Prospect: Information for the User

Tremfya 100 mg injectable solution in pre-filled pen

Guselkumab

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they do not appear in this prospect. See section 4.

Tremfya contains the active ingredient guselkumab, which is a type of protein called monoclonal antibody.

This medication acts by blocking the activity of a protein called IL-23,which is present in greater amounts in people with psoriasis and psoriatic arthritis.

Plaque psoriasis

Tremfya is used to treat adults with “plaque psoriasis” of moderate to severe, an inflammatory disorder that affects the skin and nails.

Tremfya may improve skin disorders and the appearance of nails and reduces symptoms, such as scaling, shedding, exfoliation, itching, pain, and burning.

Psiatic arthritis

Tremfya is used to treat a disease called “psoriatic arthritis”, an inflammatory joint disease, often accompanied by psoriasis. If you have psoriatic arthritis, you will be given other medications first. If you do not respond well enough to these medications, you will be given Tremfya to reduce the signs and symptoms of your disease. Tremfya can be used alone or with another medication called methotrexate.

The use of Tremfya in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bone of the joints, and improving your ability to perform normal daily activities.

No use Tremfya

• If you are allergic to guselkumab or any of the other components of this medication

(see section 6). If you think you may be allergic, consult your doctor before using Tremfya

• If you have an active infection, including active tuberculosis

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Tremfya:

• If you are receiving treatment for an infection

• If you have a persistent or recurring infection
• If you have tuberculosis or have been in close contact with someone with tuberculosis
• If you think you may have an infection or symptoms of an infection (see below “Infection and allergic reaction monitoring”)
• If you have recently been vaccinated or need to receive a vaccine during treatment with Tremfya.

If you are unsure whether any of the above conditions apply to you, speak with your doctor, pharmacist, or nurse before using Tremfya.

Following your doctor's instructions, before receiving Tremfya and when you are going to use it, you may need to have blood tests to check if you have elevated liver enzyme levels. Elevated liver enzyme levels may be more frequent in patients who receive Tremfya every 4 weeks than in those who receive Tremfya every 8 weeks (see “How to use Tremfya” in section 3).

Infection and allergic reaction monitoring

Tremfya has the potential to produce severe adverse reactions, including allergic reactions and infections. You should monitor the appearance of signs of these disorders while receiving Tremfya.

Stop using Tremfya and consult your doctor or seek medical help immediately if you observe

any sign that indicates a possible severe allergic reaction or infection.

Signs of infection may include fever or flu-like symptoms; muscle pain; cough; difficulty breathing; burning sensation while urinating or urinating more frequently than usual; blood in mucus (phlegm); weight loss; diarrhea or stomach pain; warm, red, or painful skin, or sores on the body that are different from psoriasis lesions.

Severe allergic reactions with Tremfya have occurred, which may include the following symptoms,swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, and hives (see “Severe adverse reactions” in section 4).

Children and adolescents

Tremfya is not recommended for children and adolescents under 18 years of age because there are no studies in this age group.

Other medications and Tremfya

Talk to your doctor or pharmacist:

• If you are using, have used recently, or may need to use any other

medication.

• If you have recently been vaccinated or need to be vaccinated. You should not receive certain types of vaccines (live organisms) while using Tremfya.

Pregnancy and breastfeeding

• Tremfya should not be used during pregnancy as the effects of this medication on pregnant women are unknown. If you are a fertile woman, it is recommended that you avoid becoming pregnant and use an appropriate contraceptive method during treatment with Tremfya and at least 12 weeks after the last dose of Tremfya.

Inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant.

• Also inform your doctor if you are breastfeeding or plan to do so. You and your doctor should decide whether you can breastfeed or use Tremfya.

Driving and operating machinery

It is unlikely that Tremfya will affect your ability to drive and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or nurse. In case of doubt, consult your doctor, nurse, or pharmacist.

What dose of Tremfya to administer and for how long

Your doctor will decide for how long you need to use Tremfya.

Plaque psoriasis

• The dose is 100 mg (the content of 1 pre-filled pen) administered by subcutaneous injection. Your doctor or nurse will probably administer this injection.
• After the first dose, you will receive the next dose 4 weeks later and then every 8 weeks.

Psoriatic arthritis

• The dose is 100 mg (the content of 1 pre-filled pen) administered as a subcutaneous injection. Your doctor or nurse will probably administer this injection.
• After the first dose, you will receive the next dose 4 weeks later and then every 8 weeks. In some patients, after the first dose, Tremfya may be administered every 4 weeks. Your doctor will decide how often you can receive Tremfya.

Initially, your doctor or nurse will administer Tremfya. However, you may decide with your doctor that you can administer Tremfya yourself, in which case, you will receive the appropriate training on how to administer Tremfya. Consult your doctor or nurse if you have any doubts about administering the injections. It is essential that you do not attempt to administer Tremfya to yourself until your doctor or nurse has taught you.

To know how to use Tremfya, read carefully the "Instructions for use" leaflet before using it, which is attached to the packaging.

If you use more Tremfya than you should

If you have received more Tremfya than you should or the dose was administered before the prescribed time, inform your doctor.

If you forget to use Tremfya

If you have forgotten to administer a dose of Tremfya, inform your doctor.

If you interrupt treatment with Tremfya

Do not stop using Tremfya without first talking to your doctor. If you suspend treatment, your symptoms may reappear.

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

Severe Adverse Effects

Inform your doctor or seek immediate medical help if you experience any of the following severe adverse effects:

Severe Allergic Reaction(may affect up to 1 in 100people)- symptoms may include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• intense itching of the skin, with a red rash or swelling

Other Adverse Effects

The following adverse effects are all mild to moderate. If any of these adverse effects become severe, consult your doctor, pharmacist, or nurse immediately.

Some adverse effects are very common (may affect more than 1 in 10 people):

• respiratory tract infections

Some adverse effects are common (may affect up to 1 in 10 people):

• headache
• joint pain (arthritis)
• diarrhea
• redness, irritation, or pain at the injection site

• increased levels of liver enzymes in the blood

Some adverse effects are uncommon (may affect up to 1 in 100 people):

• allergic reaction
• skin rash
• decrease in the number of a type of white blood cell called neutrophils
• herpes simplex infection
• skin infection by fungi, for example between the toes (e.g., athlete's foot)
• gastroenteritis (stomach upset)
• hives

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly throughtheSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the pre-filled pen label and on the box after CAD. The expiration date is the last day of the month indicated.

Store the pre-filled pen in the outer packaging to protect it from light.

Store in refrigerator (2°C–8°C). Do not freeze.

Do not shake.

Do not use this medication if it warns that it is cloudy or has an abnormal color, or contains large particles. Before using the medication, remove the container from the refrigerator and keep the pre-filled pen inside until it reaches room temperature, waiting 30 minutes.

This medication is for single use. Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the medications that you no longer need. This will help protect the environment.

Composition of Tremfya

• The active ingredient is guselkumab. Each pre-filled pen contains 100 mg of guselkumab in1 ml of solution.
• The other components are histidine, monohydrochloride monohydrate of histidine, polisorbate 80, sucrose, and water for injection.

Appearance of Tremfya and contents of the pack

Injectable solution (injection). Tremfya is a transparent and colourless to pale yellow solution. It is presented in a carton pack containing a single-dose pre-filled pen and as a multiple pack containing 2 (2 x 1) single-dose pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333CB Leiden

Netherlands

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.

Fecha de la última revisión de este prospecto: 02/2021

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

If your doctor decides that you or a carer can administer Tremfya injections at home, you must learn to prepare and administer Tremfya correctly with the pre-filled pen before attempting the injection.

Read these instructions for use before using the pre-filled pen of Tremfya and each time you renew the prescription for the pre-filled pen. There may be new information. This guide does not replace the need to discuss your disease or treatment with your doctor.

Also, read carefully the leaflet before starting to inject and discuss any doubts you may have with your doctor or nurse.

Store in refrigerator between 2 °C and 8 °C.

Do notfreeze.

Keep Tremfya and all medicines out of the reach of children.

Do notshake the pre-filled pen at any time.

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

Inspect the carton pack

Remove the carton pack with the pre-filled pen from the refrigerator.

Keep the pre-filled pen in the carton pack and place it on a flat surface at room temperaturefor at least 30 minutesbefore using it.

Do notheat it in any other way.

Check the expiry date(EXP) on the carton pack.

Do notuse the medicinal product after the expiry date.

Do notinject the medicinal product if the holes in the pack are broken.

Speak to your doctor or pharmacist to have a new pre-filled pen prescribed.

Choose the injection site

Choose between the following areas to administer the injection:

Do notuse the area 5 cm around the navel.

• Upper back of the upper arm (if a carer administers the injection)

Do notinject into skin that is painful, bruised, red, scaly, hard or in areas with scars or stretch marks.

Wash your hands

Wash your hands thoroughly with warm water and soap.

Clean the injection site

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

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

Inspect the liquid in the viewing window

Remove the pre-filled pen from the carton pack.

Check the liquid in the viewing window. The liquid should be transparent or pale yellow and may contain small, translucent or white particles. You may also see one or more air bubbles.

This is normal.

Do notinject if the liquid is cloudy or has an abnormal colour, or contains large particles. If you are unsure, consult your doctor or pharmacist to obtain a new pre-filled pen.

Turn and remove the lower cap

Keep your hands away from the needle guard after removing the cap.

Inject within 5 minutes of removing the needle guard

Do notreplace the cap as the needle may be damaged.

Do notuse the pre-filled pen if it falls after removing the cap.

Speak to your doctor or pharmacist to obtain a new pre-filled pen.

Place it on the skin

Place the pre-filled pen directly on the skin (at an angle of about 90 degrees to the injection site).

Press the plunger down

The medicinal product is injected by pressing the plunger. Perform these steps at a comfortable pace.

Do notlift the pre-filled pen during the injection. The needle guard will be blocked and the full dose will not be administered.

Injection completed

The injection is complete when the plunger is pressed down fully, you hear a click, and the green body is no longer visible.

Remove the pre-filled pen

The yellow line indicates that the needle guard is blocked.

Dispose of the used pre-filled pen

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

When the container is full, dispose of the contents as instructed by your doctor or nurse.

Check the injection site

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

Apply gentle pressure to the skin with a cotton ball or gauze until the bleeding stops.

Do notrub the injection site.

If necessary, cover the injection site with a bandage.

Your injection is complete!