Novo-helisen depot

Patient Information Leaflet

Novo-Helisen Depot
Animal-derived allergen extracts (hair, epithelia, feathers)
Injection suspension
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents:

1. What Novo-Helisen Depot is and what it is used for
2. Important information before using Novo-Helisen Depot
3. How to use Novo-Helisen Depot
4. Possible side effects
5. How to store Novo-Helisen Depot
6. Contents of the pack and other information

1. What Novo-Helisen Depot is and what it is used for

Novo-Helisen Depot is an allergen extract intended for desensitization (specific immunotherapy).
During specific immunotherapy, increasing doses of a clinically relevant allergen causing an allergic reaction in the patient are administered by injection until an individual maximum dose is reached, which is then maintained as a maintenance dose.
The aim of this treatment is to alleviate clinical symptoms related to the specific allergen(s) and to reduce the need for symptomatic medications.
Novo-Helisen Depot is used in allergic diseases (IgE-mediated), such as allergic rhinitis, allergic conjunctivitis, allergic asthma, etc., caused by allergens that cannot be eliminated from the patient's environment.
Novo-Helisen Depot is used in adults, adolescents, and children above 5 years of age.

2. Important information before using Novo-Helisen Depot

When not to use Novo-Helisen Depot

• If the patient has hypersensitivity (allergy) to any of the excipients listed in section 6;
• If the patient has uncontrolled asthma, i.e. FEV1 is below 70% of predicted value despite appropriate pharmacological treatment;
• If the patient has permanent lung changes, e.g. pulmonary emphysema (emphysema), bronchiectasis;
• If the patient has inflammatory or febrile diseases, severe acute or chronic illnesses (e.g. neoplastic diseases, active tuberculosis);
• If clinically significant cardiovascular insufficiency has been diagnosed in the patient. In case of a severe allergic reaction after injection of Novo-Helisen Depot, adrenaline is used as emergency treatment. In patients with heart disease, there is an increased risk of adverse reactions following administration of adrenaline;
• If the patient has been diagnosed with immunological disorders (severe systemic autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies or multiple sclerosis, etc.);
• If the patient has previously experienced severe systemic reactions related to specific allergen immunotherapy;
• If the patient has severe psychiatric disorders.

Warnings and precautions
This medicinal product for subcutaneous allergen immunotherapy must be administered only by physicians, nurses, and medical personnel trained or experienced in the treatment of allergies.
Before starting treatment with Novo-Helisen Depot, discuss with your doctor if:

• The patient is being treated with angiotensin-converting enzyme (ACE) inhibitors due to high blood pressure;
• The patient is being treated with beta-blockers (medicines used to treat high blood pressure or heart disease, or as eye drops for glaucoma treatment);
• The patient is pregnant;
• If acute symptoms of illness are present (e.g. allergic symptoms or cold);
• If the patient has symptoms of bronchial asthma;
• If the patient has received or is scheduled to receive vaccination.

The patient should inform the doctor of any changes in health status, such as infectious diseases or pregnancy, and discuss further management. If indicated, lung function tests (e.g. peak expiratory flow measurement) may be performed before injection in patients with bronchial asthma.
The patient should inform the doctor whether the previous injection was well tolerated.
Before each injection, the doctor will determine the individual dose based on tolerance of the last administered dose and clinical history.
In the event of severe allergic adverse reactions occurring after or during injection, the doctor may administer adrenaline as emergency treatment. It should be clarified in advance whether adrenaline treatment is feasible for the patient.
On the day of injection, strenuous activities such as sports or heavy physical work should be avoided. Consumption of alcohol, visits to saunas, and taking hot showers should also be avoided.
In the case of planned vaccination against pathogens, an interval of at least 1 week should be maintained between the last injection of this medicine and the vaccination date. Treatment with this medicine is continued for 2 weeks after vaccination at the last administered dose. Vaccinations that are immediately necessary (e.g. tetanus vaccination after injury) may be given at any time.

Children and adolescents
Treatment with Novo-Helisen Depot is generally not recommended for children under 5 years of age.

Novo-Helisen Depot and other medicines
Inform the doctor about all medicines currently or recently taken or used by the patient, as well as any medicines the patient plans to take or use.
No studies on drug interactions have been conducted.
Please keep in mind the following advice and discuss it with your doctor:

• Beta-blockers (medicines used in the treatment of high blood pressure or heart disease, and also as eye drops in glaucoma treatment) may be taken concurrently with Novo-Helisen Depot only after consultation with a doctor.
• ACE inhibitors (medicines used in the treatment of high blood pressure) may be taken concurrently with Novo-Helisen Depot only after consultation with a doctor.
• Concomitant treatment with medicines used in allergy treatment (e.g. antihistamines, corticosteroids, mast cell stabilizers) or medicines that partially act similarly to antiallergic drugs (e.g. certain sedatives, antiemetics, antacids) may influence treatment with Novo-Helisen Depot. This may allow for better tolerance of higher doses of this medicine. If these medicines are discontinued, it may be necessary to reduce the dose of Novo-Helisen Depot.
  During treatment with Novo-Helisen Depot, exposure to allergens causing allergy—particularly animal-derived allergens—should be avoided as much as possible, especially on the day of injection. Other factors that may provoke allergic reactions should also be avoided.

Novo-Helisen Depot with food, drink and alcohol
Alcohol should not be consumed on the day of injection.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
There is insufficient experience with the use of animal-derived allergen extracts in pregnant women.
Therefore, allergen immunotherapy is not recommended during pregnancy.
There are insufficient data available regarding breastfeeding mothers. Although it is unlikely that a breastfed infant would be exposed to risk, the doctor will have to weigh the benefits and risks during breastfeeding.
There are insufficient data on the effect of Novo-Helisen Depot on fertility.

Driving and operating machinery
Novo-Helisen Depot has a minor influence on the ability to drive and operate machinery, as fatigue may occur. This should be taken into account when driving, operating machinery, or working without secure support.

Novo-Helisen Depot contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1.0 mL of maximum dose (concentration 3), meaning the medicine is considered "sodium-free".

3. How to use Novo-Helisen Depot

Recommended dose
A doctor trained or experienced in the treatment of allergies will determine the most appropriate treatment schedule for the patient and will inform the patient about the intervals at which injections will be administered.
The doctor will also determine the appropriate dose. The individual dose depends, among other factors, on how well the patient tolerated the injection.
The maximum dose is 1.0 mL of concentration 3. The individual maximum dose may be lower.
Treatment consists of 2 different phases: initial treatment and maintenance treatment.

Initial treatment (dose escalation)
Treatment should begin, whenever possible, during a symptom-free period.
The doctor may choose one of 2 different dose escalation schedules:

• standard dose escalation schedule (14 injections),
• dose escalation schedule for highly sensitive patients (23 injections).

During initial treatment, the doctor will determine the maximum dose tolerated by the patient by gradually increasing the dose until reaching the individual maximum tolerated dose or the maximum recommended dose of the medicinal product.
Injections will be administered at regular intervals of 7 to 14 days until the individual maximum dose or the maximum recommended dose is achieved.
If the interval between two injections is exceeded, the doctor may be unable to increase the dose according to the planned schedule. Therefore, it is important always to adhere to the scheduled injection dates and not to interrupt initial treatment.

Maintenance treatment
Once the doctor has established the individual maximum dose during initial treatment, or once the maximum recommended dose of the medicinal product has been reached, maintenance treatment begins.
For perennial allergens, after reaching the maximum dose, the intervals between injections are gradually extended so that ultimately injections are administered every 4 to 6 weeks.
If the intended 6-week interval is exceeded, the doctor must reduce the next dose. The dose is then increased again at shorter intervals.
It is also important always to adhere to the scheduled injection dates and not to interrupt maintenance treatment.
When starting a new batch of Novo-Helisen Depot, the doctor will reduce the dose. The dose will then be gradually increased again at intervals of 7 to 14 days.

Use in children and adolescents
Allergen-specific immunotherapy (desensitization) is generally not performed in children under 5 years of age, as in this age group there is a higher likelihood of problems with acceptance and cooperation compared to adults.
In children and adolescents, the same initial and maintenance treatment schedules are used as in adults.

Method of administration
Novo-Helisen Depot is administered by subcutaneous injection by a doctor. The injection is given into the outer part of the upper arm, approximately one hand's width (of the patient) above the elbow. Doses of 0.5–1 mL may be divided and administered into both arms to improve tolerance. The doctor will shake the medicinal product well before use.
The patient must remain under medical supervision for at least 30 minutes after the injection. The doctor will ask the patient about their general condition. The observation period may be individually extended. In case of adverse reactions, even after the observation period, the patient should contact the doctor immediately.

The doctor may use two different desensitizing preparations. If both preparations are to be administered on the same day, at least a 30-minute interval between injections should be maintained. However, it is recommended that injections be administered 2 to 3 days apart. Each time, the preparations should be injected separately into the right and left arm.

Duration of treatment
The recommended duration of treatment is generally 3 years.

Use of a higher than recommended dose of Novo-Helisen Depot
Overdosing may lead to allergic reactions and even anaphylactic shock. In such a case, the doctor will take the necessary countermeasures. Typical symptoms are described in section 4, "Possible side effects."

Missed dose of Novo-Helisen Depot
Patients should always attend their scheduled appointments to ensure treatment success is not compromised. If a patient misses a scheduled appointment, the treatment schedule may need to be adjusted. The patient should contact their doctor, who will advise on the appropriate course of action.

Discontinuation of Novo-Helisen Depot treatment
This should be discussed with the doctor in advance. Premature discontinuation of treatment may result in a reduced therapeutic effect.

If you have any questions or doubts regarding the use of this medicinal product, please consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
After administration of this medicine, the patient will be monitored for at least 30 minutes.
The physician will ask the patient about their general condition. It should be remembered that adverse reactions may also occur after this observation period. If any adverse symptoms occur, contact a physician immediately.

Important adverse reactions and countermeasures
If intolerance symptoms occur during injection, the physician will immediately stop the injection.
Reactions at the injection site (e.g. redness, itching, swelling) as well as systemic reactions (e.g. shortness of breath, whole-body itching, generalized redness) may occur.
Severe allergic reactions may occur, up to anaphylactic shock. Anaphylactic reactions, including anaphylactic shock, may occur within seconds to minutes after injection. Typical warning symptoms include itching and a sensation of heat on and under the tongue and in the throat, shortness of breath, itching or burning of the palms and/or soles of the feet, generalized urticaria, pruritus, drop in blood pressure, dizziness, malaise. The medical staff must be informed immediately if the patient notices these symptoms.
The physician must have an emergency anaphylaxis kit readily available whenever this medicine is administered. If an allergic (anaphylactic) shock occurs, the patient must remain under medical supervision for 24 hours.

Post-marketing data
The list below provides an overview of adverse reactions reported spontaneously after marketing authorization for Novo-Helisen Depot, a medicinal product containing allergenic extract of animal origin. Due to the small number of reported cases, the frequency of adverse reactions cannot be estimated based on the available data.

At the injection site: redness, itching, swelling, local reaction at the injection site;
Other adverse reactions: anaphylactic reaction, anaphylactic shock, cold sweats, altered state of consciousness, headache, anxiety, loss of consciousness, rapid heartbeat (tachycardia), bluish discoloration of the skin and lips (cyanosis), redness, arterial hypertension, decreased blood pressure, chest discomfort, asthma, airway constriction, bronchospasm, cough, dyspnea, stridor, cerebral hypoxia, allergic conjunctivitis, allergic rhinitis, conjunctivitis, rhinitis, weakness, malaise, fatigue, foreign body sensation, joint pain, muscle pain, hemiparesis, dry mouth, difficulty swallowing, angioedema, redness, itching, rash, scar pain, urticaria.

Children and adolescents
The safety profile in children and adolescents is comparable to that in adults.
Other adverse reactions should not be expected in these age groups.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49 21-309.
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to collect further information on the safety of the medicine.

5. How to store Novo-Helisen Depot

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "EXP".
Store in a refrigerator (2 **°**C–8 **°**C).
Do not freeze!
The shelf life after opening the vial is 12 months. However, the medicine must not be used after the expiry date stated on the carton and vial.
Do not use this medicine if you notice any particles.
Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the package and other information

What Novo-Helisen Depot contains
Novo-Helisen Depot contains allergenic extracts of animal origin, house dust mites, and mould fungi.
The composition of the medicinal product is individually selected according to the patient's sensitization profile and as specified in the attached list. The names of individual allergens and their percentage content are indicated on the packaging.
Standardization is performed in PNU (protein nitrogen units).
Concentration 1 contains 25 PNU/mL
Concentration 2 contains 250 PNU/mL
Concentration 3 contains 2500 PNU/mL

Other ingredients are: aluminium hydroxide, sodium chloride, sodium hydrogen carbonate, phenol, water for injections.

What Novo-Helisen Depot looks like and contents of the pack
The medicinal product is a suspension which, after shaking, shows a clearly cloudy appearance.
Depending on the starting material and concentration, the suspensions may vary in appearance and are sometimes intensely coloured.

Pack sizes:

• Pack containing 1 vial of 4.5 mL of concentration 1, 1 vial of 4.5 mL of concentration 2, and 1 vial of 4.5 mL of concentration 3,
• Pack containing 1 vial of 4.5 mL of concentration 3,
• Pack containing 2 vials of 4.5 mL of concentration 3,
• Pack containing 1 vial of 9.5 mL of concentration 3.

Marketing Authorisation Holder and Manufacturer
Allergopharma GmbH & Co. KG
Hermann-Koerner-Str. 52-54
21465 Reinbek
Germany
Tel. +49 40 / 72765-0
Fax +49 40 / 7227713
e-mail: [email protected]

For further information, please contact the representative of the Marketing Authorisation Holder:
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Poland
Tel. 22 350 66 69
Fax 22 350 77 03

DOSING SCHEDULE
Read the patient leaflet before use! Do not exceed the individual maximum dose!
Patient.....................................................................................................................................
Batch number........................................................................................................................
Initial treatment:

Maintenance treatment:

List of allergen extracts that may be included in the Novo-Helisen Depot product
Animal-derived allergen extracts (animal hair and epithelia, feathers):
304 Hamster hair
306 Dog hair
308 Rabbit hair
309 Cat hair
311 Guinea pig hair
314 Horse hair
317 Cow hair
318 Sheep wool
321 Parrot feathers

Information intended exclusively for healthcare professionals:

This medicinal product for subcutaneous allergen immunotherapy must be administered only by
physicians, nurses, and healthcare personnel trained or experienced in allergy treatment.
In the event of severe local or systemic reactions or anaphylaxis during
treatment with Novo-Helisen Depot, the treating physician must have an
anaphylactic shock emergency kit available. Patients experiencing anaphylactic shock must be monitored by
a physician for 24 hours. National and international guidelines for the management of
anaphylaxis should be taken into account.
Special warnings and precautions for use
If adverse reactions occur during injection, administration of the product must be discontinued immediately.
Allergen immunotherapy products (desensitization) should be prescribed and used only
by physicians, nurses, and medical personnel trained or experienced in allergy treatment.
On the day of injection, the patient must not have acute symptoms of illness (such as allergic symptoms, e.g.
allergic rhinitis, allergic conjunctivitis, cold), and especially not asthmatic symptoms.
Before each injection, patients should be encouraged to inform the physician of any changes in their
health status, such as infectious diseases or pregnancy, and whether the last administered dose was well tolerated.
In asthmatic patients, lung function should be assessed when necessary (e.g., by measuring peak expiratory flow).
The dose for each injection must be individually determined based on previous tolerance and current medical history.
Particular caution is recommended

• in patients treated with angiotensin-converting enzyme inhibitors (see also section 4.5 of SmPC),
• in patients treated with beta-blockers (local or systemic, see also section 4.5 of SmPC),
• during pregnancy (see section 4.6 of SmPC).

Since adrenaline is recommended for the treatment of severe allergic reactions,
contraindications to adrenaline use must be considered.
On the day of injection, strenuous activities (physical exertion, alcohol consumption, sauna, hot shower, etc.) should be avoided, as they may exacerbate allergic reactions.
If vaccination is planned, a minimum interval of one week should be maintained between the last allergen extract injection and the vaccination date. Vaccination should therefore be scheduled during the maintenance phase of treatment. Vaccination for urgent medical indications (e.g., tetanus after injury) may be administered regardless of the phase of allergen immunotherapy. Desensitization continues two weeks after vaccination with the last administered dose.
This medicinal product contains less than 1 mmol of sodium (23 mg) per 1 mL of maximum dose (concentration 3), thus being considered "sodium-free".
Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered product must be clearly documented.
Method of administration
Precautions to be taken prior to use or administration of the medicinal product
Intravascular injection must be strictly avoided (aspirate before injection!).
The subcutaneous injection should be administered on the extensor side of the upper arm, approximately one hand's width (of the patient) above the elbow.
After each injection, the patient must be observed for at least 30 minutes, after which their condition should be evaluated by a physician. In individual cases, the observation period may be extended.
Adverse reactions may occur even after the observation period.
Patients should be instructed to contact their treating physician or medical staff immediately in case of adverse symptoms, even after the observation period.
Doses of 0.5–1 mL may be divided and administered into both arms to improve tolerance.
When concurrent therapy with two allergen immunotherapy products is administered on the same day, a minimum interval of 30 minutes between injections must be maintained. The second injection may only be given after it has been confirmed that the first injection did not cause an adverse reaction. Concurrent therapy should be conducted only according to the standard dose escalation schedule (Table 1) or the dose escalation schedule for highly sensitive patients (Table 2). To avoid cumulative effects, it is recommended to maintain a 2–3 day interval between the two injections. Additionally, each allergen extract should be administered into a separate arm.
Treatment outcome depends, among other factors, on achieving the individual maximum dose, which must not be exceeded (see dosing).
When continuing treatment with a new package bearing a new batch number, the first dose must not exceed 20% of the last administered dose. The dose may then be gradually increased to the individual maximum dose at intervals of 7 to 14 days, following the appropriate initial treatment schedule.
If the allergen composition is changed, therapy must be restarted at the lowest concentration. This also applies if previous specific immunotherapy was conducted with another product (including oral or sublingual).
Instructions for preparation of the medicinal product before administration – see section 6.6 of SmPC.
The recommended duration of treatment is generally 3 years.
Dosage
Dosage must be individually adjusted; dosage recommendations provided in the dosing schedules serve only as guidance. Dosing must be adapted to the individual course of therapy. The patient's individual sensitivity level is determined based on thorough medical history and diagnostic testing (skin test results).
Regular dose escalation must be ensured. The dose may only be increased if the previously administered dose was well tolerated. Otherwise, the last administered dose should be maintained or reduced.
In the event of a local or systemic reaction following administration of the medicinal product, the following management approach is recommended:

• Enhanced local reaction: repeat the last well-tolerated dose or reduce the last dose by one level.
• Mild systemic reaction: reduce the last dose by one level.
• Moderate systemic reaction: reduce the last dose by two levels or, if necessary, restart treatment at concentration 1 according to the standard dose escalation schedule (see Table 1) or the dose escalation schedule for highly sensitive patients (see Table 2).
• Severe systemic reaction: restart treatment at concentration 1 according to the standard dose escalation schedule (see Table 1) or the dose escalation schedule for highly sensitive patients (see Table 2).

The decision on whether to continue treatment must be based on the course and severity of the
allergic reactions!
Novo-Helisen Depot therapy consists of two phases: initial treatment and maintenance treatment.
Initial treatment (dose escalation)
Treatment should begin during a period with minimal symptom expression.
Initial treatment may follow one of two dose escalation schedules:

• standard dose escalation schedule (14 injections) (Table 1),
• dose escalation schedule for highly sensitive patients (23 injections) (Table 2).

Table 1 Standard dose escalation schedule
Dose
Concentration
mL
1 0.1
Green 0.2
label 0.4
0.8
0.1
2
0.2
Orange
0.4
label
0.8
0.1
3 0.2
Red 0.4
label 0.6
0.8
1.0
Table 2 Dose escalation schedule for highly sensitive patients
Dose
Concentration
mL
0.05
0.1
1
Green 0.2
label 0.4
0.6
0.8
0.05
0.1
2
0.2
Orange
0.4
label
0.6
0.8
0.05
0.1
0.2
0.3
3 0.4
Red 0.5
label 0.6
0.7
0.8
0.9
1.0
Dose escalation, especially in highly sensitive patients, must be gradual until the individual tolerance threshold is reached. This defines the individual maximum dose, which must not be exceeded. The maximum dose is 1.0 mL of concentration 3. The individual maximum dose for a given patient may be lower.
During dose escalation, injections are administered at intervals of 7 to 14 days. If the recommended interval between doses is prolonged, treatment should continue according to the following schedule (Table 3):
Table 3 Dose adjustment in case of prolonged interval between doses during initial treatment
Interval since last injection Dose adjustment

2 weeks Reduce by one dose level in the current dosing schedule
4 weeks Restart initial treatment at the lowest dose according to the appropriate dosing schedule
Maintenance treatment
Maintenance treatment may be administered continuously (year-round).
The first maintenance dose is administered 14 days after reaching the individual maximum dose (usually 1.0 mL of concentration 3) during initial treatment. The interval between injections is then gradually extended to 4 to 6 weeks.
If the interval between maintenance doses is prolonged, treatment should continue according to the following schedule (Table 4):
Table 4 Dose adjustment in case of prolonged interval during maintenance treatment
Interval since last injection Dose adjustment
6 to 8 weeks Reduce by one dose level according to the appropriate dosing schedule
Then gradually increase to the individual maximum dose following the schedule at 7–14 day intervals.
8 weeks 5% of the last well-tolerated dose
Then gradually increase to the individual maximum dose following the schedule at 7–14 day intervals.
52 weeks Restart dose escalation from the lowest dose according to the appropriate dosing schedule
Children and adolescents
Children under 5 years of age are generally not suitable candidates for immunotherapy (desensitization) due to a higher likelihood of cooperation and acceptance issues compared to adults.
In children over 5 years of age and adolescents, clinical data are limited and insufficient to confirm efficacy and safety; however, safety data do not indicate a higher risk than in adults.
The same initial and maintenance treatment schedules used in adults should be applied in children and adolescents.
Important patient information regarding dosage is provided in section 3 "How to use Novo-Helisen Depot".