Patient Information Leaflet

STELARA 45 mg injectable solution in pre-filled syringe

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, and you must 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 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:

• 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.

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 whether 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 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.

Be aware of serious side effects

Stelara may cause serious 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 “Serious 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.

• If you have any new injury or change in lesionswithin the psoriasis area or on intact skin.

• If you have ever had an allergic reaction to latex or to Stelara injection– the container of this medication contains latex, which may cause severe allergic reactions in people who are sensitive to latex. See “Be aware of serious side effects” in section 4 for signs of an allergic reaction.

• 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. These treatments have not been studied in combination 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– itis unknown whether Stelara may affect these treatments.
• If you are 65 years or older– you are more likely to acquire infections.

If you are unsure whether you have 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 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 appropriate 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. In case of 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 (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 you should 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 of each dose.

• A 45 mg vial is available for children who need to receive less than the total dose of 45 mg.
• 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 should inject Stelara yourself. In that case, you will be trained on how to inject Stelara yourself.
• For instructions on how to inject Stelara, see "Administration Instructions" at the end of this prospectus.

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

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 make up 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 symptoms.

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

• 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 serious.

You should monitor the 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 a painful skin rash with blisters
• Difficulty urinating
• Diarrhea.

Notify 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 notify 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 disorders. If you notice any of these symptoms, you should notify 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 (pustular psoriasis)
• 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 can 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 can 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.

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

• Store in refrigerator (2 °C–8 °C). Do not freeze.
• Store the pre-filled syringe in the outer packaging to protect it from light.
• Individual pre-filled Stelara syringes can also be stored at room temperature up to 30°C for a maximum period of up to 30 days in their original packaging to protect them from light. Write the date when the pre-filled syringe is first removed from the refrigerator and the date when it should be discarded in the designated spaces on the outer packaging. The discard date must not exceed the original expiration date printed on the box. Once a syringe has been stored at room temperature (up to a maximum of 30°C), it must not be stored back in the refrigerator. Discard the syringe if it is not used within the 30-day storage period at room temperature or beyond the original expiration date, whichever occurs first.

• Do not shake the pre-filled Stelara syringes. Prolonged vigorous shaking may damage the product.

Do not use this medication:

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

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

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

Composition of Stelara

• The active ingredient is ustekinumab. Each pre-filled syringe 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 pack

Stelara is a transparent or slightly opalescent (with a pearlescent sheen), colourless to pale yellow solution. The solution may contain a few translucent or white protein particles.

It is presented in a pack containing 1 pre-filled syringe of 1 ml of glass for single use. Each pre-filled syringe 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

Responsible for manufacturing

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorisation 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 14 64 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 last revision of the text{MM/AAAA}.

The detailed information on this medicinal product 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 pre-filled syringes of Stelara. The medicine may deteriorate if it is shaken vigorously. Do not use the medicine if it has been shaken vigorously.

The Figure 1 shows how the pre-filled syringe looks like.

Figure 1

1. Check the number of pre-filled syringes and prepare the materials:Preparation for using the pre-filled syringe

?Take the pre-filled syringe(s) out of the refrigerator. Leave the pre-filled syringe out of the box for 30 minutes. This will allow the liquid to reach a comfortable temperature for administration (room temperature). Do not remove the needle capwhile waiting for the liquid to reach room temperature.

?Hold the pre-filled syringe by the body with the needle cap pointing upwards.

?Do not pick up the pre-filled syringe by the plunger, the plunger, the wings of the needle shield or the needle cap.

?Do not remove the plunger at any time.

?Do not remove the needle cap from the pre-filled syringe until instructed to do so.

?Do not touch the activation clips of the needle shield (marked with asterisks* in Figure 1) to prevent the needle shield from covering the needle too early.

Check the pre-filled syringe(s) to ensure that

• The number of pre-filled syringes and the concentration are correct

• If your dose is 45 mg, you will have a pre-filled syringe of 45 mg of Stelara.
• If your dose is 90 mg, you will have two pre-filled syringes of 45 mg of Stelara and you will need to administer two injections. Choose two different places for these injections (e.g. one in the right thigh and one in the left thigh), and inject one after the other.

• It is the correct medicine.
• It has not expired.
• The pre-filled syringe is not damaged.
• The solution in the pre-filled syringe is transparent to slightly opalescent (with a pearlescent sheen) and colourless to pale yellow.
• The solution in the pre-filled syringe does not have an abnormal colour, is turbid or contains foreign particles.
• The solution in the pre-filled syringe is not frozen.

Prepare all the materials you need and place them on a clean surface. Including antiseptic wipes, cotton or gauze and a sharps container.

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

?Stelara is administered by subcutaneous injection.

?Some suitable places for injection are the upper part of the thigh or the abdominal area (the abdomen) 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 very well with soap and water.

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

3. Remove the needle cap (see Figure 3):

• The needle capmust notbe removed until you are ready to inject.

• Hold the pre-filled syringe, and hold thebody of the pre-filled syringe with one hand.
• Remove the needle cap and dispose of it. Do not touch the plunger while doing this.

Figure 3

• You may observe a bubble of air in the pre-filled syringe or a drop of liquid at the end of the needle. Both are normal and do not need to be removed.
• Do not touch the needle or allow it to touch any surface.
• Do not use the pre-filled syringe if it has fallen without the needle cap. If this happens, tell your doctor or pharmacist.
• Inject the dose immediately after removing the needle cap.

4. Inject the dose:

• Hold the pre-filled syringe with one hand between your index and middle fingers, place your thumb over the plunger and with the other hand gently pinch a disinfected piece of skin with your thumb and index finger. Do not squeeze.
• Do not remove the plunger at any time.

• With one quick movement, insert the needle through the skin until it can go no further (see Figure 4).

Figure 4

• Inject all the medicine by pushing the plunger until the plunger head is completely between the wings of the needle shield (see Figure 5).

Figure 5

• When you have pushed the plunger as far as it will go, keep the pressure on the plunger head, remove the needle and release the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head to allow the empty pre-filled syringe to advance until the needle is completely covered by the needle shield, as shown in Figure 7:

5. After the injection:

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

• You may see a small amount of blood or liquid at the injection site. This is normal.
• You can press with a cotton ball or gauze the injection site 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 must be disposed of in a puncture-resistant container, similar to a sharps container (see Figure 8). For your safety and health and for the safety of others, never reuse the syringe. Dispose of your sharps container according to your local regulations.
• The antiseptic wipes and other materials can be disposed of in the trash.