Stelara 45 mg solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

STELARA 45 mg injectable solution

ustekinumab

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

This leaflet has been written for the person using the medicine. If you are a parent or caregiver administering Stelara to a child, please read this information carefully.

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

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

• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Contents of this leaflet

1. What Stelara is and what it is used for

2. What you need to know before using 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:

• 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 cyclosporine, methotrexate, or phototherapy, or when these treatments are ineffective.

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 when these treatments are ineffective.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease, which is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond well to these medications, you may be treated with Stelara to:

• Reduce the signs and symptoms of your disease.
• Improve your physical function.
• Reduce joint damage.

Crohn's disease

Crohn's disease is an inflammatory bowel disease. If you have Crohn's disease, you will first be given other medications. If you do not respond adequately or cannot tolerate these medications, you may be given Stelara 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 medications. If you do not respond sufficiently or cannot tolerate these medications, you may be given Stelara 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 important.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Stelara. Your doctor will check your health status before each treatment. Make sure to inform your doctor about any medical conditions you have before each treatment. Your doctor will also ask whether you have recently been in contact with someone who might 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 of tuberculosis, you may be given 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 section 4 under “Serious adverse effects.”

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.

• If you have any new skin lesions or changes in existing lesions in the area affected by psoriasis 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, doing so could increase the likelihood of developing illnesses related to a weakened 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 any of these conditions apply to you, speak with your doctor or pharmacist before using Stelara.

Children and adolescents

The use of Stelara is not recommended 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 these age groups.

Use of Stelara with other medicines and 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) must not be administered while you are receiving 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 contraception while receiving 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 at the same time.

Driving and using machines

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

3. How to use Stelara

Stelara must be used under the guidance and supervision of a physician experienced in the treatment of the conditions for which STELARA is indicated.

Always follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor. 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 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, the next dose is given 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the starting dose.

Crohn’s disease or ulcerative colitis

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

• In some patients, after the first subcutaneous injection, 90 mg of Stelara will be administered 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 determine the correct dose for you, including the amount (volume) of Stelara to inject to deliver the correct dose. The appropriate dose for you will depend on your body weight at the time each dose is given.

• 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 administered

• Stelara is administered by injection under the skin (“subcutaneously”). At the beginning of your treatment, medical or nursing staff may administer Stelara to you.

• However, you and your doctor may decide that you can self-inject Stelara. In that case, you will be trained in how to inject Stelara yourself.

• For instructions on how to inject Stelara, see “Administration instructions” at the end of this leaflet.

Consult 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, speak immediately with your doctor or pharmacist.

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

If you forget to use Stelara

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

If you stop treatment with Stelara

Stopping Stelara is not dangerous. However, if you stop, 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 people taking 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 no longer use Stelara.

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 taking Stelara. These include:

• fever, flu-like symptoms, night sweats
• feeling tired or having difficulty breathing; persistent cough
• skin that is warm, red, and painful, or a painful blistering skin rash
• 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 that could lead to severe complications. You should also inform your doctor if you have any infection that does not go away or keeps recurring. Your doctor may decide that you should not use Stelara until the infection resolves. Also contact your doctor if you have any open cuts or sores 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 raised spots, 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 listed in Appendix V. By reporting adverse 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 the refrigerator (2°C–8°C). Do not freeze.

• Keep the vial in its 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 the carton after “EXP”. The expiry date refers to the last day of the month indicated.

• If the liquid changes colour, becomes cloudy, or contains floating particles (see section 6, “What Stelara looks like and contents of the pack”).

• 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 product remaining in the vial or syringe must be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Stelara

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

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

Appearance of Stelara and contents of the pack

Stelara is a transparent or slightly opalescent (with a pearly sheen), colourless to pale yellow injectable solution. The solution may contain a few translucent or white protein particles. It is supplied in a pack containing one single-dose 2 ml glass vial. Each vial contains 45 mg of ustekinumab in 0.5 ml of injectable solution.

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]

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

Ceská 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]

Ελλ?δα Österreich
Janssen-Cilag Φαρμακευτικ? Α.Ε.Β.Ε. Janssen-Cilag Pharma GmbH
Tηλ: +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]

Κ?προς Sverige
Βαρν?βας Χατζηπαναγ?ς Λτδ Janssen-Cilag AB
Tηλ: +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 on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

Instructions for administration

At the beginning of treatment, a healthcare professional will assist you with your first injection. However, you and your doctor may decide that you can self-administer Stelara. In such a case, you will be trained on how to inject Stelara. Speak with your doctor if you have any questions about administering the injections.

• Do not mix Stelara with other injectable liquids.

• Do not shake Stelara vials. The medicine may become damaged if shaken vigorously. Do not use the medicine if it has been shaken vigorously.

1. Check the number of vials and prepare materials:

• Remove the vial(s) from the refrigerator. Allow the vial to stand for about 30 minutes so that the liquid reaches a comfortable temperature for administration (room temperature).

Check the vial(s) to ensure that:

• The number of vials and concentration are correct.

  o If the dose is 45 mg or less, you will receive one 45 mg Stelara vial.

  o If the dose is 90 mg, you will receive two 45 mg Stelara vials, and you will need to administer two injections. Choose two different injection sites for these injections (for example, one injection in the right thigh and the other 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 medicine.

• The expiry date has not been exceeded.

• The vial is not damaged and the seal is intact.

• The solution in the vial is transparent to slightly opalescent (with a pearly sheen) and colourless to slightly yellow.

• The solution has not changed colour, is not cloudy, and does not contain any foreign particles.

• The solution has not been frozen.

Children weighing less than 60 kilograms require a dose lower than 45 mg. Make sure you know the correct amount (volume) to withdraw from the vial and the type of syringe required for accurate dosing. If you are unsure about the amount or type of syringe needed, contact your healthcare professional for further instructions.

Gather all necessary supplies and place them on a clean surface. Include the syringe, needle, antiseptic wipes, cotton wool or gauze, and a sharps container for disposal of used needles and syringes (see Figure 1).

Figure 1

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

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

• Suitable injection sites include the upper thigh or the abdominal area (at least 5 cm away from the navel).

• Avoid areas of skin showing signs of psoriasis, if possible.

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

Figure 2

Prepare the injection site:

• Wash your hands thoroughly with soap and lukewarm 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 covering 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 cap from the needle.

• Do not touch the needle and avoid contact with other objects.

• Insert the needle through the rubber stopper.

• Turn the vial and syringe upside down.

• Pull back the plunger of the syringe to draw up the amount of liquid prescribed by your doctor.

• It is important that the needle tip remains in the liquid at all times to prevent air bubbles from entering the syringe (see Figure 4).

Figure 4

• Remove the needle from the vial.

• Hold the syringe with the needle pointing upwards to check for air bubbles.

• If air bubbles are present, gently tap the side of the syringe until the bubbles rise to the top (see Figure 5).

Figure 5

• Then push the plunger to expel all air (but no liquid).

• Do not place the syringe down and avoid contact of the needle with any object.

1. Administer the dose:

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

• Insert the needle into the skin fold.

• Push the plunger slowly and steadily with your thumb until fully depressed, while keeping the skin fold gently pinched.

• Once the plunger is fully depressed, withdraw the needle and release the skin fold.

1. After the injection:

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

• A small amount of blood or fluid may appear at the injection site. This is normal.

• You may press a cotton ball or gauze pad against the injection site and hold for 10 seconds.

• Do not rub the skin at the injection site. You may cover the injection site with a plaster if needed.

1. Disposal:

• Used syringes and needles must be placed in a puncture-resistant container, such as a sharps container. For your safety and the safety of others, never reuse needles or syringes. Dispose of the sharps container according to local regulations.

• Empty vials, antiseptic-soaked gauze, and other materials may be discarded in regular household waste.