YESINTEK 90 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

Yesintek90 mg solution for injection in pre-filled syringe

Ustekinumab

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

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

This leaflet has been written for the person taking the medicine. If you are the parent or caregiver of a child who will be givenYesintek, please read this information carefully.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Yesintek and what is it used for

What is Yesintek

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

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

What is Yesintek used for

Yesintek is used to treat the following inflammatory diseases:

• Plaque psoriasis - in adults and children aged 6 years and over
• 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. Yesintek reduces inflammation and other signs of the disease.

Yesintek is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or where these treatments do not work.

Yesintek is used in children and adolescents aged 6 years and over with moderate to severe plaque psoriasis who are not able to tolerate phototherapy or other systemic therapies or where these treatments do not work.

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory disease of the joints, 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 Yesintek 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 cannot tolerate these medicines, you may be given Yesintek to reduce the signs and symptoms of your disease.

2. What you need to know before you use Yesintek

Do not use Yesintek

• If you are allergic to ustekinumabor any of the other ingredients of this medicine (listed in section 6).
• If you have an active infectionthat your doctor thinks is important.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Yesintek.

Warnings and precautions

Talk to your doctor or pharmacist before starting Yesintek. Your doctor will check how you are before each treatment. Make sure you tell your doctor about any illness you have before each treatment. Also, tell your doctor if you have recently been near someone who may have tuberculosis. Your doctor will examine you and do a test to detect tuberculosis before you use Yesintek. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Watch for serious side effects

Yesintek may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while you are using Yesintek. See the complete list of these side effects in “Serious side effects” in section 4.

Tell your doctor before using Yesintek:

• If you have ever had an allergic reaction to Yesintek. Talk to your doctor if you are not sure.
• If you have ever had any type of cancer– this is because immunosuppressants like Yesintek weaken part of the immune system. This may increase the risk of having cancer.
• If you have been treated for psoriasis with other biologics (a medicine produced from a biological source and usually given by injection)– the risk of having cancer may be higher.
• If you have had a recent infection.
• If you have any new or changing lesionswithin the area of psoriasis or on intact skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis –such as any other immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet light (UV)). These treatments may also weaken part of the immune system. It has not been studied whether these treatments can be used together with Yesintek. However, it is possible that it may increase the likelihood of suffering from diseases related to a weaker immune system.
• If you are receiving or have ever received allergy shots– it is not known if Yesintek can affect these treatments.
• If you are 65 years of age or older– you are more likely to get infections.

If you are not sure if any of these conditions apply to you, talk to your doctor or pharmacist before using Yesintek.

Some patients have experienced lupus-like reactions during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Talk to your doctor immediately if you experience a red, raised, and scaly skin rash, sometimes with a darker border, in areas of skin exposed to the sun or if accompanied by joint pain.

Heart attacks and strokes

In a study of patients with psoriasis treated with Yesintek, heart attacks and strokes have been observed. Your doctor will periodically check your risk factors for heart disease and stroke to ensure they are being treated properly. Seek medical attention immediately if you experience chest pain, weakness, or an unusual feeling on one side of your body, facial paralysis, or abnormalities in speech or vision.

Children and adolescents

Yesintek is not recommended for use in children under 6 years of age with psoriasis or in children under 18 years of age with psoriatic arthritis, Crohn's disease, as it has not been studied in this age group.

Using Yesintek with other medicines, vaccines

Tell your doctor or pharmacist:

• If you are using, have recently used, or might use other medicines.
• If you have been vaccinated recently or are going to have a vaccination.Certain types of vaccines (live vaccines) should not be given while you are using Yesintek.
• If you received Yesintek during pregnancy, inform your baby's doctor about your treatment with Yesintek before your baby receives any vaccination, including live vaccines such as the BCG vaccine (used to prevent tuberculosis).Live vaccines are not recommended for your baby in the first 12 months after birth if you received Yesintek during pregnancy, unless your baby's doctor recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant or think you may be pregnant, consult your doctor before using this medicine.
• No increased risk of birth defects has been seen in babies exposed to Yesintek in the womb.However, there is limited experience with Yesintek in pregnant women. Therefore, it is preferable to avoid using Yesintek during pregnancy.
• If you are a woman of childbearing age, you are advised to avoid becoming pregnant and to use adequate contraceptive measures while you are using Yesintek and for at least 15 weeks after the last treatment with Yesintek.
• Yesintek may pass through the placenta to the fetus.If you received Yesintek during pregnancy, your baby may have a higher risk of getting an infection. It is important that you inform your baby's doctors and other healthcare professionals if you received Yesintek during your pregnancy before your baby receives any vaccination. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your baby in the first 12 months after birth if you received Yesintek during pregnancy, unless your baby's doctor recommends otherwise.
• Ustekinumab may be excreted in breast milk in very small amounts.Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether you should breastfeed or use Yesintek. Do not do both.

Driving and using machines

Yesintek has no or negligible influence on the ability to drive and use machines.

Yesintek contains polysorbate 80 (E 433)

This medicine contains 0.04 mg of polysorbate 80 (E 433) in each pre-filled syringe of 90 mg/1 ml, equivalent to 0.04 mg/ml (0.0004 mg/kg per day). Polysorbates may cause allergic reactions. Tell your doctor if you or your children have allergies.

3. How to use Yesintek

Yesintek should be used under the guidance and supervision of a doctor with experience in the treatment of the conditions for which Yesintek is indicated.

Always follow exactly the instructions of your doctor. If you are not sure, ask your doctor. Ask your doctor when you should have the injections and about follow-up appointments.

How much Yesintek is given

Your doctor will decide how much Yesintek you need to use and the duration of treatment.

Adults aged 18 years and over

Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg of Yesintek.Patients weighing more than 100 kilograms (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 following doses are usually the same as the starting dose.

Crohn's disease

• During treatment, your doctor will give you the first dose of approximately 6 mg/kg of Yesintek through a vein in your arm (intravenous infusion).After the initial dose, you will receive the next dose of 90 mg of Yesintek 8 weeks later and then every 12 weeks, given as an injection under the skin (“subcutaneously”).
• In some patients, after the first injection under the skin, 90 mg of Yesintek will be given every 8 weeks.Your doctor will decide when you should receive the next dose.

Children and adolescents aged 6 years and over

Psoriasis

• Your doctor will tell you the correct dose for you, including the amount (volume) of Yesintek to inject to give the correct dose.The correct dose for you will depend on your body weight at the time each dose is given.
• A vial of 45 mg is available for children who need to receive less than the full dose of 45 mg.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Yesintek per kilogram of body weight.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Yesintek.
• If you weigh more than 100 kg, the recommended dose is 90 mg of Yesintek.
• After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks.

How Yesintek is given

• Yesintek is given as an injection under the skin (“subcutaneously”).At the start of your treatment, medical staff may give you the injection.
• However, you and your doctor may decide that you can give yourself the injection of Yesintek.In this case, you will be trained on how to inject Yesintek yourself.
• For instructions on how to inject Yesintek, see “Administration instructions” at the end of this leaflet.

Talk to your doctor if you have any questions about how to inject yourself.

If you use more Yesintek than you should

If you have used or been given too much Yesintek, talk to your doctor or pharmacist immediately. Always carry the medicine box with you, even if it is empty.

If you forget to use Yesintek

If you miss a dose, talk to your doctor or pharmacist. Do not take a double dose to make up for forgotten doses.

If you stop using Yesintek

Stopping Yesintek is not dangerous. However, if you stop using it, your symptoms may come back.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Some patients may have severe adverse effects that may require urgent treatment.

Allergic Reactions – these may require urgent treatment. Contact your doctor or get emergency medical help immediately if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in the population using Yesintek (may 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 hives (these may affect up to 1 in 100 people).

In rare cases, allergic reactions at the lung level and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you have symptoms such as cough, difficulty breathing, and fever.

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

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

• Nose or throat infections and the common cold are frequent (may affect up to 1 in 10 people).
• Chest infections are uncommon (may affect up to 1 in 100 people).
• Inflammation of the tissues under the skin ("cellulitis") is uncommon (may affect up to 1 in 100 people).
• Herpes (a type of painful rash with blisters) is uncommon (may affect up to 1 in 100 people).

Yesintek may affect your ability to fight infections. Some of them could become serious and be caused by viruses, fungi, bacteria (including tuberculosis), or parasites, and include infections that occur mainly in people with a weakened immune system (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving treatment with ustekinumab.

You should watch for signs of infection while using Yesintek. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or having difficulty breathing; cough that does not go away
• having hot, red, and painful skin or having a painful skin rash with blisters
• burning when urinating
• diarrhea
• visual impairment or loss of vision
• headache, neck stiffness, photosensitivity, nausea, or confusion.

Communicate with your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as chest infections, skin infections, herpes, or opportunistic infections that could have serious complications. You should also inform your doctor if you have any type of infection that does not go away or comes back. Your doctor may decide that you should not use Yesintek until the infection goes away. Also, contact your doctor if you have any open cuts or ulcers that could become infected.

Skin Detachment – increased redness and skin detachment over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin disorders. If you notice any of these symptoms, you should inform your doctor immediately.

Other Adverse Effects

Frequent Adverse Effects(may affect up to 1 in 10 people):

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

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• Dental infections
• Vaginal yeast infections
• Depression
• Nasal congestion or stuffiness
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and sinking of the muscles on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small, yellow, or white skin blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (skin exfoliation)
• Acne

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• Redness and skin detachment over a large area of the body, which can cause itching or pain (exfoliative dermatitis). Similar symptoms may develop as a natural change in psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which can cause a skin rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Blisters on the skin, which can be red and cause itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, and scaly skin rash in sun-exposed areas, possibly accompanied by joint pain).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Yesintek

• Keep this medicine out of sight and reach of children.
• Store in the refrigerator (2 °C – 8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect it from light.
• If necessary, individual pre-filled syringes of Yesintek can also be stored at room temperature up to 30°C for a maximum of one period of up to 30 days in their 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 must be discarded in the space provided 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 30°C), it must not be stored in the refrigerator again. Discard the syringe if it is not used within 30 days of storage at room temperature or from the original expiration date, whichever comes first.
• Do not shake the pre-filled syringes of Yesintek. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiration date stated on the label and packaging after "EXP". The expiration date is the last day of the month indicated.
• After the expiration date recorded on the packaging once the product has been stored at room temperature; i.e., no more than 30 days at a maximum of 30 °C.
• If the liquid changes color, is cloudy, or has foreign particles floating in it (see section 6 "Appearance of the product and packaging").
• If you know or believe that it has been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been vigorously shaken.

Yesintek is for single use. You must discard any unused product remaining in the syringe. Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Container Contents and Additional Information

Yesintek Composition

• The active ingredient is ustekinumab. Each prefilled syringe contains 90 mg of ustekinumab in 1 ml.
• The other components are L-histidine, L-histidine monohydrate monohydrochloride, polysorbate 80 (E433), sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injectable preparations.
• This medication contains 0.04 mg of polysorbate 80 (E 433) in each 90 mg/1 ml prefilled syringe, equivalent to 0.04 mg/ml (0.0004 mg/kg/day). Polysorbates can cause allergic reactions. Inform your doctor if you or your children have allergies.

Product Appearance and Container Contents

Yesintek is a clear, pale yellow to colorless solution for infusion. It is presented in a container that contains 1 prefilled syringe of 1 ml of glass. Each prefilled syringe contains 90 mg of ustekinumab in 1 ml of injectable solution.

Marketing Authorization Holder

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate,

Dublin 13, DUBLIN

Ireland, D13 R20R

Manufacturer

Biosimilar Collaborations Ireland Limited

Block B, The Crescent Building, Santry Demesne

Dublin

D09 C6X8

Ireland

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

Date of Last Revision of this Leaflet

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: https://www.ema.europa.eu.

Instructions for Administering the Yesintek Injection

Figure 1 shows what the prefilled syringe looks like.

Administration Instructions

At the start of treatment, your healthcare professional will help you with your first injection. However, you and your doctor may decide that you can inject Yesintek yourself. In this case, they will teach you how to inject Yesintek.

Talk to your doctor if you have any questions about administering the injections.

• Do not mix Yesintek with other injectable liquids.
• Do not shake the Yesintek prefilled syringes. The medication may deteriorate if shaken vigorously. Do not use the medication if it has been shaken vigorously.

1. Check the number of prefilled syringes and prepare the materials:

Preparation for using the prefilled syringe

• Remove the prefilled syringe(s) from the refrigerator. Let the prefilled syringe sit outside the carton for 30 minutes. This will allow the liquid to reach a comfortable temperature for administration (room temperature). Do not remove the needle cap while waiting for it to reach room temperature.
• Hold the prefilled syringe by the body with the needle cap pointing upwards.
• Do not hold the prefilled syringe by the plunger head, plunger, or needle cap.
• Do not remove the plunger at any time.
• Do not remove the safety guard from the prefilled syringe.
• Do not remove the needle cap from the prefilled syringe until instructed to do so.
• Check the prefilled syringe(s) to ensure that the number of prefilled syringes and concentration are correct. If your dose is 45 mg, you will have one 45 mg prefilled syringe of Yesintek. If your dose is 90 mg, you will have two 45 mg prefilled syringes of Yesintek and you will need to administer two injections. Choose two different injection sites (e.g., one in the right thigh and one in the left thigh), and inject one after the other.
• It is the correct medication.
• It has not expired.
• The prefilled syringe is not damaged.
• The solution in the prefilled syringe is clear, pale yellow to colorless.
• The solution in the prefilled syringe does not have an abnormal color, is not cloudy, or contains foreign particles.
• The solution in the prefilled syringe is not frozen.
• Place all necessary items on a flat, clean, and well-lit surface, including antiseptic wipes, cotton balls or gauze, and a sharps container.

Storage

Yesintek prefilled syringes should be stored at a temperature of 2 °C to 8 °C (36 F to 46 F) in the original carton to protect it from light until the time of use.

• Do not freeze. Do not shake.
• If necessary, individual prefilled syringes can be stored at room temperature up to 30 °C (86 F) for a maximum of 30 days in the original carton to protect it from light.
• Once the prefilled syringe is stored at room temperature, it must not be put back in the refrigerator.
• Discard the prefilled syringe if not used after 30 days stored at room temperature.

Prepare the necessary items

Place all necessary items on a flat, clean, and well-lit surface. This includes:

• antiseptic wipes
• cotton balls or gauze
• sharps container
• Your prescribed dose of Yesintek injection (see Figure 2)

Figure 2

1. Choose and prepare the injection site:

Choose the injection site (see Figure 3).

• Yesintek is administered by injection under the skin (subcutaneously).
• Some suitable injection sites are the upper thigh or the abdominal area, at least 5 cm from the navel.
• Whenever possible, do not use skin areas that show signs of psoriasis.
• If someone else is administering the injection, they can also choose the upper arm as an injection site.

*The blue areas represent the recommended injection sites.

Prepare the injection site

• Wash your hands thoroughly with soap and warm water. Do not touch your face or hair after washing your hands.
• Clean the skin at the injection site with an antiseptic wipe.
• Do nottouch this area again before administering the injection.
• Remove the prefilled syringe from the carton.
• Open the container by removing the cover. Hold the needle guard (as shown in Figure 4) to remove the prefilled syringe from the container.

Figure 4

• Hold the prefilled syringe with the needle guard pointing upwards without removing the needle guard.

1. Remove the needle cap (see Figure 5):

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

Figure 5

• You may notice an air bubble in the prefilled 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 prefilled syringe if it has been dropped without the needle cap. If this happens, inform your doctor or pharmacist.
• Inject the dose immediately after removing the needle cap.

1. Inject the dose:

• Hold the prefilled syringe with one hand between the index and middle fingers, place your thumb on the plunger head, and with the other hand gently pinch a fold of disinfected skin with your thumb and index finger. Do not squeeze.
• Do not remove the plunger at any time.
• With a single rapid motion, insert the needle through the skin until it reaches as far as it can (see Figure 6).

Figure 6

Inject all the medication by pushing the plunger until the plunger head is fully between the wings of the needle guard (see Figure 7).

Figure 7

When you have pushed the plunger as far as it will go, maintain pressure on the plunger head, remove the needle, and release the skin (see Figure 8).

Figure 8

Slowly remove your thumb from the plunger head so that the empty syringe moves forward until the needle is completely covered by the needle guard, as shown in Figure 9:

Figure 9

1. After the injection:

• Press the injection site with an antiseptic wipe for a few seconds after the injection.
• A small amount of blood or liquid may appear at the injection site. This is normal.
• You can press the injection site with a cotton ball or gauze 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:

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 10). For your safety and health and the safety of others, never reuse the syringe. Dispose of your sharps container according to local regulations.
• Antiseptic wipes and other materials can be discarded in the trash.

Figure 10

Manufactured by:

Biosimilar Collaborations Ireland Limited

Block B, The Crescent Building, Santry Demesne

Dublin

D09 C6X8

Ireland

Marketed by:

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate,

Dublin 13, DUBLIN

Ireland, D13 R20R

Revised: MM/YYYY