidney disease.
• The patient has a disease affecting the immune system or is taking medicines that suppress immune function.
• The patient is taking beta-blockers, for example, to reduce blood pressure.
• The patient has fever or any other signs of infection.
• The patient has recently experienced symptoms of severe allergic reaction, such as hay fever, asthma, or rash, in the days preceding the injection.

The dose of injected medicine should be adjusted or the injection postponed in the following cases:

• Occurrence of fever or other signs of infection
• Occurrence of allergic symptoms within the last 3–4 days
• Significant reduction in lung function (as assessed by the physician)
• Previous occurrence of adverse reactions (local or systemic)
• Worsening of atopic dermatitis
• Receipt of a prophylactic vaccination

ALUTARD SQ and other medicines

Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to take.

Inform your doctor or healthcare professional about the use of antiallergic medicines such as antihistamines or corticosteroids, as they may influence possible adverse reactions to this treatment. In such cases, the doctor may adjust the dose.

When receiving other vaccinations, e.g., prophylactic vaccines, an interval of at least one week should be maintained before and after administration of ALUTARD SQ.

If undergoing concurrent treatment with other allergens, injections should be administered sequentially into separate arms. Wait at least 30 minutes between consecutive injections.

During treatment with ALUTARD SQ, avoid taking large amounts of medicines containing aluminium, such as certain antacids.

Some medicines may interfere with the action of adrenaline. Adrenaline is used in the treatment of severe allergic reactions. Therefore, inform your doctor or healthcare professional if you are taking any of the following medicines: beta-blockers for lowering blood pressure, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) used in the treatment of depression, or COMT inhibitors used in the treatment of Parkinson's disease.

ALUTARD SQ with food and drink

Avoid alcohol consumption on the day of injection, as it may increase the risk and severity of a severe allergic reaction (anaphylaxis).

Pregnancy and breastfeeding

Pregnancy

If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult her doctor or pharmacist before using this medicine.

Initiation of treatment during pregnancy is not recommended. Women who become pregnant during treatment with ALUTARD SQ may continue treatment only after prior evaluation of their general condition and response to previous doses by the physician.

Breastfeeding

It is unknown whether ALUTARD SQ is excreted in human breast milk. If the patient is breastfeeding, she should consult her doctor before starting treatment.

Driving and using machines

Treatment with ALUTARD SQ is not expected to affect the patient's ability to drive or operate machinery.

ALUTARD SQ contains sodium

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

3. How to use ALUTARD SQ

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Administration method
Before administration, the ALUTARD SQ vial should be slowly inverted upside down 10–20 times. The medicine
is administered by subcutaneous injection into the upper arm or forearm. It is recommended to alternate
injections between the right and left arm with each subsequent injection.
Dosage:
ALUTARD SQ must be administered exclusively in medical facilities under the supervision of a physician
experienced in specific immunotherapy, and in medical settings where appropriate medications and
equipment for managing potential anaphylactic reactions are available.
The patient must remain at the medical facility for at least 30 minutes after each injection.
Treatment consists of two phases: a dose-increase phase (during which the dose is gradually increased) and a
maintenance phase (during which a constant dose is administered).
Dosage during both phases is individually determined by the treating physician, depending on
the patient's tolerance and sensitivity to the allergen.

Dose-increase phase
During the initial phase, the allergen dose is increased until reaching the highest tolerated dose,
which becomes the maintenance dose.
During the initial phase, one injection is administered weekly for 13 weeks until the maintenance dose is reached.

Maintenance phase (maintenance treatment)
After reaching the maintenance dose, the interval between injections is gradually extended from 1 to 2, 4, and then 6 weeks. Subsequently, treatment continues for 3 years, with injections administered every 6 weeks ± 2 weeks.

Dose reduction:
The physician should adjust the dose of ALUTARD SQ in the following situations:

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

Use in children and adolescents
ALUTARD SQ is generally not recommended for the treatment of allergies in children under 5 years of age.

Use of a higher than recommended dose of ALUTARD SQ
If an excessive dose of ALUTARD SQ is accidentally administered, there is an increased risk
of allergic reactions. Therefore, the patient must remain under observation at the medical facility for at least 30 minutes. If necessary, treatment for any adverse reactions will be provided.
In case of any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicinal product can cause adverse reactions, although not everybody experiences them.
Ask your doctor what to do if you experience any adverse reaction.
Contact your doctor immediately if you experience a serious adverse reaction.
An adverse reaction may be an allergic reaction to the allergen the patient is being treated for.
Symptoms of adverse reactions may occur within the first 30 minutes after injection,
although they may also appear within 24 hours after administration of the injection.
Most adverse reactions are mild or moderate in severity and, if necessary,
can be treated with antihistamines.
Seek immediate medical help if any of the following symptoms occur, which may
indicate the onset of an anaphylactic reaction:

• Sudden swelling of the face, lips or throat
• Difficulty swallowing
• Breathing difficulties
• Hives
• Voice changes
• Worsening of existing asthma
• Nausea, abdominal pain and cramps, vomiting or diarrhoea
• A feeling of severe discomfort

Other possible adverse reactions
Very common adverse reactions (may affect more than 1 in 10 people)

• Reactions at the injection site, including: swelling, hives, skin discoloration, nodules, pain, bruising, haematoma, induration, inflammation, rash, feeling of warmth, lumps, redness and (or) itching

Common adverse reactions (may affect up to 1 in 10 people)

• Severe allergic reactions
• Dizziness
• Eye inflammation
• Wheezing
• Asthma symptoms, shortness of breath, bronchospasm, cough or sneezing
• Throat irritation
• Itching of the nose
• Nasal discomfort, blocked or runny nose
• Abdominal pain, diarrhoea, vomiting, nausea, heartburn
• Hives, itching, rash, skin redness
• Skin rash
• Hot flushes (sudden reddening)
• Itching of the ears
• Discomfort
• Fatigue
• Chills
• Feeling of warmth
• Sensation of a foreign body in the throat

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Anaphylactic shock
• Eyelid swelling
• Facial swelling

Other adverse reactions with unknown frequency

• Skin tingling sensation
• Sensation of rapid or irregular heartbeat
• Abnormally fast heart rate
• Bluish skin discoloration
• Low blood pressure
• Pallor
• Bronchospasm
• Throat tightness
• Swelling of the face or throat
• Joint swelling, joint pain
• Chest discomfort
• Increased hair growth at the injection site

Tell your doctor if any adverse reactions occur in the patient. This is
important information for the doctor, who will determine the optimal dose of the medicine for the patient.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, consult your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ALUTARD SQ

Keep this 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 stated month.
Store in a refrigerator (2ºC - 8ºC). Do not freeze.
Keep the vials in the outer packaging to protect from light.
After first opening the vial, the medicine may be used for up to 6 months, provided it is stored as recommended, i.e. in a refrigerator (2ºC - 8ºC); after this period, the medicine must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Alutard SQ contains
Animal-derived allergen extracts:
552 Horse hair
553 Dog hair
555 Cat hair
Maintenance treatment: 100,000 SQ-U/ml
Initial treatment: 100 SQ-U/ml, 1,000 SQ-U/ml, 10,000 SQ-U/ml, 100,000 SQ-U/ml
injection suspension
Excipients: aluminium hydroxide, hydrated, sodium chloride, sodium bicarbonate, phenol,
sodium hydroxide – for pH adjustment, water for injections.

What Alutard SQ looks like and contents of the pack
The initial 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).
Vials are made of type I glass, with chlorobutyl rubber stoppers and aluminium caps (each concentration has a differently coloured cap: grey for 100 SQ-U/ml, green for 1,000 SQ-U/ml, gold for 10,000 SQ-U/ml, red for 100,000 SQ-U/ml).

Alutard SQ must be administered by a qualified person (e.g. physician, nurse).
It is recommended that Alutard SQ be stored at the medical facility.

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

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

Information intended exclusively for healthcare professionals:

Treatment with ALUTARD SQ should be administered only by a physician experienced in specific immunotherapy. The patient must be observed for at least 30 minutes after each injection.

During storage, sediment and clear liquid may be observed in the medicinal product. This is a normal phenomenon. The sediment may range in color from white to light brown or greenish. Before use, the vial should be slowly inverted 10 to 20 times to obtain a uniform suspension. Before administration, the suspension should be inspected to ensure it does not contain solid particles. If solid particles are visible in the suspension, the product must be discarded.

ALUTARD SQ is administered subcutaneously. The injection should be given either on the lateral aspect of the distal upper arm or on the dorsal side of the proximal forearm.

ALUTARD SQ must never under any circumstances be administered intravenously.
To avoid intravenous administration, careful aspiration must be performed prior to injection.
Aspiration should be repeated every 0.2 mL during injection of the suspension.
The injection must be administered slowly.

Appropriate equipment and medications for the treatment of anaphylactic reactions must be available during administration of ALUTARD SQ.

Since compatibility studies have not been conducted, this medicinal product must not be mixed with other medicinal products.