Patient Information Leaflet: Product Characteristics

STELARA 90 mg 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.

• 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, 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.

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 administered with the pre-filled pen is used to treat the following inflammatory diseases:

• Plaque psoriasis – in adults
• 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 administered with the pre-filled pen is used in adults with plaque psoriasis of moderate to severe severity, who cannot use ciclosporin, methotrexate, or phototherapy, or when these treatments have not worked.

Psoriatic 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 medicines. If you do not respond well to these medicines, 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 bowel disease. If you have Crohn's disease, you will first be given other medicines. If you do not respond adequately or do not tolerate those medicines, 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 medicines. If you do not respond well enough or do not tolerate those medicines, you may be given Stelara to reduce the signs and symptoms of your disease.

No use Stelara

• Si es alérgico a ustekinumabor to any of the other components of this medication (listed in section 6).
• Si tiene una infección activathat your doctor thinks is important.

If you are not sure if any of the above points concern you, talk to your doctor or pharmacist before using Stelara.

Advertencias y precauciones

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.

Observe los efectos adversos graves

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.

Antes de utilizar Stelara dígale a su médico:

• Si usted ha tenido alguna vez una reacción alérgica a Stelara.Consult with your doctor if you are unsure.
• Si usted alguna vez ha tenido algún tipo de cáncer– this is because the immunosuppressants of the type of Stelara weaken part of the immune system. This may increase the risk of having cancer.
• Si usted ha recibido tratamiento para la psoriasis con otros biológicos (a medication produced from a biological source and usually administered by injection)– the risk of having cancer may be higher.
• Si tiene o ha tenido una infección reciente.
• Si tiene cualquier lesión nueva o cambio de las lesioneswithin the area of psoriasis or on intact skin.
• Si usted alguna vez ha tenido una reacción alérgica al látex o a la inyección de Stelara– the packaging of this medication contains latex, which may cause severe allergic reactions in people who are sensitive to latex. See "Observe los efectos adversos graves" in section 4 for signs of an allergic reaction.
• Si usted está tomando cualquier otro tratamiento para la psoriasis and/or artritis psoriásica– 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 increase the likelihood of suffering from diseases related to a weaker immune system.
• Si usted está recibiendo or has received any injections for treating allergies– it is unknown if Stelara may affect these treatments.
• Si usted tiene 65 años or more– you have a higher probability of acquiring infections.

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

Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including lupus cutaneous or lupus-like syndrome. Talk to your doctor immediately if you experience a red, elevated, and scaly rash, sometimes with a darker border, in sun-exposed areas or accompanied by joint pain.

Ataques al corazón e ictus

In a study of patients with psoriasis treated with Stelara, heart attacks and strokes have been observed. Your doctor will check your risk factors for heart disease and stroke regularly to ensure they are being treated properly. Seek medical attention immediately if you experience chest pain, weakness, or abnormal sensation in one side of the body, facial paralysis, or abnormalities in speech or vision.

Niños y adolescentes

Stelara is not recommended for use in a pre-filled pen in children and adolescents under 18 years of age with psoriasis, as it has not been studied in this age group. For children aged 6 years and older and adolescents with psoriasis, use a pre-filled syringe or vial instead.

Stelara is not recommended for use in children and adolescents under 18 years of age with psoriatic arthritis, Crohn's disease, or ulcerative colitis, as it has not been studied in this age group.

Uso de Stelara con otros medicamentos, vacunas

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.
• If you received Stelara during pregnancy, inform your baby's doctor about your treatment with Stelara before your baby receives any vaccine, including live vaccines, such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your baby in the first six months after birth if you received Stelara during pregnancy, unless your baby's doctor recommends otherwise.

Embarazo y lactancia

• 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.
• Stelara may pass through the placenta to the fetus. If you received Stelara during pregnancy, your baby may have a higher risk of contracting an infection.
• It is essential to inform your baby's doctors and other healthcare professionals if you received Stelara during pregnancy before your baby receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your baby in the first six months after birth if you received Stelara during pregnancy, unless your baby's doctor recommends otherwise.
• Ustekinumab may be excreted in breast milk in very small amounts. 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.

Conducción y uso de máquinas

The influence of Stelara on the ability to drive and use machines 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 receive 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 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, the next dose will be administered 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 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, they will receive 90 mg of Stelara every 8 weeks. Your doctor will decide when you should receive the next dose.

How Stelara is administered

• Stelara is administered through a subcutaneous injection. Initially, medical or nursing staff may administer Stelara.
• 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 administered 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 using 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 experience 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 respiratory tract infections are frequent (they can affect up to 1 in 10 people).
• Chest infections are rare (they can affect up to 1 in 100 people).
• Cellulitis, an inflammation of the tissues under the skin, is rare (it can affect up to 1 in 100 people).
• Herpes, a painful rash with blisters, are rare (they can affect up to 1 in 100 people).

Stelara may affect your ability to fight infections. Some of them may be severe and caused by viruses, fungi, bacteria (including tuberculosis) or parasites, and include opportunistic infections that occur mainly in people with a weakened immune system. Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving ustekinumab treatment.

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

• Fever, flu-like symptoms, night sweats, weight loss
• Feeling tired or difficulty breathing; persistent coughing
• Warm, red, and painful skin or a painful rash with blisters
• Difficulty urinating
• Diarrhea
• Visual deterioration or loss of vision
• Headache, neck stiffness, photosensitivity, nausea, or confusion.

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, herpes, or opportunistic infections that could have serious complications. You should also inform your doctor if you have any type of infection that does not resolve or reappears. Your doctor may decide that you should not use Stelara until the infection resolves. 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 severe skin disorders. 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

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

• Dental infections
• Vaginal yeast infections
• Depression
• Stuffy nose or nasal congestion
• Bleeding, petechiae, 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 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)

Very rare side effects(they can affect up to 1 in 10,000 people)

• Blisters on the skin, which may be red and cause itching and pain (pemphigoid bullous).
• Cutaneous lupus or lupus-like syndrome (a red, elevated, and scaly skin rash in sun-exposed areas, possibly accompanied by joint pain).

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 reporting system included in Appendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Store in refrigerator (2°C and 8°C). Do not freeze.
• Store the pre-filled pen in the outer packaging to protect it from light.
• Individual pre-filled pens of Stelara may also be stored at room temperature up to 30°C for a maximum period of up to 30 days, keeping them in their original box to protect them from light. Write the date when the pre-filled pen is first removed from the refrigerator and the date when it should be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiration date printed on the box. Once a syringe or pre-filled pen 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 or pre-filled pen if it has not been used within the 30 days of storage at room temperature or if it has expired according to the original expiration date, whichever occurs first.
• Do not shake the pre-filled pens of Stelara. Prolonged vigorous shaking 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 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 overheating or freezing).
• If the product has been vigorously shaken.

Stelara is for single use only. Dispose of the unused product remaining in the syringe or pre-filled pen. 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 pre-filled syringe contains 90 mg of ustekinumab in 1 ml.
• The other components are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

Appearance of Stelara and contents of the pack

Stelara is a transparent, 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 90 mg of ustekinumab in 1 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

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet

The detailed information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

Instructions for use

Stelara

(ustekinumab)

injection, for subcutaneous use

Pre-filled syringe

These instructions for use contain information on how to administer Stelara.

Important

Stelara is presented in a pre-filled syringe for single use that contains a dose of 45 mg or a dose of 90 mg.

If your doctor considers that you or your caregiver are able to administer your Stelara injections at home, you will receive training to prepare and correctly administer Stelara using the pre-filled syringe.Do not attempt to administer the injections yourself without having received training from your doctor.

Each pre-filled syringe can only be used once. Dispose of the pre-filled syringe (see step 3) after use, even if there is still medicine inside.

Do not reuse the pre-filled syringe.

Read these instructions for use before using the Stelara pre-filled syringe and each time you use a new pre-filled syringe.You may have new information. This leaflet does not replace the conversation with your doctor about your health or your treatment.

If you cannot administer the injection yourself:

• ask your doctor or nurse, or
• ask someone who has been trained by a doctor or nurse to administer the injections for you.

To reduce the risk of accidental needlestick injuries, each pre-filled syringe incorporates a safety guard that automatically covers the needle and blocks after administering the injection and lifting the pre-filled syringe. Do not lift the pre-filled syringe until you have completed the injection.

The needle cap located inside the lower cap of the pre-filled syringe contains latex.Do not handle the needle cap if you are allergic to latex.

Read this leaflet carefully before starting to administer the injection and discuss any questions you have with your doctor or nurse.

Storage information

Store in a refrigerator between 2 °C and 8 °C. If necessary, store at room temperature up to 30 °C for a maximum of 30 days in the original packaging.Do not return to the refrigeratoronce stored at room temperature.

Do not freezethe pre-filled syringe.

Keep the pre-filled syringe and all medicines out of the reach of children.

Do not shakethe pre-filled syringe. Shaking may damage the Stelara medicine. If the pre-filled syringe has been shaken, do not use it. Use a new pre-filled syringe.

Store the pre-filled syringe in the original packaging to protect it from light and physical damage.

Do you need help?

Consult your doctor if you have any questions. For additional help or to share your experience, see the contact information of your local representative in the leaflet.

1. Preparation for Stelara injection

Take the pack(s)

If refrigerated, take the pack(s) out of the refrigerator and place it/them on a flat surface.

Leave at room temperaturefor at least 30 minutesbefore use.

Do notheat it in any other way.

Check the expiry date (“CAD”) and seals of the pack(s)

Do notuse the pre-filled syringe if the seals of the pack are broken or if the expiry date has passed.

Do notuse the pre-filled syringe if it has been stored at room temperature for more than 30 days or if it has been stored at a temperature above 30 °C. Consult your doctor or pharmacist to obtain a new pre-filled syringe.

Choose the injection site

Choose between the following areas to administer the injection:

• Front of the thighs
• Lower abdomen (lower belly), avoiding the area 5 cm around the navel

If someone else is administering the injection for you, they can also use:

• Back of the arms

Do notinject into sensitive, bruised, red, or hardened skin.

Wash your hands

Wash your hands thoroughly with warm water and soap.

Clean the injection site

Clean the chosen injection site with an alcohol-soaked swab and let it dry.

Do nottouch, fan, or blow on the injection site after cleaning it.

Inspect the liquid in the view window

Choose a well-lit, clean, and flat work surface.

Take the pre-filled syringe out of the pack and check if it is damaged.

Check the liquid in the view window. It should betransparent or slightly opalescentandcolourless to pale yellowand may containsmall white or transparent particlesandone or more air bubbles. This is normal.

Do notinject if the liquid is frozen or cloudy, has an abnormal colour, or contains large particles.

Consult your doctor or pharmacist to obtain a new pre-filled syringe.

2. Stelara injection

Remove the lower cap

Keep your hands away from the safety guardafter removing the lower cap. It is normal to see some liquid droplets.

Inject Stelara within 5 minutes of removing the lower cap.

Do notput the lower cap back on. This may damage the needle.

Do notuse a pre-filled syringe that has fallen after removing the lower cap. Consult your doctor or pharmacist to obtain a new pre-filled syringe.

Push the plunger straight onto the skin. Press the plunger until the purple part of the pre-filled syringe is completely hidden.

You may hear a click when the injection starts. Continue pressing.

If you feel resistance, continue pressing. This is normal.

The medicine is injected as you press. Do it at a comfortable pace.

Confirm that your injection is complete

Your injection is complete when:

• The purple part of the pre-filled syringe is not visible.
• You cannot press the plunger any further.
• You may hear a click.

Lift the pre-filled syringe straight up

The yellow line indicates that the safety guard has blocked.

3. After the injection

Dispose of the pre-filled syringe

Place the used pre-filled syringe in a sharps container after use.

Do notthrow (dispose of) the pre-filled syringe in household waste.

Do notrecycle the used sharps container.

Inspect the injection site

You may see a small amount of blood or liquid at the injection site. This is normal.

Press a cotton ball or gauze on the injection site until it stops bleeding.

Do notrub the injection site.

If necessary, cover the injection site with a bandage.