Uzpruvo 130 mg – patient leaflet, side effects, dosage

What Uzpruvo is used for

Uzpruvo is used to treat the following inflamma • Moderate to severe Crohn’s disease - in adul • Moderate to severe ulcerative colitis - in adul

Crohn’s disease

Crohn’s disease is an inflammatory disease of you will first be given other medicines. If yo intolerant to these medicines, you may be g symptoms of your disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease colitis you will first be given other medicines. are intolerant to these medicines, you may be symptoms of your disease.

2. What you need to know before you u

Do not use Uzpruvo

• If you are allergic to ustekinumab or any (listed in section 6).
• If you have an active infection which your

If you are not sure if any of the above applies before using Uzpruvo.

Warnings and precautions

Talk to your doctor or pharmacist before using you are before treatment. Make sure you tell before treatment. Also tell your doctor if you ha have tuberculosis. Your doctor will examine yo you have Uzpruvo. If your doctor thinks you are medicines to treat it.

Look out for serious side effects

Uzpruvo can cause serious side effects, includ must look out for certain signs of illness whil side effects’ in section 4 for a full list of these s

Before you use Uzpruvo tell your doctor • If you ever had an allergic reaction to U

sure.

• If you have ever had any type of cancer – t Uzpruvo weaken part of the immune system. • If you have been treated for psoriasis with produced from a biological source and u

  cancer may be higher.

• If you have or have had a recent infec

  openings (fistulae).

• If you have any new or changing lesions

• If you are having any other treatment fo

  • such as another immunosuppressant or p with a type of ultraviolet (UV) light). These t immune system. Using these therapies toge However, it is possible it may increase the immune system.

• If you are having or have ever had injectio

  Uzpruvo may affect these.

• If you are 65 years of age or over – you m

If you are not sure if any of the above applies before using Uzpruvo.

Some patients have experienced lupus-like r like syndrome during treatment with ustekinum experience a red, raised, scaly rash sometim skin that are exposed to the sun or with joint pa

Heart attack and strokes

Heart attack and strokes have been observe treated with ustekinumab. Your doctor will reg disease and stroke in order to ensure that they attention right away if you develop chest pain, side of your body, facial droop, or speech or vis

Children and adolescents

Uzpruvo is not recommended for use in child disease or ulcerative colitis because it has not

Other medicines, vaccines and Uzpruvo

Tell your doctor or pharmacist

• If you are taking, have recently taken or migh
• If you have recently had or are going to hav (live vaccines) should not be given while usin • If you received Uzpruvo while pregnant, tell treatment before the baby receives any vacc BCG vaccine (used to prevent tuberculosis). your baby in the first twelve months after b pregnancy unless your baby’s doctor recomm

Pregnancy and breast-feeding

• It is preferable to avoid the use of Uzpruvo pregnant women are not known. If you are

  Package leaflet: Inform

  Uzpruvo 1 concentrate for solu

  ustekinu

  oring. This will allow quick identification orting any side effects you may get. See cts.

  start using this medicine because it

  taking the medicine.

  ain.

  octor or pharmacist.

  octor or pharmacist. This includes any See section 4.

  uvo

  for

  stekinumab’, a monoclonal antibody. ognise and bind specifically to certain

  called ‘immunosuppressants’. These ne system.

  tory diseases:

  ts

  ts

  the bowel. If you have Crohn’s disease u do not respond well enough or are iven Uzpruvo to reduce the signs and

  of the bowel. If you have ulcerative If you do not respond well enough or given Uzpruvo to reduce the signs and

  se Uzpruvo

  of the other ingredients of this medicine

  doctor thinks is important.

  to you, talk to your doctor or pharmacist

  Uzpruvo. Your doctor will check how well your doctor about any illness you have ve recently been near anyone who might u and do a test for tuberculosis, before at risk of tuberculosis, you may be given

  ing allergic reactions and infections. You e you are taking Uzpruvo. See ‘Serious ide effects.

  zpruvo. Ask your doctor if you are not

  his is because immunosuppressants like This may increase the risk of cancer. other biologic medicines (a medicine sually given by injection) – the risk of

  tion or if you have any abnormal skin

  within psoriasis areas or on normal skin. r psoriasis and/or psoriatic arthritis

  hototherapy (when your body is treated reatments may also weaken part of the ther with Uzpruvo has not been studied. chance of diseases related to a weaker

  ns to treat allergies – it is not known if

  ay be more likely to get infections.

  to you, talk to your doctor or pharmacist

  eactions including skin lupus or lupus-ab. Talk to your doctor right away if you es with a darker border, in areas of the ins.

  d in a study in patients with psoriasis ularly check your risk factors for heart are appropriately treated. Seek medical weakness or abnormal sensation on one ual abnormalities.

  ren under 18 years of age with Crohn’s been studied in this age group.

  t take any other medicines.

  e a vaccination. Some types of vaccines g Uzpruvo.

  your baby’s doctor about your Uzpruvo ine, including live vaccines, such as the Live vaccines are not recommended for irth if you received Uzpruvo during the ends otherwise.

  in pregnancy. The effects of Uzpruvo in a woman of childbearing potential, you

  are advi using U • Talk to have a • Ustekin Uzpruvo infection • It is imp if you vaccine not reco Uzpruvo • Ustekin you are decide i

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If you hav Uzpruvo a

Infection you notic

• Infectio 10 peop • Infectio • Inflamm 100 peo • Shingle 100 peo

Uzpruvo serious a tuberculos weakened brain (enc treatment

You must • fever, fl • feeling t • warm, r • burning • diarrhoe • visual d • headac

Tell your be signs o infections infection t should no any open

Shedding the body which ar you notic ation for the user

30 mg tion for infusion

mab

sed to avoid becoming pregnant and must use adequ zpruvo and for at least 15 weeks after the last Uzpruvo your doctor if you are pregnant, think you may be preg baby.

umab can pass across the placenta to the unborn during your pregnancy, your baby may have a hig .

ortant that you tell your baby’s doctors and other he received Uzpruvo during your pregnancy before t . Live vaccines such as the BCG vaccine (used to pr mmended for your baby in the first twelve months af during the pregnancy unless your baby’s doctor reco umab may pass into breast milk in very small amount breast-feeding or are planning to breast-feed. You f you should breast-feed or use Uzpruvo - do not do b

nd using machines

as no or negligible influence on the ability to drive and

contains sodium

ontains less than 1 mmol sodium (23 mg) per dose, t ee’. However, before Uzpruvo is given to you, it is mi odium. Talk to your doctor if you are on a low salt diet

Uzpruvo will be given

intended for use under the guidance and supervision nosis and treatment of Crohn’s disease or ulcerative c

30 mg concentrate for solution for infusion will be give drip in the vein of your arm (intravenous infusion) ove ctor about when you will have your injections and follo

h Uzpruvo is given

or will decide how much Uzpruvo you need to receive

ed 18 years or older

tor will work out the recommended intravenous infus body weight.

dy weight

o ≤ 85 kg

e starting intravenous dose, you will have the next dos tion under your skin (subcutaneous injection) 8 week s therafter.

ruvo is given

t dose of Uzpruvo for treatment of Crohn’s disease or u ctor as a drip in the vein of an arm (intravenous infusio ur doctor if you have any questions about receiving Uz

get to use Uzpruvo

get or miss the appointment for receiving the dose, e your appointment.

p using Uzpruvo

angerous to stop using Uzpruvo. However, if you sto k.

ve any further questions on the use of this medici t.

ble side effects

edicines, this medicine can cause side effects, althou

ide effects

ents may have serious side effects that may need urg

eactions – these may need urgent treatment. Te cy medical help straight away if you notice any of

allergic reactions (‘anaphylaxis’) are rare in people ta p to 1 in 1,000 people). Signs include:

ulty breathing or swallowing

blood pressure, which can cause dizziness or light-he ling of the face, lips, mouth or throat.

n signs of an allergic reaction include skin rash and h eople).

related reactions – If you are being treated fo colitis, the first dose of Uzpruvo is given throu ous infusion). Some patients have experienc during the infusion.

ses, allergic lung reactions and lung inflammatio s who receive ustekinumab. Tell your doctor righ s such as cough, shortness of breath, and fever.

e a serious allergic reaction, your doctor may decide gain.

s – these may need urgent treatment. Tell your d e any of the following signs.

ns of the nose or throat and common cold are commo le)

ns of the chest are uncommon (may affect up to 1 in 1 ation of tissue under the skin (‘cellulitis’) is uncommo ple)

s (a type of painful rash with blisters) are uncommon ple)

may make you less able to fight infections. Some in nd may include infections caused by viruses, fun is), or parasites, including infections that mainly o immune system (opportunistic infections). Opportu ephalitis, meningitis), lungs, and eye have been report with ustekinumab.

look out for signs of infection while you are using Uzpr u-like symptoms, night sweats, weight loss ired or short of breath; cough which will not go away ed and painful skin, or a painful skin rash with blisters when passing water

a

isturbance or vision loss

he, neck stiffness, light sensitivity, nausea or confusio

doctor straight away if you notice any of these signs f infections such as chest infections, skin infections, s that could have serious complications. Tell your docto hat will not go away or keeps coming back. Your doct t use Uzpruvo until the infection goes away. Also tell cuts or sores as they might get infected.

of skin – increase in redness and shedding of ski may be symptoms of erythrodermic psoriasis or e serious skin conditions. You should tell your d e any of these signs.

1 in 10 people)

n

the injection is given

to 1 in 100 people)

ess, swelling and itching where the injection is given

ging muscles on one side of the face (‘facial palsy’ or emporary

with redness and new tiny, yellow or white skin bl by fever (pustular psoriasis)

exfoliation)

1,000 people)

of skin over a larger area of the body, which may be matitis). Similar symptoms sometimes develop as a n riasis symptoms (erythrodermic psoriasis) od vessels, which can lead to a skin rash with small int pain (vasculitis)

1 in 10,000 people)

may be red, itchy, and painful (Bullous pemphigoid) yndrome (red, raised scaly rash on areas of the skin ex oint pains)

talk to your doctor or pharmacist. This includes any po his leaflet. You can also report side effects directly v www.mhra.gov.uk/yellowcard or search for ‘MHRA or Apple App Store. By reporting side effects you ca n the safety of this medicine.

‘Bell’s

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The following information is intende

Traceability: In order to improve the traceability of biolog

vo

trate for solution for infusion is given in a hospital or eed to store or handle it.

f the sight and reach of children.

°C–8 °C). Do not freeze.

carton in order to protect from light.

uvo vials. Prolonged vigorous shaking may damag

ich is stated on the label and the carton after ‘EXP ast day of that month.

d, cloudy or you can see other foreign particles floatin ruvo looks like and contents of the pack’). it may have been exposed to extreme temperatures (s ated).

haken vigorously.

ly. Any diluted infusion solution or unused product rem hould be thrown away in accordance with local require

k and other information

stekinumab. Each vial contains130 mg ustekinumab in 26 are EDTA disodium salt dihydrate, histidine, hi ionine, polysorbate 80, sucrose and water for injection

and contents of the pack

ess to light yellow and practically free from visible pa infusion. It is supplied as a carton pack containing 1 h vial contains 130 mg ustekinumab in 26 mL of conce

Holder

rsfield, HD7 5QH, UK

a 15-19, Reykjavik, 102, Iceland

ed in April 2025.

d for healthcare professionals only:

ical medicinal products, the tradename and the batch number of the administered produ

ct should be clearly recorded.

Instructions for dilution:

Uzpruvo concentrate for solution for infusion

must be diluted, prepared and infused by a healthcare professional using aseptic techni

que.

1. 1.

   Calculate the dose and the number o

   f Uzpruvo vials needed based on patient weight (see section 3, Table 1). Each 2

   6 mL vial of Uzpruvo contains 130 mg of ustekinumab.

2. 2.

   Withdraw and then discard a volume of t

   he sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to t

   he volume of Uzpruvo to be added (discard

   26 mL sodium chloride for each vial of U

   zpruvo needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, for 4 vials- dis

   card 104 mL).

3. 3.

   Withdraw 26 mL of Uzpruvo from each vi

   al needed and add it to the 250 mL infusion bag. The final volume in the infusion bag

   should be 250 mL. Gently mix.

4. 4.

   Visually inspect the diluted solution bef

   ore infusion. Do not use if visibly opaque particles, discolouration or foreign partic

   les are observed.

5. 5.

   Infuse the diluted solution over a perio

   d of at least one hour. Once diluted, the infusion should be completed within eigh

   t hours of the dilution in the infusion bag.

6. 6.

   Use only an infusion set with an in-line,

   sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer). 7. Each vial is for single use only and

   any unused medicinal product should be disposed of in accordance with local req

   uirements.

Storage:

If necessary, the diluted infusion solution may

be stored at room temperature. The infusion should be completed within 8 hours of the dilu

tion in the infusion bag. Do not freeze.

Produkt/Product: UZPRUVO INJ VIA SD GB:PIL with

Ulcerative Colitis

STADA Mat.-Nr./Mat.-No.: 9357755 DZ: 2504

STADA Art.-Nr./Art.-No.: 179306

Hersteller/Manufacturer:

Hersteller Art.-Nr./ Manufacturer Art.-No.: -

Format/Size: 500 x 1000 mm (folded to 64 x 77 mm)

Schriftgröße/Font-size: 9 pt - 16 pt

PZN/EAN:

Flattermarke/Collating mark:

1.. arbe/Colour: 100% Black

2.. arbe/Colour:

3.. arbe/Colour:

4.. arbe/Colour:

5.. arbe/Colour:

6.. arbe/Colour:

7.. arbe/Colour:

8.. arbe/Colour: Contour

Version: 2. Loop Datum/Date: 28.04.2025.

Agentur/Agency:

Grafik erstellt von/Graphic made by:

Aktueller Umlauf/Current loop:

Genehmigt/Approved

Other side effects

Common (may affect up to • Diarrhoea

• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• Headache
• Itching (‘pruritus’)
• Back, muscle or joint pai • Sore throat
• Redness and pain where • Sinus infection

Uncommon (may affect up • Tooth infections

• Vaginal yeast infection • Depression
• Blocked or stuffy nose • Bleeding, bruising, hardn
• Feeling weak
• Drooping eyelid and sag palsy’), which is usually t • A change in psoriasis sometimes accompanied • Peeling of the skin (skin • Acne

Rare (may affect up to 1 in • Redness and shedding or painful (exfoliative der change in the type of pso • Inflammation of small blo purple bumps, fever or jo

Very rare (may affect up to • Blistering of the skin that • Skin lupus or lupus-like s to the sun possibly with j

Reporting of side effects

If you get any side effects, side effects not listed in t Yellow Card Scheme at: Card’ in the Google Play provide more information o

5. How to store Uzpru

• Uzpruvo 130 mg concen and patients should not n • Keep this medicine out o • Store in a refrigerator (2 • Keep the vial in the outer • Do not shake the Uzpr medicine.

Do not use this medicine

• After the expiry date wh expiry date refers to the l • If the liquid is discoloure (see section 6 ‘What Uzp • If you know, or think that accidentally frozen or he • If the product has been s • If the seal is broken.

Uzpruvo is for single use on in the vial and the syringe s

6. Contents of the pac

What Uzpruvo contains

• The active substance is u • The other ingredients monohydrochloride, meth

What Uzpruvo looks like

Uzpruvo is a clear, colourl concentrate for solution for dose, glass 30 mL vial. Eac for solution for infusion.

Marketing Authorisation

STADA, Linthwaite, Hudde

Manufacturer

Alvotech Hf, Sæmundargat

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