Patient Medication Information: uses, side effects, how to take - Nemluvio

What NEMLUVIO is used for:

Atopic Dermatitis (AD)

NEMLUVIO is used to treat adults and adolescents who have a moderate-to-severe inflammatory skin condition called ‘atopic dermatitis’ (eczema) that causes symptoms such as dry, itchy, scaly skin. These patients cannot be adequately treated using therapies that are applied on the surface of the skin (topical).
It is not known if NEMLUVIO is effective and safe in children less than 12 years of age.

Prurigo Nodularis (PN)

NEMLUVIO is used to treat adults who have a moderate-to-severe chronic inflammatory skin condition called prurigo nodularis that is characterised by intense itch and many firm bumps (nodules) on the skin. Nodules may have a thick, dry crust and appear on the arms, legs, and trunk.
It is not known if NEMLUVIO is effective and safe in children less than 18 years of age.

How NEMLUVIO works:

NEMLUVIO works by blocking a specific protein in the body that plays a central role in driving the itch and skin nodules of AD and PN. NEMLUVIO can improve the condition of your skin (reduces redness, scaling, firmness, and the number of bumps) and reduce symptoms including itching and sleep disturbance.

The ingredients in NEMLUVIO are:

Medicinal ingredients: nemolizumab

Non-medicinal ingredients: L-arginine hydrochloride, Poloxamer 188, Sucrose, Tris-hydrochloride (for pH-adjustment), Trometamol and water for injection.

NEMLUVIO comes in the following dosage form(s):

Pre-filled pen:

NEMLUVIO consists of a pre-filled pen enclosing a glass cartridge supplying a white powder and a clear liquid. The liquid is not visible from the inspection window before dissolving.

NEMLUVIO is available as 30 mg pre-filled pen in a pack containing 1 pre-filled pen or in multipacks containing 2 (2 packs of 1).

Pre-filled syringe:

NEMLUVIO consists of a white powder and a clear liquid supplied in a glass pre-filled syringe with a separate needle with safety shield.

NEMLUVIO is available as 30 mg pre-filled syringe in a pack containing 1 pre-filled syringe.

Not all pack sizes may be marketed.

Do not use NEMLUVIO if:

You are allergic or sensitive to any of the ingredients.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NEMLUVIO. Talk about any health conditions or problems you may have, including if you:

Are scheduled to receive any vaccination. You should not receive a “live vaccine” right before or during treatment with NEMLUVIO.
Are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby. Treatment with NEMLUVIO when pregnant is not recommended. Tell your healthcare provider if you become pregnant while taking NEMLUVIO. It is preferable to avoid the use of NEMLUVIO in pregnancy.
Are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will breastfeed or use NEMLUVIO. You should not do both.
Have asthma, chronic obstructive pulmonary disease (COPD), or bronchitis.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may [also] interact with NEMLUVIO:

Inform your healthcare professional if you have recently received a vaccine or if you are about to receive a vaccine. NEMLUVIO should not be used at the same time with certain types of vaccines.

How to take NEMLUVIO:

Use NEMLUVIO exactly as prescribed by your healthcare professional.
NEMLUVIO is given as an injection under your skin (subcutaneous injection) into the front upper thigh or abdomen, avoiding a 5 cm area around the navel. If somebody else gives the injection, it can also be given into the upper arm. You and your doctor or nurse will decide if you can inject NEMLUVIO yourself.
It is recommended that you change the injection site with each injection. NEMLUVIO should not be injected into skin that is tender, inflamed, swollen, damaged or has bruises, scars or open wounds.
Before injecting NEMLUVIO yourself, you must have received proper instruction by a doctor or nurse. Your NEMLUVIO injection may also be given by a caregiver after proper instruction by a doctor or nurse.
See the detailed “Instructions for Use” included at the end of this package insert for information on how to prepare and inject NEMLUVIO and how to properly store and throw away (dispose of) used NEMLUVIO prefilled pens and syringes.

Usual dose:

Atopic Dermatitis (12 years of age and older):

For patients with AD, the recommended dose of NEMLUVIO is:

An initial dose of 60 mg (two 30 mg injections) followed by 30 mg given every 4 weeks
Based on how well the medicine works, your doctor may decide that you can have a dose every

8 weeks.

NEMLUVIO can be used together with other topical therapies (corticosteroids or calcineurin inhibitors).

Prurigo Nodularis:

The recommended dose of NEMLUVIO for adults with PN is based on body weight:

Body weight of patient	Initial dose	Subsequent doses
less than 90 kg	60 mg (two 30 mg injections)	30 mg every 4 weeks
90 kg or more	60 mg (two 30 mg injections)	60 mg (two 30 mg injections) every 4 weeks

Overdose:

If you think you, or a person you are caring for, have taken too much NEMLUVIO , contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you have forgotten to inject a dose of NEMLUVIO, talk to your doctor, pharmacist or nurse.

Give the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.

Possible side effects from using NEMLUVIO:

These are not all the possible side effects you may have when taking NEMLUVIO. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects of NEMLUVIO in people with prurigo nodularis include:

Headache
Skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches on the skin)

The most common side effects of NEMLUVIO in people with atopic dermatitis include:

Headache
Hives

The following additional side effects have been reported with NEMLUVIO:

Sudden swelling of the face, lips, mouth, tongue, eyelids, or throat (allergy/angioedema)
Injection site reactions (i.e. redness, rash, pain, irritation, bruising, swelling at the injection site)
Fungal skin infections such as ringworm of the body (body tinea) or athlete’s foot (tinea pedis), fungal infection of the nail, and jock itch

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional
Only if severe	In all cases
UNCOMMON
Allergic reactions: breathing problems (wheezing), swelling of the face, lips, mouth, throat or tongue; skin rash; itching; dizziness or light-headedness; fast of weak pulse, nausea, vomiting or diarrhea, stomach pain/cramps		✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store in the refrigerator (2°C to 8°C).

NEMLUVIO can be stored at room temperature (up to 25°C) for a single period of up to 90 days. Write the date first removed from the refrigerator in the space provided on the outer carton.

Once reconstituted, NEMLUVIO must be used within 4 hours or discarded.

Do not freeze. Do not expose to extreme heat.

Keep the syringe or pen in the original carton to protect from light.

Keep out of reach and sight of children.

If you want more information about NEMLUVIO (nemolizumab for injection):

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.galderma.com; or by calling 1-800-234-2345.

NEMLUVIO ® is a registered trademark of Galderma.

Date of Authorization: 2025-12-18

INSTRUCTIONS FOR USE

NEMLUVIO (nemolizumab for injection) 30 mg powder and solvent solution for injection in pre-filled pen

CAREFULLY read and follow Instructions for Use.

This pen requires specific steps before injection.

^PrNEMLUVIO ®

Nemolizumab for injection

powder and solvent solution for subcutaneous injection

These “Instructions for Use” contain information on how to inject NEMLUVIO.

Read and understand these instructions before using the NEMLUVIO pen.

Do not inject yourself or someone else until you have been shown how to inject NEMLUVIO.

In adolescents (ages 12 to < 18 years old), it is recommended that NEMLUVIO be administered by or under supervision of a trained adult or caregiver.

Your healthcare professional will instruct you or your caregiver how to prepare and inject a dose of NEMLUVIO (nemolizumab for injection) before you try to do it yourself the first time.

Call your healthcare professional if you have any questions.

NEMLUVIO is supplied as a single-use pre-filled dual-chamber pen (called “NEMLUVIO pen” or “pen” in these instructions). It contains medicine (30 mg of lyophilized powder) in one chamber and water for dissolving the medicine in the other chamber. Before you can inject it, you must mix the lyophilized powder with the water for dissolving the medicine.

Device Overview

NEMLUVIO pre-filled dual-chamber pen

Important Information

What you need to know before use

Read all the instructions carefully before using the NEMLUVIO pen.
Mark your calendar ahead of time to remember when to take NEMLUVIO .
Follow all steps exactly as described. This ensures that you get the correct dose of medicine.
Make sure that the lyophilized powder is completely dissolved before injecting (Step 9).
After dissolving, proceed right away with the injection to avoid any contamination or break down of medicine (degradation).
Do not use the NEMLUVIO pen if it has been dropped or is damaged or cracked.
In some cases, your doctor will prescribe two pens. Use one NEMLUVIO pen after the other.
To reduce the risk of accidental needle sticks, each NEMLUVIO pen has an orange needle guard. After injecting the medicine, as you lift the pen from your skin, the orange needle guard locks into place to cover the needle (Step 16).
When preparing the NEMLUVIO pen for injection, do not pull the grey cap. Instead, twist the grey cap until the orange needle guard pops up. Then, gently pull the cap off the orange needle guard (Step 12).
Throw away the used NEMLUVIO pen right away after use in a sharps disposal container. See Section “C: Throwing away NEMLUVIO ” below.

Storage Information

Keep the NEMLUVIO pen and all medicines out of the reach and sight of children.
Store the NEMLUVIO pen in the refrigerator between 2°C to 8°C until the expiration date.
The NEMLUVIO pen can be stored at room temperature up to 25°C for a single period of up to 90 days.
If removed from the refrigerator, write down the date of removal on the carton, 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 is earlier).
Store the NEMLUVIO pen in the original carton to protect it from light.
After reconstitution the NEMLUVIO (nemolizumab for injection) pen should be used within 4 hours.
Do not heat or put the NEMLUVIO pen into direct sunlight.
Do not freeze the NEMLUVIO pen.
If the NEMLUVIO pen was heated or frozen throw it away and use a new one.

Travelling Information

Generally, you are allowed to carry pens with you on an airplane. Be sure to carry the NEMLUVIO pens with you in your carry-on luggage.

If you have any other questions, please refer to the FAQs and further information on the back of this package leaflet.

A. Preparing to inject NEMLUVIO

Step 1: Let NEMLUVIO reach room temperature

Injecting cold medicine might result in pain at the injection site. Take the NEMLUVIO carton out of the refrigerator and let it come to room temperature for 30 to 45 minutes before starting Step 2 (see Figure A).

Do not:

warm the pen with any heat source (such as microwave, direct sunlight). This might damage NEMLUVIO.
directly expose the pen to liquids.

Step 2: Wash your hands

a. To avoid contamination and infection, wash your hands with soap (see Figure B).
b. Dry them properly.

Step 3: Gather supplies (see Figure C)

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a. Remove the pen from the carton.
b. Gather the following supplies on a clean, flat and well-lit surface:
1. Pen
2.
Alcohol wipes*
3. Sharps disposal container*
4. Gauze pads or cotton balls*

*Items not included in the carton.

Note: In some cases, your doctor will prescribe two pens. Use one pen after the other.

Step 4: Inspect the NEMLUVIO pen for the following:

a. Expiration date has not passed.
b. The lyophilized powder is white and not dissolved (see Figure D).
c. The pen has not been dropped and is not damaged or cracked.

Do not use the pen unless all the conditions above are met. If any condition is not met, throw away the pen and use a new one (see Section C: “Throwing away NEMLUVIO ”).

Step 5: Activate the NEMLUVIO pen

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Hold the pen upright and turn activation knob to the right until it stops (see Figure E).

This starts the process of transferring water to the powder chamber.

Step 6: Wait until grey rod stops moving

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Watch inspection window until grey stopper has stopped moving (see Figure F).

Do not shake the pen before the grey stopper has completely stopped. You might get an incorrect dose of medicine.

Step 7: Shake to dissolve the medicine

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When the grey rod has completely stopped, shake the pen up and down for 30 seconds (see Figure G).

Step 8: Wait 5 minutes for bubbles to decrease

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Wait for bubbles to decrease and the lyophilized powder to dissolve completely. This will take about 5 minutes (see Figure H).

Note: If the medicine has not dissolved completely, shake the pen up and down again for 30 seconds and then wait 5 minutes.

Note: It is normal for a small foam layer or a few small air bubbles to remain in the dissolved medicine.

Step 9: Check the medicine in the inspection window

Check to see if the dissolved medicine:

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a. is clear and colourless to slightly yellow,
b. does not contain particles. (see Figure i).

Do not use the pen if the dissolved medicine is cloudy or contains any particles.

Throw away the pen and use a new one (see Section C:“Throwing away NEMLUVIO ”).

Note: After the medicine has dissolved, it must be used within 4 hours. During this time, it should be kept at room temperature (up to 25°C). If you have not used it within 4 hours, throw it away.

B. Injecting NEMLUVIO

Step 10: Select one injection site (see Figure J)

When using a second pen, select a different injection site at least 2.5 cm away from the first injection site.

Select the injection site using the following chart:

Where not to inject:

Near your waistline or about 5 cm around the navel.
Into tender, bruised, red skin, or areas with scars or stretch marks.
Twice into the same site (for example, within 2.5 cm).

Step 11: Clean the injection site

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a. Always use a new alcohol wipe to clean the injection site (see Figure K). This avoids contamination and infection.
b. Let the skin air dry.

Do not:

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

Step 12: Twist the grey cap

Do not:

pull the grey cap when unscrewing to avoid damaging the device.
touch the orange needle guard.
Hold the pen upright (see Figure L a)
Unscrew the grey cap until the orange needle guard pops up (see Figure L b).
Gently pull the cap off the orange needle guard (see Figure L c).
After cap removal, please throw away the cap in a sharps disposal container (see Step 17).

Note: If the cap cannot be removed, refer back to Step 5 and make sure activation knob is turned completely to the right until it stops.

Step 13: Place the NEMLUVIO pen

Read Steps 13-16 before starting Step 13.

Note: Always inject the way your healthcare professional showed you.

Place the pen on the injection site vertically so that the orange needle guard is flat against the skin (see Figure M).

Note: Make sure you can easily see the inspection window during injection.

Step 14: Start injection and hold the NEMLUVIO pen on the skin

Gently push the pen down until orange needle guard is completely pushed in. The injection starts right away with a click (see Figure N).

The orange rod will begin to move down the injection window. Do not lift the pen yet and keep pushing down.

Step 15: Inject for 15 seconds

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Hold slowly and count to 15.

Check inspection window to make sure orange rod and grey stopper have stopped (see Figure O).

This means the injection has been completed.

Note: It is normal that the orange rod does not cover the whole inspection window at the end of injection.

Do not lift pen until orange rod and grey rod have stopped moving.

If the orange rod is not visible, please throw away the pen and use a new one (see Section C:“Throwing away NEMLUVIO (nemolizumab for injection)”).

Step 16: Lift the NEMLUVIO pen up

a.
Lift the pen straight up from your skin.
The orange needle guard locks into place to cover the needle (see Figure P).
b. If there is bleeding, press a cotton ball or gauze over the injection site.

Do not rub the injection site.

Turn over to read about the pen disposal, FAQs and package leaflet

C. Throwing away NEMLUVIO

Step 17: Throw away the pen and the cap

Avoid contact with the needle.

Throw away the used pen and the grey cap in a sharps disposal container right away after use (see Figure Q).

Do not:

recap the pen after use.
throw away the NEMLUVIO pen and cap in your household trash.
throw away your used sharps disposal container in your household trash unless your community guidelines permit this.
recycle your used sharps disposal container.

If you do not have an sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic,
closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
upright and stable during use,
leak-resistant, and
properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.

There may be local laws about how you should throw away used pens.

FAQs (Frequently asked questions)

Needle

Where is the needle?

The needle is attached to the NEMLUVIO pen and covered by the grey cap.

When you twist the grey cap, the orange needle guard pops up and keeps the needle covered until you inject.

For more information, please see the figures in Step 12 in the Instructions for Use.

Dissolving the medicine

How do I know if the medicine is fully dissolved?

To dissolve, shake the NEMLUVIO pen up and down until the white particles are no longer on the bottom, top, or sides. The dissolved medicine should look clear. Please refer to Step 9 in the Instructions for Use.

After shaking the NEMLUVIO pen, look through both sides of the inspection window. You should not see any white particles along the bottom, top, or sides. It is acceptable to have small air bubbles or a small foam layer on top of the medicine. It does not harm you.

If you see white particles in the medicine, it is not fully dissolved.

Storage

How should I store the NEMLUVIO pen?

The NEMLUVIO pen should be stored in the refrigerator. Write the date that the pen was first removed from the refrigerator in the space provided on the outer carton. It can be stored at room temperature up to 25°C for a single period of up to 90 days.

The device should not come in contact with liquids.

Where do I find the expiration date?

You can find the expiration date on the pen, it is labelled EXP MM YYYY.

Do not use the NEMLUVIO pen past the expiration date.

What should I do if the medicine has been frozen?

Do not use the NEMLUVIO pen if it has been frozen. Throw away the NEMLUVIO pen and use a new one.

Injecting the medicine

Why do I need to hold the pen upright while removing the grey cap?

Holding the NEMLUVIO pen with the grey cap upright helps prevent the medicine from leaking. It is normal to see a few drops of medicine inside the grey cap even when you hold the pen upright and remove the grey cap.

How do I know I injected myself the full content of the pen?

To be sure you get the full content, press and hold the NEMLUVIO pen against your skin.

You will feel the needle go into your skin.

Hold the NEMLUVIO pen against your skin for 15 seconds.

This will allow enough time for all the medicine to go from the pen to under your skin.

Only remove the NEMLUVIO pen when the orange rod and the grey rod have stopped moving.

After removing the NEMLUVIO pen, look for the orange rod in the window as a way to tell that the content has been given. If the orange rod does not appear, throw away the pen and use a new one.

For details, please refer to Step 15 in the Instructions for Use.

General Information