TREMFYA 100 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Tremfya 100 mg solution for injection in pre-filled syringe

guselkumab

This medicine is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may have. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tremfya and what is it used for
2. What you need to know before you use Tremfya
3. How to use Tremfya
4. Possible side effects
5. Storage of Tremfya
6. Contents of the pack and further information

1. What is Tremfya and what is it used for

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

This medicine works by blocking the activity of a protein called IL-23, which is found in higher amounts in people with psoriasis and psoriatic arthritis.

Plaque psoriasis

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

Tremfya may improve skin and nail conditions and reduce symptoms such as scaling, shedding, exfoliation, itching, pain, and discomfort.

Psoriatic arthritis

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

Using Tremfya for psoriatic arthritis will help you by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bones of the joints, and improving your ability to perform normal daily activities.

2. What you need to know before you use Tremfya

Do not use Tremfya

• If you are allergic to guselkumab or any of the other ingredients of this medicine (listed in 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

Talk to your doctor, pharmacist, or nurse before using Tremfya:

• If you are being treated 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 have an infection or symptoms of an infection (see below "Monitoring for infections and allergic reactions").
• If you have been vaccinated recently or are about to be vaccinated. You should not receive certain types of vaccines (live vaccines) while using Tremfya.

If you are not sure if any of the above conditions apply to you, talk to your doctor, pharmacist, or nurse before using Tremfya.

Following your doctor's instructions, before you receive Tremfya and when you are about to use it, you may need to have blood tests to check if you have elevated levels of liver enzymes. Increases in liver enzymes 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).

Monitoring for infections and allergic reactions

Tremfya has the potential to cause serious side effects, including allergic reactions and infections. You should monitor for signs of these conditions while you are receiving Tremfya.

Stop using Tremfya and consult your doctor or seek immediate medical attention if you notice any signs that may indicate a serious allergic reaction or infection.

Signs of infection may include fever or flu-like symptoms; muscle pain; cough; difficulty breathing; painful urination or urinating more frequently than usual; blood in the sputum; weight loss; diarrhea or stomach pain; hot, red, or painful skin, or sores on the body that are different from psoriasis lesions.

Serious allergic reactions have occurred with Tremfya, which may include the following symptoms: swelling of the face, lips, tongue, or throat; difficulty swallowing or breathing; and hives (see "Serious side effects" in section 4).

Children and adolescents

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

Other medicines and Tremfya

Talk to your doctor or pharmacist:

• If you are using, have recently used, or might use any other medicine.

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

Pregnancy and breastfeeding

• Tremfya should not be used during pregnancy, as the effects of this medicine on pregnant women are not known. If you are a woman of childbearing age, you are advised to avoid becoming pregnant and to use an adequate method of contraception during treatment with Tremfya and for at least 12 weeks after the last dose of Tremfya.

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.

• Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide if you can breastfeed or use Tremfya.

Driving and using machines

Tremfya is unlikely to affect your ability to drive or use machines.

3. How to use Tremfya

Follow exactly the administration instructions of this medicine given by your doctor or nurse. If you are not sure, consult your doctor, nurse, or pharmacist.

How much Tremfya to use and for how long

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

Plaque psoriasis

• The dose is 100 mg (the contents of 1 pre-filled syringe) given by injection under the skin (subcutaneous injection). Your doctor or nurse will probably give you 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 contents of 1 pre-filled syringe) given by injection under the skin (subcutaneous injection). Your doctor or nurse will probably give you 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 given every 4 weeks. Your doctor will decide how often you can receive Tremfya.

At first, your doctor or nurse will inject Tremfya. However, you and your doctor may decide that you can inject Tremfya yourself, in which case you will receive proper training on how to inject Tremfya. Consult your doctor or nurse if you have any questions about administering the injections. It is important that you do not try to inject yourself until your doctor or nurse has taught you how to do it.

To learn how to use Tremfya, read the "Instructions for use" leaflet carefully 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 has been given before the scheduled time, tell your doctor.

If you forget to use Tremfya

If you have forgotten to inject a dose of Tremfya, tell your doctor.

If you stop using Tremfya

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor or seek immediate medical attention if you experience any of the following side effects:

Possible serious allergic reaction(may affect up to 1 in 100 people) - the signs may include:

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

Other side effects

The following side effects are all mild to moderate. If any of these side effects gets serious, talk to your doctor, pharmacist, or nurse immediately.

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

• respiratory tract infections

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

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

• increased levels of liver enzymes in the blood

Some side 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 infections
• skin fungal infections, for example, between the toes (e.g., athlete's foot)
• stomach upset (gastroenteritis)
• hives

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tremfya

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

Do not use this medicine after the expiry date which is stated on the label of the syringe and on the carton after EXP. The expiry date is the last day of the month stated.

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

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

Do not shake.

Do not use this medicine if you notice it is cloudy or has an unusual color, or if it contains large particles. Before using the medicine, take the packaging out of the refrigerator and keep the pre-filled syringe inside until it reaches room temperature, waiting for 30 minutes.

This medicine is for single use only. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Tremfya

• The active substance is guselkumab. Each prefilled syringe contains 100 mg of guselkumab in 1 ml of solution.
• The other components are histidine, monohydrated histidine monohydrochloride, polysorbate 80, sucrose, and water for injectable preparations.

Appearance of Tremfya and Container Contents

Injectable solution (injection). Tremfya is a clear to light yellow solution. It is presented in a cardboard container containing a single-dose glass syringe

and as a multiple container containing 2 (2 containers of 1) single-dose prefilled syringes. Not all pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333CB Leiden

Netherlands

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

Date of the last revision of this leaflet: 02/2021

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

Instructions for Use

Tremfya

Prefilled Syringe

Important

If your doctor decides that you or a caregiver can administer the Tremfya injections at home, you must learn to prepare and inject Tremfya correctly with the prefilled syringe before attempting the injection.

Read these instructions for use before using the Tremfya prefilled syringe and each time you renew your prescription. There may be new information. This instruction guide does not replace the need to talk to your doctor about your disease or treatment. Also, read the package leaflet carefully before starting to inject yourself and consult any questions you have with your doctor or nurse.

The Tremfya prefilled syringe should be injected under the skin and not into a muscle or vein. After the injection, the needle will retract into the syringe body and lock into place.

Store in the refrigerator between 2 °C and 8 °C. Do notfreeze.

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

Do notshake the prefilled syringe at any time.

FOR SINGLE USE ONLY

The Prefilled Syringe at a Glance

Inspect the Carton

Remove the carton containing the prefilled syringe from the refrigerator.

Keep the prefilled syringe in the carton and place it on a flat surface at room temperature for at least 30 minutesbefore using it.

Do notheat it in any other way.

Check the Expiration Date (EXP)on the back of the carton.

Do notuse the medicine after the expiration date.

Do notinject the medicine if the carton perforations are broken.

Talk to your doctor or pharmacist to have the medicine prescribed again.

Choose the Injection Site

Choose from the following areas to administer the injection:

• Front of the thighs(recommended)
• Lower abdomen

Do notuse the area within 5 cm of the navel.

• Upper outer arm (if a caregiver is administering the injection)

Do notinject into painful, bruised, red, scaly, or hard skin.

Do notinject into areas with scars or stretch marks.

Clean the Injection Site

Wash your hands well with warm water and soap.

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

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

Inspect the Liquid

Remove the prefilled syringe from the carton.

Check the liquid in the viewing window. The liquid should be clear or light yellow and may contain tiny 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 color, or contains large particles. If you are unsure, consult your doctor or pharmacist to have the medicine prescribed again.

Remove the Needle Cap

Hold the syringe by the body and remove the needle cap.

It is normal to see a drop of liquid.

Inject within 5 minutes of removing the needle cap.

Do notreplace the needle cap because the needle could be damaged.

Do nottouch the needle or let it touch any surface.

Do notuse the Tremfya prefilled syringe if it is dropped. Consult your doctor or pharmacist to have the medicine prescribed again.

Place Fingers and Insert Needle

Place your thumb, index, and middle fingers directly below the finger flange, as indicated.

Do nottouch the plunger or the area above the finger flange because this could activate the needle safety device.

Use your other hand to pinch the skin at the injection site.

Place the syringe at a 45° angle to the skin.

It is important to pinch a sufficient amount of skin to inject under the skinand not into the muscle.

Insert the needle with a quick motion, like throwing a dart.

Release Pinch and Replace Hand

Use your free hand to grasp the syringe body.

Press the Plunger

Place the thumb of your other hand on the plunger and press it until it stops.

Release Plunger Pressure

The safety protector will cover the needle and lock it into place, removing it from the skin.

Dispose of the Used Syringe

Place the used syringe in a sharps container after use.

When the container is full, dispose of the material according to the instructions of your doctor or nurse.

Check the Injection Site

There may be a small amount of blood or liquid at the injection site.

Apply 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 band-aid.

Your injection is complete!

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