Nemluvio

Package leaflet: Information for the user

Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen

nemolizumab
Medicinal product subject to additional monitoring. This will allow rapid identification of new
safety information. You can help by reporting any side effects you experience while taking this
medicinal product. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start 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, pharmacist, 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, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet

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

1. What Nemluvio is and what it is used for

Nemluvio contains the active substance nemolizumab, a monoclonal antibody (a specialised protein that recognises and binds to a specific target).
Nemluvio is used in adults and adolescents aged 12 years and older for the treatment of moderate-to-severe atopic dermatitis (also known as atopic eczema), a condition in which the skin is itchy, red, and dry. It may be used when patients are eligible for systemic treatment (a medicine given by mouth or by injection).
Nemluvio is also used in adults for the treatment of moderate-to-severe nodular prurigo (NP), also known as chronic nodular prurigo (CNPG), a long-term skin disease associated with skin rashes causing itchy lumps. It is used when patients are eligible for systemic treatment.
Nemolizumab, the active substance in Nemluvio, blocks the action of a protein called interleukin (IL)-31. IL-31 plays an important role in skin inflammation and itching observed in people with atopic dermatitis and nodular prurigo. By blocking IL-31, this medicine can reduce these symptoms.

2. What you need to know before using Nemluvio

Do not use Nemluvio

• if you are allergic to nemolizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic or are unsure, consult your doctor, pharmacist, or nurse before using Nemluvio.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Nemluvio.
Traceability
It is important to record the batch number of Nemluvio. Each time you receive a new pack of Nemluvio, you should record the date and the batch number (shown on the packaging after "Batch") and keep this information in a safe place.
Allergic reactions
Nemluvio can cause allergic reactions (hypersensitivity), which may be severe. Allergic reactions may occur shortly after taking this medicine, but they may also occur later. You should be aware of the signs of such reactions while using Nemluvio. These may include:

• breathing problems
• swelling of the face, mouth, and tongue
• fainting, dizziness, or feeling lightheaded due to low blood pressure
• hives
• itching
• skin rash

If you notice any signs of an allergic reaction, stop using Nemluvio and contact your doctor or seek immediate medical help.
Worsening of asthma
If you have a serious respiratory condition such as asthma, chronic obstructive pulmonary disease (COPD), or chronic bronchitis, inform your doctor before using Nemluvio. If your respiratory condition worsens after starting treatment with Nemluvio, inform your doctor immediately.
Vaccination
It is recommended to complete the recommended vaccination schedule before starting Nemluvio. Avoid vaccination with so-called live vaccines while using Nemluvio. Talk to your doctor about your current vaccination schedule.
Children and adolescents

• Do not give this medicine to children with atopic dermatitis under 12 years of age and weighing less than 30 kg; it has not been studied in this age group.
• Do not give this medicine to children and adolescents with nodular prurigo under 18 years of age; it has not been studied in this age group.

Other medicines and Nemluvio
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you have recently received or are planning to receive any vaccination.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The effects of this medicine in pregnant women are unknown; therefore, it is preferable to avoid using Nemluvio during pregnancy unless your doctor advises you to use it.
Breastfeeding
It is not known whether Nemluvio passes into breast milk. Nemluvio may pass into breast milk in the first few days after birth. Therefore, you must inform your doctor if you are breastfeeding or plan to breastfeed, so that you and your doctor can decide whether you can take Nemluvio.
Driving and using machines
It is unlikely that Nemluvio will affect your ability to drive or operate machinery.

3. How to use Nemluvio

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Treatment must be initiated and supervised by a doctor experienced in the diagnosis and treatment of atopic dermatitis and nodular prurigo.

Dose of Nemluvio and duration of treatment
Your doctor will decide the dose of Nemluvio you need and how long you should use it.

Adult and adolescent patients with atopic dermatitis (aged 12 years and older)
The recommended dose of Nemluvio is:

• an initial dose of 60 mg (two injections of 30 mg)
• subsequent doses of 30 mg every 4 weeks for 16 weeks.

After 16 weeks of treatment, your doctor will assess the effectiveness of the medicine for you. If your doctor determines that you may benefit from continued use of this medicine, you will continue with a dose of 30 mg every 8 weeks.
Nemluvio may be used with or without topical eczema medications applied to the skin.

Adults with nodular prurigo (PN)
The recommended dose is based on body weight.
If you weigh less than 90 kg:

• an initial dose of 60 mg (two injections of 30 mg)
• subsequent doses of 30 mg every 4 weeks.

If you weigh 90 kg or more:

• an initial dose of 60 mg (two injections of 30 mg)
• subsequent doses of 60 mg (two injections of 30 mg) every 4 weeks.

After 16 weeks of treatment, your doctor will evaluate the effectiveness of the medicine for you to determine whether continued use may be beneficial.

How to use Nemluvio
Read the instructions for use carefully before using Nemluvio. They are included at the end of this leaflet. The instructions provide a step-by-step guide on how to use this medicine.
Nemluvio is administered as an injection under the skin (subcutaneous injection) using the pre-filled pen. It must be injected into the front of the thigh or the abdomen, avoiding an area within 5 cm of the navel. If the injection is given by someone else, it may also be administered into the upper arm.
You and your doctor or nurse will decide whether you can self-inject this medicine.
Only self-inject after receiving proper training from your doctor or nurse. A caregiver may also administer the injection after adequate training.
It is recommended to rotate the injection site with each dose. Nemluvio must not be injected into painful, inflamed, swollen, tender, or damaged skin, or into areas with bruising, scars, or open wounds.

If you use more Nemluvio than you should
If you have used more Nemluvio than you should have, or if you took the next dose too early, contact your doctor, pharmacist, or nurse.

If you forget to use Nemluvio
Do not take a double dose to make up for a forgotten dose. If you forget to inject a dose of Nemluvio, take it as soon as possible, then continue with your original schedule.

If you stop using Nemluvio
Do not stop using Nemluvio without first discussing it with your doctor.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Common (may affect up to 1 in 10 people)
Nemluvio can cause allergic reactions (hypersensitivity).
Stop using Nemluvio and contact a doctor or seek immediate medical help
if you notice any signs of an allergic reaction. Signs may include:

• breathing problems
• swelling of the face, mouth and tongue
• fainting, dizziness, feeling lightheaded due to low blood pressure
• hives
• itching
• rash

Other side effects
Common (may affect up to 1 in 10 people)

• fungal skin infections such as ringworm (tinea corporis) or athlete’s foot (tinea pedis), fungal nail infection, and groin itching
• headache
• worsening of asthma (in people with pre-existing asthma)
• eczema
• atopic dermatitis (itching, redness and dryness of the skin in people with a tendency to allergies)
• discoid eczema (nummular eczema) (a skin condition causing itching, dryness, and round or oval patches of inflamed skin)
• injection site reactions, including redness, itching, bruising, pain, irritation and swelling at the injection site

Uncommon (may affect up to 1 in 100 people)

• increase in the number of white blood cells, which may be seen in blood tests (eosinophilia)
• blisters or fluid-filled blisters on the skin (signs of a skin condition called bullous pemphigoid)

Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nemluvio

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following
Exp. The expiry date refers to the last day of that month.
Store in the refrigerator (between 2°C and 8°C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
If necessary, Nemluvio may be stored at room temperature (up to 25°C) for a single period of
up to 90 days. Write the date the pen was removed from the refrigerator
in the designated space on the outer packaging. Do not use Nemluvio if the expiry date has been
exceeded or 90 days after the date it was removed from the refrigerator (whichever occurs first).
After reconstitution is complete, Nemluvio must be used within 4 hours or discarded.
Do not use this medicine if you notice that the powder is not white.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Nemluvio contains

• The active substance is nemolizumab. Each single-use pre-filled pen contains 30 mg of nemolizumab.
• The other components are: powder: sucrose, tromethamine, tromethamine hydrochloride (for pH adjustment), arginine hydrochloride, poloxamer 188. solvent: water for injections.

Description of the appearance of Nemluvio and contents of the pack
Nemluvio powder and solvent for injectable solution in a pre-filled pen consists of a single-use
pre-filled pen containing a glass cartridge with a white powder and a colourless, transparent liquid.
The liquid is not visible through the inspection window before reconstitution.
Nemluvio is available as a 30 mg pre-filled pen in a pack containing 1 pre-filled pen or in multiple packs composed of 2 or 3 boxes, each containing 1 pre-filled pen.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Galderma International
La Defense 4, Tour Europlaza
20 Avenue Andre Prothin
92927 Paris La Defense Cedex
France

Manufacturers
Q-Med AB
Seminariegatan 21
Uppsala Lan
752 28 Uppsala
Sweden
Nuvisan France S.A.R.L.
2400 Route Des Colles
06410 Biot
France
Galderma Laboratorium GmbH
Toulouser Allee 23a
40211 Duesseldorf
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Italia
Luxembourg/Luxemburg Galderma Italia S.p.A.
Galderma Benelux BV Tel: +39 3371176197
Tél/Tel : +31 183691919 e-mail: [email protected]

България/ Česká republika/ Eesti/ Ελλάδα/ Nederland
France/ Hrvatska/ Κύπρος/ Latvija/ Lietuva/ Galderma Benelux BV
Magyarország/ Malta/ România/ Slovenija/ Tel: +31 183691919
Slovenská republika e-mail: [email protected]
Galderma International
Teл./Tel/Tél/Τηλ/Tel.: +33 (0)1 58 86 45 45
e-mail: [email protected]

Danmark/ Norge/ Ísland/ Suomi/Finland/ Österreich
Sverige Galderma Austria GmbH
Galderma Nordic AB Tel: 0043 732 715 993
Tlf./Sími/Puh/Tel: +46 18 444 0330 e-mail: [email protected]
e-mail: [email protected]

Deutschland Polska
Galderma Laboratorium GmbH Galderma Polska Sp. Z o.o.
Tel: +49 (0) 800 – 5888850 Tel.: +48 22 331 21 80
e-mail: [email protected] e-mail: [email protected]

España Portugal
Laboratorios Galderma SA Laboratorios Galderma SA – Sucursal em
Tel: +34 902 02 75 95 Portugal
e-mail: [email protected] Tel: +351 21 315 19 40
e-mail: [email protected]

Ireland
Galderma (UK) Ltd.
Tel: +44 (0)300 3035674
e-mail: [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
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Instructions for use

IMPORTANT: Read the package leaflet before use.
This pen requires specific steps before injection.
Nemluvio 30 mg powder and solvent for injectable solution in pre-filled pen
(nemolizumab)
Do not perform the injection on yourself or on another person until you have been trained by a
healthcare professional on how to inject Nemluvio.
If you have any questions, contact your healthcare provider.
Nemluvio is supplied as a single-use, dual-chamber, pre-filled pen (referred to as “pen with Nemluvio” or “pen” in these instructions).
The pen contains two chambers: one with the medicine (the powder) and one with water to dissolve the powder.
Before you can inject the medicine, you must mix the powder with the water, following the instructions below.

Overview of the device
Dual-chamber pre-filled pen with Nemluvio

Important information
What you should know before use

• Read all instructions carefully before using the Nemluvio pen.
• Mark your calendar in advance to remind yourself when to take Nemluvio.
• Follow all steps exactly as described. This ensures that you receive the correct dose of medicine.
• Do not use the Nemluvio pen if it has been dropped on a hard surface or if it is damaged, cracked, or broken.

Storage information

• Keep the Nemluvio pen and all medicines out of the sight and reach of children.
• Store the Nemluvio pen in the refrigerator at a temperature between 2°C and 8°C.
• Do not freeze the Nemluvio pen.
• Store the Nemluvio pen in its original packaging to protect it from light.
• The Nemluvio pen may be stored outside the refrigerator, in its original packaging, at room temperature up to 25°C for a single period of up to 90 days. If removed from the refrigerator, note the removal date on the box and use Nemluvio within 90 days.
• Do not use Nemluvio if the expiry date has passed or 90 days after the date it was removed from the refrigerator (whichever occurs first).
• Once reconstitution steps are completed, Nemluvio must be used within 4 hours.

A. Preparing for Nemluvio injection
Step 1: Allow Nemluvio to reach room temperature
Injecting cold medicine may cause discomfort at the injection site. Remove the Nemluvio pen from the refrigerator and allow it to warm to room temperature for 30–45 minutes before starting Step 2.
Do not:

• heat the pen with any heat source (e.g., microwave, direct sunlight). This may damage Nemluvio;
• expose the pen directly to liquids.

Note: In some cases, your doctor may prescribe two pens for simultaneous use. If this applies to you, remove two pens and use one pen after the other.
Step 2: Wash your hands with soap and dry them thoroughly.
Step 3: Prepare materials
Remove the pen from its packaging and

place the following items on a clean, flat, well-lit surface:

• Pen with medicine
• Alcohol wipes*
• Gauze or cotton balls*
• Sharps disposal container* *Items not included in the package.

Step 4: Check the Nemluvio pen to ensure that:

• The expiry date has not been exceeded.
• The powder is white and not dissolved.
• The pen has not been dropped and is not damaged or cracked.

Do not use the pen unless all the above conditions are met. If any condition is not met, discard the pen and use a new one (see Step 13.5 “Dispose”).

Step 5: Activate the Nemluvio pen
Hold the pen upright and rotate the activation knob clockwise until it stops.
This initiates the transfer of water to the chamber containing the powder.

Step 6: Wait until the grey rod stops moving
Observe the inspection window until the grey rod has completely stopped.
Do not shake the pen before the grey rod has fully stopped, to ensure accurate delivery.

Step 7: Shake to dissolve the medicine
When the grey rod has completely stopped, hold the pen with the grey cap facing upwards and shake it up and down for 30 seconds.

Step 8: Wait 5 minutes for bubbles to decrease
Wait for the bubbles to subside and for the powder to dissolve completely. This will take approximately 5 minutes.
Note: If the medicine has not dissolved completely, shake again for 30 seconds, then wait 5 minutes.
Note: It is normal for a small layer of foam or a few small air bubbles to remain in the dissolved medicine.
Step 9: Check the medicine in the inspection window

Check that the dissolved medicine:

• is clear and colorless to slightly yellow.
• does not contain particles.

Do not use the pen if the dissolved medicine is cloudy or contains particles.
Discard the pen and use a new one (see Step 13.5 “Dispose”).
Note: Once dissolved, the medicine must be used within 4 hours. During this time, it must be stored at room temperature (up to 25°C). If not used within 4 hours, discard it.

B. Injecting Nemluvio
Step 10: Select an injection site

You may self-inject into the abdomen or upper thigh.
A caregiver may also administer the injection into the outer area of the upper arm.
Do not inject into:

• Near the waistline or within approximately 5 cm around the navel.
• Painful, bruised, red, scarred, or stretch-marked skin.
• The same site twice (e.g., within 2.5 cm).

Step 11: Clean the injection site

• Always use a new alcohol wipe to clean the injection site. This helps prevent contamination and infection.
• Allow the skin to dry in the air.

Do not:

• touch the injection site after cleaning.
• fan or blow air onto the cleaned injection site.
• reuse the alcohol wipe.

Step 12: Rotate the grey cap to expose the needle shield

• Hold the pen upright to avoid leakage.
• Unscrew the grey cap until the orange needle shield lifts up.
• Gently remove the cap from the orange needle shield.
• After removal, discard the cap into a sharps disposal container (see Step 13.5 “Dispose”). Do not:
• pull the grey cap while unscrewing, to avoid damaging the device.
• touch the orange needle shield.

Note: If the cap cannot be removed, refer to Step 5 and ensure the activation knob has been fully rotated clockwise until it stops.

Step 13: Inject the medicine

1. Place the pen vertically on the injection site, ensuring the orange needle shield is in contact with the skin.

Note: Ensure you can clearly see the inspection window during injection.

2. Gently push the pen downward until the
   orange needle shield is fully depressed
   into the pen. The injection starts immediately with a click. The orange and grey rods should move.
   Continue pushing down on the pen for 15 seconds.

3. Check the inspection window to ensure that both the orange and grey rods have stopped moving. This indicates that the injection is complete.

Do not lift the pen until both the orange and grey rods have stopped.
If the orange rod is not visible, discard the pen and use a new one (see Step 13.5 “Dispose”).
Note: It is normal for the orange rod not to cover the entire inspection window at the end of the injection.

4. Lift the pen away from the skin. The orange needle shield will lock in place to cover the needle.

Note: If bleeding occurs, press a cotton ball or gauze pad on the injection site.
Do not rub the injection site.

5. Dispose of the used pen and the grey cap immediately in a sharps disposal container after use. Avoid contact with the needle.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE CHANGE OF THE TERMS OF THE
MARKETING AUTHORISATION(S)
Scientific conclusions
Taking into account the assessment by the Pharmacovigilance Risk Assessment Committee (PRAC) of the Periodic Safety Update Reports (PSURs) for nemolizumab, the PRAC’s scientific conclusions are as follows:
Based on available data on Bullous Pemphigoid (BP) from literature, spontaneous reports, and clinical trials, including:

• at least 12 possible cases of BP with a close temporal relationship, confirmed diagnosis of BP, and recovery (with treatment) after discontinuation;
• and 2 probable cases from the literature with a close temporal relationship, confirmed diagnosis of BP, and recovery (with treatment) after discontinuation, without recurrence of BP after discontinuation, supported by anti-BP180 data and exclusion of most confounding factors;

the PRAC considers that a causal relationship between nemolizumab and Bullous Pemphigoid is at least a reasonable possibility. The PRAC concluded that the product information for medicines containing nemolizumab should be updated accordingly.
Having reviewed the PRAC recommendation, the Committee for Medicinal Products for Human Use (CHMP) agrees with the general conclusions and the rationale of the recommendation.

Reasons for the change of the terms of the marketing authorisation(s)
Based on the scientific conclusions on nemolizumab, the CHMP considers that the benefit-risk balance of the medicinal product(s) containing nemolizumab remains favourable, subject to the proposed changes to the product information.
The CHMP recommends a change to the terms of the marketing authorisation(s).