Patient leaflet - UZPRUVO 90 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
What Uzpruvo® is used for
Uzpruvo® is used to treat the following inflam
- Plaque psoriasis - in adults and children a
- Psoriatic arthritis - in adults
- Moderate to severe Crohn’s disease - in a
- Moderate to severe ulcerative colitis - in ad
Plaque psoriasis
Plaque psoriasis is a skin condition that caus Uzpruvo® will reduce the inflammation and o
Uzpruvo® is used in adults with moderate to ciclosporin, methotrexate or phototherapy, or
Uzpruvo® is used in children and adolescent severe plaque psoriasis who are unable to to or where these treatments did not work.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease If you have active psoriatic arthritis you will fi respond well enough to these medicines, yo
- Reduce the signs and symptoms of your d
- Improve your physical function.
- Slow down the damage to your joints.
Crohn’s disease
Crohn’s disease is an inflammatory disease will first be given other medicines. If you do n these medicines, you may be given Uzpruvo disease.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease will first be given other medicines. If you do n these medicines, you may be given Uzpruvo disease.
2. What you need to know before you
Do not use Uzpruvo®
- If you are allergic to ustekinumab or any in section 6).
- If you have an active infection which you
If you are not sure if any of the above applie before using Uzpruvo®.
Warnings and precautions
Talk to your doctor or pharmacist before usin you are before each treatment. Make sure yo before each treatment. Also tell your doctor i might have tuberculosis. Your doctor will exa you have Uzpruvo®. If your doctor thinks you medicines to treat it.
Look out for serious side effects
Uzpruvo® can cause serious side effects, inc must look out for certain signs of illness whil effects’ in section 4 for a full list of these side
Before you use Uzpruvo® tell your doctor
- If you ever had an allergic reaction to U
If you have ever had any type of cancer
Uzpruvo® weaken part of the immune syst
If you have been treated for psoriasis w produced from a biological source and
cancer may be higher.
- If you have or have had a recent infecti
- If you have any new or changing lesion
If you are having any other treatment fo
as another immunosuppressant or phototh ultraviolet (UV) light). These treatments m Using these therapies together with Uzpru possible it may increase the chance of dis
If you are having or have ever had injec
Uzpruvo® may affect these.
- If you are 65 years of age or over – you
If you are not sure if any of the above applie before using Uzpruvo®.
Some patients have experienced lupus-like r syndrome during treatment with ustekinumab experience a red, raised, scaly rash sometim that are exposed to the sun or with joint pain
Heart attack and strokes
Heart attack and strokes have been observe with ustekinumab. Your doctor will regularly c stroke in order to ensure that they are appro away if you develop chest pain, weakness or facial droop, or speech or visual abnormalitie
Children and adolescents
Uzpruvo® is not recommended for use in chil for use in children and adolescents under 18 disease or ulcerative colitis, because it has n
Other medicines, vaccines and Uzpruvo®
Tell your doctor or pharmacist
- If you are taking, have recently taken or mi
- If you have recently had or are going to ha vaccines) should not be given while using
- If you received Uzpruvo® while pregnant, t treatment before the baby receives any va vaccine (used to prevent tuberculosis). Liv in the first twelve months after birth if you r your baby’s doctor recommends otherwise
Pregnancy and breast-feeding
- It is preferable to avoid the use of Uzpruvo pregnant women are not known. If you are advised to avoid becoming pregnant and m Uzpruvo® and for at least 15 weeks after th
- Talk to your doctor if you are pregnant, thin a baby.
- Uzpruvo® can pass across the placenta to during your pregnancy, your baby may hav
- It is important that you tell your baby’s doc received Uzpruvo® during your pregnancy vaccines such as the BCG vaccine (used t for your baby in the first twelve months aft pregnancy unless your baby’s doctor reco
- Ustekinumab may pass into breast milk in are breast-feeding or are planning to breas you should breast-feed or use Uzpruvo® -
Driving and using machines
Uzpruvo® has no or negligible influence on th
Uzpruvo® contains polysorbate 80
This medicine contains 0.04 mg of polysorba allergic reactions. Tell your doctor if you have
3. How to use Uzpruvo®
Uzpruvo® is intended for use under the guida treating conditions for which Uzpruvo® is inte
Always use this medicine exactly as your do are not sure. Talk to your doctor about when appointments.
pre-filled syringe
nal monitoring. This will allow quick on. You can help by reporting any side section 4 for how to report side effects.
u start using this medicine because it
n taking the medicine. If you are the parent hild, please read this information carefully.
gain.
doctor or pharmacist.
only. Do not pass it on to others. It may harm ame as yours.
tor or pharmacist. This includes any possible ction 4.
pruvo®
ed for
ekinumab’, a monoclonal antibody. Monoclonal nd specifically to certain proteins in the body.
alled ‘immunosuppressants’. These medicines m.
matory diseases:
ged 6 years and older
dults
ults
es inflammation affecting the skin and nails. ther signs of the disease.
severe plaque psoriasis, who cannot use where these treatments did not work.
s aged 6 years and older with moderate to lerate phototherapy or other systemic therapies
of the joints, usually accompanied by psoriasis. rst be given other medicines. If you do not u may be given Uzpruvo® to:
isease.
of the bowel. If you have Crohn’s disease you ot respond well enough or are intolerant to ® to reduce the signs and symptoms of your
of the bowel. If you have ulcerative colitis you ot respond well enough or are intolerant to ® to reduce the signs and symptoms of your
use Uzpruvo®
of the other ingredients of this medicine (listed
r doctor thinks is important.
s to you, talk to your doctor or pharmacist
g Uzpruvo®. Your doctor will check how well u tell your doctor about any illness you have f you have recently been near anyone who mine you and do a test for tuberculosis, before are at risk of tuberculosis, you may be given
luding allergic reactions and infections. You e you are taking Uzpruvo®. See ‘Serious side effects.
zpruvo®. Ask your doctor if you are not sure.
- this is because immunosuppressants like em. This may increase the risk of cancer. ith other biologic medicines (a medicine usually given by injection) – the risk of
on.
s within psoriasis areas or on normal skin. r psoriasis and/or psoriatic arthritis – such erapy (when your body is treated with a type of ay also weaken part of the immune system. vo® has not been studied. However it is eases related to a weaker immune system. tions to treat allergies – it is not known if
may be more likely to get infections.
s to you, talk to your doctor or pharmacist
eactions including skin lupus or lupus-like . Talk to your doctor right away if you es with a darker border, in areas of the skin s.
d in a study in patients with psoriasis treated heck your risk factors for heart disease and priately treated. Seek medical attention right abnormal sensation on one side of your body, s.
dren with psoriasis under 6 years of age, or years of age with psoriatic arthritis, Crohn’s ot been studied in this age group.
ght take any other medicines.
ve a vaccination. Some types of vaccines (live Uzpruvo®.
ell your baby’s doctor about your Uzpruvo® ccine, including live vaccines, such as the BCG e vaccines are not recommended for your baby eceived Uzpruvo® during the pregnancy unless .
® in pregnancy. The effects of Uzpruvo® in a woman of childbearing potential, you are ust use adequate contraception while using e last Uzpruvo® treatment.
k you may be pregnant or are planning to have
the unborn baby. If you received Uzpruvo® e a higher risk for getting an infection. tors and other health care professionals if you before the baby receives any vaccine. Live
o prevent tuberculosis) are not recommended er birth if you received Uzpruvo® during the mmends otherwise.
very small amounts. Talk to your doctor if you t-feed. You and your doctor should decide if do not do both.
e ability to drive and use machines.
te 80 in each mL. Polysorbates may cause any known allergies.
nce and supervision of a doctor experienced in nded.
ctor has told you. Check with your doctor if you you will have your injections and follow-up
How much Uzpruvo® is given
Your doctor will decide how much Uzpruvo® you
Adults aged 18 years or older
Psoriasis or Psoriatic Arthritis
- The recommended starting dose is 45 mg Uzp 100 kilograms (kg) may start on a dose of 90 m
- After the starting dose, you will have the next d 12 weeks. The following doses are usually the
Crohn’s disease or ulcerative colitis
- Uzpruvo® is not available for the first dose (intravenous infusion).
- Another ustekinumab product will be given
- Uzpruvo® is administered by injection under th the first dose of 90 mg Uzpruvo® 8 weeks after 12 weeks thereafter subcutaneously. In some skin, 90 mg Uzpruvo® may be given every 8 w should receive your next dose.
Children and adolescents aged 6 years or old Psoriasis
- The doctor will work out the right dose for you, to be injected to give the right dose. The right weight at the time each dose is given.
- If you weigh less than 60 kg, there is no dosag 60 kg body weight.
- If you weigh 60 kg to 100 kg, the recommende more than 100 kg, the recommended dose is 9
- After the starting dose, you will have the next d 12 weeks.
How Uzpruvo® is given
- Uzpruvo® is given as an injection under the ski treatment, medical or nursing staff may inject U
- However, you and your doctor may decide that case you will get training on how to inject Uzpr
- For instructions on how to inject Uzpruvo®, see of this leaflet.
Talk to your doctor if you have any questions abo
If you use more Uzpruvo® than you should
If you have used or been given too much Uzpruv away. Always have the outer carton of the medic
If you forget to use Uzpruvo®
If you forget a dose, contact your doctor or phar up for a forgotten dose.
If you stop using Uzpruvo®
It is not dangerous to stop using Uzpruvo®. How back.
If you have any further questions on the use of th
4. Possible side effects
Like all medicines, this medicine can cause side
Serious side effects
Some patients may have serious side effects tha
Allergic reactions – these may need urgent tr emergency medical help straight away if you
Serious allergic reactions (‘anaphylaxis’) are ra affect up to 1 in 1,000 people). Signs include: ○ difficulty breathing or swallowing
○ low blood pressure, which can cause dizzine ○ swelling of the face, lips, mouth or throat.
- Common signs of an allergic reaction include s 100 people).
In rare cases, allergic lung reactions and lung in patients who receive ustekinumab. Tell you symptoms such as cough, shortness of breat
If you have a serious allergic reaction, your docto Uzpruvo® again.
Infections – these may need urgent treatment notice any of the following signs.
- Infections of the nose or throat and common c 10 people)
- Infections of the chest are uncommon (may aff
- Inflammation of tissue under the skin (‘cellulitis 100 people)
- Shingles (a type of painful rash with blisters) a 100 people)
Uzpruvo® may make you less able to fight infecti and may include infections caused by viruses, fu parasites, including infections that mainly occur i (opportunistic infections). Opportunistic infection lungs, and eye have been reported in patients re
You must look out for signs of infection while you
- fever, flu-like symptoms, night sweats, weight l
- feeling tired or short of breath; cough which wil
- warm, red and painful skin, or a painful skin ra
- burning when passing water
- diarrhoea
- visual disturbances or vision loss
- headache, neck stiffness, light sensitivity, naus
Tell your doctor straight away if you notice any of be signs of infections such as chest infections, s infections that could have serious complications. infection that will not go away or keeps coming b should not use Uzpruvo® until the infection goes open cuts or sores as they might get infected.
Shedding of skin – increase in redness and s body may be symptoms of erythrodermic pso are serious skin conditions. You should tell y any of these signs.
Other side effects
Common (may affect up to 1 in 10 people):
- Diarrhoea
- Nausea
- Vomiting
- Feeling tired
- Feeling dizzy
- Headache
- Itching (‘pruritus’)
- Back, muscle or joint pain
- Sore throat
- Redness and pain where the injection is given
- Sinus infection
Uncommon (may affect up to 1 in 100 people):
- Tooth infections
- Vaginal yeast infection
- Depression
- Blocked or stuffy nose
- Bleeding, bruising, hardness, swelling and itch
- Feeling weak
- Drooping eyelid and sagging muscles on one s palsy’), which is usually temporary
- A change in psoriasis with redness and new tin accompanied by fever (pustular psoriasis)
- Peeling of the skin (skin exfoliation)
- Acne
Rare (may affect up to 1 in 1,000 people)
- Redness and shedding of skin over a larger ar painful (exfoliative dermatitis). Similar symptom in the type of psoriasis symptoms (erythroderm
- Inflammation of small blood vessels, which can bumps, fever or joint pain (vasculitis)
Very rare (may affect up to 1 in 10,000 people)
- Blistering of the skin that may be red, itchy, an
- Skin lupus or lupus-like syndrome (red, raised the sun possibly with joint pains).
Reporting of side effects
If you get any side effects, talk to your doctor or effects not listed in this leaflet. You can also repo Scheme at: www.mhra.gov.uk/yellowcard or sear Play or Apple App Store. By reporting side effect the safety of this medicine.
5. How to store Uzpruvo®
- Keep this medicine out of the sight and reach
- Store in a refrigerator (2 °C – 8 °C). Do not fre
- Keep the pre-filled syringe in the outer carton i
- The pre-filled syringe should be allowed to rea an hour).
- If needed, individual Uzpruvo® pre-filled syring up to 30 °C for a maximum single period of up protect from light. Once removed from the refri space provided on the outer carton. The discar date printed on the carton. Once a syringe has 30 °C), it should not be returned to the refriger 30 days at room temperature storage or by the
- Do not shake the pre-filled syringes. Prolonged medicine.
Do not use this medicine
After the expiry date which is stated on the lab date refers to the last day of that month.
need to use and for how long.
ruvo®. Patients who weigh more than g instead of 45 mg.
ose 4 weeks later, and then every same as the starting dose.
through a drip in a vein in your arm
as intravenous infusion as first dose.
e skin (subcutaneously). You will receive the intravenous infusion, then every patients, after the first injection under the eeks. Your doctor will decide when you
er
including the amount (volume) of Uzpruvo® dose for you will depend on your body
e form for Uzpruvo® for children below
d dose is 45 mg Uzpruvo®. If you weigh 0 mg Uzpruvo®.
ose 4 weeks later, and then every
n (‘subcutaneously’). At the start of your zpruvo®.
you may inject Uzpruvo® yourself. In this uvo® yourself.
‘Instructions for administration’ at the end
ut giving yourself an injection.
o®, talk to a doctor or pharmacist straight ine with you, even if it is empty.
macist. Do not take a double dose to make
ever, if you stop, your symptoms may come
is medicine, ask your doctor or pharmacist.
effects, although not everybody gets them.
t may need urgent treatment.
eatment. Tell your doctor or get notice any of the following signs.
re in people taking ustekinumab (may
ss or light-headedness
kin rash and hives (may affect up to 1 in
inflammation have been reported r doctor right away if you develop h, and fever.
r may decide that you should not use
. Tell your doctor straight away if you
old are common (may affect up to 1 in
ect up to 1 in 100 people)
’) is uncommon (may affect up to 1 in
re uncommon (may affect up to 1 in
ons. Some infections could become serious ngi, bacteria (including tuberculosis), or n people with a weakened immune system s of the brain (encephalitis, meningitis), ceiving treatment with ustekinumab.
are using Uzpruvo®. These include: oss
l not go away
sh with blisters
ea or confusion.
these signs of infection. These may kin infections, shingles or opportunistic Tell your doctor if you have any kind of ack. Your doctor may decide that you away. Also tell your doctor if you have any
hedding of skin over a larger area of the riasis or exfoliative dermatitis, which our doctor straight away if you notice
ing where the injection is given
ide of the face (‘facial palsy’ or ‘Bell’s
y, yellow or white skin blisters, sometimes
ea of the body, which may be itchy or s sometimes develop as a natural change ic psoriasis)
lead to a skin rash with small red or purple
d painful (Bullous pemphigoid).
scaly rash on areas of the skin exposed to
pharmacist. This includes any possible side rt side effects directly via the Yellow Card ch for ‘MHRA Yellow Card’ in the Google s you can help provide more information on
of children.
eze.
n order to protect from light.
ch room temperature (approximately half
es may also be stored at room temperature to 30 days in the original carton in order to gerator, record the discard date in the d date must not exceed the original expiry been stored at room temperature (up to ator. Discard the syringe if not used within original expiry date, whichever is earlier. vigorous shaking may damage the
el and the carton after “EXP”. The expiry
•
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If the liquid is discoloured, cloudy or you can se section 6 ‘What Uzpruvo® looks like and content If you know, or think that it may have been expo accidentally frozen or heated).
If the product has been shaken vigorously.
zpruvo® is for single use only. Any unused produ hrown away. Do not throw away any medicines vi our pharmacist how to throw away medicines you rotect the environment.
e other foreign particles floating in it (see s of the pack’).
sed to extreme temperatures (such as ct remaining in the syringe should be a wastewater or household waste. Ask no longer use. These measures will help tion
filled syringe contains 90 mg nohydrochloride, polysorbate 80, sucrose, ack
d practically free of visible particles k containing 1 single-dose, glass 1 mL 90 mg ustekinumab in 1 mL solution for
2, Iceland
6. Contents of the pack and other informa
What Uzpruvo® contains
The active substance is ustekinumab. Each pre-ustekinumab in 1 mL.
The other ingredients are histidine, histidine mo water for injections.
What Uzpruvo® looks like and contents of the p
zpruvo® is a clear, colourless to slightly yellow an olution for injection. It is supplied as a carton pac re-filled syringe. Each pre-filled syringe contains njection.
arketing Authorisation Holder
TADA, Linthwaite, Huddersfield, HD7 5QH, UK
anufacturer
lvotech Hf, Sæmundargata 15-19, Reykjavik, 10
his leaflet was last revised in April 2025.
9354306
2504
GB
Instructions for administration
INSTRUCTION FOR USE
Uzpruvo® 90 mg solution for injection pre-filled syringe ustekinumab
for subcutaneous use
Read carefully these instructions for use before using Uzpruvo® solution for injection in pre-filled syringe.
At the start of treatment, your healthcare provider will assist you with your first injection. However, you and your doctor may decide that you may inject Uzpruvo® yourself. If this happens, you will get training on how to inject Uzpruvo®. Talk to your doctor if you have any questions about giving yourself an injection.
Important information you need to know before injecting Uzpruvo® solution for injection in pre-filled syringe
Uzpruvo® solution for injection in pre-filled syringe is not suitable for intravenous use, other ustekinumab products must be used for the initiation of treatment of Crohn’s disease and ulcerative colitis.
Uzpruvo® solution for injection in pre-filled syringe is not suitable for paediatric patients below 60 kg of body weight, other ustekinumab products allowing weight-based dosing must be used.
Important information:
- For subcutaneous use only
- Do not mix Uzpruvo® with other liquids for injection
- Do not shake Uzpruvo® pre-filled syringes. This is because shaking may damage the medicine. Do not use the medicine if it has been shaken. Get a new pre-filled syringe
Check the pre-filled syringe(s) to make sure:
the number of pre-filled syringes and strength is correct
○ If your dose is 90 mg, you will get one 90 mg pre-filled syringe of Uzpruvo®
- it is the right medicine
- it has not passed its expiry date
- the pre-filled syringe is not damaged
- the solution in the pre-filled syringe is clear and colourless to slightly yellow and practically free of visible particles
- the solution in the pre-filled syringe is not frozen
- it should be allowed to reach room temperature (approximately half an hour).
Figure 1 shows what the Uzpruvo® pre-filled syringe looks like
Needle
Syringe Body Plunger Needle Cover
Figure 1
- 1. Prepare the materials
Gather the supplies you will need to prepare and to give your injection. You will need: • Antiseptic wipes
- Cotton balls or gauze pads
- Adhesive bandage
- Your prescribed dose of Uzpruvo® (see Figure 1)
Puncture-resistant sharps disposal container (not included). See Figure 2 Get everything together that you need and lay out on a clean surface.
Adhesive
Bandage
Antiseptic Wipes
Cotton Ball or Gauze Pad Uzpruvo® Pre-filled
Syringe
Sharps Disposal Container
Figure 2
- Choose and prepare the injection site:
Choose an injection site (see Figure 3)
- Uzpruvo® is given by injection under the skin (subcutaneously)
- Choose an injection site. Good places for the injection are the upper thigh (legs), buttocks, or around the belly (abdomen) at least 5 cm away from the navel (belly button) • If a caregiver is giving you the injection, the outer area of the upper arms may also be used (see Figure 3)
Use a different injection site for each injection. Do not give an injection in an area of the skin that is tender, bruised, red or hard
Areas in yellow are recommended injection sites.
Figure 3
Prepare the injection site
- Wash your hands very well with soap and warm water
- Clean the skin with the antiseptic wipe where you plan to give your injection • Do not touch this area again before giving the injection. Let your skin dry before injection • Do not fan or blow on the clean area
- Do not inject through clothes
- Remove the needle cover (see Figure 4):
- Remove the needle cover when you are ready to inject Uzpruvo®
- Do not touch the plunger while removing the needle cover
- Hold the body of the pre-filled syringe with one hand, and pull the needle cover straight off (see Figure 4)
- Put the needle cover in the trash. Do not recap
- You may also see a drop of liquid at the end of the needle. This is normal • Do not touch the needle or let it touch anything
Inject the dose promptly after removing the needle cover
Figure 4
- Inject the dose:
Grasp the syringe:
- Hold the body of the pre-filled syringe with one hand between the thumb and index finger (see Figure 5)
Do not use the pre-filled syringe if it is dropped without the needle cover in place. If this happens, please contact your doctor or pharmacist for instructions • Do not pull back on the plunger at any time
Figure 5
Pinch the skin and insert needle:
Use the other hand to gently pinch the cleaned area of the skin. Hold firmly • Use a quick, dart-like motion to insert the needle into the pinched skin at about 45-degree angle (see Figure 6)
45°
Figure 6
Inject the drug:
Inject all of the liquid by using your thumb to push in the plunger all the way in until the pre-filled syringe is empty (see Figure 7)
Figure 7
Allow the needle to retract:
- When the plunger is pushed as far as it will go, keep pressure on the plunger head. Take the needle out of the skin and let go of the skin
Slowly take your thumb off the plunger head. The plunger will move up with your finger and retract the needle into the needle guard (see Figure 8)
Figure 8
- After the injection:
- After completing the injection, press a cotton ball or gauze pad on the skin of the injection site for a few seconds after the injection (see Figure 9)
- There may be a slight bleeding at the injection site. This is normal
- Do not rub the skin at the injection site
You may cover the injection site with a small adhesive bandage, if necessary
Figure 9
- Disposal:
- Put the used syringes in a puncture-resistant container, like a sharps disposal container right away after use according to your local regulations. Do not throw away (dispose of) loose syringes in your household garbage (see Figure 10).
Dispose of the antiseptic wipes, cotton ball or gauze pad, and packaging in your garbage • Never re-use a syringe, for your safety and health, and for the safety of others
Figure 10
Produkt/Product: UZPRUVO 90MG INJ SYR SD GB:PIL
STADA Mat.-Nr./Mat.-No.: 9354306 DZ: 2504
STADA Art.-Nr./Art.-No.: 179358
Hersteller/Manufacturer:
Hersteller Art.-Nr./ Manufacturer Art.-No.: -
Format/Size: 420 x 891 mm (folding 72 x 150 mm)
Schriftgröße/Font-size: 9 pt - 16 pt
PZN/EAN: -
Flattermarke/Collating mark: -
1.. arbe/Colour: Black (100% - 10%)
3.. arbe/Colour:
4.. arbe/Colour:
5.. arbe/Colour:
6.. arbe/Colour:
7.. arbe/Colour:
8.. arbe/Colour: Contour
Version: 1. Loop Datum/Date: 15.04.2025
Agentur/Agency:
Grafik erstellt von/Graphic made by:
Aktueller Umlauf/Current loop:
Genehmigt/Approved