Patient Information Leaflet

IMULDOSA 45 mg injectable solution in pre-filled syringe

ustekinumab

This medicine is subject to additional monitoring, which will help to quickly identify any new information about its safety. Healthcare professionals are invited to report any suspected adverse reactions. See section 4.8, which includes information on how to report them.

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 IMULDOSA, 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.

What is IMULDOSA

IMULDOSA contains the active ingredient “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically identify and bind to certain proteins in the body.

IMULDOSA belongs to a group of medicines called “immunosuppressants”. These medicines act by weakening part of the immune system.

For what IMULDOSA is used

IMULDOSA is used for the treatment of the following inflammatory diseases:

• Plaque psoriasis - in adults and children 6 years and older
• Psoriatic arthritis - in adults
• Moderate to severe Crohn's disease - in adults

Plaque psoriasis

Plaque psoriasis is a skin disease that causes inflammation affecting the skin and nails. IMULDOSA reduces inflammation and other symptoms of the disease.

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

IMULDOSA 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 are not effective.

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 medications. If you do not respond well to these medications, you may be treated with IMULDOSA 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 IMULDOSA to reduce the signs and symptoms of your disease.

No use IMULDOSA

• 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 sialgunode los puntos anteriores le concierne, hable con su médico o farmacéutico antes de usar IMULDOSA.

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a usar IMULDOSA. 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 IMULDOSA. Si su médico cree que usted está en riesgo de tuberculosis, puede darle medicamentos para tratarla.

Observe los efectos adversos graves

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

Antes de utilizar IMULDOSA dígale a su médico:

• Si usted ha tenido alguna vez una reacción alérgica a IMULDOSA.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 IMULDOSA 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 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 IMULDOSA. 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 IMULDOSA puede afectar a estos tratamientos.
• Si usted tiene 65 años o más– usted tiene más probabilidades de adquirir infecciones.

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

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 ustekinumab 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 IMULDOSA en niños menores de 6 años de edad con psoriasis ni en niños menores de 18 años de edad con artritis psoriásica, enfermedad de Crohn o colitis ulcerosa, ya que no ha sido estudiado en este grupo de edad.

Uso de IMULDOSA 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 IMULDOSA.
• Si recibió IMULDOSA durante el embarazo, informe al médico de su lactante sobre su tratamiento con IMULDOSA 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 doce meses después del nacimiento si usted recibió IMULDOSA durante el embarazo, a menos que el médico de su lactante recomiende lo contrario.

Embarazo y lactancia

• Si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico antes de utilizar este medicamento.
• No se ha observado un mayor riesgo de defectos de nacimiento en bebés expuestos a Imuldosa en el útero. Sin embargo, existe experiencia limitada con Imuldosa en mujeres embarazadas. Por tanto, es preferible evitar el uso de Imuldosa durante el embarazo.
• Si es una mujer en edad fértil, se le recomienda que evite quedarse embarazada y use medidas anticonceptivas adecuadas mientras esté utilizando Imuldosa y durante al menos 15 semanas tras el último tratamiento con Imuldosa. Imuldosa puede pasar a través de la placenta al feto. Si recibió Imuldosa 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 Imuldosa 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 doce meses después del nacimiento si usted recibió Imuldosa 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 Imuldosa. No haga ambas cosas a la vez.

Conducción y uso de máquinas

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

IMULDOSA contiene polisorbato

IMULDOSA contiene 0.02 mg de polisorbato 80 en cada unidad de volumen, equivalente a 0.02 mg por dosis de 45 mg.

Los polisorbatos pueden causar reacciones alérgicas. Informe a su médico si tiene alergias conocidas.

IMULDOSA should be used under the guidance and supervision of a doctor with experience in treating the conditions for which IMULDOSA 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 IMULDOSA is administered

Your doctor will decide the amount of IMULDOSA 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 IMULDOSA. 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

• During treatment, your doctor will administer the first dose of approximately 6 mg/kg of IMULDOSA through a vein in your arm (intravenous infusion). After the initial dose, you will receive the next dose of 90 mg of IMULDOSA 8 weeks later and then every 12 weeks through a subcutaneous injection.
• In some patients, after the first subcutaneous injection, 90 mg of IMULDOSA 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 IMULDOSA 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, there is no IMULDOSA dosage form for children with a body weight of less than 60 kg, and you should use other ustekinumab products.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of IMULDOSA.
• If you weigh more than 100 kg, the recommended dose is 90 mg of IMULDOSA.
• After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks.

How IMULDOSA is administered

• IMULDOSA is administered through a subcutaneous injection. Initially, medical or nursing staff may administer IMULDOSA to you.
• However, you and your doctor may decide that you will administer IMULDOSA yourself. In that case, you will be trained on how to administer IMULDOSA yourself.
• For instructions on how to administer IMULDOSA, see "Administration Instructions" at the end of this prospectus.

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

If you use more IMULDOSA than you should

If you have used or have been given too much IMULDOSA, speak immediately with your doctor or pharmacist. Always carry the medication box with you, even if it is empty.

If you forget to use IMULDOSA

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 IMULDOSA

Stopping IMULDOSA is not hazardous. However, if you stop, your symptoms may return.

If you have any other doubts 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 IMULDOSA (they may affect up to 1 in 1,000 people). The signs include:

• Difficulty breathing and swallowing
• Low blood pressure, which may cause dizziness or mild headaches
• Swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include skin rash and urticaria (these may 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 experience symptoms such as coughing, difficulty breathing, and fever.

If you experience a severe allergic reaction, your doctor may decide that you should not use IMULDOSA again.

Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of these signs.

IMULDOSA 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 IMULDOSA. 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 impairment 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 resolve or reappears. Your doctor may decide that you should not use IMULDOSA until the infection resolves. 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 severe skin disorders. If you notice any of these symptoms, you should inform your doctor immediately.

Other side effects

Frequent side effects(may affect up to 1 in 10 people):

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching (“pruritus”)
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

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

• Dental infections
• Vaginal yeast infections
• Depression
• Blocked or congested nose
• 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 (psoriasis pustular)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects(may 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(may 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 the national 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 ºC – 8 ºC). Do not freeze.
• Store the pre-filled syringe in the outer packaging to protect it from light.
• Individual pre-filled syringes of IMULDOSA can also be stored at room temperature up to 30ºC for a maximum period of up to 30 days in the original box 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 30ºC), it must not be stored again 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 syringes of IMULDOSA. 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 presents unusual particles floating in it (see section 6 “Appearance of IMULDOSA 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.

IMULDOSA 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 empty containers and unused medications. This will help protect the environment.

Composition of IMULDOSA

• 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 hydrochloride monohydrate, polisorbate 80 (E433), sucrose, and water for injection.

Appearance of IMULDOSA and contents of the package

IMULDOSA is a transparent to slightly opalescent injectable solution, colorless to slightly yellowish. It is presented in a package 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 Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th Floor

08039 Barcelona

Spain

Responsible for manufacturing

Accord Healthcare Polska Sp. z.o.o.

ul. Lutomierska 50,

95-200, Pabianice, Poland

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht, Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Tel : +30 210 74 88 821

Last review date 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 IMULDOSA yourself. In this case, they will teach you how to administer IMULDOSA. Talk to your doctor if you have any doubts about administering the injections.

• Do not mix IMULDOSA with other injectable liquids.
• Do not shake the pre-filled syringes of IMULDOSA. The medicine may deteriorate if it is shaken vigorously. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows what the pre-filled syringe looks like.

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 outside the box for 30 minutes. This will allow the liquid to reach a comfortable temperature for administration (room temperature). Do not remove the cap from the needle while waiting for the temperature to reach room temperature.
• Hold the pre-filled syringe by the body with the capped needle pointing upwards.
• Do not pick up the syringe by the plunger, the plunger, the wings of the needle shield, or the cap of the needle.
• Do not remove the plunger at any time.
• Do not remove the cap from the pre-filled syringe until you are told to.
• Do not touch the activation clips of the needle shield to avoid covering the needle shield too early.

Check the pre-filled syringe(s) to make sure 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 IMULDOSA.
• If your dose is 90 mg, you will have two pre-filled syringes of 45 mg of IMULDOSA 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.

• the medicine is correct
• has not expired the expiration date
• the pre-filled syringe is not damaged
• the solution in the pre-filled syringe is transparent to slightly opalescent and colorless to slightly yellowish
• the solution in the pre-filled syringe does not have an abnormal color, 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 container for sharp objects.

1. Choose and prepare the injection site:

Choose the injection site (see Figure 2).

• IMULDOSA 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.

Prepare the injection site

• Wash your hands very well with soap and warm water.
• Clean the skin of the injection site with an antiseptic wipe.
• Do not touch this area again before putting in the injection.

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

• The cap of the needle must not be removed until you are ready to inject.
• Hold the pre-filled syringe and hold the body of the pre-filled syringe with one hand.
• Remove the cap from the needle and dispose of it. Do not touch the plunger while doing this.

• 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 let it touch any surface.
• Do not use the pre-filled syringe if it has fallen without the cap on the needle. If this happens, tell your doctor or pharmacist.
• Inject the dose immediately after removing the cap from the needle.

1. Inject the dose:

• Hold the pre-filled syringe with one hand between the index and middle fingers, place the thumb on the head of the plunger, and with the other hand gently pinch a disinfected piece of skin with the thumb and index finger. Do not squeeze.
• Do not remove the plunger at any time.
• With a single quick movement, insert the needle through the skin until it can go no further (see Figure 4).

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

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

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

1. 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.

1. Disposal:

• The used syringes must be deposited in a puncture-resistant container, similar to a container for sharp objects (see Figure 8). For your safety and health and for the safety of others, never reuse the syringe. Dispose of your sharp object container according to your local regulations.
• The antiseptic wipes and other materials can be disposed of in the trash.