Usrenty

Package leaflet: Information for the user

Usrenty 130 mg concentrate for solution for infusion

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid
identification of new safety information. You can help by reporting any side effects you experience
while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 people who are taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Usrenty is and what it is used for
2. What you need to know before using Usrenty
3. How Usrenty will be used
4. Possible side effects
5. How to store Usrenty
6. Contents of the pack and other information

1. What Usrenty is and what it is used for What Usrenty is

Usrenty contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific target proteins in the body.
Usrenty belongs to a group of medicines called “immunosuppressants”. These medicines reduce the activity of the immune system.
What Usrenty is used for
Usrenty is used to treat moderately to severely active Crohn's disease in adults.
Crohn's disease is an inflammatory bowel disease. If you have Crohn's disease, you will first be treated with other medicines. If you do not respond adequately or are intolerant to these treatments, Usrenty may be given to reduce the signs and symptoms of the disease.

2. What you need to know before using Usrenty

Do not use Usrenty

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6)
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or
pharmacist before using Usrenty.
Warnings and precautions
Talk to your doctor or pharmacist before using Usrenty. Your doctor will check your health status
before starting treatment. Make sure to inform your doctor about any medical conditions you have
before treatment. Also, inform your doctor if you have recently been in contact with people who
might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis
before administering Usrenty. If your doctor believes you are at risk of tuberculosis, you may be
given medication to treat tuberculosis.
Be aware of serious side effects
Usrenty may cause serious side effects, including allergic reactions and infections. You should be
alert to certain signs of illness while taking Usrenty. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using Usrenty, inform your doctor:

• If you have ever had an allergic reaction to Usrenty – ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Usrenty partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicine derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you currently have or have recently had an infection or if you have abnormal openings on the skin (fistulas).
• If you have ever had any new or changed lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The use of these therapies together with Usrenty has not been studied. However, it could increase the likelihood of conditions related to a weakened immune system.
• If you are using or have ever used injections for allergy treatment – it is not known whether Usrenty could affect these treatments.
• If you are aged 65 years or older – you may have an increased risk of infections. If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before starting treatment with Usrenty.

During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on sun-exposed areas of skin, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with Usrenty, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Usrenty is not recommended for the treatment of children under 18 years of age with Crohn’s disease, as it has not been studied in this age group.
Other medicines, vaccines, and Usrenty
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Usrenty.
• if you received Usrenty during pregnancy, inform the child’s paediatrician about the Usrenty treatment before the child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Usrenty during pregnancy, live vaccines are not recommended for the child during the first twelve months after birth, unless otherwise recommended by the child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• No increased risk of congenital malformations has been observed in infants exposed to Usrenty in utero. However, experience with Usrenty in pregnant women is limited. Therefore, it is preferable to avoid using Usrenty during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Usrenty and for at least 15 weeks after stopping treatment with Usrenty.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Usrenty during pregnancy, the infant may have an increased risk of developing an infection.
• If you received Usrenty during pregnancy, it is important to inform the paediatrician and other healthcare providers before the infant receives any vaccine. If you received Usrenty during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for the infant during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Usrenty. You cannot do both.

Driving and using machines
Usrenty does not affect or has negligible effect on the ability to drive vehicles or use machines.
Usrenty contains sodium
Usrenty contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".
However, before Usrenty is administered, it is mixed with a solution containing sodium. Talk to your doctor if you are on a low-salt diet.
Usrenty contains Polysorbate 80
This medicine contains 10.4 mg of polysorbate 80 (E 433) in each 130 mg/26 mL vial, equivalent to 0.4 mg/mL (0.6 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How Usrenty will be used

Usrenty is intended for use under the guidance and supervision of a physician experienced in the diagnosis and
treatment of Crohn's disease.
Usrenty 130 mg concentrate for solution for infusion will be administered by your doctor through
an intravenous drip into a vein in your arm (intravenous infusion) for at least one hour. Discuss with your doctor
when you should have your injections and follow-up appointments.
How much Usrenty is administered
Your doctor will decide how much Usrenty you need and for how long.
Adults from 18 years of age

• Your doctor will calculate the recommended intravenous infusion dose for you based on your body weight.

Body weight Dose
≤ 55 kg 260 mg

55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

• After the initial intravenous dose, you will receive the next dose of 90 mg Usrenty as an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks.

How Usrenty is administered

• The first dose of Usrenty for the treatment of Crohn's disease is administered by your doctor via an intravenous drip into a vein in the arm (intravenous infusion).
• Inform your doctor if you have any questions about the use of Usrenty.

If you forget to use Usrenty
If you forget or miss your scheduled dose appointment, contact your doctor to arrange a new appointment.
If you stop using Usrenty
Stopping treatment with Usrenty is not dangerous. However, if you discontinue treatment, symptoms may return.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment. Contact your doctor immediately or seek emergency medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Usrenty (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness, or
  o swelling of the face, lips, mouth, or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

Infusion-related reactions – If you are being treated for Crohn’s disease, your first dose of Usrenty is given by intravenous infusion (drip). Some patients have experienced severe allergic reactions during the infusion.
In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Usrenty again.
Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections, and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the skin and underlying tissue ('cellulitis') is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Usrenty may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while taking Usrenty. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, pain, or a painful blistering rash on the skin
• burning sensation when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion.

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can lead to serious complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Usrenty until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness 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 blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple spots, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Blistering of the skin, possibly with redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed areas of skin, sometimes with joint pain).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Usrenty

• Usrenty 130 mg concentrate for solution for infusion is administered in a hospital or clinic setting, and patients do not need to handle or store it.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C – 8°C). Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.
• Do not shake the vials of Usrenty. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and packaging after “Exp.”. The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if you see floating foreign particles (see section 6 “Description of the appearance of Usrenty and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously.
• If the seal is broken.

Usrenty is for single use only. Any unused diluted infusion solution remaining in the vial and syringe must be discarded in accordance with local regulations.

6. Package contents and other information What Usrenty contains

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
• The excipients are: disodium EDTA dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Usrenty and contents of the pack
Usrenty is a clear concentrate for solution for infusion, colourless to pale yellow. It is supplied in a
package containing one single dose in a 30 mL glass vial. Each vial contains 130 mg of ustekinumab in
26 mL of concentrate for solution for infusion.
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910
България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)
Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910
Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910
Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910
Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671
Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biocon Biologics Germany GmbH
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910
España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
France Portugal
Biocon Biologics France S.A.S Biocon Biologics Spain S.L.
Tel: 0080008250910 Tel: 0080008250910
Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910
Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910
Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910
Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Τηλ: 0080008250910 Tel: 0080008250910
Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
The following information is intended for healthcare professionals only.
Traceability
To improve the traceability of biological medicinal products, the trade name and batch number of the administered product must be clearly recorded.
Instructions for dilution.
Usrenty concentrate for solution for infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and number of Usrenty vials required based on the patient's body weight (see section 3, Table 1). Each 26 mL vial of Usrenty contains 130 mg of ustekinumab.

2. Remove and discard a volume of 9 mg/mL (0.9%) sodium chloride solution from the 250 mL infusion bag equal to the volume of Usrenty to be added (discard 26 mL of sodium chloride for each Usrenty vial required; for 2 vials discard 52 mL, for 3 vials discard 78 mL, for 4 vials discard 104 mL).

3. Withdraw 26 mL of Usrenty from each required vial and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Gently mix.

4. Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, colour change or foreign particles are observed.

5. Administer the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within 12 hours of dilution in the infusion bag.

6. Use a single infusion set with an in-line sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometres).

7. Each vial is for single use only and any unused medicinal product must be disposed of in accordance with local regulations.

Storage
If necessary, the diluted infusion solution may be stored at room temperature.
The infusion must be completed within 12 hours of dilution in the infusion bag. Do not freeze. Do not return to the refrigerator after dilution.

Package leaflet: Information for the user

Usrenty 45 mg solution for injection

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicinal product, as it contains important information for you.
This leaflet has been written for people taking this medicine. If you are a parent or caregiver of a child who is to be given Usrenty, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Usrenty is and what it is used for What Usrenty is

Usrenty contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific proteins in the body.
Usrenty belongs to a group of medicines called "immunosuppressants". These medicines reduce the activity of the immune system to some extent.
What Usrenty is used for
Usrenty is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from the age of 6 years)
• psoriatic arthritis (in adults)
• moderate to severe Crohn's disease in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Usrenty will reduce inflammation and other signs of the disease.
Usrenty is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate or phototherapy, or in whom these treatments do not work.
Usrenty is used in children and adolescents from the age of 6 years with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not worked.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Usrenty to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage.

Crohn's disease
Crohn's disease is an inflammatory bowel disease. If you have Crohn's disease, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Usrenty may be given to reduce the signs and symptoms of the disease.

2. What you need to know before using Usrenty Do not use Usrenty

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infection that your doctor considers important. If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Usrenty.

Warnings and precautions
Talk to your doctor or pharmacist before using Usrenty. Your doctor will check your health status before each treatment. Make sure to inform your doctor about any medical conditions you have before each treatment. Also, inform your doctor if you have recently been in contact with people who may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Usrenty. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.
Be aware of serious side effects
Usrenty may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Usrenty. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Usrenty, tell your doctor:

• If you have ever had an allergic reaction to Usrenty. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Usrenty partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicine derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also reduce immune system activity. The concomitant use of these therapies with Usrenty has not been studied. However, it could increase the risk of conditions related to a weakened immune system.
• If you are using or have ever used allergy shots (immunotherapy) – it is not known whether Usrenty could affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before starting treatment with Usrenty.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in sun-exposed skin areas, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with Usrenty, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or numbness on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Usrenty is not recommended for the treatment of children under 6 years of age with psoriasis, or for children under 18 years of age with psoriatic arthritis or Crohn’s disease, as it has not been studied in these age groups.
Other medicines, vaccines, and Usrenty
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Usrenty.
• if you received Usrenty during pregnancy, inform the child’s pediatrician about the Usrenty treatment before the child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Usrenty during pregnancy, live vaccines are not recommended for the child during the first twelve months after birth, unless otherwise recommended by the child’s pediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• In newborns exposed to Usrenty in the womb, no increased risk of congenital malformations has been observed. However, experience with Usrenty in pregnant women is limited. Therefore, it is preferable to avoid using Usrenty during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Usrenty and for at least 15 weeks after stopping treatment with Usrenty.
• Usrenty can pass to the unborn child through the placenta. If you received Usrenty during pregnancy, your baby may have an increased risk of developing infections.
• If you received Usrenty during pregnancy, it is important to inform the pediatrician and other healthcare providers before your baby receives any vaccine. If you received Usrenty during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your baby during the first twelve months after birth, unless otherwise recommended by the pediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Usrenty. You cannot do both.

Driving and using machines
Usrenty does not affect or has negligible effects on the ability to drive vehicles or operate machinery.
Usrenty contains Polysorbate 80 (E433)
This medicine contains 0.02 mg of polysorbate 80 (E 433) in each 45 mg/0.5 ml vial, equivalent to 0.02 mg/0.5 ml (0.0003 mg/kg/day). Polysorbates may cause allergic reactions. Inform your doctor if you or your child have known allergies.

3. How to use Usrenty

Usrenty is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Usrenty is indicated.
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive your injections and follow-up appointments.

How much Usrenty is administered
Your doctor will decide how much Usrenty you need and for how long.

Adults from 18 years of age Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Usrenty. 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 receive the next dose 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Usrenty is administered by your doctor as an intravenous infusion (IV infusion) into a vein in your arm. After the initial dose, you will receive the next dose of 90 mg of Usrenty 8 weeks later, then every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Usrenty may be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents from 6 years of age Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Usrenty to be injected to ensure the correct dose is administered. The correct dose will depend on the child’s body weight at the time each dose is given.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of Usrenty per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Usrenty.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Usrenty.
• After the initial dose, the next dose should be administered 4 weeks later, and then every 12 weeks.

How Usrenty is administered

• Usrenty is administered by subcutaneous injection (“subcutaneously”). At the beginning of treatment, medical or nursing staff may administer Usrenty to you.
• However, you and your doctor may decide whether you can self-inject Usrenty. In this case, you will be trained on how to self-inject Usrenty.
• For instructions on how to inject Usrenty, see “Instructions for administration” at the end of this leaflet.

Inform your doctor if you have any questions about self-injecting.

If you use more Usrenty than you should
If you have used or received too much Usrenty, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Usrenty
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using Usrenty
Stopping treatment with Usrenty is not dangerous. However, if you stop treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

Some patients may experience serious side effects that may require urgent treatment.

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

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Usrenty (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing
  o low blood pressure, which may cause dizziness or a feeling of lightheadedness
  o swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.

If you experience a severe allergic reaction, your doctor may decide that you should no longer use Usrenty.

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

• Nasal, throat infections, and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Usrenty may reduce your body's ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that occur mainly in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.

You should be aware of signs of infection while using Usrenty. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can have serious complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Usrenty until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.

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

Other side effects

Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness 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 blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed areas of skin, sometimes with joint pain)

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Usrenty

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.
• Do not shake the Usrenty vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and packaging following “Exp.”. The expiry date refers to the last day of that month.
• If the liquid has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Usrenty and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously.
• If the seal is broken.

Usrenty is for single use only. Any unused product remaining in the vial and syringe must be
discarded. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information What Usrenty contains

• The active substance is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Usrenty and contents of the pack
Usrenty is a clear injectable solution, colourless to pale yellow. It is supplied in a pack containing 1 single dose in a 2 mL glass vial. Each vial contains one dose of ustekinumab 45 mg in 0.5 mL of injectable solution.
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910
България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)
Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910
Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910
Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910
Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671
Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biocon Biologics Germany GmbH
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910
España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
France Portugal
Biocon Biologics France S.A.S Biocon Biologics Spain S.L.
Tel: 0080008250910 Tel: 0080008250910
Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910
Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910
Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910
Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Τηλ: 0080008250910 Tel: 0080008250910
Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .
Instructions for administration
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Usrenty. In this case, you will be taught how to self-inject Usrenty. Inform your doctor if you have any questions about self-injection.

• Do not mix Usrenty with other injectable liquids.
• Do not shake the Usrenty vials, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

1. Check the number of vials and prepare materials

Remove the vial(s) you need from the refrigerator. Leave the vial(s) outside the refrigerator for about half an hour. This will allow the liquid to reach a comfortable temperature for injection (room temperature).
Check that:

• the number of vials and the dose are correct; if the dose is 45 mg or less, you will use one 45 mg vial of Usrenty; if the dose is 90 mg, you will use two 45 mg vials of Usrenty and will need to perform two injections. Choose two different injection sites for these injections (for example, one injection in the right thigh and the other in the left thigh), and carry out the injections one after the other. Use a new needle and a new syringe for each injection.
• the vial must not be used and must be disposed of if:
  • it is not the correct medicine
  • the expiry date has been exceeded
  • the vial is damaged or the seal is broken
  • the solution in the vial does not appear clear, ranging from colourless to pale yellow
  • the solution has changed colour or is cloudy and contains foreign particles
  • the solution has been frozen.

Children with a body weight below 60 kg require a dose lower than 45 mg. Ensure you know the correct amount (volume) to withdraw from the vial and the type of syringe required for accurate dosing. If you are unsure about the amount of medicine or the type of syringe to use, contact your doctor for further instructions.

Gather all necessary supplies and place them on a clean surface. You will need a syringe, a needle, antiseptic wipes, a cotton ball or gauze, and a sharps container (see Figure 1).

Figure 1

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

• Usrenty is administered by injection under the skin (subcutaneously).
• A suitable injection site is the upper thigh or the abdominal area (abdomen), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting you with the injection, the upper arm may also be used as an injection site.

Figure 2
Preparing the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the injection site on the skin with an antiseptic swab.
• Do not touch this area again before administering the injection.

3. Prepare the dose:

• Remove the cap from the top of the vial (see Figure 3).

Figure 3

• Do not remove the stopper.
• Invert the vial and syringe.
• Pull back the syringe plunger to draw up the amount of liquid prescribed by your doctor.
• It is important that the needle remains fully immersed in the liquid to prevent air bubbles from entering the syringe (see Figure 4).

Figure 4

• Remove the needle from the vial.
• Hold the syringe with the needle pointing upwards to check whether any air bubbles are present.
• If there are air bubbles, gently tap the side of the syringe until the air bubbles rise to the top of the syringe (see Figure 5).

Figure 5

• Then push the plunger to expel all the air (but not the liquid).
• Do not place the syringe down and avoid letting the needle touch anything.

4. Inject the dose

• Gently pinch the clean area of skin, holding it between the thumb and index finger. Do not squeeze too firmly.
• Insert the needle into the pinched skin.
• Push the plunger with the thumb until all the liquid has been injected. Press slowly and steadily, keeping the skin gently pinched.
• When the plunger reaches the end of the syringe, remove the needle and release the skin.

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or fluid at the injection site. This is normal.
• You may 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 may cover the injection site with a small plaster, if needed.

6. Disposal

• Used syringes and needles must be placed in a puncture-resistant container, such as a sharps container. For your safety and the safety of others, never reuse needles or syringes. Dispose of the sharps container according to local regulations.
• Empty vials, antiseptic swabs, and other devices may be discarded in regular waste.

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

Patient Information Leaflet: Information for the User

Usrenty 45 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You are encouraged to contribute by reporting any side effects observed. For instructions on how to report side effects, see the end of section 4.
Please read this leaflet carefully before using this medicine as it contains important information for you.
This leaflet has been written for people taking this medicine. If you are a parent or caregiver of a child who is to be given Usrenty, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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 could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

What Usrenty is and what it is used for
Usrenty contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific target proteins in the body.
Usrenty belongs to a group of medicines called “immunosuppressants”. These medicines partially reduce the activity of the immune system.

What Usrenty is used for
Usrenty is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from the age of 6 years)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Usrenty will reduce inflammation and other signs of the disease.
Usrenty is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or in whom these treatments are ineffective.
Usrenty is used in children and adolescents from the age of 6 years with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these treatments, you may be given Usrenty to:

• reduce the signs and symptoms of the disease,
• improve physical function,
• slow down joint damage.

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond adequately or are intolerant to these medicines, Usrenty may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Usrenty Do not use Usrenty

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important. If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Usrenty.

Warnings and precautions
Talk to your doctor or pharmacist before using Usrenty. Your doctor will check your health status
before each treatment. Make sure to inform your doctor, before each treatment, about any medical
conditions you have. Also, inform your doctor if you have recently been in contact with people who
might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before
administering Usrenty. If your doctor believes you are at risk of tuberculosis, you may be given
medicines to treat tuberculosis.
Be aware of serious side effects
Usrenty can cause serious side effects, including allergic reactions and infections. You should be
alert to certain signs of illness while taking Usrenty. See “Serious side effects” in section 4 for a complete
list of these side effects.
Before using Usrenty, contact your doctor

• If you have ever had an allergic reaction to Usrenty. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants such as Usrenty partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changing skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with Usrenty has not been studied. However, it may increase the likelihood of conditions related to a weakened immune system.
• If you are using or have ever used allergy injections – it is not known whether Usrenty may affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or
pharmacist before starting treatment with Usrenty.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on sun-exposed areas of skin or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with Usrenty, heart attack and stroke were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation on one side of the body, facial drooping, or abnormalities in speech or vision.
Children and adolescents
Usrenty is not recommended for the treatment of children under 6 years of age with psoriasis, or for children under 18 years of age with psoriatic arthritis or Crohn’s disease, as it has not been studied in these age groups.
Other medicines, vaccines, and Usrenty
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are about to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Usrenty.
• if you received Usrenty during pregnancy, inform your child’s pediatrician about the Usrenty treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Usrenty during pregnancy, live vaccines are not recommended for your child during the first twelve months of life, unless otherwise recommended by your child’s pediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• No increased risk of congenital malformations has been observed in newborns exposed to Usrenty in utero. However, experience with Usrenty in pregnant women is limited. Therefore, it is preferable to avoid using Usrenty during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Usrenty and for at least 15 weeks after stopping treatment with Usrenty.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Usrenty during pregnancy, your child may have an increased risk of developing infections. If you received Usrenty during pregnancy, it is important to inform your child’s pediatrician and other healthcare providers before your child receives any vaccine. If you received Usrenty during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s pediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Usrenty. You cannot do both.

Driving and using machines
Usrenty has no or negligible influence on the ability to drive vehicles or use machines.
Usrenty contains Polysorbate 80 (E433)
This medicine contains 0.02 mg of polysorbate 80 (E 433) in each 45 mg/0.5 ml vial,
equivalent to 0.02 mg/0.5 ml (0.0003 mg/kg/day). Polysorbates may cause allergic reactions.
Inform your doctor if you or your child have known allergies.

3. How to use Usrenty

Usrenty is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Usrenty is indicated.
Always use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive your injections and follow-up visits.

How much Usrenty is administered

Your doctor will decide how much Usrenty you need and for how long.

Adults from 18 years of age Psoriasis and psoriatic arthritis

• The recommended starting dose is 45 mg of Usrenty. 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 receive the next dose 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the starting dose.

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Usrenty is administered by your doctor via an intravenous infusion into your arm. After the initial dose, you will receive the next dose of 90 mg of Usrenty 8 weeks later, then every 12 weeks via a subcutaneous injection (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Usrenty may be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents from 6 years of age Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Usrenty to be injected to ensure the correct dose is administered. The correct dose will depend on the child’s body weight at the time each dose is given.
• A 45 mg vial is available if a lower dose than 45 mg is required.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of Usrenty per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Usrenty.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Usrenty.
• After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks.

How Usrenty is administered

• Usrenty is administered by subcutaneous injection (“subcutaneous route”). At the beginning of treatment, medical or nursing staff may administer Usrenty to you.
• However, you and your doctor may decide whether you can self-inject Usrenty. In this case, you will be taught how to self-inject Usrenty.
• For instructions on how to inject Usrenty, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Usrenty than you should
If you have used or received too much Usrenty, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Usrenty
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using Usrenty
Stopping treatment with Usrenty is not dangerous. However, if you stop treatment, symptoms may return.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Some patients may experience serious side effects that may require treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency
medical help immediately if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Usrenty (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or lightheadedness, or
  o swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.
If you experience a severe allergic reaction, your doctor may decide that you should no longer use Usrenty.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue under the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Usrenty may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while using Usrenty. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• vision problems or loss of vision
• headache, neck stiffness, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which can have serious complications. Contact your doctor if you have any type of infection that persists or keeps recurring. Your doctor may decide to stop Usrenty until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Blocked or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness 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 blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Usrenty

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Usrenty may also be stored at room temperature up to 30°C for a single period of up to 30 days, while remaining in the outer packaging to protect them from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date when it must be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Usrenty. Vigorous and prolonged shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Exp. The expiry date refers to the last day of the month.
• After the discard date indicated on the packaging; following storage at room temperature up to 30°C for more than 30 days.
• If the solution has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Usrenty and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously.

Usrenty is for single use only. Any unused product remaining in the syringe must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What Usrenty contains

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

Description of the appearance of Usrenty and contents of the pack
Usrenty is a clear, colourless to pale yellow injectable solution. It is supplied in a pack containing one single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains a dose of 45 mg ustekinumab in 0.5 mL of injectable solution.
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910
България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)
Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910
Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910
Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910
Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671
Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biocon Biologics Germany GmbH
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910
España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
Portugal
France Biocon Biologics Spain S.L.
Biocon Biologics France S.A.S Tel: 0080008250910
Tel: 0080008250910
Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910
Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910
Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910
Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Τηλ: 0080008250910 Tel: 0080008250910
Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Other sources of information
More detailed information about this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .
Instructions for administration
Figure 1 shows the appearance of the pre-filled syringe

Instructions for administering the Usrenty injection.
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Usrenty. If so, you will be taught how to self-administer Usrenty. Inform your doctor if you have any questions about self-injection.

• Do not mix Usrenty with other injectable liquids.
• Do not shake the pre-filled syringes of Usrenty, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

1. Check the number of prefilled syringes and prepare materials

Prepare for using the prefilled syringes.

• Remove from the refrigerator the required number of prefilled syringes. Leave the prefilled syringe outside the box for about half an hour. This will allow the liquid to reach a comfortable injection temperature (room temperature). Do not remove the needle protective cap while waiting for the syringe to warm to room temperature.
• Hold the prefilled syringe by the barrel with the covered needle pointing upwards.
• Do not hold the prefilled syringe by the plunger rod, the plunger, the needle safety guard, or the needle protective cap.
• Never pull back the plunger.
• Do not attempt to remove the needle safety device from the prefilled syringe.
• Do not remove the needle cap from the prefilled syringe until ready to use. Check the following:
• Ensure the correct number of prefilled syringes and the correct dose.

If the dose is 45 mg, use one 45 mg prefilled syringe of Usrenty.
If the dose is 90 mg, use two 45 mg prefilled syringes of Usrenty and two injections will be required. Choose two different injection sites (for example, one injection in the right thigh and the other in the left thigh), and administer the injections one after the other.

• Confirm that the medicine is the correct one.
• Confirm that the medicine has not expired.
• Confirm that the prefilled syringe is not damaged.
• Confirm that the solution in the prefilled syringe is clear, colorless to pale yellow.
• Confirm that the liquid in the prefilled syringe has not changed color, is not cloudy, and does not contain foreign particles.
• Confirm that the solution in the prefilled syringe has not been frozen.

Gather all necessary items and place them on a clean, flat, well-lit surface. Include antiseptic wipes, a cotton ball or gauze, and a sharps container.

Storage information
Usrenty prefilled syringes must be stored in the refrigerator at a temperature between 2 °C and 8 °C (36 °F and 46 °F) in the original packaging to protect from light until use.

• Do not freeze. Do not shake.
• If necessary, individual prefilled syringes may be stored at room temperature up to 30 °C (86 °F) for a single period not exceeding 30 days, remaining in the original packaging to protect from light.
• Once stored at room temperature, the syringe must not be returned to the refrigerator.
• Discard the syringe if not used within 30 days of storage at room temperature.

Gather materials
Collect all necessary items and place them on a clean, flat, well-lit surface. This includes:

• antiseptic wipes,
• a cotton ball or gauze,
• a sharps container,
• the prescribed dose for Usrenty injection (see Figure 2).

Figure 2

2. Choose and prepare the injection site

Choose an injection site (see Figure 3)

• Usrenty is administered by injection under the skin (subcutaneously).
• Suitable injection sites are the upper thigh or the area around the abdomen (abdominal wall), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting with the injection, the upper arm may also be used as an injection site.

Figure 3
*The blue areas indicate recommended injection sites.
Prepare the injection site

• Select a clean, flat, and well-lit work surface.
• Wash your hands thoroughly with soap and warm water.
• Clean the injection site on the skin with an antiseptic swab.
• Do not touch this area again before administering the injection. Wait for the skin to dry completely before injecting.
• Open the tray by removing the cover. Hold the tray at the level of the needle safety device (as shown in Figure 4) to remove the pre-filled syringe from the tray.

Figure 4

• Hold the pre-filled syringe with the needle cap facing upwards.

3. Remove the needle cap (see Figure 5)

• The needle cap must not be removed until you are ready to administer the dose.
• Hold the pre-filled syringe by its body with one hand.
• Remove and discard the needle cap. Do not touch the plunger during this step.

Figure 5

• If you notice an air bubble in the pre-filled syringe or a drop of liquid at the needle tip, this is normal. Do not remove them.

• Do not touch the needle and avoid contact between the needle and any surface.

• Do not use the pre-filled syringe if it has been dropped without the needle cap in place. If this happens, consult your doctor or pharmacist.

• Inject the contents immediately after removing the protective needle cap.

4. Inject the dose

• Hold the pre-filled syringe in one hand between the middle finger and index finger, placing the thumb on the plunger head. Use the other hand to gently pinch the cleaned area of skin between the thumb and index finger. Do not pinch too tightly.
• Do not squeeze the syringe too hard.
• Do not pull back the plunger in any way.
• With one quick motion, insert the needle into the skin as far as possible (see Figure 6).

Figure 6
Inject the full dose by pushing the plunger until the plunger head is completely inside the needle shield (see Figure 7).

Figure 7
Push the plunger until it reaches the end of its travel, and continue to keep pressure on the plunger head while withdrawing the needle and gently releasing the skin (see Figure 8).

Figure 8
Slowly remove your thumb from the plunger head to allow the empty syringe to rise upward, so that the needle is fully covered by the needle safety device, as shown in Figure 9.

Figure 9

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or liquid at the injection site. This is normal.
• You may press a cotton ball or gauze pad on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small plaster, if necessary.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 10). For your safety and the safety of others, never reuse the syringe. Dispose of the sharps container according to local regulations.
• Antiseptic swabs and other devices may be disposed of in the waste.

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
Revision: MM/YYYY

Package leaflet: Information for the user

Usrenty 90 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You are encouraged to contribute by reporting any side effects observed. For instructions on how to report side effects, see the end of section 4.
Please read all of this leaflet carefully before using this medicine as it contains important information for you.
This leaflet has been written for people taking this medicine. If you are a parent or caregiver of a child who is to be given Usrenty, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Usrenty is and what it is used for What Usrenty is

Usrenty contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific proteins in the body.
Usrenty belongs to a group of medicines called "immunosuppressants". These medicines partially reduce the activity of the immune system.
What Usrenty is used for
Usrenty is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from the age of 6 years)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Usrenty will reduce inflammation and other signs of the disease.
Usrenty is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or in whom these treatments do not work.
Usrenty is used in children and adolescents from the age of 6 years with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not worked.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Usrenty to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Usrenty may be given to reduce the signs and symptoms of your disease.

2. What you should know before using Usrenty Do not use Usrenty

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important. If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Usrenty.

Warnings and precautions
Talk to your doctor or pharmacist before using Usrenty. Your doctor will check your health status
before each treatment. Make sure to inform your doctor about any medical conditions you have
before each treatment. Also, inform your doctor if you have recently been in contact with people
who may have had tuberculosis. Your doctor will examine you and perform tests for
tuberculosis before administering Usrenty. If your doctor believes you are at risk of tuberculosis,
you may be given medicines to treat tuberculosis.
Be aware of serious side effects
Usrenty may cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Usrenty. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Usrenty, contact your doctor

• If you have ever had an allergic reaction to Usrenty. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Usrenty partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changing lesions within the area of psoriasis or on normal skin.
• If you are receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with Usrenty has not been studied. However, it could increase the risk of conditions related to a weakened immune system.
• If you are using or have ever used injections for allergy treatment – it is not known whether Usrenty could affect these.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or
pharmacist before starting treatment with Usrenty.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including
cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with Usrenty, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensations on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Usrenty is not recommended for the treatment of children under 6 years of age with psoriasis, or for children under 18 years of age with psoriatic arthritis, Crohn's disease, as it has not been studied in these age groups.
Other medicines, vaccines and Usrenty
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) must not be administered while you are using Usrenty.
• if you received Usrenty during pregnancy, inform your child’s paediatrician about the Usrenty treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Usrenty during pregnancy, live vaccines are not recommended for your child during the first twelve months of life, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• In newborns exposed to Usrenty in the womb, no increased risk of congenital malformations has been observed. However, experience with Usrenty in pregnant women is limited. Therefore, it is preferable to avoid using Usrenty during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Usrenty and for at least 15 weeks after stopping treatment with Usrenty.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Usrenty during pregnancy, your baby may have an increased risk of developing infections.
• If you received Usrenty during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Usrenty during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Usrenty. You cannot do both.

Driving and using machines
Usrenty has no or negligible influence on the ability to drive or use machines.
Usrenty contains Polysorbate 80 (E433)
This medicine contains 0.04 mg of polysorbate 80 (E 433) in each 90 mg/1 mL pre-filled syringe (PFS), equivalent to 0.04 mg/mL (0.0004 mg/kg/day). Polysorbates may cause allergic reactions.
Inform your doctor if you or your child have known allergies.

3. How to use Usrenty

Usrenty is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Usrenty is indicated.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor. Discuss with your doctor when you should receive your injections and follow-up appointments.

How much Usrenty is administered

Your doctor will decide how much Usrenty you need and for how long.

Adults from 18 years of age Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Usrenty. 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 receive the next dose 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn's disease

• During treatment, the first dose of approximately 6 mg/kg of Usrenty will be administered by your doctor via an intravenous infusion (IV infusion) into your arm. After the initial dose, you will receive the next dose of 90 mg of Usrenty 8 weeks later, then every 12 weeks via a subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Usrenty may be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents from 6 years of age Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Usrenty to be injected to ensure the correct dose is administered. The correct dose will depend on the child's body weight at the time each dose is given.
• A 45 mg vial is available in case a dose lower than 45 mg is required.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of Usrenty per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Usrenty.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Usrenty.
• After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks.

How Usrenty is administered

• Usrenty is administered by subcutaneous injection ("subcutaneously"). At the beginning of treatment, medical or nursing staff may administer Usrenty to you.
• However, you and your doctor may decide whether you can self-inject Usrenty. In this case, you will be taught how to self-inject Usrenty.
• For instructions on how to inject Usrenty, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Usrenty than you should

If you have used or received too much Usrenty, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Usrenty

If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop using Usrenty

It is not dangerous to stop using Usrenty. However, if you discontinue treatment, symptoms may return. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Some patients may experience serious side effects that may require treatment.
Allergic reactions – these may require urgent treatment, so contact your
doctor or seek emergency medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking Usrenty (affect up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness, or
  o swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (affect up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in
patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as
cough, shortness of breath and fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Usrenty again.
Infections – these may require urgent treatment, so contact your doctor immediately
if you notice any of the following signs.

• Nasal, throat infections and the common cold are common (affect up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Usrenty may reduce the ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that occur mainly in people with weakened immune systems (opportunistic infections). In patients treated with ustekinumab, opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported.
You should be alert for signs of infection while using Usrenty. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be symptoms of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which can have serious complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Usrenty until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large
area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis,
which are serious skin conditions. If you notice any of these signs, inform your
doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness 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 blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters with possible redness, itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Usrenty

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Usrenty may also be stored at room temperature up to 30°C for a single period of maximum 30 days, while remaining in the outer packaging to protect them from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date it must be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Usrenty. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton following EXP or "Scad". The expiry date refers to the last day of the month.
• After the discard date indicated on the packaging; following storage at room temperature up to 30°C for more than 30 days.
• If the solution has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Usrenty and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously.

Usrenty is for single use only. Any unused product remaining in the syringe must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Usrenty contains

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

Description of the appearance of Usrenty and contents of the pack
Usrenty is a clear, injectable solution, colourless to pale yellow. It is supplied in a pack containing 1 single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains one dose of ustekinumab 90 mg in 1 mL of injectable solution.
Marketing Authorisation 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
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910
България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)
Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910
Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910
Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910
Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671
Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biosimilar Collaborations Ireland Limited
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910
España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
France Portugal
Biocon Biologics France S.A.S Biocon Biologics Spain S.L.
Tel: 0080008250910 Tel: 0080008250910
Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910
Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910
Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910
Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Τηλ: 0080008250910 Tel: 0080008250910
Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu .
Instructions for administration
Figure 1 shows the appearance of the pre-filled syringe.

Instructions for administration
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Usrenty. In this case, you will be taught how to self-inject Usrenty.
Inform your doctor if you have any questions about self-injection.

• Do not mix Usrenty with other injectable liquids.
• Do not shake the pre-filled syringes of Usrenty, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

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

Prepare for the use of pre-filled syringes.

• Remove from the refrigerator the pre-filled syringe or pre-filled syringes you need. Leave the pre-filled syringe outside the box for about 30 minutes. This will allow the liquid to reach a comfortable injection temperature (room temperature). Do not remove the needle protective cap while waiting for the syringe to reach room temperature.
• Hold the pre-filled syringe by the barrel with the covered needle pointing upwards.
• Do not hold the pre-filled syringe by the plunger rod, plunger, needle safety guard, or needle protective cap.
• Under no circumstances should you pull back the plunger.
• Do not attempt to remove the needle safety device from the pre-filled syringe.
• Do not remove the needle cap from the pre-filled syringe until ready to use.

Check the following:

• the pre-filled syringe to ensure the correct number of syringes and dose. If the dose is 45 mg, take one 45 mg pre-filled syringe of Usrenty. If the dose is 90 mg, take two 45 mg pre-filled syringes of Usrenty, and two injections will be required. Choose two different injection sites for these injections (e.g., one injection in the right thigh and the other in the left thigh), and administer the injections one after the other.
• that the medicine is the correct one
• that the medicine has not expired
• that the pre-filled syringe is not damaged
• that the solution in the pre-filled syringe is clear, colorless to pale yellow
• that the liquid in the pre-filled syringe has not changed color or become cloudy and contains no foreign particles
• that the solution in the pre-filled syringe is not frozen

Gather all necessary items and place them on a clean, flat, well-lit surface. These include antiseptic wipes, a cotton ball or gauze, and a sharps container.

Storage information
Pre-filled syringes must be stored in the refrigerator at a temperature between 2 °C and 8 °C (36 °F and 46 °F) in the original packaging to protect from light until use.

• Do not freeze. Do not shake.
• If necessary, individual pre-filled syringes may be stored at room temperature up to 30 °C (86 °F) for a single period of up to 30 days in the original packaging to protect from light.
• Once stored at room temperature, the syringe must not be returned to the refrigerator.
• Discard the syringe if not used within 30 days of storage at room temperature.

Gather materials
Collect all necessary items and place them on a clean, flat, well-lit surface. This includes:

• antiseptic wipes,
• a cotton ball or gauze,
• a sharps container,
• the prescribed dose for Usrenty injection (see Figure 2)

Figure 2

2. Choose and prepare the injection site

Choose an injection site (see Figure 3).

• Usrenty is administered by injection under the skin (subcutaneously).
• A suitable place for the injection is the upper thigh or around the abdomen (abdominal area), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting you during the injection, the upper arm may also be used as an injection site.

Figure 3
*The blue areas indicate 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 injection site on the skin with an antiseptic swab.
• Do not touch this area again before administering the injection.
• Open the tray by removing the cover. Hold at the level of the needle safety device (as shown in Figure 4) to remove the pre-filled syringe from the tray.

Figure 4

• Hold the pre-filled syringe with the needle cap facing upwards.

3. Remove the needle cap (see Figure 5)

• The needle cap must not be removed until you are ready to inject the dose.
• Hold the prefilled syringe by its body with one hand. Remove and discard the needle cap. Do not touch the plunger while performing this

operation
Figure 5

• If you notice an air bubble in the prefilled syringe or a drop of liquid at the needle tip, this is normal. Do not remove them.
• Do not touch the needle and avoid contact between the needle and any surface.
• Do not use the prefilled syringe if it has been dropped without the needle cap in place. If this

happens, consult your doctor or pharmacist. Do not attempt to reattach the needle cap. If this
occurs, contact your doctor or pharmacist.

• Inject the contents immediately after removing the needle protective cap.

4. Inject the dose

• Hold the pre-filled syringe in one hand between the middle finger and index finger, with the thumb placed on the plunger head. Use the other hand to gently pinch a cleaned area of skin between the thumb and index finger. Do not pinch too tightly.
• Do not pull back the plunger in any way.
• With one quick motion, insert the needle into the skin as far as possible (see Figure 6).

Figure 6
Inject all the medicine by pushing the plunger until the plunger head is completely within the needle guard wings (see Figure 7).

Figure 7
Push the plunger until it reaches the end of its travel, and continue to keep pressure on the plunger head while withdrawing the needle and gently releasing the skin (see Figure 8).

Figure 8
Slowly remove your thumb from the plunger head to allow the empty syringe to rise upward, so that the needle is fully covered by the needle safety device, as shown in Figure 9.

Figure 9

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or fluid at the injection site. This is normal.
• You may press a cotton ball or gauze pad on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small adhesive bandage if needed.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 10). For your health and safety and the safety of others, never reuse the syringe. Dispose of the sharps container according to local regulations.
• Antiseptic swabs and other devices may be disposed of in regular waste.

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