STELARA 45mg solution for injection

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 special care 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 doctor about 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

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

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, contactyour 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:

-Infectionof the throat or airways.

Common DepressionFeeling dizzyHeadacheSore throatBlocked or stuffy noseDiarrhoeaItchingRashItchy bumps Back 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 vial in the outer carton in order to protect from light.

Do not shake STELARA vials. 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
-If the seal is broken.
STELARA is for single use only. Any unused product remaining in the vial and 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 vial contains 45 mg ustekinumab in 0.5 ml.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 2ml vial. Each vial 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 411LuxembourgLuxemburgJANSSEN-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 vials. This is because strong shaking may damage the medicine. Do not use the medicine if it has been shaken strongly.

1. Check the number of vials and prepare the materials:

Take the vial(s) out of the refrigerator. Let the vial stand for about half an hour. This will let the liquid come to a comfortabletemperature for injection(room temperature).

Check the vial(s) to make sure
-the number of vials andstrength is correct

• If your dose is 45mg you will get one 45mg vial of STELARA
• If your dose is 90mg you will get two 45mg vials of STELARA and you will need to give yourself two injections. Choose two different sites for these injections (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. Use a new needle and syringe for each injection.-it is the right medicine-it has not passed its expiry date-the vial is not damaged andthe seal is not broken-the solution in the vial is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow-the solution is not discoloured or cloudy and does not contain any foreign particles-the solution is not frozen.

Get everything together that you need and lay out on a clean surface. This includes a syringe, needle, antiseptic wipes, a cotton ball or gauze, and a sharps container see Figure 1.

Figure 1

2. Choose and prepare the injection site:

Choose an injection site (see Figure 2)
-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 not touch this area again before giving the injection.

3. Prepare the dose:

-Take the cap off the top of the vial (see Figure 3)

Figure 3

Do not remove the stopperClean the stopper with an antiseptic swabPut the vial on a flat surface

Remove the needle coverDo not touch the needle or let the needle touch anythingPush the needle through the rubber stopperTurn the vial and the syringe upside downPull on the syringe plunger to fill the syringe with the required amount of liquid, as prescribed by your doctor 0.5 mlIt is important that the needle is always in the liquid. This stops air bubbles forming in the syringe see Figure 4

Figure 4

Remove the needle from the vialHold the syringe with the needle pointing up to see if it has any air bubbles insideIf there are air bubbles, tap the side gently until the air bubbles go to the top of the syringe see Figure 5

Figure 5

Then press the plunger until all of the air but none of the liquid has been removedDo not lay the syringe down or allow the needle to touch anything

4. Inject the dose:

-Gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly-Push the needle into the pinched skin
-Push the plunger with your thumb as far as it will go to inject all of the liquid. Push it slowly and evenly, keeping the skin gently pinched
-When the plunger is pushed as far as it will go, take out the needle and let go of the skin

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

6. Disposal:

-Used syringes and needles should be placed in a puncture-resistant container, like a sharps container. Do not ever re-use needles and syringes, for your safety and health and for the safety of others. Dispose of your sharps container according to your local regulations-Empty vials, antiseptic wipes, and other supplies can be disposed of in your garbage.