Stelara 130 mg concentrate for solution for infusion

Package Leaflet: Information for the User

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 using the medicine.

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

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

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

Contents of the leaflet

1. What Stelara is and what it is used for

2. What you need to know before you use Stelara

3. How to use Stelara

4. Possible side effects

5. How to store Stelara

6. Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is

Stelara contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognize and bind to certain 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:

• Moderately to severely active Crohn’s disease – in adults

• Moderately to severely active ulcerative colitis – in adults

Crohn’s disease

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

Ulcerative colitis

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

2. What you need to know before using Stelara

Do not use Stelara:

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

• If you have an active infection that your doctor considers significant.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before using Stelara.

Warnings and precautions

Talk to your doctor or pharmacist before starting Stelara. Your doctor will assess your health status before treatment. Make sure to inform your doctor about any medical conditions you have before starting treatment. Also, inform your doctor if you have recently been in contact with someone who may have tuberculosis. Your doctor will examine you and perform a test for tuberculosis before you start using Stelara. If your doctor believes you are at risk for tuberculosis, they may prescribe medication to treat it.

Watch for serious adverse effects

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

Before using Stelara, tell your doctor:

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

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

• If you have or have recently had an infection, or have a skin fissure (fistula).

• If you have any new lesions or changes in existing lesions within the psoriasis-affected area or on intact skin.

• If you are receiving any other treatment for psoriasis and/or psoriatic arthritis – such as other immunosuppressants 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 in combination with Stelara has not been studied. However, it may increase the likelihood of developing illnesses related to a weaker immune system.

• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether Stelara may affect these treatments.

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

If you are unsure whether you have any of these conditions, speak with your doctor or pharmacist before using Stelara.

Children and adolescents

The use of Stelara is not recommended in children under 18 years of age with Crohn’s disease or ulcerative colitis, as it has not been studied in this age group.

Use of Stelara with other medicines, vaccines

Inform your doctor or pharmacist:

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

• If you have recently been vaccinated or are scheduled 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 using Stelara during pregnancy. The effects of Stelara in pregnant women are unknown. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use adequate contraceptive measures while using Stelara and for at least 15 weeks after the last dose of Stelara.

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

• Inform 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 simultaneously.

Driving and use of machines

The influence of Stelara on the ability to drive and use machines is negligible or none.

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, it is mixed with a solution containing 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 physician experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.

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

How much Stelara is administered

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

Adults aged 18 years and older

• Your doctor will calculate the recommended intravenous 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 subsequently every 12 weeks.

How Stelara is administered

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

If you forget to use Stelara

If you miss a dose or fail to attend your appointment for administration, speak with your doctor to schedule another appointment.

If you stop treatment with Stelara

Stopping Stelara is not dangerous. However, if you discontinue treatment, your symptoms may return.

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

4. Possible adverse effects

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

Serious adverse effects

Some patients may experience serious adverse 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 patients using Stelara (may affect up to 1 in 1,000 people). Signs include:

• difficulty breathing and swallowing

• low blood pressure, which may cause dizziness or mild headaches

• swelling of the face, lips, mouth, or throat

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

In rare cases, allergic reactions affecting the lungs and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, difficulty breathing, or 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.

• Nasal 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 beneath the skin ("cellulitis") is uncommon (may affect up to 1 in 100 people).

• Herpes (a type of painful blistering rash) is uncommon (may affect up to 1 in 100 people).

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

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

• fever, flu-like symptoms, night sweats

• feeling tired or having difficulty breathing; persistent cough

• skin that feels hot, red, and painful, or a painful skin rash with blisters

• burning sensation when urinating

• diarrhea.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate serious infections such as chest infections, skin infections, or herpes. You should also inform your doctor if you have any infection that does not go away or keeps coming back. Your doctor may decide that you should not use Stelara until the infection resolves. Also contact your doctor if you have an open wound or ulcer that could become infected.

Skin peeling – increased redness and peeling 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 must inform your doctor immediately.

Other adverse effects

Common adverse effects (may 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

Uncommon adverse 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 paralysis" or "Bell's palsy"), which is usually temporary

• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)

• Skin peeling (skin exfoliation)

• Acne

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

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

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 does not need to be stored or handled by patients.
• 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 stated on the label and packaging following “EXP”. The expiry date refers to the last day of the month indicated.

• If the liquid changes colour, becomes cloudy, or contains foreign particles floating in it (see section 6, “Appearance of Stelara and contents of the container”).

• If you know or suspect it has been exposed to extreme temperatures (such as accidental overheating or freezing).

• If the product has been vigorously shaken.

• If the seal is broken.

Stelara is for single use only. Any unused diluted infusion solution remaining in the vial or syringe must be discarded according to local regulations.

6. Contents of the pack and other information

Composition of Stelara

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

• The other components are disodium edetate dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and water for injections.

Appearance of Stelara and contents of the pack

Stelara is a clear, colourless to pale yellow concentrate for solution for infusion. It is supplied in a single-dose 30 ml glass vial. Each vial contains 130 mg of ustekinumab in 26 ml of concentrate for solution for infusion.

Marketing Authorisation Holder

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer

Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

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

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

???????? Luxemburg/Luxembourg
„??????? & ??????? ????????” ????\tJanssen-Cilag NV
???.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: +49 2137 955 955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Janssen-Cilag Pharma GmbH
Τηλ: +30 210 80 90 000 Tel: +43 1 610 300

España Polska
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]

France Portugal
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]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: +353 1 800 709 122 Tel: +386 1 401 18 00
[email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/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]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija United Kingdom
UAB "JOHNSON & JOHNSON" filiale Janssen-Cilag Ltd.
Latvija Tel: +44 1 494 567 444
Tel: +371 678 93561
[email protected]

Date of the most recent revision of this leaflet: {MM/YYYY}.

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

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 should be clearly documented.

Dilution instructions:

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

2. Remove and discard a volume from the 250 ml 0.9% (9 mg/ml) sodium chloride infusion bag equal to the volume of STELARA to be added (discard 26 ml of sodium chloride per vial of STELARA required: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml).

3. Withdraw 26 ml of STELARA from each required vial and add it to the infusion bag of 250 ml. The final volume of the infusion bag must be 250 ml. Gently mix.

4. Visually inspect the diluted solution before infusion. Do not use if particulate matter, discoloration, or foreign particles are observed.

5. 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.

6. Use only an infusion set with an in-line, sterile, pyrogen-free, low protein-binding filter (pore size 0.2 micrometers).

7. Each vial is for single use only. Any unused medicine must be discarded in accordance with local regulations.

Storage

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