STELARA 45 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

STELARA 45 mg Solution for Injection

Ustekinumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

This leaflet has been written for the person taking the medicine. If you are the parent or carer of a child who will be taking Stelara, please read this information carefully.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Stelara and what is it used for
2. What you need to know before you use Stelara
3. How to use Stelara

1. Possible side effects
2. Storage of Stelara

1. Contents of the pack and other information

1. What is Stelara and what is it used for

What is Stelara

Stelara contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that identify and bind to specific proteins in the body.

Stelara belongs to a group of medicines called “immunosuppressants”. These medicines work by weakening part of the immune system.

What is Stelara used for

Stelara is used to treat the following inflammatory diseases:

• Plaque psoriasis - in adults and children aged 6 years and older

• Psoriatic arthritis - in adults
• Moderate to severe Crohn's disease - in adults
• Moderate to severe ulcerative colitis - in adults

Plaque Psoriasis

Plaque psoriasis is a skin disease that causes inflammation affecting the skin and nails. Stelara reduces inflammation and other signs of the disease.

Stelara is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporin, methotrexate, or phototherapy, or where these treatments do not work.

Stelara is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments do not work.

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first receive other medicines. If you do not respond well to these medicines, you may be treated with Stelara to:

• Reduce the signs and symptoms of your disease.

• Improve your physical function.
• Reduce damage to your joints.

Crohn's Disease

Crohn's disease is an inflammatory disease of the intestine. If you have Crohn's disease, you will first be given other medicines. If you do not respond adequately or do not tolerate these medicines, you may be given Stelara to reduce the signs and symptoms of your disease.

Ulcerative Colitis

Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough or do not tolerate these medicines, you may be given Stelara to reduce the signs and symptoms of your disease.

2. What you need to know before you use Stelara

Do not use Stelara:

• If you are allergic to ustekinumabor any of the other ingredients of this medicine (listed in section 6).

• If you have an active infectionthat your doctor thinks is important.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Stelara. Your doctor will check how you are before each treatment. Make sure to tell your doctor about any illness you have before each treatment. Your doctor will also ask if you have recently been near someone who might have tuberculosis. Your doctor will examine you and do a test to detect tuberculosis before you use Stelara. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Watch for serious side effects

Stelara may cause serious side effects, including allergic reactions and infections. You should be aware of certain signs of illness while using Stelara. See the complete list of these side effects in “Serious side effects” in section 4.

Before using Stelara, tell your doctor:

• If you have ever had an allergic reaction to Stelara.Check with your doctor if you are not sure.

• If you have ever had any type of cancer– this is because immunosuppressants like Stelara weaken part of the immune system. This may increase the risk of having cancer.

• If you have had a recent infection.

• If you have any new or changing lesionswithin the area of psoriasis or on intact skin.

• If you are taking any other treatment for psoriasis and/or psoriatic arthritis– such as any other immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet light (UV)). These treatments may also weaken part of the immune system. It has not been studied whether these treatments can be used together with Stelara. However, it is possible that it may increase the likelihood of suffering from diseases related to a weaker immune system.

• If you are receiving or have ever received allergy shots– it is not known if Stelara can affect these treatments.

• If you are 65 years of age or older– you are more likely to get infections.

If you are not sure if you have any of these conditions, talk to your doctor or pharmacist before using Stelara.

Children and adolescents

Stelara is not recommended for use in children under 6 years of age with psoriasis or in children under 18 years of age with psoriatic arthritis, Crohn's disease, or ulcerative colitis, as it has not been studied in this age group.

Using Stelara with other medicines, vaccines

Tell your doctor or pharmacist:

• If you are using, have recently used, or might use other medicines.

• If you have been vaccinated recently or are going to have a vaccination. Certain types of vaccines (live vaccines) should not be given while using Stelara.

Pregnancy and breastfeeding

• It is recommended to avoid using Stelara during pregnancy. The effects of Stelara in pregnant women are not known. If you are a woman of childbearing age, you are advised to avoid becoming pregnant and use adequate contraceptive measures while using Stelara and for at least 15 weeks after the last treatment with Stelara.
• Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether you should breastfeed or use Stelara. Do not do both.

Driving and using machines

Stelara has no or negligible influence on the ability to drive and use machines.

3. How to use Stelara

Stelara should be used under the guidance and supervision of a doctor with experience in the treatment of the conditions for which STELARA is indicated.

Always follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, ask your doctor. Ask your doctor when you should have the injections and about follow-up appointments.

How much Stelara is given

Your doctor will decide how much Stelara you need to use and the duration of treatment.

Adults aged 18 years and older

Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg of Stelara. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.

• After the initial dose, you will take the next dose 4 weeks later and then every 12 weeks. The following doses are usually the same as the starting dose.

Crohn's disease or ulcerative colitis

• During treatment, your doctor will give you the first dose of approximately 6 mg/kg of Stelara by infusion into a vein in your arm (intravenous infusion). After the initial dose, you will receive the next dose of 90 mg of Stelara 8 weeks later and then every 12 weeks, by injection under the skin (“subcutaneously”).

• In some patients, after the first injection under the skin, 90 mg of Stelara will be given every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents aged 6 years and older Psoriasis

• Your doctor will tell you the correct dose for you, including the amount (volume) of Stelara to inject to give the correct dose. The dose that is right for you will depend on your body weight at the time of each dose.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg of body weight.

• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Stelara.
• If you weigh more than 100 kg, the recommended dose is 90 mg of Stelara.
• After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks.

How Stelara is given

• Stelara is given by injection under the skin (“subcutaneously”). At the start of your treatment, medical or nursing staff may inject Stelara for you.

• However, you and your doctor may decide that you will inject Stelara yourself. In that case, you will be trained on how to inject Stelara yourself.
• For instructions on how to inject Stelara, see “Administration instructions” at the end of this leaflet.

Talk to your doctor if you have any questions about how to self-inject.

If you use more Stelara than you should

If you have used or been given too much Stelara, talk to your doctor or pharmacist immediately.

Always carry the medicine box with you, even if it is empty.

If you forget to use Stelara

If you miss a dose, talk to your doctor or pharmacist. Do not take a double dose to make up for forgotten doses.

If you stop using Stelara

Stopping Stelara is not dangerous. However, if you stop using it, your symptoms may come back.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Some patients may have serious side effects that may need urgent treatment.

Allergic reactions – these may need urgent treatment. Contact your doctor or get urgent medical help immediately if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in people using Stelara (may affect up to 1 in 1,000 people). Signs include:

• difficulty breathing and swallowing
• low blood pressure, which can cause dizziness or mild headaches
• swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include skin rash and hives (these may affect up to 1 in 100 people).

In rare cases, allergic reactions in the lungs and inflammation of the lungs have been reported in patients treated with ustekinumab. Tell your doctor immediately if you have symptoms such as cough, difficulty breathing, and fever.

If you have a severe allergic reaction, your doctor may decide that you should not use Stelara again.

Infections – these may need urgent treatment. Contact your doctor immediately if you notice any of these signs.

• Nose or throat infections and the common cold are common (may affect up to 1 in 10 people).

• Chest infections are uncommon (may affect up to 1 in 100 people).
• Inflammation of the tissues under the skin (“cellulitis”) is uncommon (may affect up to 1 in 100 people).
• Herpes (a type of painful rash with blisters) is uncommon (may affect up to 1 in 100 people).

Stelara may affect your ability to fight infections, and some of them may become serious.

You should watch for signs of infection while using Stelara. These include:

• fever, flu-like symptoms, night sweats

• feeling tired or having trouble breathing; cough that does not go away
• having hot, red, and painful skin or having a painful skin rash with blisters
• pain when urinating

• diarrhea.

Talk to your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as chest infections, or skin or herpes infections that may have serious complications. You should also tell your doctor if you have any infection that does not go away or comes back. Your doctor may decide that you should not use Stelara until the infection goes away. Also, talk to your doctor if you have any open cuts or ulcers that may become infected.

Shedding of the skin – increased redness and shedding of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin disorders. If you notice any of these symptoms, you should tell your doctor immediately.

Other side effects

Common side effects(may affect up to 1 in 10 people):

• Diarrhea

• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• Headache
• Itching (“pruritus”)
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site

• Sinusitis

Uncommon side effects(may affect up to 1 in 100 people):

• Dental infections

• Vaginal yeast infections
• Depression
• Nasal congestion or stuffiness
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak.
• Drooping eyelid and sinking of the muscles on one side of the face (“facial palsy” or “Bell's palsy”), which is usually temporary
• A change in psoriasis with redness and new small, yellow or white bumps on the skin, sometimes accompanied by fever (pustular psoriasis)
• Shedding of the skin (exfoliation of the skin)
• Acne

Rare side effects(may affect up to 1 in 1,000 people):

• Redness and shedding of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms may develop, such as a change in the natural symptoms of psoriasis (erythrodermic psoriasis)

• Inflammation of small blood vessels, which may cause a skin rash with small red or purple bumps, fever, or joint pain (vasculitis)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Stelara

• Keep this medicine out of the sight and reach of children.

• Store in a refrigerator (2°C–8°C). Do not freeze.
• Keep the vial in the outer packaging to protect it from light.
• Do not shake Stelara vials. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date which is stated on the label and carton after “EXP”. The expiry date is the last day of the month stated.

• If the liquid changes color, is cloudy, or has particles floating in it (see section 6 “Appearance of Stelara and pack contents”).
• If you know or think that it has been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been shaken vigorously.
• If the seal is broken.

Stelara is for single use only. You must discard any unused product left in the vial or syringe. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Stelara

• The active ingredient is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 ml.

• The other components are L-histidine, L-histidine monohydrate monohydrochloride, polysorbate 80, sucrose, and water for injectable preparations.

Appearance of Stelara and Container Contents

Stelara is a clear or slightly opalescent (with a pearly sheen) injectable solution, colorless to light yellow. The solution may contain a few translucent or white protein particles. It is presented in a container containing 1 vial of 2 ml of single-dose glass. Each vial contains 45 mg of ustekinumab in 0.5 ml of injectable solution.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

België/Belgique/BelgienLietuva

Janssen-Cilag NV UAB "JOHNSON & JOHNSON"

Tel/Tél: + 32 14 64 94 11 Tel: +370 5 278 68 88

janssen@jacbe.jnj.com lt@its.jnj.com

????????Luxembourg/Luxemburg

„??????? & ??????? ????????” ???? Janssen-Cilag NV

???.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11

jjsafety@its.jnj.com janssen@jacbe.jnj.com

Ceská republikaMagyarország

Janssen-Cilag s.r.o. Janssen-Cilag Kft.

Tel: +420 227 012 227 Tel.: +36 1 884 2858

janssenhu@its.jnj.com

DanmarkMalta

Janssen-Cilag A/S AM MANGION LTD

Tlf: +45 4594 8282 Tel: +356 2397 6000

jacdk@its.jnj.com

DeutschlandNederland

Janssen-Cilag GmbH Janssen-Cilag B.V.

Tel: +49 2137 955 955 Tel: +31 76 711 1111

jancil@its.jnj.com janssen@jacnl.jnj.com

EestiNorge

UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS

Tel: +372 617 7410 Tlf: + 47 24 12 65 00

ee@its.jnj.com jacno@its.jnj.com

Ελλ?δαÖsterreich

Janssen-Cilag Φαρμακευτικ? Α.Ε.Β.Ε. Janssen-Cilag Pharma GmbH

Tηλ: +30 210 80 90 000 Tel: +43 1 610 300

EspañaPolska

Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.

Tel: +34 91 722 81 00 Tel.: + 48 22 237 60 00

contacto@its.jnj.com

FrancePortugal

Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.

Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600

medisource@its.jnj.com

HrvatskaRomânia

Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL

Tel: +385 1 6610 700 Tel: +40 21 207 1800

jjsafety@JNJCR.JNJ.com

IrelandSlovenija

Janssen Sciences Ireland UC Johnson & Johnson d.o.o.

Tel: +353 1 800 709 122 Tel. +386 1 401 18 00

Janssen_safety_slo@its.jnj.com

ÍslandSlovenská republika

Janssen-Cilag AB Johnson & Johnson, s.r.o.

c/o Vistor hf. Tel: +421 232 408 400

Sími: +354 535 7000

janssen@vistor.is

ItaliaSuomi/Finland

Janssen-Cilag SpA Janssen-Cilag Oy

Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300

janssenita@its.jnj.com jacfi@its.jnj.com

Κ?προςSverige

Βαρν?βας Χατζηπαναγ?ς Λτδ Janssen-Cilag AB

Tηλ: +357 22 207 700 Tfn: +46 8 626 50 00

jacse@its.jnj.com

LatvijaUnited Kingdom

UAB "JOHNSON & JOHNSON" filiale Janssen-Cilag Ltd.

Latvija Tel: +44 1 494 567 444

Tel: +371 678 93561

lv@its.jnj.com

Date ofthe last revision of this prospectus{MM/AAAA}.

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/.

Administration Instructions

At the start of treatment, your healthcare professional will help you with your first injection. However, you and your doctor may decide that you can inject Stelara yourself. In this case, they will teach you how to inject Stelara. Talk to your doctor if you have any questions about administering the injections.

• Do not mix Stelara with other injectable liquids.

• Do not shake the Stelara vials. The medication may deteriorate if shaken vigorously. Do not use the medication if it has been shaken vigorously.

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

• Remove the vial(s) from the refrigerator. Let the vial sit for half an hour. This will allow the liquid to reach a comfortable temperature for administration (room temperature).

Check the vial(s) to ensure that:

• The number of vials and concentration are correct

If the dose is 45 mg or less, you will be given a 45 mg Stelara vial.

If the dose is 90 mg, you will be given two 45 mg Stelara vials, and you will need to administer two injections. Choose two different injection sites for these injections (e.g., one injection in the right thigh and the other injection in the left thigh), and administer the injections one immediately after the other. Use a new needle and syringe for each injection.

• It is the correct medication.

• The expiration date has not passed.
• The vial is not damaged and the seal is not broken.
• The solution contained in the vial is clear to slightly opalescent (with a pearly sheen) and colorless to light yellow.
• The solution has not changed color or is not cloudy and does not contain any foreign particles.
• The solution is not frozen.

Children who weigh less than 60 kilograms require a dose less than 45 mg. Make sure you know the correct amount (volume) to extract from the vial and the type of syringe needed for dosing. If you do not know the amount or type of syringe needed, contact your healthcare professional for further instructions.

Gather everything you need and place it on a clean surface, including the syringe, needle, antiseptic wipes, a cotton ball or gauze, and a container for disposing of sharp objects (see Figure 1).

Figure 1

1. Choose and prepare the injection site:Choose the injection site (see Figure 2).

Stelara is administered by injection under the skin (subcutaneously).

• Some suitable injection sites are the upper thigh or the abdominal area, at least 5 cm from the navel.
• Whenever possible, do not use skin areas that show signs of psoriasis.

• If someone else is administering the injection, they may also choose the upper arm as an injection site.

Figure 2

Prepare the injection site

• Wash your hands thoroughly with soap and warm water.

• Clean the skin at the injection site with an antiseptic wipe.
• Do not touch this area again before administering the injection.

1. Prepare the dose:

• Remove the cap that covers the top of the vial (see Figure 3).

Figure 3

• Do not remove the stopper.

• Clean the stopper with an alcohol swab.
• Place the vial on a flat surface.
• Take the syringe and remove the needle cap.
• Do not touch the needle and prevent it from coming into contact with other objects.
• Pierce the rubber stopper with the needle.
• Turn the vial and syringe upside down.
• Pull the syringe plunger to fill it with the amount of liquid indicated by your doctor.
• It is essential that the needle remains in the liquid at all times. This prevents air bubbles from forming in the syringe (see Figure 4).

Figure 4

• Remove the needle from the vial.

• Hold the syringe with the needle facing upwards to check for air bubbles inside.
• If there are air bubbles, gently tap the side of the syringe until the bubbles rise to the top (see Figure 5).

Figure 5

• Then push the plunger until all the air is expelled (but no liquid).

• Do not rest the syringe on any surface and prevent the needle from coming into contact with other objects.

1. Inject the dose:

• Gently pinch the disinfected skin with your thumb and index finger, without squeezing.

• Insert the needle into the skin fold.
• Push the plunger with your thumb until you reach the stop to inject all the liquid. Do this slowly and evenly, keeping the skin fold gently pinched.
• When you have pushed the plunger to the stop, remove the needle and release the skin fold.

1. After the injection:

• Press the injection site with an antiseptic wipe for a few seconds after the injection.

• A small amount of blood or liquid may appear at the injection site. This is normal.
• You can press the injection site with a cotton ball or gauze and hold it for 10 seconds.
• Do not rub the skin at the injection site. You can cover the injection site with a band-aid if necessary.

1. Disposal:

• Used syringes and needles must be placed in a puncture-resistant container, such as a sharps container. For your safety and health and the safety of others, never reuse needles and syringes. Dispose of your sharps container according to local regulations.
• Empty vials, antiseptic wipes, and other materials can be discarded in the trash.