STELARA 45mg solution for injection in pre-filled syringe

STELARA belongs to a group of medicines called immunosuppressants (medicines that inhibit your immune system). STELARA contains the active substance ustekinumab, a monoclonal antibody.Monoclonal antibodies are proteins that recognise and bind to other specific proteins in the body.

STELARA is used to treat moderate to severe plaque psoriasis in adultpatients who cannot use or did not respond to other medicines and phototherapy. This disease causes inflammation of skin and nails. STELARA will reduce the inflammation and other signs of the disease.

Do not use STELARA

-If you are allergic (hypersensitive) to ustekinumab or to any of the other ingredients of STELARA (listed in section 6 ?What STELARA contains?).
-If you have an active infection which your doctor considers important (see also below ?Take specialcare with STELARA?).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using STELARA.

Take special care with STELARA

Your doctor will assess your health before each treatment. Make sure you tell your doctorabout any illness you have before each treatment. Check with your doctor before using STELARA if you have:

InfectionsYou must tell your doctor if you have any kind of infectionSTELARA may make you less able to fight infections. Some infections could also become serious.Tell your doctor if you have any signs of infection, even if it is very minor. Signs may include fever, feeling tired, cough, flu-like symptoms, diarrhoea, dental problems and burning when urinating. If you are not sure, talk to your doctor straight awayIt is particularly important to tell your doctor if you have an infection that will not go away or keeps coming bac

• Tell your doctor if you have any open cuts or sores ?they might get infected.
• Tuberculosis (TB)-Tell your doctor if you have had tuberculosis. Also tell him or her if you have recently been near anyone who might have tuberculosis -Your doctor will examine you for tuberculosis and perform a test to see if you have tuberculosis, before you are given STELARA -If your doctor thinks that you are at risk of tuberculosis, you may be given medicines for tuberculosis. This will be before you begin treatment with STELARA, and during treatment with STELARA

Latex sensitivity The container of this medicinal product contains latex rubber. This may cause severe allergic reactions in people who are sensitive to latex. Tell your doctor if you have ever had an allergic reaction to latex or developed any allergic reaction to STELARA injection

Cancer. Immunosuppressants like STELARA decrease the activity of the immune system. This may increase the risk of cancer. Tell your doctor if you have ever had any type of cancer

Vaccinations. Tell your doctor if you have recently had or are going to have a vaccine

Other therapies for psoriasis. Tell your doctor if you are receiving any other immunosuppressant or phototherapy when your body is treated with specific ultraviolet UV light while using STELARA, which may also decrease the activity of your immune system. The combination of these therapies has not been investigated and it may increase the risk of diseases related to a weakened immune system

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using STELARA.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You should not be given certain types of vaccines while on treatment with STELARA.

Pregnancy and breastfeeding

Talk to your doctor before using STELARA:
-If you are pregnant or are planning to become pregnant while using STELARA. The effects of this medicine in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using STELARA and for at least 15weeks after the last STELARA treatment.
-If you are breastfeeding or if you plan to breastfeed while using STELARA. Your doctor will decide whether you should use this medicine.

Driving and using machines

It is not known if STELARA can affect the ability to drive or use machines.

Always use STELARA exactly as your doctor has told you. You should check with your doctor if you are not sure. Make sure you discuss with your doctor when you will have your injections and your follow-up appointments.

How much STELARA is given

-Your doctor will decide how much STELARA you need and for how long
-This may depend on your weight

The usual starting dose is 45 mg ustekinumab. After the starting dose, you will receive the next dose 4 weeks later, and then every 12 weeksPatients who weigh more than 100 kg may be given 90 mg instead of 45 mg

Children and adolescents (under 18years)

STELARA is not recommended for children and adolescents (under 18 years old) because it has not been studied in this age group.

How STELARA is given

-STELARA is given by injection under your skin (subcutaneously)
-At the start, medical or nursing staff may inject STELARA. However, you and your doctor may decide that you may inject STELARA yourself. In this case you will get training on how to inject STELARA yourself.
Talk to your doctor if you have any questions about giving yourself an injection. See below in section ?Instructions for administration?for further information about how to inject STELARA.

If you use more STELARA than you should

If you have used or been given too much STELARA, talk to a doctor or pharmacist straight away. Always have the outer carton of the medicine with you, even if it is empty.

If you forget to use STELARA

If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose.

If you stop using STELARA

It is not dangerous to stop using STELARA. However, the symptoms for which STELARA was prescribed may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, STELARA can cause side effects, although not everybody gets them.Most side effects are mild to moderate. However, some patients may experience serious side effects and may require treatment.

Tell your doctor straight away if you notice any of the following serious side effects ?you may need urgent medical treatment:

Signs of an allergic reaction such as swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe skin rash hives swelling of the hands, feet or anklesSigns of infection including tuberculosis such as fever, feeling tired or short of breath, cough which will not go away, flu-like symptoms, night sweats, diarrhoea, wounds, dental problems and burning when urinating

Side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 user in 10common affects 1 to 10 users in 100uncommon affects 1 to 10 users in 1,000rare affects 1 to 10 users in 10,000very rare affects less than 1 user in 10,000not known frequency cannot be estimated from the available data

The following side effects have been observed with STELARA:

Very common:

-Infection of the throat or airways.

Common DepressionFeeling dizzyHeadacheSore throatBlocked or stuffy noseDiarrhoeaItchingRashItchy bumpsBack or muscle painFeeling tiredRedness of the injection siteInflammation of tissue under the skin. The signs include warmth, swelling, redness and pain

Uncommon:

-Pain, swelling, itching, hardness, bleeding, bruising and irritation where the injection is given.

Rare:

-

Serious allergic reactions including anaphylaxis, angioedema. Symptoms of serious allergic reaction may include wheezing, dizziness and swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Store in a refrigerator (2°C?8°C). Do not freeze.
Keep the pre-filled syringein the outer carton in order to protect from light.

Do not shake STELARA pre-filled syringes. Prolonged vigorous shaking may damage the medicine.

Do not use STELARA

-After the expiry date which is stated on the label and the carton after ?EXP?. The expiry date refers to the last day of that month
-If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see further section 6 ?What STELARA looks like and contents of the pack?)
-If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated)
-If the product has been shaken vigorously
STELARA is for single use only. Any unused product remaining in the syringe should be disposed of.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What STELARA contains

-The active substance is ustekinumab. Each pre-filled syringecontains 45mg ustekinumab in 0.5ml.
-The other ingredients are sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 and water for injections.

What STELARA looks like and contents of the pack

STELARA is a clear to slightly opalescent, colourless to light yellow solution for injection. The solutionmay contain a few small translucent or white particles of protein.It is supplied as a carton pack containing 1single-dose, glass 1ml pre-filled syringe. Each pre-filled syringe contains 45mg ustekinumab in 0.5ml of solution for injection.

Marketing Authorisation Holder

Janssen-Cilag International NV
Turnhoutseweg 30
2340 Beerse
Belgium

Manufacturer

Janssen BiologicsB.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgienJANSSEN-CILAG NVAntwerpseweg 15-17B-2340 BeerseTélTel 32 14 649 411 LuxembourgLuxemburgJANSSEN-CILAG NVAntwerpseweg 15-17B-2340 BeerseBelgiqueBelgienTél 32 14 649 41

MagyarországJANSSEN-CILAG Kft.H-2045 Törökbálint, Tó ParkTel 36 23-510-919 Johnson Johnson d.o.o. , 4, 4, 3 1766. 359 2 489 94 0

eská republikaJANSSEN-CILAG s.r.o.Karla Englie 3201615000 Praha 5eská republikaTel 420 227 012 222 MaltaA.M. Mangion Ltd.Mangion BuildingTriq dida fi triq VallettaLuqa LQA 6000MaltaTEL 00356 2397 6000641

DanmarkJANSSEN-CILAG ASHammerbakken 19DK-3460 BirkerødTlf 45 45 94 82 82 NederlandJANSSEN-CILAG B.V.Dr. Paul Janssenweg 1505026 RH TilburgTel 31 13 583 73 73

DeutschlandJANSSEN-CILAG GmbHJohnson Johnson Platz 1D-41470 NeussTel 49 2137-955-955 NorgeJANSSEN-CILAG A.S.Drammensveien 288NO-0283 OsloTlf 47 24 12 65 00

ÖsterreichJANSSEN-CILAG Pharma GmbHVorgartenstraße 206BA-1020 WienTel 43 1 610 300 EestiJanssen-Cilag Polska Sp. z o.o.Eesti filiaalLõõtsa 2EE-11415 TallinnTel 372 617 741

JANSSEN-CILAG .... 56GR-151 21 T 30 210 80 90 000 PolskaJANSSENCILAGPOLSKA Sp. z o.o.ul.Iecka 2402135 WarszawaTel. 48 22 237 60 0

EspañaJANSSEN-CILAG, S.A.Paseo de las Doce Estrellas, 5-7Campo de las NacionesE-28042 MadridTel 34 91 722 81 00 PortugalJANSSEN-CILAG FARMACÊUTICA, LDA.Estrada Consiglieri Pedroso, 69 AQueluz de BaixoP-2734-503 BarcarenaTel 351 21 43 68 83

FranceJANSSEN-CILAG1, rue Camille DesmoulinsTSA 9100392787 Issy Les MoulineauxCedex 9Tél 0800 25 50 75 33 1 55 00 44 44 RomâniaJohnson Johnson d.o.o.Str. Tipografilor nr. 11-15,Cldirea S-Park,Corp A2, Etaj 5013714 BucuretiTel 40 21 207 18 0

SlovenijaJohnson Johnson d.o.o.martinska 53SI-1000, LjubljanaTel. 386 1 401 18 30IrelandJANSSEN-CILAG Ltd.50 -100 Holmers Farm Way,High Wycombe,Buckinghamshire, HP12 4EGTel 44 1 494 567 56

Slovenská republikaJohnson Johnson, s.r.o.Plynárenská 7B824 78 BratislavaTel 421 233 552 600ÍslandJANSSEN-CILAGco Vistor hf.Hörgatún 2IS-210 GarðabærSími 354 535 700

ItaliaJANSSEN-CILAG SpAVia M.Buonarroti, 23I-20093 Cologno Monzese MITel 39 022510.1 SuomiFinlandJANSSEN-CILAG OYVaisalantieVaisalavägen 2FI-02130 EspooEsboPuhTel 358 207 531 30

7 CY-1060 T 357 22 755 214 SverigeJANSSEN-CILAG ABBox 7073192 07 SollentunaTel 46 8 626 50 00

LatvijaJanssen-Cilag Polska Sp. z o.o.fille LatvijBauskas iela 58A-3LV-1004, RgaTel 371 678 93561 United KingdomJANSSEN-CILAG Ltd.50 -100 Holmers Farm Way,High Wycombe,Buckinghamshire, HP12 4EGTel 44 1 494 567 56

Lietuva

UAB ?Johnson & Johnson?
Gele-inio Vilko g. 18A
LT-08104 Vilnius
Tel: +370 5 278 68 88

This leaflet was last approved in {MM/YYYY}.

INSTRUCTIONS FOR ADMINISTRATION

At the start of treatment, your healthcare provider assists you with your first injection. However, you and your doctor may decide that you may inject STELARA yourself. If this happens, you will get training on how to inject STELARA. Talk to your doctor if you have any questions about giving yourself an injection.
-Do not mix STELARA with other liquids for injection
-Do not shake STELARA pre-filled syringes. This is because strong shaking may damage the medicine. Do not use the medicine if it has been shaken strongly.

Figure 1 shows whatthe pre-filled syringe looks like.

Figure 1

1. Check the number of pre-filled syringes and prepare the materialsPreparing for use of the pre-filled syringe Take the pre-filled syringes out of the refrigerator. Let the pre-filled syringe stand outside the box for about half an hour. This will let the liquid come to a comfortable temperature for injection room temperature. Do not remove the syringes needle cover while allowing it to reach room temperatureHold the pre-filled syringe by the body of the syringe with the covered needle pointing upwardDo not hold by the plunger head, plunger, needle guard wings, or needle coverDo not pull back on the plunger at any timeDo not remove the needle cover from the pre-filled syringe until instructed to do soDo not touch the needle guard activation clips as indicated by asterisks in Figure 1 to prevent prematurely covering the needle with the needle guard

Check the pre-filled syringe(s) to make sure
-the number of pre-filled syringes and strength is correct

• If your dose is 45mg you will get one 45mg pre-filled syringe of STELARA
• If your dose is 90mg you will get two 45mg pre-filled syringes of STELARA and you will need to give yourself two injections. Choose two different sites for theseinjections (e.g. one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.-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 to slightly opalescent (having a pearl-like shine) and colourless to light yellow-the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any foreign particles-the solution in the pre-filled syringe is not frozen.

Get everything together that you need and lay out on a clean surface. This includes antiseptic

wipes, a cotton ball or gauze, and a sharps container.

2. Choose and prepare the injection site:

Choose an injection site (see Figure2)
-STELARA is given by injection under your skin (subcutaneously)
-Good places for the injection are the upper thigh or around the belly (abdomen) at least 5cm away from the navel (belly button)
-If possible, do not use areas of skin that show signs of psoriasis
-If someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site.

*Areas in gray are recommended injection sites.

Figure 2

Prepare the injection site
-Wash your hands very well with soap and warm water
-Wipe the injection site on the skin with an antiseptic wipe
- Do nottouch this area again before giving the injection.

3. Remove the needle cover (see Figure 3):

-The needle cover should notbe removed until you are ready to inject the dose-Pick up the pre-filled syringe, hold the bodyof the syringe with one hand
-Pull the needle cover straight off and throw it away. Do nottouch the plunger while you do this

Figure 3

You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle. These are both normal and do not need to be removedDo not touch the needle or allow it to touch any surfaceDo not use the pre-filled syringe if it is dropped without the needle cover in place. If this happens, please contact your doctor or pharmacistInject the dose promptly after removing the needle cover

4. Inject the dose:

-Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly

Do not pull back on the plunger at any timeIn a single and swift motion, insert the needle through the skin as far as it will go see Figure 4

Figure 4

Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings see Figure 5

Figure 5

When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin see Figure 6

Figure 6

Slowly take your thumb off the plunger head to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by Figure 7

Figure 7

5. After the injectionPress an antiseptic wipe over the injection site for a few seconds after the injection.There may be a small amount of blood or liquid at the injection site. This is normal.You can press a cotton ball or gauze over the injection site and hold for 10 seconds.Do not rub your skin. You may cover the injection site with a small adhesive bandage, if necessary

6. Disposal:

-Used syringes should be placed in a puncture-resistant container, like a sharps container (see Figure 8). Do not ever re-use a syringe, for your safety and health and for the safety of others.Dispose of your sharps container according to your local regulations
-Antiseptic wipes and other supplies can be disposed of in your garbage.

Figure 8