Patient Information Leaflet: Package Insert

STELARA 45 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 act by weakening part of the immune system.

What is Stelara used for

Stelara administered with the pre-filled pen is used for the treatment of 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 disease of the intestine. 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 disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond sufficiently 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.

Si no está seguro sialgunoof the above points applies to you, talk to your doctor or pharmacist before using Stelara.

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a usar Stelara. Su médico comprobará cómo se encuentra antes de cada tratamiento. Asegúrese de informar a su médico sobre cualquier enfermedad que sufra antes de cada tratamiento. También su médico le preguntará si recientemente ha estado cerca de alguien que pudiera tener tuberculosis. Su médico le examinará y le hará un test para detección de la tuberculosis, antes de usar Stelara. Si su médico cree que usted está en riesgo de tuberculosis, puede darle medicamentos para tratarla.

Observe los efectos adversos graves

Stelara puede causar efectos adversos graves, incluyendo reacciones alérgicas e infecciones. Usted debe prestar atención a ciertos signos de enfermedad mientras esté utilizando Stelara. Ver la lista completa de estos efectos adversos en “Efectos adversos graves” de la sección 4.

Antes de utilizar Stelara dígale a su médico:

• Si usted ha tenido alguna vez una reacción alérgica a Stelara.Consulte con su médico si no está seguro.
• Si usted alguna vez ha tenido algún tipo de cáncer– esto es porque los inmunosupresores del tipo de Stelara debilitan parte del sistema inmunitario. Esto puede aumentar el riesgo de tener cáncer.
• Si usted ha recibido tratamiento para la psoriasis con otros biológicos (un medicamento producido a partir de una fuente biológica y que suele administrarse mediante inyección)– el riesgo de padecer cáncer puede ser mayor.
• Si tiene o ha tenido una infección reciente.
• Si tiene cualquier lesión nueva o cambio de las lesionesdentro del área de psoriasis o sobre la piel intacta.
• Si usted alguna vez ha tenido una reacción alérgica al látex o a la inyección de Stelara– el envase de este medicamento contiene goma de látex, que puede causar reacciones alérgicas graves en personas que son sensibles al látex. Ver “Observe los efectos adversos graves” en la sección 4 para los signos de una reacción alérgica.
• Si usted está tomando cualquier otro tratamiento para la psoriasis y/o artritis psoriásica– como cualquier otro inmunosupresor o fototerapia (cuando su cuerpo es tratado con un tipo de luz ultravioleta (UV)). Estos tratamientos pueden también debilitar parte del sistema inmunitario. No se ha estudiado el uso de estos tratamientos de manera conjunta con Stelara. Sin embargo, es posible que pueda aumentar la probabilidad de sufrir enfermedades relacionadas con un sistema inmune más débil.
• Si usted está recibiendo o ha recibido alguna vez inyecciones para tratar las alergias– se desconoce si Stelara puede afectar a estos tratamientos.
• Si usted tiene 65 años o más– usted tiene más probabilidad de adquirir infecciones.

Si no está seguro de no padecer alguno de estos trastornos, hable con su médico o farmacéutico antes de usar Stelara.

Algunos pacientes han experimentado reacciones similares al lupus durante el tratamiento con ustekinumab, incluido lupus cutáneo o síndrome tipo lupus. Hable con su médico de inmediato si experimenta erupción cutánea roja, elevada y escamosa, a veces con un borde más oscuro, en zonas de la piel expuestas al sol o si van acompañadas de dolores articulares.

Ataques al corazón e ictus

En un estudio realizado en pacientes con psoriasis tratados con Stelara se han observado ataques al corazón e ictus. Su médico comprobará periódicamente sus factores de riesgo de enfermedad cardíaca e ictus para garantizar que se traten adecuadamente. Busque atención médica de inmediato si presenta dolor torácico, debilidad o sensación anormal en un lado del cuerpo, parálisis facial o anomalías en el habla o la vista.

Niños y adolescentes

No se recomienda el uso de Stelara en pluma precargada en niños y adolescentes menores de 18 años de edad con psoriasis, ya que no ha sido estudiado en este grupo de edad. Para niños de 6 años en adelante y adolescentes con psoriasis debe utilizarse en su lugar la jeringa precargada o el vial.

No se recomienda el uso de Stelara en niños y adolescentes menores de 18 años de edad con artritis psoriásica, enfermedad de Crohn o colitis ulcerosa, ya que no se ha estudiado en este grupo de edad.

Uso de Stelara con otros medicamentos, vacunas

Informe a su médico o farmacéutico:

• Si está utilizando, ha utilizado recientemente o puede utilizar otros medicamentos.
• Si ha sido vacunado recientemente o va a recibir una vacuna. No se deben administrar determinados tipos de vacunas (vacunas vivas) mientras se utilice Stelara.
• Si recibió Stelara durante el embarazo, informe al médico de su lactante sobre su tratamiento con Stelara antes de que el lactante reciba cualquier vacuna, incluidas las vacunas vivas, como la vacuna BCG (utilizada para prevenir la tuberculosis). No se recomiendan las vacunas vivas para su lactante en los primeros seis meses después del nacimiento si usted recibió Stelara durante el embarazo, a menos que el médico de su lactante recomiende lo contrario.

Embarazo y lactancia

• Es preferible evitar el uso de Stelara en el embarazo. No se conocen los efectos de Stelara en mujeres embarazadas. Si es una mujer en edad fértil, se le recomienda que evite quedarse embarazada y use medidas anticonceptivas adecuadas mientras esté utilizando Stelara y durante al menos 15 semanas tras el último tratamiento con Stelara.
• Informe a su médico si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada.
• Stelara puede pasar a través de la placenta al feto. Si recibió Stelara durante el embarazo, su lactante podría tener un mayor riesgo de contraer una infección.
• Es importante que informe a los médicos de su lactante y a otros profesionales de la salud si recibió Stelara durante su embarazo antes de que el lactante reciba cualquier vacuna. No se recomiendan las vacunas vivas, como la vacuna BCG (utilizada para prevenir la tuberculosis) para su lactante en los primeros seis meses después del nacimiento si usted recibió Stelara durante el embarazo, a menos que el médico de su lactante recomiende lo contrario.
• Ustekinumab puede excretarse en la leche materna en cantidades muy pequeñas. Informe a su médico si está dando el pecho o tiene previsto hacerlo. Usted y su médico decidirán si debe dar el pecho o utilizar Stelara. No haga ambas cosas a la vez.

Conducción y uso de máquinas

La influencia de Stelara sobre la capacidad para conducir y utilizar máquinas es nula o insignificante.

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 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, 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 the 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 should inject Stelara yourself. In that case, you will be trained on how to inject 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-injecting.

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 interrupt treatment, your symptoms may reappear.

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, 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. 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 weakened immune systems. 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 on the skin
• 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 may have serious complications. You should also inform your doctor if you have any type of infection that does not disappear or reappears. Your doctor may decide that you should not use Stelara until the infection has cleared up. 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

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

• Dental infections
• Vaginal yeast infections
• Depression
• Stuffy nose or nasal congestion
• Bleeding, petechiae, induration, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and facial muscle weakness (“Bell's palsy” or “facial paralysis”), 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 (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 thenational reporting system included in theAppendix 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.
• If necessary, individual pre-filled pens of Stelara can 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 should not be stored back in the refrigerator. Discard the syringe or pre-filled pen if it has not been used within the 30-day storage period 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 shaken vigorously.

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 45 mg of ustekinumab in 0.5 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 one 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

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 the summary of product characteristics

The detailed information on 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 containing 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 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 manipulate the needle cap if you are allergic to latex.

Read also carefully the leaflet 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, consult 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 expiration 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 expiration 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 of 5 centimeters around the navel

If someone else is administering the injection for you, you 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 has any damage.

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.