Patient Information Leaflet

STELARA 45 mg injectable solution

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. If you are the parent or carer of a child to whom you will administer Stelara, please read this information carefully.

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

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

1. Possible side effects
2. Storage of Stelara

1. 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 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 6 years of age 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 symptoms of the disease.

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

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

Psiatic arthritis

Psiatic arthritis is an inflammatory joint disease, which is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first receive 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 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 medications. 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 first be given other medications. 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.

Do not use Stelara:

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

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

If you are unsure whether any of the above points apply to you, talk to 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 each treatment. Make sure to inform your doctor about any illness you suffer from before each treatment. Your doctor will also ask 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 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.

• 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. It has not been studied to use these treatments together with Stelara. However, it may be possible that it increases the likelihood of suffering from diseases related to a weaker immune system.

• If you are receiving or have received any injections to treat allergies– it is unknown if Stelara may affect these treatments.

• If you are 65 years or older– you have a higher likelihood of acquiring infections.

If you are unsure whether 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 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 using 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 adequate contraceptive measures while using Stelara and for at least 15 weeks after the last treatment with Stelara.
• 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 should be used under the guidance and supervision of a doctor with experience in treating the conditions for which Stelara is indicated.

Always follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor. Ask your doctor when to administer the injections and about follow-up appointments.

What amount of Stelara is administered

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

Adults 18 years of age and older

Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg of Stelara. Patients weighing more than 100 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 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 through 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 through a subcutaneous injection.

• In some patients, after the first subcutaneous injection, 90 mg of Stelara will be administered every 8 weeks. Your doctor will decide when to receive the next dose.

Children and adolescents 6 years of age and older Psoriasis

• Your doctor will indicate the correct dose for you, including the amount (volume) of Stelara to inject to give the correct dose. The suitable 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 through a subcutaneous injection. Initially, medical or nursing staff may administer Stelara to you.

• However, you and your doctor may decide that you will administer Stelara yourself. In that case, you will be trained on how to administer Stelara yourself.
• For instructions on how to administer Stelara, see "Administration Instructions" at the end of this prospectus.

Consult with your doctor if you have any questions about self-administering.

If you use more Stelara than you should

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

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

If you forget to use Stelara

If you forget a dose, speak with your doctor or pharmacist. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Stelara

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, are infrequent (they 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 the signs of infection while using Stelara. These include:

• Fever, flu-like symptoms, night sweats

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

• Diarrhea.

Inform your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as pneumonia, skin infections, or herpes 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 – increased redness and skin peeling over a large area of the body may be symptoms of psoriasis erythroderma or dermatitis exfoliativa, which are serious skin conditions. 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
• Blocked or congested nose
• 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 skin peeling over a large area of the body, which may cause itching or pain (dermatitis exfoliativa). Similar symptoms may develop as a natural change in psoriasis symptoms (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 throughthe national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• 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 shaking may damage the product.

Do not use this medication:

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

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

Stelara is for single use only. Dispose of the unused product in the vial or syringe. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

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 monohydrochloride monohydrate, polisorbate 80, sucrose, and water for injection.

Appearance of Stelara and contents of the package

Stelara is a transparent or slightly opalescent (with a pearlescent sheen), colorless to light yellow solution. The solution may contain a few translucent or white protein particles. It is presented in a 2 ml glass single-dose vial containing 1 vial. 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

Responsible for manufacturing

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/Belgien

Janssen-Cilag NV

Tel/Tél: +32 14 64 94 11

[email protected]

????????Luxembourg/Luxemburg

„??????? & ??????? ????????” ????

Janssen-Cilag NV

???.: +359 2 489 94 00

[email protected]

Czech RepublicHungary

Janssen-Cilag s.r.o.

Tel: +420 227 012 227

[email protected]

DenmarkMalta

Janssen-Cilag A/S

Tlf: +45 4594 8282

[email protected]

GermanyNetherlands

Janssen-Cilag GmbH

Tel: +49 2137 955 955

[email protected]

EstoniaNorway

UAB "JOHNSON & JOHNSON" Eesti filiaal

Tel: +372 617 7410

[email protected]

GreeceAustria

Janssen-Cilag Φαρμακευτικ? Α.Ε.Β.Ε.

Tηλ: +30 210 80 90 000

SpainPoland

Janssen-Cilag, S.A.

Tel: +34 91 722 81 00

[email protected]m

FrancePortugal

Janssen-Cilag

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

[email protected]

CroatiaRomania

Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700

[email protected]

IrelandSlovenia

Janssen Sciences Ireland UC

Tel: +353 1 800 709 122

[email protected]

IcelandSlovakia

Janssen-Cilag AB

c/o Vistor hf.

Sími: +354 535 7000

[email protected]

ItalyFinland

Janssen-Cilag SpA

Tel: 800.688.777 / +39 02 2510 1

[email protected]

CyprusSweden

Βαρν?βας Χατζηπαναγ?ς Λτδ

Tηλ: +357 22 207 700

[email protected]

LatviaUnited Kingdom

UAB "JOHNSON & JOHNSON" filiale

Latvija

Tel: +371 678 93561

[email protected]

Last date of 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/.

Administration instructions

At the beginning of treatment, the healthcare professional will help you with your first injection. However, it is possible that you and your doctor may decide that you can administer Stelara yourself. In this case, they will teach you how to administer Stelara. Talk to your doctor if you have any doubts about the administration of injections.

• Do not mix Stelara with other injectable liquids.

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

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

• Take the vial(s) out of the refrigerator. Leave the vial to stand for 30 minutes. 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 the concentration are correct

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

orIf the dose is 90 mg, you will be given two vials of Stelara containing 45 mg each, and you will need to administer two injections. Choose two different injection sites (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.

• It has not expired.
• The vial is not damaged and the cap is not broken.
• The solution contained in the vial is transparent to slightly opalescent (with a pearlescent sheen) and colorless to slightly yellow.
• The solution has not changed color or become turbid and does not contain any foreign particles.
• The solution is not frozen.

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

Gather everything you need and place it on a clean surface. This includes 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 subcutaneous injection.

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

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

Figure 2

Prepare the injection site

• Wash your hands thoroughly with soap and water.

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

3. 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 cap from the needle.
• 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 plunger of the syringe 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 upwards to check if there are any air bubbles in it.
• 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 comes out (but no liquid).

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

4. Administer the dose:

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

• Insert the needle into the skin fold.
• Push the plunger with your thumb until the top mark to inject all the liquid. Do this slowly and uniformly, keeping the skin fold gently pinched.
• When you have pressed the plunger to the top mark, remove the needle and release the skin fold.

5. 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 bandage, if necessary.

6. Disposal:

• The used syringes and needles must be disposed of in a puncture-proof container, similar to a container for sharp objects. For your safety and health and for the safety of others, never reuse the needles and syringes. Dispose of your sharp object container according to local regulations.
• The empty vials, antiseptic wipes, and other materials can be disposed of in the trash.