Novo-helisen Depot

Leaflet accompanying the packaging: information for the user

Novo-Helisen Depot

Mold fungus allergen extracts

Suspension for injection

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.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Novo-Helisen Depot and what is it 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 packaging and other information

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

Novo-Helisen Depot is an allergen extract intended for desensitization (specific immunotherapy). During specific immunotherapy, increasingly larger doses of clinically significant allergens causing an allergic reaction in the patient are administered by injection to achieve an individual maximum dose, which is then administered as a maintenance dose. The treatment aims to alleviate clinical symptoms dependent on the given allergen(s) and reduce the consumption of symptomatic drugs. Novo-Helisen Depot is used in allergic diseases (IgE-dependent), such as allergic rhinitis (hay fever), 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 over 5 years of age.

2. Important information before using Novo-Helisen Depot

When not to use Novo-Helisen Depot

• If the patient is hypersensitive (allergic) to any of the excipients listed in section 6;
• If the patient has uncontrolled asthma, i.e., FEV1 is below 70% of the expected value despite appropriate pharmacotherapy;
• If the patient has permanent lung changes, such as pulmonary emphysema (emphysema), bronchiectasis (bronchiectasis);
• If the patient has inflammatory or febrile diseases, severe acute or chronic conditions (e.g., cancer, active tuberculosis).
• If the patient has been diagnosed with significant cardiovascular system failure. In the event of a severe allergic reaction after injection of Novo-Helisen Depot, adrenaline is used as a rescue medication. In patients with heart disease, there is an increased risk of adverse reactions after administration of adrenaline;
• If the patient has been diagnosed with immune system disorders (severe systemic autoimmune diseases, immunopathies induced by immune complexes, immunity deficiencies, or multiple sclerosis, etc.);

autoimmune diseases, immunopathies induced by immune complexes, immunity deficiencies, or multiple sclerosis, etc.);

• If the patient has experienced severe systemic reactions related to specific allergen immunotherapy in the past;
• If the patient has been diagnosed with severe mental disorders.

Warnings and precautions

This medicinal product for subcutaneous allergen immunotherapy should only be administered by doctors, nurses, and medical staff trained or experienced in the treatment of allergies. Before starting treatment with Novo-Helisen Depot, the patient should discuss with their doctor if:

• The patient is being treated with ACE inhibitors for 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 to treat glaucoma);
• The patient is pregnant;
• There are acute symptoms of the disease (e.g., allergic symptoms or a cold);
• The patient has symptoms of asthma;
• The patient has been vaccinated or is scheduled to be vaccinated.

The patient should inform their doctor about any changes in their health, such as infectious diseases or pregnancy, and discuss further action. If indicated, a lung function test (e.g., measurement of peak expiratory flow) may be performed before injection if the patient has asthma. The doctor should be informed whether the previous injection was well tolerated. Before each injection, the doctor will determine the individual dose based on the tolerance of the last administered dose and the collected medical history. In the event of severe allergic reactions after injection or during it, the doctor may use adrenaline as a rescue medication. It should be explained in advance whether adrenaline treatment is possible for the patient. On the day of injection, the patient should avoid strenuous activities, such as sports or heavy physical work. The patient should also avoid consuming alcohol, visiting a sauna, and taking a hot shower. In the case of planned vaccinationagainst pathogens, a minimum interval of 1 week should be maintained between the last injection of this medicine and the vaccination date. Treatment with this medicine is continued 2 weeks after vaccination with the last administered dose. Vaccinations that are immediately necessary (e.g., against tetanus after injuries) can be given at any time.

Children and adolescents

Treatment with Novo-Helisen Depot is generally not recommended in children under 5 years of age.

Novo-Helisen Depot and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. No drug interaction studies have been conducted. The following guidelines should be remembered and discussed with the doctor:

• Beta-blockers(medicines used to treat high blood pressure or heart disease, as well as eye drops to treat glaucoma) may be taken concurrently with Novo-Helisen Depot only after consulting a doctor.
• ACE inhibitors(medicines used to treat high blood pressure) may be taken concurrently with Novo-Helisen Depot only after consulting a doctor.
• Concomitant treatment with medicines used to treat allergies(e.g., antihistamines, corticosteroids, mast cell stabilizers) or medicines that partially act similarly to antiallergic medicines (e.g., some sedatives, anti-nausea and vomiting medicines, antacids) may affect treatment with Novo-Helisen Depot. It may then be possible to tolerate a higher dose of this medicine. If they are discontinued, it may be necessary to reduce the dose of Novo-Helisen Depot.

During treatment with Novo-Helisen Depot, it is recommended to avoid contact with allergens that cause allergies: mold fungi, especially on the day of injection. It is also recommended to avoid other factors that may cause allergic reactions.

Novo-Helisen Depot with food, drink, and alcohol

On the day of injection, the patient should not drink alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine. There is insufficient experience with the use of mold fungus allergen extracts in pregnant women. Therefore, desensitization is not recommended during pregnancy. There is insufficient data on breastfeeding mothers. Although it is unlikely that the breastfed infant would be at risk, the doctor will have to weigh the benefits and risks during breastfeeding. There is insufficient data on the effect of Novo-Helisen Depot on fertility.

Driving and using machines

Novo-Helisen Depot has a minor influence on the ability to drive and use machines, as dizziness may occur. This should be taken into account when driving a vehicle, using machines, or working without safe support.

Novo-Helisen Depot contains sodium

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

3. How to use Novo-Helisen Depot

Recommended dose The doctor, who is trained or experienced in the treatment of allergies, will determine the most suitable treatment schedule for the patient and tell them at what intervals they will receive injections. The doctor will also determine the appropriate dose. The individual dose depends, among other things, 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 two different phases: initial treatment and maintenance treatment. Initial treatment (dose escalation) In the case of seasonal mold fungus allergens, treatment should be started out of season. In the case of year-round mold fungus allergens, treatment should be started as soon as possible in a period free from symptoms. The doctor may choose one of two different dosing 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 that the patient tolerates, regularly increasing the dose up to the maximum recommended dose of the medicine. Injections will be administered at regular intervals of 7 to 14 days until the individual maximum dose or the maximum recommended dose of the medicine is reached. If the interval between two injections is exceeded, the doctor may not be able to increase the dose according to the plan. Therefore, it is essential to always follow the injection schedule and not interrupt initial treatment. Maintenance treatment After the doctor has determined the individual maximum dose during initial treatment or after reaching the maximum recommended dose of the medicine, maintenance treatment begins. In the case of non-seasonal allergens, after reaching the maximum dose, the time intervals between two injections are gradually increased so that injections are eventually administered at intervals of 4 to 6 weeks. If the planned interval of 6 weeks is exceeded, the doctor must reduce the next dose. Then the dose is increased again in shorter time intervals. It is also essential to always follow the injection schedule and not interrupt maintenance treatment. When starting a new series of Novo-Helisen Depot, the doctor will reduce the dose. Then the dose will be increased again in intervals of 7 to 14 days.

Use in children and adolescents

Specific allergen immunotherapy (desensitization) is not usually performed in children under 5 years of age, as there is a greater likelihood of acceptance and cooperation problems in this age group than in adults. In children and adolescents, the same treatment schedule is used as in adults.

Method of administration

Novo-Helisen Depot is injected subcutaneously by a doctor. The injection is performed on the outer part of the arm, about the width of the patient's hand above the elbow. Doses of 0.5-1 mL may be divided and administered in both arms to achieve better tolerance. The doctor will shake the medicine well before use. The patient must remain under the doctor's supervision for at least 30 minutes after injection. The doctor will ask the patient about their general condition. The observation period may be extended individually. In case of side effects, the patient should contact the doctor immediately, even after the observation period. The doctor may use two different preparations for desensitization. If both preparations are to be injected on the same day, a minimum interval of 30 minutes should be maintained between injections. However, it is recommended that injections be administered at an interval of 2 to 3 days. Each time, the preparations are injected separately into the right and left arm.

Duration of treatment

The recommended duration of treatment is usually 3 years.

Use of a higher than recommended dose of Novo-Helisen Depot

Overdose may lead to allergic reactions, even anaphylactic shock. In such a case, the doctor will take the necessary measures. Typical symptoms can be found in section 4 "Possible side effects".

Missing a dose of Novo-Helisen Depot

The patient should always come to scheduled visits, so that the success of the treatment is not jeopardized. If the patient forgets about the scheduled visit, the treatment schedule may change. The patient should contact the doctor, who will explain how to proceed.

Stopping the use of Novo-Helisen Depot

This should be discussed with the doctor in advance. If treatment is stopped prematurely, the therapeutic effect may be weakened. In case of any doubts related to the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Novo-Helisen Depot can cause side effects, although not everybody gets them. After injection of this medicine, the patient will be monitored for at least 30 minutes. The doctor will ask the patient about their general condition. It should be remembered that side effects may occur even after this observation period. In case of side effects, the patient should contact the doctor immediately.

Important side effects and measures

If symptoms of intolerance occur during injection, the doctor will immediately stop the injection. Local reactions (e.g., redness, itching, swelling) and generalized reactions (e.g., shortness of breath, itching all over the body, redness all over the body) may occur. Severe allergic reactions up to anaphylactic shock may occur. Anaphylactic reactions, including anaphylactic shock, may occur within a few seconds to a few minutes after injection. Typical warning symptoms are itching, feeling of heaton and under the tongue and in the throat, shortness of breath, itching or burning of the hands and (or) soles of the feet, hives all over the body, itching, drop in blood pressure, dizziness, malaise. The patient should immediatelyinform the medical staff if they notice these symptoms. The doctor must have an emergency kit available for immediate use when treating the patient with this medicine. If anaphylactic shock occurs, the patient must be under medical observation for 24 hours. Data after marketing authorizationThe following list provides an overview of side effects reported spontaneously after marketing authorization of Novo-Helisen Depot containing mold fungus allergen extract. Due to the small number of reports, the frequency of side effects cannot be estimated based on the available data. At the injection site: redness, swelling, reaction at the injection site, edema, hives, feeling of heat Other side effects: anaphylactic reaction, dizziness, anxiety, rapid heartbeat (tachycardia), blue discoloration of the skin and lips (cyanosis), redness, decreased blood pressure, chest discomfort, chills, malaise, feeling of cold, increased body temperature, depressive mood, rhinitis, allergic conjunctivitis, eye itching, asthma, cough, shortness of breath, sneezing, difficulty swallowing, gastrointestinal disorders, vomiting, loss of subcutaneous fat (lipoatrophy), angioedema, facial edema, redness, itching, rash, skin reaction, hives, joint pain, muscle weakness, spondyloarthritis, peripheral edema Children and adolescentsThe safety profile in children and adolescents is comparable to the safety profile in adults. In these age groups, no other side effects are expected.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49 21-309. Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Novo-Helisen Depot

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "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 should not be used after the expiry date stated on the carton and vial. Do not use this medicine if you notice sediment. Ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Novo-Helisen Depot contains

Novo-Helisen Depot contains allergen extracts of animal origin, house dust mites, and mold fungi. The composition of the medicine is selected individually depending on the patient's spectrum of allergy and in accordance with the attached list. The names of individual allergens and their percentage share are given on the packaging. Standardization is carried out in PNU (protein nitrogen units). Concentration 1 contains 5 PNU/mL Concentration 2 contains 50 PNU/mL Concentration 3 contains 500 PNU/mL Other ingredients of the medicine are:aluminum hydroxide, sodium chloride, sodium bicarbonate, phenol, water for injections

What Novo-Helisen Depot looks like and what the packaging contains

The medicine is a suspension and shows distinct turbidity after shaking. Depending on the starting material and concentration of the suspension, they are varied and sometimes intensely colored.

Pack sizes:

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

Marketing authorization 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 more detailed information, please contact the representative of the marketing authorization holder: SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki Tel. 22 350 66 69 Fax 22 350 77 03

Date of last revision of the leaflet:

DOSING SCHEME

Before use, read the patient leaflet! Do not exceed the individual maximum dose! Patient.....................................................................................................................................

Batch number..............................................................................................................................

Initial treatment:

Maintenance treatment:

List of allergen extracts that may be part of Novo-Helisen Depot

Mold fungus allergen extracts: 400 Alternaria tenuis401 Aspergillus fumigatus402 Botrytis cinerea405 Cladosporium herbarum406 Curvularia lunata407 Fusarium moniliforme408 Helminthosporium halodes410 Mucor mucedo412 Penicillium notatum413 Pullularia pullulans414 Rhizopus nigricans416 Serpula lacrymans

Information intended for healthcare professionals only:

This medicinal product for subcutaneous allergen immunotherapy may only be administered by doctors, nurses, and healthcare professionals trained or experienced in the treatment of allergies. In the event of severe local or systemic reactions or anaphylaxis during treatment with Novo-Helisen Depot, the attending physician must have an emergency kit available. In the event of anaphylactic shock, patients must be monitored by a doctor for 24 hours. National and international guidelines for the treatment of anaphylaxis should be taken into account.

Special warnings and precautions for use

In the event of side effects during injection, the administration of the product should be stopped immediately. Allergen immunotherapy products (desensitization) should only be prescribed and used by doctors, nurses, and healthcare professionals trained or experienced in the treatment of allergies. On the day of injection, the patient must not have acute symptoms of the disease (such as allergic symptoms, e.g., allergic rhinitis, allergic conjunctivitis, cold), and in particular, asthma symptoms. Before each injection, patients should inform their doctor about any changes in their health, such as infectious diseases or pregnancy, and whether the last dose was well tolerated. In the case of asthmatics, lung function (e.g., by measuring peak expiratory flow) should be assessed if necessary. The dose for each injection should be determined individually based on previous tolerance and current medical history. In the event of a severe allergic reaction, the dose should be reduced or the treatment should be interrupted.

Special caution is recommended

• in patients treated with ACE inhibitors (see also section 4.5),
• in patients treated with beta-blockers (local, systemic, see also section 4.5),
• during pregnancy (see section 4.6).

Since adrenaline is recommended for the treatment of severe allergic reactions, the contraindications for the use of adrenaline must be taken into account. On the day of injection, the patient should avoid strenuous activities(physical exertion, alcohol consumption, sauna, hot shower, etc.), as they may exacerbate allergic reactions. If vaccination is planned, a minimum interval of at least 1 week should be maintained between the last injection of the allergen extract and the vaccination date. Vaccination should be performed during maintenance treatment. Vaccination for urgent reasons (e.g., against tetanus after injuries) can be given at any time. The product contains less than 1 mmol of sodium (23 mg) per 1 mL of the maximum dose (concentration 3), i.e., the product is considered "sodium-free".

Identifiability

To improve the identifiability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Method of administration

Precautions to be taken before use or administration of the medicinal productInjections should be administered subcutaneously, avoiding intravascular administration (aspiration!). The injection should be performed on the outer part of the arm, about the width of the patient's hand above the elbow. After each injection, the patient must be observed for at least 30 minutes, after which their condition should be assessed by the doctor. The observation period may be extended individually. Side effects may occur even after the observation period. The patient should be instructed to contact the doctor immediately if they experience side effects, even after the observation period. Doses of 0.5-1 mL may be divided and administered in both arms to achieve better tolerance. When conducting concurrent therapy with two allergen immunotherapy products, a minimum interval of 30 minutesshould be maintained between injections. The second injection can only be administered after it has been confirmed that the first injection did not cause a side effect. Concurrent therapyshould only be conducted according to the standard dose escalation schedule(Table 1) or the dose escalation schedule for highly sensitive patients(Table 2). To avoid the effect of accumulation, it is recommended to maintain a 2-3 day interval between two injections. Additionally, it is recommended to administer each allergen extract in a separate arm. The outcome of treatment depends, among other things, on achieving the individual maximum dose, which must not be exceeded (see dosing). When continuing treatment with a new packaging with a new batch number, the first dose must not exceed 20% of the last administered dose. Then the dose can be increased again to the individual maximum dose at intervals of 7 to 14 days according to the appropriate initial treatment schedule. If the composition of the allergens is changed, treatment should be restarted from the lowest concentration. This also applies to the case of previous specific immunotherapy using another product (also sublingual or oral). Instructions for preparing the medicinal product before administration - see section 6.6. The recommended duration of treatment is usually 3 years.

Dosing

Dosing must be individualized; the recommended dosing schedules serve only as guidelines. Dosing must be adapted to the individual course of therapy. The individual degree of sensitivity of the patient is determined based on a thorough medical history and diagnosis (test reaction result). It should be remembered that regular dose escalationis necessary. The dose can only be increased if the last administered dose was well tolerated. Otherwise, the last dose used should be maintained or reduced. In the event of side effects during injection, the following procedures are proposed:

• Severe local reaction:repeat the last well-tolerated dose or reduce the last dose by one level.
• Mild generalized reaction:reduce the last dose by one level.
• Moderate generalized reaction: reduce the last dose by two levels or, if necessary, restart treatment with 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 generalized reaction:restart treatment with 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 to continue treatment must be made based on the course and severity of allergic reactions! Treatment with Novo-Helisen Depot consists of two phases: initial treatment and maintenance treatment.

Initial treatment (dose escalation)

In the case of seasonal mold fungus allergens, treatment should be started out of season. In the case of year-round mold fungus allergens, treatment should be started as soon as possible in a period with minimal symptoms. Initial treatment can be conducted according to 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

Concentration

Dose

mL

1

Green label

0.1 0.2 0.4 0.8 0.1 0.2 0.4 0.8

2

Orange label

0.1 0.2 0.4 0.6 0.8 1.0

Table 2 Dose escalation schedule for highly sensitive patients

3

Red label

Concentration

Dose

mL0.05 0.1 0.2 0.4 0.6 0.8

1

Green label

0.05 0.1 0.2 0.4 0.6 0.8

2

Orange label

0.05 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9

3

Red label

Concentration

Dose

mL1.0 Dose escalation, especially in highly sensitive patients, must be done gradually until the individual tolerance limit is reached. This is 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 exceeded, treatment should be continued according to the following schedule (Table 3).

Table 3 Dose modification in case of extended interval between doses during initial treatment

Interval from the last injection Dose modification

>2 weeks Reduction by one dose in the used dosing schedule >4 weeks Restart initial treatment from the lowest dose of the appropriate dosing schedule

Maintenance treatment

Maintenance treatment can be conducted continuously (year-round). The first dose of maintenance treatment is administered 14 days after reaching the individual maximum dose (usually 1.0 mL of concentration 3) during initial treatment, then the interval between injections is gradually increased to 4 to 6 weeks. If the interval between maintenance doses is exceeded, treatment should be continued according to the following schedule (Table 4):

Table 4 Dose modification in case of extended interval during maintenance treatment

Interval from the last injection Dose modification

>6 to 8 weeks Reduction by 1 dose according to the appropriate dosing schedule. Then, gradual increase to the individual maximum dose according to the schedule at 7-14 day intervals. >8 weeks 5% of the last tolerated dose. Then, gradual increase to the individual maximum dose according to 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 not usually suitable candidates for immunotherapy (desensitization) due to a higher likelihood of cooperation and acceptance issues with treatment in this age group.
In children over 5 years of age and in adolescents, clinical data are limited and insufficient to confirm efficacy and safety; however, safety data do not indicate a higher risk than in adults.
In children and adolescents, the same initial and maintenance treatment regimen is used as in adults.

Important information for the patient regarding dosing can be found in section 3 "How to use the medicinal product

Novo-Helisen Depot"