STELARA 130 mg CONCENTRATE for SOLUTION for INFUSION

Introduction

Package Leaflet: Information for the Patient

STELARA 130 mg Concentrate for Solution for Infusion

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.

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

• If you have any further questions, ask your doctor or pharmacist.
• 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

1. How to use Stelara
2. Possible side effects

1. Storage of Stelara
2. 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 Stelara is used for

Stelara is used to treat the following inflammatory diseases:

• Moderate to severe Crohn's disease - in adults

• Moderate to severe ulcerative colitis - in adults

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 well enough or cannot 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 cannot 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 treatment. Make sure you tell your doctor about any illness you have before treatment. Also, tell your doctor 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, they may give you medicines to treat it.

Watch for serious side effects

Stelara may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while you are 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.Talk to 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 or have had a recent infection or have any open sores on your skin (fistula).

• 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 18 years of age with 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 you are 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 you are 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.

Stelara contains sodium

Stelara contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”. However, before Stelara is administered to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low-salt diet.

3. How to use Stelara

Stelara must be used under the guidance and supervision of a doctor with experience in the diagnosis and treatment of Crohn's disease or ulcerative colitis.

Your doctor will give you Stelara 130 mg concentrate for solution for infusion through a drip in a vein in your arm (intravenous infusion) over at least one hour. Ask your doctor when you should have your injections and about follow-up appointments.

How much Stelara is given

Your doctor will decide how much Stelara you need to receive and how long your treatment will last.

Adults aged 18 years and over

• Your doctor will calculate the recommended infusion dose for you based on your body weight.

• After the initial intravenous dose, you will receive the next dose of 90 mg of Stelara as an injection under the skin (subcutaneous injection) 8 weeks later and then every 12 weeks.

How Stelara is given

The first dose of Stelara for the treatment of Crohn's disease or ulcerative colitis is given by a doctor through a drip in a vein in your arm (intravenous infusion). Talk to your doctor if you have any questions about treatment with Stelara.

If you miss a dose of Stelara

If you miss a dose or do not attend your appointment to have it given to you, talk to your doctor to schedule another appointment.

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 further questions on the use of 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 can require urgent treatment. Contact your doctor or get emergency 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 can require 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 these may become serious.

You should watch for signs of infection while you are 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
• burning when you urinate

• 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 could have serious complications. You should also tell your doctor if you have any type of infection that does not go away or comes back. Your doctor may decide that you should not use Stelara until the infection goes away. You should also talk to your doctor if you have any open cuts or sores that could become infected.

Shedding of the skin – increased redness and shedding of the skin over a large area of the body may be symptoms of psoriasis erythroderma 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 (skin exfoliation)
• 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 (psoriasis erythroderma)

• 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

• Stelara 130 mg concentrate for solution for infusion is administered in a hospital or medical center and it is not necessary for patients to store or handle it.

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

• Store in a refrigerator (2 °C–8 °C). Do not freeze.

• Store 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 shown.

• If the liquid changes color, is cloudy, or has particles floating in it (see section 6 “Appearance of Stelara and contents of the pack”).

• 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 should dispose of any unused diluted solution left in the vial or syringe in accordance with local regulations.

6. Container Contents and Additional Information

Stelara Composition

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 ml.

• The other components are disodium dihydrate EDTA, L-histidine, L-histidine monohydrate hydrochloride, L-methionine, polysorbate 80, sucrose, and water for injectable preparations.

Appearance of Stelara and Container Contents

Stelara is a clear, colorless to pale yellow solution for infusion concentrate. It is presented in a container containing 1 vial of 30 ml glass, single dose. Each vial contains 130 mg of ustekinumab in 26 ml of solution for infusion concentrate.

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 medicine 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

[email protected] [email protected]

????????Luxembourg/Luxemburg

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

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

[email protected] [email protected]

Ceská republikaMagyarország

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

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

[email protected]

DanmarkMalta

Janssen-Cilag A/S AM MANGION LTD

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

[email protected]

DeutschlandNederland

Janssen-Cilag GmbH Janssen-Cilag B.V.

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

[email protected] [email protected]

EestiNorge

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

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

[email protected] [email protected]

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

[email protected]

FrancePortugal

Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.

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

[email protected]

HrvatskaRomânia

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

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

[email protected]

IrelandSlovenija

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

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

[email protected]

ÍslandSlovenská republika

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

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

Sími: +354 535 7000

[email protected]

ItaliaSuomi/Finland

Janssen-Cilag SpA Janssen-Cilag Oy

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

[email protected] [email protected]

Κ?προςSverige

Βαρν?βας Χατζηπαναγ?ς Λτδ Janssen-Cilag AB

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

[email protected]

LatvijaUnited Kingdom

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

Latvija Tel: +44 1 494 567 444

Tel: +371 678 93561

[email protected]

Date of Last Revision of this Leaflet{MM/AAAA}.

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

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The following information is intended exclusively for healthcare professionals:

Traceability:

In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly recorded.

Instructions for Dilution:

STELARA solution for infusion concentrate must be diluted, prepared, and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of STELARA vials needed based on the patient's weight (see section 3, Table 1). Each 26 ml vial of STELARA contains 130 mg of ustekinumab.

1. Withdraw and then discard a volume of the 9 mg/ml (0.9%) sodium chloride solution from the 250 ml infusion bag equivalent to the volume of STELARA to be added (discard 26 ml of sodium chloride for each STELARA vial needed: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml).

1. Withdraw 26 ml of STELARA from each required vial and add it to the 250 ml infusion bag. The final volume of the infusion bag should be 250 ml. Mix gently.

Perform a visual inspection of the diluted solution before infusion. Do not use if opaque particles, color changes, or foreign particles are detected.

1. Infuse the diluted solution over a minimum period of one hour. Once diluted, the infusion must be completed within 8 hours of dilution in the infusion bag.
2. Use only an infusion system with an in-line filter, sterile, apyrogenic, and low protein binding (pore size 0.2 microns).
3. Each vial is for single use, and unused medication should be discarded in accordance with local regulations.

Storage

If necessary, the diluted infusion solution can be stored at room temperature. The infusion must be completed within 8 hours of dilution in the infusion bag. Do not freeze.