Patient Information Leaflet

IMULDOSA 90 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 for 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 refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

What is IMULDOSA used for

IMULDOSA is used to treat the following inflammatory diseases:

• Plaque psoriasis - in adults and children 6 years of age 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 moderate to severe plaque psoriasis 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 moderate to severe plaque psoriasis 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 bowel disease. If you have Crohn's disease, you will first be given other medications. If you do not respond adequately or cannot tolerate these medications, you may be given IMULDOSA to reduce the signs and symptoms of your disease.

Do not use IMULDOSA

• If you are allergic to ustekinumabor to 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 points apply to you, talk to your doctor or pharmacist before using IMULDOSA.

Warnings and precautions

Consult your doctor or pharmacist before starting to use IMULDOSA. Your doctor will check how you are before each treatment. Make sure to tell your doctor about any illness you have before each treatment. Your doctor will also ask if you have recently been near someone who may have tuberculosis. Your doctor will examine you and do a test for tuberculosis before using IMULDOSA. If your doctor thinks you are at risk of tuberculosis, they may give you medicine to treat it.

Watch for serious side effects

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

Tell your doctor:

• If you have ever had an allergic reaction to IMULDOSA.Consult your doctor if you are not sure.
• If you have ever had any type of cancer– this is because the immunosuppressants like IMULDOSA weaken part of the immune system. This may increase the risk of getting cancer.
• If you have received treatment for psoriasis with other biologics (a medicine made from a biological source and usually given by injection)– the risk of getting cancer may be higher.
• If you have any new lesions or changes to the lesionswithin the psoriasis area or on intact skin.
• If you have or have had a recent infection.
• 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 (UV) light). These treatments may also weaken part of the immune system. The use of these treatments together with IMULDOSA has not been studied. However, it may increase the likelihood of getting diseases related to a weaker immune system.
• If you are receiving or have received injections to treat allergies– it is unknown if IMULDOSA may affect these treatments.
• If you are 65 years or older– you are more likely to get infections.

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

Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including lupus cutaneous 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 sun-exposed areas or if accompanied by joint pain.

Heart attacks and strokes

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

Children and adolescents

IMULDOSA 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, or ulcerative colitis, as it has not been studied in this age group.

Using IMULDOSA with other medicines, vaccines

Tell your doctor or pharmacist:

• If you are using, have used recently, or may use other medicines.
• If you have been vaccinated recently or are to receive a vaccine. Certain types of vaccines (live vaccines) should not be given while using IMULDOSA.
• If you received IMULDOSA during pregnancy, inform your baby's doctor about your treatment with IMULDOSA before your baby receives any vaccine, 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 IMULDOSA during pregnancy, unless your baby's doctor recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• No increased risk of birth defects has been observed in babies exposed to Imuldosa in the womb. However, there is limited experience with Imuldosa in pregnant women. Therefore, it is preferable to avoid using Imuldosa during pregnancy.
• If you are a fertile woman, it is recommended that you avoid becoming pregnant and use adequate contraceptive measures while using Imuldosa and for at least 15 weeks after the last treatment with Imuldosa. Imuldosa may pass through the placenta to the fetus. If you received Imuldosa during pregnancy, your baby may be at increased risk of infection.
• It is essential to inform your baby's doctors and other healthcare professionals if you received Imuldosa during pregnancy before your baby receives any vaccine. 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 Imuldosa during pregnancy, unless your baby's doctor recommends otherwise.
• Ustekinumab may be excreted in breast milk in very small amounts. Inform your doctor if you are breastfeeding or plan to do so. You and your doctor will decide whether to breastfeed or use Imuldosa. Do not do both at the same time.

Driving and operating machines

The influence of IMULDOSA on the ability to drive and operate machines is negligible or insignificant.

IMULDOSA contains polysorbate

IMULDOSA contains 0.05 mg of polysorbate 80 in each volume unit, equivalent to 0.04 mg per dose of 90 mg.

Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

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. If in 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-injecting.

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 have 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 treatment with ustekinumab.

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 cough
• Warm, red, and painful skin or a painful rash with blisters on the skin
• Difficulty urinating
• Diarrhea
• Visual deterioration or loss of vision
• Headache, neck stiffness, photosensitivity, nausea, or confusion.

Contact 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 disappear or reappears. Your doctor may decide that you should not use IMULDOSA until the infection has cleared up. 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 on 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(they 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(they may affect up to 1 in 100 people):

• Dental infections
• Vaginal yeast infections
• Depression
• Stuffy nose or nasal congestion
• Bleeding, petechiae, induration, 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 (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects(they may affect up to 1 in 1,000 people):

• Redness and skin peeling on 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(they 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 about the safety of this medicine.

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

Do not use this medication:

• After the expiration date that appears on the label and packaging 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 packaging”).
• 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 the packaging and unused medications. This will help protect the environment.

Composition of IMULDOSA

• The active ingredient is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 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 pack

IMULDOSA is a transparent to slightly opalescent, colourless to slightly yellowish injectable solution. It is presented in a pack containing 1 pre-filled syringe of 1 ml of glass for single use. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml of injectable solution.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th Floor

08039 Barcelona

Spain

Responsible Person

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 authorisation 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 update 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 the administration of 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 how the pre-filled syringe looks.

1. Check the number of pre-filled syringes and prepare the materials:

Preparing to use the pre-filled syringe

• Take the pre-filled syringe(s) out of the refrigerator. Leave the pre-filled syringe out of the box 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 the temperature to reach room temperature.
• Hold the pre-filled syringe by the body with the needle cap pointing upwards.
• Do not pick up the pre-filled syringe by the plunger, the plunger, the wings of the needle shield, or the needle cap.
• Do not remove the plunger at any time.
• Do not remove the needle cap until instructed to do so.
• Do not touch the activation clips of the needle shield to avoid the needle shield covering the needle too soon.

Check the pre-filled syringe(s) to ensure that

• the number of pre-filled syringes and the concentration are correct

• If your dose is 90 mg, you will have a pre-filled syringe of 90 mg of IMULDOSA

• it is the correct medicine.
• the expiration date has not expired.
• the pre-filled syringe is not damaged.
• the solution in the pre-filled syringe is transparent to slightly opalescent and colourless to slightly yellowish.
• the solution in the pre-filled syringe does not have an abnormal colour, 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 sharps container.

1. Choose and prepare the injection site:

Choose the injection site (see Figure 2).

• IMULDOSA is administered by subcutaneous injection.
• Some suitable injection sites 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 skin areas 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 thoroughly with soap and water.
• Clean the skin at the injection site with an antiseptic wipe.
• Do not touch this area again before administering the injection.

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

• The needle capmust not be removeduntil you are ready to administer the injection.
• Hold the pre-filled syringe, and hold the body of the pre-filled syringe with one hand.
• Remove the needle cap 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 allow it to touch any surface.
• Do not use the pre-filled syringe if it has fallen without the needle cap. If this happens, tell your doctor or pharmacist.
• Administer the dose immediately after removing the needle cap.

1. Administer the dose:

• Hold the pre-filled syringe with one hand between the index and middle fingers, place the thumb on 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).

• Administer the entire 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, maintain the pressure on the plunger, remove the needle, and release the skin (see Figure 6).

• Slowly remove the thumb from 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.
• A small amount of blood or liquid may appear at the injection site. This is normal.
• You can press a cotton ball or gauze on 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, preferably a sharps container (see Figure 8). For your safety and health and for the safety of others, never reuse the syringe. Dispose of your sharps container according to local regulations.
• The antiseptic wipes and other materials can be disposed of in the trash.