01.Item code: EM-30999Date of Preparation: May 2020

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.

GETTING TO KNOW TREMFYA®▼▼ (guselkumab)

A guide about your prescribed treatment for plaque psoriasis.

THIS GUIDE PROVIDES INFORMATION TO HELP YOU TO GET TO KNOW YOUR TREATMENT, TREMFYA®. Who is this treatment for?

How does it work?

What does Tremfya® contain?

How could this treatment help you with your psoriasis?

What you need to know before taking Tremfya®

How often you will receive your treatment

Side effects you should be aware of

Reporting side effects

Lifestyle factors and your psoriasis

Common questions

Notes

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15.iIf you have any questions about your treatment which are not covered in this guide, please speak with your healthcare professional.

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HOW DOES IT WORK?Tremfya® is for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Systemic therapies are treatments which work throughout the entire body rather than targeting just one area, such as topical treatments or UV therapy.

Tremfya® contains the active substance ‘guselkumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.

As part of your immune system response, a small protein in the body’s cells called IL-23 signals to your skin to grow more cells to replace old ones. Researchers have found that IL-23 can be overactive in sufferers of plaque psoriasis, which may cause your skin to grow up to ten times faster than normal.

Tremfya® targets and attaches itself to IL-23, blocking these signals and preventing the accelerated skin growth that results in plaque psoriasis symptoms. As this treatment suppresses this part of your immune system, it is classed as an immunosuppressant.

WHO IS THIS TREATMENT FOR?

WHAT IS TREMFYA®?

WHAT DOES TREMFYA® CONTAIN? HOW COULD THIS TREATMENT HELP YOU WITH YOUR PSORIASIS?Each pre-filled pen contains 100 mg of guselkumab in

1 mL solution.

Other ingredients contained in the pre-filled pen are histidine, histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injections.

Three large studies have shown how Tremfya® can help patients with moderate to severe plaque psoriasis.

In two of these studies, the majority of patients treated with Tremfya® found a significant reduction in the redness, thickness and peeling of their skin, and in the size of the affected area after 16 weeks.

In the third study, patients were switched to Tremfya® after they did not respond to a different treatment for psoriasis. After switching, more patients experienced skin clearance than those who didn’t switch.

Patients also reported an improvement in the impact of their skin on their quality of life, as well as improvements in symptoms such as itchiness, pain, skin tightness, dryness, cracking or bleeding.

You may experience a different response to your treatment compared to patients who took part in these studies. If you have any questions about how Tremfya® is working, you should speak to your healthcare professional.

WHAT IS TREMFYA®?

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WHAT YOU NEED TO KNOW BEFORE TAKING TREMFYA®

Before you use this treatment, please read the leaflet enclosed in the packaging carefully. It includes essential information such as possible side effects and when you shouldn’t use it.

If you have any questions or concerns it is important that you speak with your healthcare professional, especially if you:

• Have or have had a recent infection. Tremfya® may increase the chance of infection. If you have an active infection you will need to wait until this is resolved, or is adequately treated, before starting Tremfya®. If you are currently being treated with Tremfya® and have an active infection, this may need to be discontinued until the infection is treated. Please refer to the “What side effects should you look out for?” section for the signs and symptoms of an infection.

• Have or have had tuberculosis, or have been in close contact with someone who has tuberculosis. A doctor will perform a test to see if you have tuberculosis, if you do you will be treated for this prior to starting Tremfya®.

WHAT IS TREMFYA®?

• Need to receive a live vaccination. Before this type of vaccination, Tremfya® should be stopped for at least 12 weeks; you can restart your treatment from 2 weeks after receiving the vaccination. Before starting Tremfya®, you and your healthcare professional should consider if you should receive any immunisations.

• Are pregnant or are planning to become pregnant while using Tremfya®. The effects of this medicine on pregnant women and unborn babies are not known. Women who are able to have children are advised to use a reliable form of contraception whilst receiving their treatment and for at least 12 weeks after their last injection. If you are pregnant, or are planning to become pregnant during your treatment, please discuss this with your healthcare professional.

iYou should not use Tremfya® if you are allergic to any of its ingredients or if you have a clinically important active infection. If you are unsure if this applies to you, you should speak to your healthcare professional.

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HOW TO TAKE TREMFYA®

HOW OFTEN YOU WILL RECEIVE YOUR TREATMENTTremfya® is administered by a subcutaneous injection, meaning an injection under the skin.

The recommended dose is 100 mg. You will receive one dose at week 0 (the beginning of your treatment), then one dose at week 4, followed by one dose every 8 weeks.

You will be able to discuss with your healthcare professional how you want to receive your treatment, depending on what works best for you:

• Visit the hospital or clinic for your injection to be administered by a healthcare professional

• Sign up for the Homecare service to:

- Have a qualified nurse visit you and administer the injection - Have your medication delivered to you to then self-

administer the injection. You will need to be trained before you can inject yourself

The Homecare service is a personalised delivery and care service which may make it easier and more convenient for you to take your treatment.

Tremfya® dosing (weeks)

and so on...Weeks 0 4 8 12 16 20 24 28 32 36

= Injection due

Weeks Weeks Weeks Weeks Weeks Weeks Weeks Weeks Weeks

SIDE EFFECTS YOU SHOULD BE AWARE OFLike all medicines, Tremfya® can cause side effects, although not everybody gets them.

Most side effects experienced by patients in studies evaluating the effectiveness of the treatment were mild to moderate. These included:

• Upper respiratory infection - such as nose, sinus or throat infections

• Headache

• Joint pain

• Diarrhoea and stomach flu

• Redness at the injection site

• Hives

• Fungal infection of the skin

• Herpes simplex infections

This list is not exhaustive; you may experience other, less common side effects. You can find the full list of side effects in the leaflet in your medication packaging.

You should seek medical help immediately if you experience either of these more serious side effects:

• Signs of an allergic reaction such as difficulty breathing or swallowing, low blood pressure, which can cause dizziness or light-headedness, swelling of the face, lips, mouth or throat, severe itching of the skin with a red rash or raised bumps.

• Signs or symptoms of infection, such as fever or flu-like symptoms, muscle aches, persistent cough, blood in your phlegm, shortness of breath, weight loss, diarrhoea, stomach pain, warm, red or painful or sores which are different from your psoriasis, burning when you urinate or urinating more often than usual.

Please refer to the “Reporting side effects” section on the next page for information on what to do if you experience any side effects.

HOW TO TAKE TREMFYA®

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REPORTING SIDE EFFECTSIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store; and to Janssen-Cilag Ltd on 01494 567447.

By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO TAKE TREMFYA®

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.

Both inherited and environmental factors play a role in the development of psoriasis.

Some factors which may trigger a flare up of psoriasis for individuals include:

Stress• Simple changes to your lifestyle, such as practicing

relaxation techniques and being active may help you to cope with stress.

Alcohol and/or smoking• Alcohol can interact with certain psoriasis treatments,

although there are no known interactions with Tremfya®. If you drink alcohol excessively, reducing your intake might be helpful. You could also try to stop smoking.

Certain medications• Certain medications such as beta blockers (used to

treat high blood pressure and angina), lithium, anti-inflammatory medicines including ibuprofen and medicines used to treat malaria can cause psoriasis to flare up.

Injury to your skin• Such as a cut, scrape, insect bite or sunburn (this is

known as the Koebner response).

LIFESTYLE FACTORS AND YOUR PSORIASIS

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1. HOW DO I STORE TREMFYA®?

You must store it in the following ways:

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

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

• Keep the pre-filled medicine in the outer carton to protect them from light.

• Do not shake the pre-filled medicine.

• Remove the medicine from the fridge 30 minutes before your injection so it can reach room temperature.

If you think you’ve left your medicine out of the fridge longer than you should, place the pre-filled medicine back in the fridge and contact your healthcare professional, or homecare service, as soon as possible for advice.

COMMON QUESTIONS ABOUT YOUR TREATMENT

3. WHAT IF MY TREMFYA® IS LEFT OUTSIDE THE FRIDGE?

You should not use the dose if it is left out of the fridge for more than 30 minutes.

You can contact your healthcare professional or call your homecare service provider for advice if you do leave it out of the fridge.

2. HOW DO I TAKE TREMFYA® WITH ME WHEN I TRAVEL?

Your doctor will tell you how often to take the treatment - typically this is once every 8 weeks. If you are travelling between your scheduled doses you will not need to bring your medication with you. Check your calendar to see when your next dose is due and when you are travelling.

If you need to travel abroad when your dose is due, speak to your doctor and follow their recommendations. They are likely to give you a letter permitting you to travel with prescription medications.

Notify your airline carrier in advance that you will need to take your medication with you, and show the letter to airport security to let them know what you are carrying.

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4. HOW DO I DISPOSE OF MY USED TREMFYA® INJECTION?

According to Department of Health guidelines, used injectables should be placed in a puncture-resistant container, like a sharps container and returned to your pharmacist.

• You will receive a sharps container from your homecare service provider, and you can request a new sharps container with your next delivery if it is full.

Alternatively, you may be able to get a sharps container from your doctor or nurse. They will be able to advise you on how to use it and how to properly dispose of your used needles. You may even be able to return your healthcare waste to your local clinic.

• If neither of the methods suggested above are possible, you can contact your local council, who then have the duty to collect your healthcare waste from your home.

For more information, call your local council or visit https://www.gov.uk/dispose-hazardous-waste

• NEVER re-use an injectable, for your safety and the health and safety of others.

• Antiseptic wipes and other supplies can be disposed of in your household waste.

• Any unused medicine (e.g. pre-filled injections that are unusable or past their expiry date) should be disposed of with the syringe intact in a sharps container.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines if you are unsure.

Check that:

• The medicine hasn’t passed its expiry date. You can find this on the label and the carton after “EXP”. The expiry date refers to the last day of that month. Do not use the injection if the expiry date has passed.

• It hasn’t been exposed to extreme temperatures. Do not use the dose if you know, or think that it may have been accidentally frozen or heated.

• The product hasn’t been shaken vigorously. If it has, do not use the dose.

• The liquid in the viewing window is clear to slightly yellow. It may contain tiny white or clear particles. You may also see one or more air bubbles. This is normal.

Do not inject if the liquid is cloudy or discoloured, or has large particles. If you are uncertain, call your doctor or pharmacist for a refill.

Do not inject if the perforations on the carton are broken. Call your doctor or pharmacist for a refill.

5. WHAT DO I NEED TO CHECK BEFORE TAKING MY INJECTION?

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You should contact your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose.

If you would like to stop your treatment, you should discuss this with your doctor first. He/she will advise you on the best way to do this. If you stop the treatment your symptoms may come back.

7. CAN I STOP USING TREMFYA®?

6. WHAT IF I FORGET A DOSE?

You should talk to your doctor if you want to take a break from taking the medication. Whilst this is ultimately your decision, your doctor will be the best person to advise if this is appropriate.

8. WHAT IF I WANT A BREAK FROM TAKING TREMFYA®?

ANY QUESTIONSIf you still have questions which have not been answered by

this guide then speak to your healthcare professional.

Write any questions you have here, to discuss next time you see them.

Electronic Signature Form

Code: EM-30999

Name: Patient Pack Booklet (No PI) - March 2020 Update - digital

Country: United Kingdom

Product: TREMFYA_UK°

DistributionMethod:

Key Account Manager (KAM)

Audience: Doctor, Nurse, Patient, Patient Family, Patient Organisations, Pharmacist

Project Owner: Hannah Wilks

Document Type: Educational Material

I hereby certify that this material is in its final form and that, in my belief, it is in accordance with therequirements of the relevant local regulations and Code of Practice and is a fair and truthfulpresentation of the facts.

Signatory Approvals

Signatories ApprovalKathryn HamptonEMEA Signatories15-May-2020 14:54:35 GMT+0000