Patient Information Leaflet

STELARA 130 mg concentrate for solution for infusion

ustekinumab

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

This leaflet has been written for the person using the medicine.

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

• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. How to use Stelara
2. Possible side effects

1. Storage of Stelara
2. Contents of the pack and additional information

What is Stelara

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

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

What is Stelara 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 be given other medications first. If you do not respond adequately or do not tolerate those medications, 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 be given other medications first. If you do not respond sufficiently or do not tolerate those medications, you may be given Stelara to reduce the signs and symptoms of your disease.

No use Stelara:

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

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

If you are unsure if any of the above points concern you, speak with your doctor or pharmacist before using Stelara.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Stelara. Your doctor will check how you are before treatment. Make sure to inform your doctor about any illness you suffer from before treatment. Also inform your doctor if you have recently been near someone who may have tuberculosis. Your doctor will examine you and perform a test for tuberculosis detection before using Stelara. If your doctor thinks you are at risk of tuberculosis, they may give you medication to treat it.

Watch for severe side effects

Stelara may cause severe side effects, including allergic reactions and infections. You must pay attention to certain signs of illness while using Stelara. See the complete list of these side effects in “Severe side effects” of section 4.

Tell your doctor before using Stelara:

• If you have ever had an allergic reaction to Stelara.Consult with your doctor if you are unsure.

• If you have ever had any type of cancer– this is because the immunosuppressants in 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 skin cracks (fistula).

• If you have any new injury or change in lesionswithin the psoriasis area 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 (UV) light). These treatments may also weaken part of the immune system. The use of these treatments together with Stelara has not been studied. However, it may increase the likelihood of suffering from diseases related to a weaker immune system.

• If you are receiving or have ever received any injections to treat allergies– itis unknown if Stelara may affect these treatments.
• If you are 65 years or older– you are more likely to acquire infections.

If you are unsure of not having any of these conditions, speak with 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 medications, vaccines

Inform your doctor or pharmacist:

• If you are using, have used recently, or may use other medications.

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

Pregnancy and breastfeeding

• It is preferable to avoid the use of Stelara during pregnancy. The effects of Stelara on pregnant women are unknown. If you are a fertile woman, it is recommended that you avoid becoming pregnant and use suitable contraceptive measures while using Stelara and for at least 15 weeks after the last Stelara treatment.

• Inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant.

• Inform your doctor if you are breastfeeding or plan to do so. You and your doctor will decide whether to breastfeed or use Stelara. Do not do both at the same time.

Driving and operating machinery

The influence of Stelara on the ability to drive and operate machinery is negligible or insignificant.

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. Speak with your doctor if you follow a low-sodium diet.

Stelara should be used under the guidance and supervision of a doctor with experience in diagnosing and treating Crohn's disease or ulcerative colitis.

Your doctor will administer Stelara 130 mg concentrate for infusion via a vein in your arm (intravenous infusion) for at least one hour. Ask your doctor when to schedule the injections and follow-up appointments.

How much Stelara is administered

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

Adults 18 years of age and older

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

• After the initial intravenous dose, you will receive the next dose of 90 mg of Stelara via a subcutaneous injection 8 weeks later, and then every 12 weeks.

How Stelara is administered

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

If you forget to use Stelara

If you forget a dose or miss an appointment, talk to your doctor to schedule another appointment.

If you interrupt Stelara treatment

Stopping Stelara is not hazardous. However, if you stop, your symptoms may return.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Some patients may experience severe side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment. Contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in the population using Stelara (they can affect up to 1 in 1,000 people). The 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 urticaria (these can affect up to 1 in 100 people).

In rare cases, pulmonary allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you have symptoms such as coughing, 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 require urgent treatment. Contact your doctor immediately if you notice any of these signs.

• Common colds and sore throats, and respiratory tract infections are frequent (they can affect up to 1 in 10 people).

• Chest infections are infrequent (they can affect up to 1 in 100 people).
• Cellulitis, an inflammation of the tissues under the skin, is infrequent (it can affect up to 1 in 100 people).
• Herpes, a painful rash with blisters, is infrequent (it can affect up to 1 in 100 people).

Stelara may affect your ability to fight infections, and some of them may be severe.

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

• Fever, flu-like symptoms, night sweats

• Feeling tired or difficulty breathing; persistent coughing
• Having hot, red, and painful skin or having a painful skin rash with blisters
• Difficulty urinating

• Diarrhea.

Contact your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as pneumonia, or skin or herpes infections that may have serious complications. You should also inform your doctor if you have any type of infection that does not go away or reappears. Your doctor may decide that you should not use Stelara until the infection has cleared up. You should also contact your doctor if you have any open wounds or ulcers that may become infected.

Skin peeling – the increase in redness and peeling of the skin on a large area of the body may be a sign of psoriasis erythroderma or dermatitis exfoliativa, a serious skin disorder. If you notice any of these symptoms, you should inform your doctor immediately.

Other side effects

Frequent side effects(they can affect up to 1 in 10 people):

• Diarrhea

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

Infrequent side effects(they can affect up to 1 in 100 people):

• Dental infections

• Vaginal yeast infections
• Depression
• Stuffy nose or nasal congestion
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and facial muscle weakness (“facial paralysis” or “Bell's palsy”), which is usually temporary
• A change in psoriasis with redness and new small skin blisters, sometimes accompanied by fever (psoriasis pustular)
• Skin peeling (exfoliation of the skin)
• Acne

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

• Redness and peeling of the skin on a large area of the body, which may cause itching or pain (dermatitis exfoliativa). Similar symptoms may develop as a natural change in the 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Stelara 130 mg concentrate for infusion solution is administered in a hospital or medical center and does not require patients to store or handle it.
• Keep this medication out of the sight and reach of children.
• Store in refrigerator (2 °C–8 °C). Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• Do not shake the Stelara vials. Prolonged vigorous agitation may damage the product.

Do not use this medication:

• After the expiration date appearing on the label and the packaging after “CAD”. The expiration date is the last day of the month indicated.

• If the liquid changes color, becomes cloudy, or presents unusual floating particles (see section 6 “Appearance of Stelara and contents of the container”).
• If you know or believe you have been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been vigorously agitated.
• If the seal is broken.

Stelara is for single use. Dispose of the unused diluted infusion solution remaining in the vial or syringe in accordance with local regulations.

Composition of Stelara

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

• The other components are disodium EDTA dihydrate, L-histidine, monochloride of L-histidine monohydrate, L-methionine, polisorbate 80, sucrose, and water for injection.

Appearance of Stelara and contents of the package

Stelara is a concentrate for solution for infusion, transparent, colorless, or light yellow in color. It is presented in a package containing 1 vial of 30 ml of glass single-use. Each vial contains 130 mg of ustekinumab in 26 ml of concentrate for solution for infusion.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

België/Belgique/BelgienLietuva

Janssen-Cilag NVUAB "JOHNSON & JOHNSON"

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

[email protected][email protected]

????????Luxembourg/Luxemburg

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

???.: +359 2 489 94 00Tél/Tel: +32 1464 94 11

[email protected][email protected]

Ceská republikaMagyarország

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

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

[email protected]

DanmarkMalta

Janssen-Cilag A/SAM MANGION LTD

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

[email protected]

DeutschlandNederland

Janssen-Cilag GmbHJanssen-Cilag B.V.

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

[email protected][email protected]

EestiNorge

UAB "JOHNSON & JOHNSON" Eesti filiaalJanssen-Cilag AS

Tel: +372 617 7410Tlf: + 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 000Tel: +43 1 610 300

EspañaPolska

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

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

[email protected]om

FrancePortugal

Janssen-CilagJanssen-Cilag Farmacêutica, Lda.

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

[email protected]

HrvatskaRomânia

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

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

[email protected]

IrelandSlovenija

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

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

[email protected]

ÍslandSlovenská republika

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

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

Sími: +354 535 7000

[email protected]

ItaliaSuomi/Finland

Janssen-Cilag SpAJanssen-Cilag Oy

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

[email protected][email protected]

Κ?προςSverige

Βαρν?βας Χατζηπαναγ?ς ΛτδJanssen-Cilag AB

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

[email protected]

LatvijaUnited Kingdom

UAB "JOHNSON & JOHNSON" filialeJanssen-Cilag Ltd.

LatvijaTel: +44 1 494 567 444

Tel: +371 678 93561

[email protected]

Date of the last revision of this leaflet{MM/AAAA}.

The detailed information about this medicine is available on the website of the European Medicines Agency: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 medicines, the name and batch number of the administered medicine must be clearly recorded.

Instructions for dilution:

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

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

1. Draw off and discard a volume of 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. Draw off 26 ml of STELARA from each vial needed and add it to the 250 ml infusion bag. The final volume of the infusion bag must be 250 ml. Mix gently.

1. Visually inspect the diluted solution before infusion. Do not use if opaque particles, color changes, or foreign particles are detected.
2. Infuse the diluted solution over a minimum period of one hour. Once diluted, the infusion must be completed within eight hours of dilution in the infusion bag.

1. Use only a system of infusion with an in-line filter, sterile, apyrogenic, and low protein binding (pore size of 0.2 micrometers).
2. Each vial is for single use only, and the unused medicine must 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 eight hours of dilution in the infusion bag. Do not freeze.