Patient leaflet - Nemluvio 30 mg powder and solvent for solution for injection in Pre-filled pen
1. What Nemluvio is and what it is used for
What Nemluvio is
Nemluvio contains the active substance nemolizumab. Nemolizumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called interleukin (IL)-31. IL-31 plays a major role in causing the signs and symptoms of atopic dermatitis and prurigo nodularis.
What Nemluvio is used for
Nemluvio is used to treat adults and patients 12 years of age and older, weighing at least 30 kg, with moderate to severe atopic dermatitis (also known as atopic eczema) who can be treated with systemic treatments (a medicine given by mouth or injection). Nemluvio can be used with certain topical eczema medicines.
Nemluvio is also used to treat prurigo nodularis (PN), also known as chronic nodular prurigo (CNPG).
How Nemluvio works
Using Nemluvio for atopic dermatitis or prurigo nodularis can improve the condition of your skin and reduce symptoms including itching and sleep disturbance. In addition, Nemluvio helps improve symptoms related to pain and overall quality of life from your atopic dermatitis or prurigo nodularis.
2. What you need to know before you use Nemluvio
Do not use Nemluvio
if you are allergic to nemolizumab or any of the other
ingredients of this medicine (listed in section 6). If you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Nemluvio.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Nemluvio.
Allergic reactions
Very rarely, medicines can cause allergic (hypersensitivity) reactions. These reactions can occur shortly after you take Nemluvio, but also may happen later. You must look out for signs of these reactions (such as breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (because of low blood pressure), hives, itching and skin rash) while you are using Nemluvio. Stop using Nemluvio and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction. Such signs are listed in the beginning of section 4.
Vaccination
Talk to your doctor regarding your current vaccinations plan. See section “Other medicines and Nemluvio”. Children and adolescents
Do not give this medicine to children with atopic
dermatitis below the age of 12 years because the safety and benefits of Nemluvio are not yet known in this population.
The safety and benefits of Nemluvio are not known in
children with prurigo nodularis below the age of 18 years.
Other medicines and Nemluvio
Tell your doctor or pharmacist
If you are using, have recently used or might use any
other medicines.
If you have recently had or are due to have a
vaccination.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The effects of this medicine in pregnant women are not known; therefore, it is preferable to avoid the use of Nemluvio in pregnancy unless your doctor advises to use it.
If you are breast-feeding or are planning to breast-feed,
talk to your doctor before using this medicine. You and your doctor should decide if you will breast-feed or use Nemluvio. You should not do both.
Driving and using machines
Nemluvio is unlikely to influence your ability to drive and use machines.
3. How to use Nemluvio
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much Nemluvio is given and for how long
Your doctor will decide how much Nemluvio you need and how long you will use it for.
Recommended dose in adults and adolescents patients with atopic dermatitis (12 years of age and older) For patients with atopic dermatitis, 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. Use Nemluvio with topical eczema medicines. When your eczema has improved, your doctor may stop topical medicines.
Recommended dose in adults with prurigo nodularis (PN) The recommended dose of Nemluvio for adults with prurigo nodularis 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
Injecting Nemluvio
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.
The pre-filled pen must not be shaken.
Read carefully the instructions for use included at the end of this package leaflet before using Nemluvio. If you use more Nemluvio than you should
If you use more Nemluvio than you should or the dose has been given too early, talk to your doctor, pharmacist or nurse. If you forget to use Nemluvio
If you have forgotten to inject a dose of Nemluvio, talk to your doctor, pharmacist or nurse.
Give the Nemluvio injection as soon as possible, then continue with your original schedule.
If you stop using Nemluvio
Do not stop using Nemluvio without speaking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nemluvio can cause serious side effects, including rare allergic (hypersensitivity) reactions such as anaphylaxis; the signs may include:
breathing problems
- swelling of the face, mouth, and tongue
fainting, dizziness, feeling lightheaded (low blood
pressure)
- hives
- itching
- skin rash
Stop using Nemluvio and tell your doctor or get medical help immediately if you notice any signs of allergic reaction.
Other side effects
Common (may affect up to 1 in 10 people):
- Headache
- Hives
- Eczema (atopic dermatitis)
Uncommon (may affect up to 1 in 100 people):
Swelling of the face, lips, mouth, throat or tongue
(angioedema)
Injection site reactions (i.e. redness, rash, pain, irritation
and bruising)
Blisters or fluid-filled spots on skin (signs of a skin
condition called bullous pemphigoid)
Rare (may affect up to 1 in 1000 people):
- Swelling at the injection site
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original carton in order to protect from light. If necessary, Nemluvio may be kept 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 for the pen. Do not use Nemluvio beyond the expiration date or 90 days after the date it was first removed from the refrigerator (whichever is earlier). Do not use this medicine if you notice that the powder is not white.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Nemluvio contains
The active substance is nemolizumab. Each pre-filled
pen contains 30 mg of nemolizumab and 0.49 mL water for injection.
The other ingredients are Sucrose, Trometamol,
Trometamol hydrochloride, L-arginine hydrochloride, Poloxamer 188, Water for injections.
What Nemluvio looks like and contents of the pack
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 pens.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Galderma (U.K.) Limited
Evergreen House North
Grafton Place
London
NW1 2DX
United Kingdom
Tel: + 44 (0) 300 3035674
Manufacturers
Q-Med AB
Seminariegatan 31
Helga Trefaldighet
752 28 Uppsala
Uppsala Lan
Sweden
Nuvisan France S.A.R.L.
2400 Route Des Colles
06410 Biot
France
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last revised in January 2026.
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 makes sure that you get the prescribed dose of medicine.
- Make sure that the lyophilized powder is completely dissolved before injecting (Step 9).
- After dissolving, proceed as soon as possible 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, cracked or broken.
- In some cases, your doctor may 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 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 Nemluvio pen as soon as possible 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 sight and reach of children.
- Store the Nemluvio pen in the refrigerator between 2°C to 8°C.
- The Nemluvio pen can be stored at room temperature up to 25°C for a single period of up to 90 days.
- Store the Nemluvio pen in the original carton to protect it from light.
- After reconstitution the Nemluvio pen must be used within 4 hours.
- Do not heat or freeze the Nemluvio pen.
Traveling 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.
Device Overview
Nemluvio pre-filled dual-chamber pen
INSTRUCTIONS FOR USE
CAREFULLY read and follow Instructions for Use. This pen requires specific steps before 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 instructed how to inject Nemluvio.
In adolescents (ages 12 to 17 years old), it is recommended that Nemluvio be given by or under supervision of a trained adult or caregiver.
Your healthcare professional will instruct you or your caregiver on how to prepare and inject a dose of Nemluvio 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 inject it, you must mix the lyophilized powder with the water for dissolving the medicine.
powder and solvent for solution for injection in pre-filled pen nemolizumab
30 mg ®
powder and solvent for solution
for injection in pre-filled pen
nemolizumab
30 mg ®
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).
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)
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: Check 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.
Step 5: Activate the Nemluvio pen
Hold the pen upright and turn the activation knob to the right until it stops
(see Figure E).
This starts the process of transferring water to the powder chamber.
A. Preparing to inject Nemluvio
Do not:
- warm the pen with any heat source (such as micro-wave, direct sunlight). This might damage Nemluvio.
- directly expose the pen to liquids.
!
Figure B
- 1.
2.
4.
3.
Figure C
Lyophilized powder
Expiration date
Figure D
Do not use the pen unless all 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”).
!
Unlock Icon
Figure E
Turn over to continue reading about the pen injection steps and FAQs
Needle cover
Orange needle
guard
Orange rod
Grey rod
Activation knob
(arrow on locked icon)
Grey cap
Water for dissolving
the medicine
(in a separate chamber,
not visible)
Inspection window
Lyophilized Powder
(medicine)
Activation knob
(arrow on unlocked icon) Before use After use
It is normal that orange rod does not cover the full window at the end of the injection
Step 6: Wait until grey rod stops moving
Watch inspection window
until grey rod has stopped
moving (see Figure F).
Step 7: Shake to dissolve the medicine
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
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 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:
a. is clear and
colourless to
slightly yellow,
b. does not contain
particles.
(see Figure i).
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.
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
(see Figure K)
a. Always use a new alcohol
wipe to clean the injection
site.
This avoids contamination
and infection.
b. Let the skin air dry.
Step 12: Twist the grey cap
a. Hold the pen upright (see Figure L, a). b. Unscrew the grey cap
until the orange needle
guard pops up (see
Figure L, b).
c. Gently pull the cap off
the orange needle
guard (see Figure L, c).
d. 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
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).
Step 15: Inject for 15 seconds
Hold and slowly
count to 15.
Check inspection
window to make
sure orange rod
and grey rod 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.
If the orange rod is not visible please throw away the pen and use a new one (see Section C:“Throwing away Nemluvio”).
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.
A. Preparing to inject Nemluvio B. Injecting Nemluvio
Injection by Caregiver
Self-Injection
Abdomen 5 cm
away from navel
- Upper thigh
Abdomen 5 cm
away from navel
- Upper thigh
Outer, upper arm
Figure J
Alcohol Wipe
Figure K
Do not pull the grey cap
Pull off cap Unscrew
cap
Hold
upright
a b c
Figure L (a,b,c)
Injection
site
Orange needle guard Figure M
Grey rod
Orange rod
Push down on the orange needle guard
click!
Start injection
Figure N
Lift straight up
Orange
needle guard
locked
Figure P Before
Grey
rod
After
Figure F
30 seconds
Shake for 30 seconds
Figure G
Dissolved
Not dissolved
Wait 5minutes
Figure H
Dissolved
Figure i
Grey rod
Orange rod
Hold and slowly count to 15.
15seconds
Figure O
Step 17: Throw away the pen and the cap
Throw away the used
pen and the grey cap
in a sharps disposal
container right away
after use (see
Figure Q).
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.
C. Throwing away Nemluvio
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. 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 labeled 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 up-right 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 medi-cine 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
Is it necessary to receive instruc-tions on how to use the Nemluvio pen from a healthcare professional?
Yes.
Do not inject the medicine if you did not receive a demonstration by your healthcare professional.
You should contact your healthcare profes-sional to receive the information on how to use the Nemluvio pen.
Where can I get more information about using Nemluvio:
Call your healthcare professional. FAQs (Frequently asked questions)
Pen Grey
cap
Figure Q
Do not shake the pen before the grey rod has completely stopped. You might get an incorrect dose of medicine.
!
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”). !
Do not:
- touch the injection site after cleaning.
- fan or blow air on the cleaned injection site.
- reuse the alcohol wipe.
!
Do not:
- pull the grey cap when unscrewing to avoid damaging the device.
touch the orange needle guard. !
Read Steps 13-16 before starting Step 13. !
Do not lift the pen yet and keep pushing down. !
Do not lift pen until orange rod and grey rod have stopped moving.
!
Do not rub the injection site.
!
Avoid contact with the needle.
!
Do not:
- recap the pen after use.
- throw away the Nemluvio pen and cap in your household trash.
- recycle your used sharps disposal container. !