Wezenla

Patient Information Leaflet

WEZENLA 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 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What WEZENLA is and what it is used for

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

What WEZENLA is used for
WEZENLA is used to treat moderate to severe Crohn’s disease in adults and children weighing at least 40 kg.
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 medicines, WEZENLA may be given to reduce the signs and symptoms of your disease.

2. What you should know before using WEZENLA

Do not use WEZENLA

• 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, consult your doctor or
pharmacist before using WEZENLA.
Warnings and precautions
Talk to your doctor or pharmacist before using WEZENLA. Your doctor will check your health status
before starting treatment. Make sure to inform your doctor about any medical conditions you have.
Additionally, 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 WEZENLA. If your doctor believes you are at risk of tuberculosis, you may be given
medicines to treat it.
Be aware of serious side effects
WEZENLA may cause serious side effects, including allergic reactions and infections. You should
pay attention to certain signs of illness while taking WEZENLA. See “Serious side effects” in section 4
for a complete list of these side effects.
Before using WEZENLA, contact your doctor

• If you have ever had an allergic reaction to WEZENLA. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants such as WEZENLA 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 currently have or have recently had an infection or have abnormal openings in 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 concomitant use of these therapies with WEZENLA has not been studied. However, it could potentially increase the risk of conditions related to a weakened immune system.
• If you are using or have ever used allergy shots (injections for allergy treatment) – it is not known whether WEZENLA may affect them.
• If you are aged 65 years or older – you may have an increased risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or
pharmacist before starting treatment with WEZENLA.
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 areas of skin, or
if you experience joint pain.
Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, 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
a strange sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
WEZENLA is not recommended for the treatment of children weighing less than 40 kg with Crohn’s
disease, as it has not been studied in this group.
Other medicines, vaccines and WEZENLA
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 WEZENLA.
• if you received WEZENLA during pregnancy, inform the pediatrician of your child about the WEZENLA treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received WEZENLA during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s pediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you might be pregnant, or are planning a pregnancy, ask your doctor for advice before taking this medicine.
• In newborns exposed to WEZENLA in the womb, no increased risk of congenital malformations has been observed. However, experience with WEZENLA in pregnant women is limited. Therefore, it is preferable to avoid using WEZENLA 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 WEZENLA and for at least 15 weeks after stopping treatment with WEZENLA.
• Ustekinumab can cross the placenta and reach the unborn child. If you received WEZENLA during pregnancy, your baby may have an increased risk of developing an infection.
• If you received WEZENLA during pregnancy, it is important to inform the pediatrician and other healthcare providers before your baby receives any vaccine. If you received WEZENLA 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 your child’s pediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine. You and your doctor will decide whether you should breastfeed or use WEZENLA. You cannot do both.

Driving and using machines
WEZENLA does not affect or has a negligible effect on the ability to drive vehicles and use
machinery.
WEZENLA contains sodium
WEZENLA contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially "sodium-free".
However, before administration, WEZENLA is mixed with a solution that contains sodium. Speak
with your doctor if you are on a low-salt diet.
WEZENLA contains polysorbate 80
WEZENLA contains 10.4 mg of polysorbate 80 (E 433) per dose, equivalent to 0.40 mg/mL.
Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How WEZENLA will be used

WEZENLA is intended for use under the guidance and supervision of a physician experienced in the
diagnosis and treatment of Crohn's disease.
Your doctor will administer WEZENLA 130 mg concentrate for solution for infusion to you via an intravenous drip into a vein in your arm (intravenous infusion) for at least one hour. Discuss with your doctor when you should receive your injections and follow-up appointments.

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

Adults from 18 years of age

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

Body weight Dose
≤ 55 kg 260 mg

55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg of WEZENLA as an injection under the skin (subcutaneous injection), followed by maintenance dosing every 12 weeks thereafter.

Children with Crohn's disease weighing at least 40 kg

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

Body weight Dose
≥ 40 to ≤ 55 kg 260 mg

55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg of WEZENLA as an injection under the skin (subcutaneous injection), followed by maintenance dosing every 12 weeks thereafter.

How WEZENLA is administered

• The first dose of WEZENLA 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 WEZENLA.

If you forget to use WEZENLA
If you forget or miss an appointment for your dose, contact your doctor to schedule a new appointment.

If you stop using WEZENLA
Stopping treatment with WEZENLA is not dangerous. However, if you discontinue treatment, your symptoms may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

Some patients may experience serious side effects that may require urgent 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 ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
  • difficulty breathing or swallowing
  • low blood pressure, which may cause dizziness or a feeling of lightheadedness
  • 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, the first dose of WEZENLA is administered via an intravenous infusion. 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 WEZENLA again.

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).

WEZENLA 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 primarily 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 WEZENLA. 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, light sensitivity, 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. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop WEZENLA 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, 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 experience any side effect, 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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store WEZENLA

• WEZENLA 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 WEZENLA vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after “Exp.”. The expiry date refers to the last day of that month.
• If you notice that the liquid has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of WEZENLA 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.

WEZENLA is for single use only. Any unused diluted infusion solution remaining in the vial and syringe must be discarded according to local regulations.

6. Contents of the pack and other information

What WEZENLA contains

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
• The other ingredients are disodium edetate dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E 433), sucrose, sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of WEZENLA and contents of the pack
WEZENLA is a concentrate for infusion solution, from clear to opalescent, colourless to pale yellow.
It is supplied in a cardboard pack containing 1 single dose in a 30 mL glass vial. Each vial contains
130 mg of ustekinumab in 26 mL of concentrate for infusion solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland

Marketing Authorisation Holder
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
s.a. Amgen n.v. Amgen Switzerland AG Vilniaus filialas
Tél/Tel: +32 (0)2 7752711 Tel: +370 5 219 7474

България Luxembourg/Luxemburg
Амджен България ЕООД s.a. Amgen
Тел.: +359 (0)2 424 7440 Belgique/Belgien
Tél/Tel: +32 (0)2 7752711

Česká republika Magyarország
Amgen s.r.o. Amgen Kft.
Tel: +420 221 773 500 Tel.: +36 1 35 44 700

Danmark Malta
Amgen, filial af Amgen AB, Sverige Amgen S.r.l.
Tlf.: +45 39617500 Italy
Tel: +39 02 6241121

Deutschland Nederland
Amgen GmbH Amgen B.V.
Tel: +49 89 1490960 Tel: +31 (0)76 5732500

Eesti Norge
Amgen Switzerland AG Vilniaus filialas Amgen AB
Tel: +372 586 09553 Tlf: +47 23308000

Ελλάδα Österreich
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Amgen GmbH
Τηλ: +30 210 3447000 Tel: +43 (0)1 50 217

España Polska
Amgen S.A. Amgen Biotechnologia Sp. z o.o.
Tel: +34 93 600 18 60 Tel.: +48 22 581 3000

France Portugal
Amgen S.A.S. Amgen Biofarmacêutica, Lda.
Tél: +33 (0)9 69 363 363 Tel: +351 21 4220606

Hrvatska România
Amgen d.o.o. Amgen România SRL
Tel: +385 (0)1 562 57 20 Tel: +4021 527 3000

Ireland Slovenija
Amgen Ireland Limited AMGEN zdravila d.o.o.
Tel: +353 1 8527400 Tel: +386 (0)1 585 1767

Ísland Slovenská republika
Vistor Amgen Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 321 114 49

Italia Suomi/Finland
Amgen S.r.l. Amgen AB, sivuliike Suomessa/Amgen AB, filial
Tel: +39 02 6241121 i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος Sverige
C.A. Papaellinas Ltd Amgen AB
Τηλ: +357 22741 741 Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals.

Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly documented.

Instructions for dilution
WEZENLA concentrate for solution for infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of WEZENLA vials required based on the patient's weight (see section 3, Table 1, Table 2). Each 26 mL vial of WEZENLA 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 WEZENLA to be added (discard 26 mL of sodium chloride for each required WEZENLA vial; for 2 vials, discard 52 mL; for 3 vials, discard 78 mL; for 4 vials, discard 104 mL).
3. Withdraw 26 mL of WEZENLA 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 opaque particles, discoloration, or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour.
6. Use only one infusion set with an in-line sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometers).
7. Each vial is for single use only; any unused medicinal product must be disposed of in accordance with current local regulations.

Storage
If necessary, the diluted infusion solution can be stored at room temperature.
After dilution between 0.86 mg/mL and 2.60 mg/mL, chemical and physical in-use stability has been demonstrated for 24 hours at 15°C–25°C. Do not return to the refrigerator. Do not freeze.

Package leaflet: information for the user

WEZENLA 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 medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who are taking this medicine. If you are a parent or caregiver of a child who needs to be given WEZENLA, 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 could 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 WEZENLA is and what it is used for
2. What you need to know before using WEZENLA
3. How to use WEZENLA
4. Possible side effects
5. How to store WEZENLA
6. Contents of the pack and other information

1. What WEZENLA is and what it is used for

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

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

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

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

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 WEZENLA to:

• reduce 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 sufficiently or are intolerant to these medicines, WEZENLA may be given to reduce the signs and symptoms of your disease.

2. What you should know before using WEZENLA

Do not use WEZENLA

• 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 not sure whether any of the conditions listed above apply to you, consult your doctor or
pharmacist before using WEZENLA.
Warnings and precautions
Talk to your doctor or pharmacist before using WEZENLA. 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 carry out tests for tuberculosis before
administering WEZENLA to you. If your doctor believes you are at risk of tuberculosis, you may be
given medicines to treat it.
Be aware of serious side effects
WEZENLA can cause serious side effects, including allergic reactions and infections. You should
pay attention to certain signs of illness while taking WEZENLA. See “Serious side effects” in section 4
for a complete list of these side effects.
Before using WEZENLA, contact your doctor:

• If you have ever had an allergic reaction to WEZENLA. Ask your doctor if you are not sure.
• If you have ever had any type of cancer – because immunosuppressants like WEZENLA 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 the activity of the immune system. The concomitant use of these therapies with WEZENLA 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 shots (injections) for the treatment of allergies – it is not known whether WEZENLA may affect them.
• If you are aged 65 years or older – you may have a higher chance of developing infections.

If you are not sure whether any of the conditions listed above apply to you, consult your doctor or
pharmacist before starting treatment with WEZENLA.
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 patients with psoriasis treated with ustekinumab, 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
a sensation of numbness on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
WEZENLA is not recommended for the treatment of children under 6 years of age with psoriasis,
children with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with
psoriatic arthritis, as it has not been studied in these age groups.
Other medicines, vaccines and WEZENLA
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 administered while you are using WEZENLA.
• if you received WEZENLA during pregnancy, inform the paediatrician of your child about the WEZENLA treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received WEZENLA during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• In newborns exposed to WEZENLA in the womb, no increased risk of congenital malformations has been observed. However, experience with WEZENLA in pregnant women is limited. Therefore, it is preferable to avoid using WEZENLA 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 WEZENLA and for at least 15 weeks after stopping treatment with WEZENLA.
• Ustekinumab can cross the placenta and reach the unborn child. If you received WEZENLA during pregnancy, your child may have an increased risk of developing an infection.
• If you received WEZENLA during pregnancy, it is important to inform the paediatrician and other healthcare providers before your child receives any vaccine. If you received WEZENLA 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 planning to breastfeed, consult your doctor before using this medicine. You and your doctor will decide whether you should breastfeed or use WEZENLA. You cannot do both.

Driving and using machines
WEZENLA has no effect or negligible effect on the ability to drive vehicles and use machines.
WEZENLA contains polysorbate 80
WEZENLA contains 0.02 mg of polysorbate 80 (E 433) per single dose, equivalent to 0.04 mg/mL.
Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use WEZENLA

WEZENLA is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which WEZENLA is indicated.
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 WEZENLA is administered

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

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of WEZENLA. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration 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 WEZENLA is administered by your doctor via an intravenous infusion into your arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of WEZENLA, followed by every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of WEZENLA may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Use in children and adolescents from 6 years of age

Psoriasis

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

Children weighing at least 40 kg

Crohn’s disease

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

How WEZENLA is administered

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

If you use more WEZENLA than you should

If you have used or received too much WEZENLA, 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 WEZENLA

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 WEZENLA

It is not dangerous to stop using WEZENLA. However, if you discontinue treatment, symptoms may return.

If you have any doubts about using this medicine, consult 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, so contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab (affect up to 1 in 1,000 patients). Signs include:
  • difficulty breathing or swallowing
  • low blood pressure, which may cause dizziness or a feeling of lightheadedness
  • 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).

Rarely, 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 WEZENLA.
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 (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).

WEZENLA may reduce your ability to fight infections. Some infections may become severe and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that primarily 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 alert for signs of infection while using WEZENLA. 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. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop WEZENLA 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, 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 accompanied by 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 referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store WEZENLA

• 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.
• If necessary, individual WEZENLA vials may also be stored at room temperature up to 30°C for a single period of up to 30 days, within the outer packaging to protect them from light. Record the date when the vial is first removed from the refrigerator and the date when it should be discarded. The discard date must not exceed the original expiry date printed on the packaging. Once a vial has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the vial if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• After withdrawal into the single-use syringe, chemical and physical in-use stability has been demonstrated for 24 hours at 15°C - 25°C. Do not return to the refrigerator. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user.
• Do not shake WEZENLA vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after “Exp.”. The expiry date refers to the last day of that month.
• If you notice that the liquid has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of WEZENLA 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 medicine has been shaken vigorously.
• If the seal is broken.

WEZENLA is for single use. Any unused product remaining in the vial or 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 required. This will help protect the environment.

6. Package contents and other information

What WEZENLA contains

• The active substance is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 mL.
• The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80 (E 433), sucrose, water for injections.

Description of the appearance of WEZENLA and contents of the pack
WEZENLA is an injectable solution ranging from clear to opalescent, from colourless to pale yellow. It is supplied
in a cardboard 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 and Manufacturer
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Marketing Authorisation Holder
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
s.a. Amgen n.v. Amgen Switzerland AG Vilniaus filialas
Tél/Tel: +32 (0)2 7752711 Tel: +370 5 219 7474
България Luxembourg/Luxemburg
Амджен България ЕООД s.a. Amgen
Тел.: +359 (0)2 424 7440 Belgique/Belgien
Tél/Tel: +32 (0)2 7752711
Česká republika Magyarország
Amgen s.r.o. Amgen Kft.
Tel: +420 221 773 500 Tel.: +36 1 35 44 700
Danmark Malta
Amgen, filial af Amgen AB, Sverige Amgen S.r.l.
Tlf.: +45 39617500 Italy
Tel: +39 02 6241121
Deutschland Nederland
Amgen GmbH Amgen B.V.
Tel: +49 89 1490960 Tel: +31 (0)76 5732500
Eesti Norge
Amgen Switzerland AG Vilniaus filialas Amgen AB
Tel: +372 586 09553 Tlf: +47 23308000
Ελλάδα Österreich
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Amgen GmbH
Τηλ: +30 210 3447000 Tel: +43 (0)1 50 217
España Polska
Amgen S.A. Amgen Biotechnologia Sp. z o.o.
Tel: +34 93 600 18 60 Tel.: +48 22 581 3000
France Portugal
Amgen S.A.S. Amgen Biofarmacêutica, Lda.
Tél: +33 (0)9 69 363 363 Tel: +351 21 4220606
Hrvatska România
Amgen d.o.o. Amgen România SRL
Tel: +385 (0)1 562 57 20 Tel: +4021 527 3000
Ireland Slovenija
Amgen Ireland Limited AMGEN zdravila d.o.o.
Tel: +353 1 8527400 Tel: +386 (0)1 585 1767
Ísland Slovenská republika
Vistor Amgen Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 321 114 49
Italia Suomi/Finland
Amgen S.r.l. Amgen AB, sivuliike Suomessa/Amgen AB, filial
Tel: +39 02 6241121 i Finland
Puh/Tel: +358 (0)9 54900500
Kύπρος Sverige
C.A. Papaellinas Ltd Amgen AB
Τηλ: +357 22741 741 Tel: +46 (0)8 6951100
Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

---

Instructions for use
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-administer WEZENLA. In this case, you will be taught how to inject WEZENLA yourself. Inform your doctor if you have any questions about self-injection.

• Do not mix WEZENLA with other injectable liquids.
• Do not shake the WEZENLA 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

Take out the vial or vials from the refrigerator. Leave the vial 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 your dose is 45 mg or less, you will use one 45 mg vial of WEZENLA
  • if your dose is 90 mg, you will use two 45 mg vials of WEZENLA 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 injection 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 medicine is the correct one
• the medicine has not expired
• the vial is undamaged and the cap is intact
• the solution in the vial is clear or opalescent and colourless or slightly yellow
• the liquid does not have a discoloured or cloudy appearance and contains no foreign particles
• it has not been frozen.

Children with paediatric psoriasis weighing less than 60 kg require a dose lower than 45 mg. Ensure the appropriate amount (volume) to be withdrawn from the vial and the type of syringe needed for dosing. If you do not know 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 should have a syringe, 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).

• WEZENLA is administered by injection under the skin (subcutaneous route).
• 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 with signs of 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.
• Wipe the injection site on the skin with an antiseptic swab.
• Do not touch this area again before giving 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.
• Clean the stopper with an antiseptic swab.
• Place the vial on a flat surface.
• Take the syringe and remove the protective needle cap.
• Do not touch the needle, and do not let the needle touch anything.
• Push the needle through the rubber stopper.
• Invert the vial and syringe.
• Pull back the plunger of the syringe to draw up the prescribed amount of liquid, as directed by your doctor.
• It is important that the needle tip remains immersed in the liquid at all times, 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 upward to check for any air bubbles inside.
• 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 until all the air is expelled (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 between your thumb and index finger. Do not squeeze too tightly.
• Insert the needle into the pinched skin at a 45-degree angle.
• Push the plunger with your 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 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 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 disposed of in regular waste.

Package leaflet: information for the user

WEZENLA 45 mg solution for injection in pre-filled syringe, 90 mg solution for injection in pre-filled syringe

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 this leaflet carefully before using this medicine as it contains important information for you.
This leaflet has been written for people who are taking this medicine. If you are the parent or caregiver of a child who is to be given WEZENLA, 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 WEZENLA is and what it is used for
2. What you need to know before using WEZENLA
3. How to use WEZENLA
4. Possible side effects
5. How to store WEZENLA
6. Package contents and other information

1. What WEZENLA is and what it is used for

What WEZENLA is
WEZENLA contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific proteins in the body.
WEZENLA belongs to a group of medicines called "immunosuppressants". These medicines reduce the activity of the immune system to some extent.

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

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn's disease in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
WEZENLA will reduce inflammation and other signs of the disease.
WEZENLA is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or in whom these treatments are ineffective.
WEZENLA is used in children and adolescents from 6 years of age 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 WEZENLA 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, WEZENLA may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using WEZENLA

Do not use WEZENLA

• 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, consult your doctor or
pharmacist before using WEZENLA.
Warnings and precautions
Talk to your doctor or pharmacist before using WEZENLA. 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 WEZENLA. If your doctor believes you are at risk of tuberculosis,
you may be given medicines to treat tuberculosis.

Be aware of serious side effects
WEZENLA may cause serious side effects, including allergic reactions and infections. You should
pay attention to certain signs of illness while taking WEZENLA. See “Serious side effects” in section 4 for a complete list of these side effects.

Before using WEZENLA, contact your doctor

• If you have ever had an allergic reaction to WEZENLA – Ask your doctor if you are unsure.
• If you have ever had any type of cancer – This is because immunosuppressants such as WEZENLA 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 currently 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 partially reduce immune system activity. The concomitant use of these therapies with WEZENLA 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 injections for the treatment of allergies – It is not known whether WEZENLA 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, consult your doctor or
pharmacist before starting treatment with WEZENLA.
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 ustekinumab, 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 numb feeling on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
WEZENLA is not recommended for the treatment of children with psoriasis under 6 years of age, children with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.
Other medicines, vaccines, and WEZENLA
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 administered while you are using WEZENLA.
• if you received WEZENLA during pregnancy, inform your child’s paediatrician about the WEZENLA treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received WEZENLA during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless your child’s paediatrician recommends otherwise.

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 WEZENLA in the womb, no increased risk of congenital malformations has been observed. However, experience with WEZENLA in pregnant women is limited. Therefore, it is preferable to avoid using WEZENLA 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 WEZENLA and for at least 15 weeks after stopping treatment with WEZENLA.
• Ustekinumab may cross the placenta and reach the unborn child. If you received WEZENLA during pregnancy, your child may have an increased risk of developing an infection.
• If you received WEZENLA during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received WEZENLA 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 before using this medicine. You and your doctor will decide whether you should breastfeed or use WEZENLA. You cannot do both.

Driving and using machines
WEZENLA has no or negligible effect on the ability to drive vehicles and use machines.
WEZENLA contains polysorbate 80
WEZENLA contains 0.02 mg (45 mg/0.5 mL) or 0.04 mg (90 mg/1.0 mL) of polysorbate 80 (E 433)
per single dose, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions.
Inform your doctor if you have any known allergies.

3. How to use WEZENLA

WEZENLA is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which WEZENLA is indicated.
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 WEZENLA is administered
Your doctor will decide how much WEZENLA you need and for how long.

Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of WEZENLA. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration 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 WEZENLA is administered by your doctor via an intravenous infusion into your arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of WEZENLA, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of WEZENLA may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Use in children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of WEZENLA 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 dose lower than 45 mg is required.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of WEZENLA per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of WEZENLA.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of WEZENLA.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

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

How WEZENLA is administered

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

If you use more WEZENLA than you should
If you have used or received too much WEZENLA, 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 WEZENLA
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 WEZENLA
It is not dangerous to stop using WEZENLA. However, if you stop treatment, your symptoms may return.

If you have any questions about the use of this medicine, consult 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 if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
  • difficulty breathing or swallowing
  • low blood pressure, which may cause dizziness or lightheadedness
  • 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).

Allergic lung reactions and lung inflammation have been reported rarely 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 WEZENLA again.

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

• Nasal, throat and common cold infections 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).

WEZENLA may reduce your body’s ability to fight infections. Some infections may become severe and may include infections 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 alert for signs of infection while using WEZENLA. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, pain and tenderness of 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 lead to serious complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop WEZENLA 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 spots, fever or joint pain (vasculitis)

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

• Blistering skin rash, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store WEZENLA

• 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 WEZENLA may also be stored at room temperature up to 30°C for a single period of up to 30 days, within 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 should be discarded. 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 WEZENLA. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or "Scad". The expiry date refers to the last day of that month.
• If you notice that the liquid has changed colour, appears cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of WEZENLA 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.

WEZENLA 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. Package contents and other information

What WEZENLA contains

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL or 90 mg of ustekinumab in 1 mL.
• The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E 433), sucrose, water for injections.

Description of the appearance of WEZENLA and contents of the pack
WEZENLA is an injectable solution ranging from clear to opalescent, colourless to pale yellow. It is supplied
in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains one dose of ustekinumab 45 mg in 0.5 mL or ustekinumab 90 mg in 1 mL of injectable solution.
Marketing Authorisation Holder and Manufacturer
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Marketing Authorisation Holder
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
s.a. Amgen n.v. Amgen Switzerland AG Vilniaus filialas
Tél/Tel: +32 (0)2 7752711 Tel: +370 5 219 7474
България Luxembourg/Luxemburg
Амджен България ЕООД s.a. Amgen
Тел.: +359 (0)2 424 7440 Belgique/Belgien
Tél/Tel: +32 (0)2 7752711
Česká republika Magyarország
Amgen s.r.o. Amgen Kft.
Tel: +420 221 773 500 Tel.: +36 1 35 44 700
Danmark Malta
Amgen, filial af Amgen AB, Sverige Amgen S.r.l.
Tlf.: +45 39617500 Italy
Tel: +39 02 6241121
Deutschland Nederland
Amgen GmbH Amgen B.V.
Tel: +49 89 1490960 Tel: +31 (0)76 5732500
Eesti Norge
Amgen Switzerland AG Vilniaus filialas Amgen AB
Tel: +372 586 09553 Tlf: +47 23308000
Ελλάδα Österreich
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Amgen GmbH
Τηλ: +30 210 3447000 Tel: +43 (0)1 50 217
España Polska
Amgen S.A. Amgen Biotechnologia Sp. z o.o.
Tel: +34 93 600 18 60 Tel.: +48 22 581 3000
France Portugal
Amgen S.A.S. Amgen Biofarmacêutica, Lda.
Tél: +33 (0)9 69 363 363 Tel: +351 21 4220606
Hrvatska România
Amgen d.o.o. Amgen România SRL
Tel: +385 (0)1 562 57 20 Tel: +4021 527 3000
Ireland Slovenija
Amgen Ireland Limited AMGEN zdravila d.o.o.
Tel: +353 1 8527400 Tel: +386 (0)1 585 1767
Ísland Slovenská republika
Vistor Amgen Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 321 114 49
Italia Suomi/Finland
Amgen S.r.l. Amgen AB, sivuliike Suomessa/Amgen AB, filial
Tel: +39 02 6241121 i Finland
Puh/Tel: +358 (0)9 54900500
Kύπρος Sverige
C.A. Papaellinas Ltd Amgen AB
Τηλ: +357 22741 741 Tel: +46 (0)8 6951100
Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

---

INSTRUCTIONS FOR USE

These Instructions for Use contain information on how to inject WEZENLA using a
pre-filled syringe.
This pre-filled syringe delivers WEZENLA via an injection under the skin (subcutaneous).
For information about the medicine, please refer to the Package Leaflet.
Pre-filled syringe presentation

Plunger head
Plunger rod
Needle shield clip
Plunger (position may vary)
Finger grip
Barrel
Label
View window
Needle cap (needle
inside)
1 Important information you must know before injecting WEZENLA
Dosage:

• WEZENLA is available in two different strengths: 45 mg/0.5 mL and 90 mg/1.0 mL. Check your prescription to ensure you have the correct strength.
• The appearance of the pre-filled syringe will differ depending on the strength. The amount of medicine in the pre-filled syringe will also vary according to the strength.
• The 45 mg/0.5 mL strength contains less medicine than the 90 mg/1.0 mL strength. Refer to the illustrations below to see how your strength appears in the pre-filled syringe.

45 mg/0.5 mL 90 mg/1.0 mL
Use of the WEZENLA pre-filled syringe:

• It is important that you do not attempt to self-inject unless you have received adequate training from your doctor or healthcare provider.
• In children aged 12 years and older with psoriasis who weigh at least 60 kg, WEZENLA is recommended to be used by or under the supervision of a parent or caregiver.
• Do not use the pre-filled syringe if the carton is damaged or the seal is broken.
• Do not use the pre-filled syringe after the expiry date stated on the label.
• Do not shake the pre-filled syringe.
• Do not remove the needle cap from the pre-filled syringe until you are ready to administer the injection.
• Do not use the pre-filled syringe if it has been frozen.
• Do not use the pre-filled syringe if it has been dropped onto a hard surface. Part of the pre-filled syringe may be broken even if the break is not visible. If available, use a new pre-filled syringe and contact your doctor or healthcare provider.

Important: Keep the pre-filled syringe and the sharps disposal container
out of sight and reach of children.
2 Prepare the necessary items to perform the WEZENLA injection
2a Grasp the pre-filled syringe by the barrel and remove it from the carton.

• Do not grasp the syringe by the plunger rod, finger grip, or needle cap.
• Do not grasp the needle shield clips.
• Remove the number of pre-filled syringes needed for the injection.
• Return any unused pre-filled syringes to the refrigerator.

2b Wait 30 minutes to allow the pre-filled syringe to reach room temperature.
WAIT
30
minutes

• The pre-filled syringe must warm up naturally.
• Do not warm it with warm water, in a microwave, or under direct sunlight.
• Do not shake the pre-filled syringe at any time.
• Using the pre-filled syringe at room temperature ensures a more comfortable injection.

2c Take and arrange the necessary items for the injection on a clean, well-lit surface.

Alcohol wipe
Plaster
Sharps disposal container
Cotton ball or gauze

• WEZENLA pre-filled syringe (at room temperature)
• Sharps disposal container
• Alcohol wipe
• Plaster
• Cotton ball or gauze

3 Prepare for the injection
3a Inspect the medicine. It should be from clear to opalescent, colourless to slightly yellow.

Medicine

• It is normal to see air bubbles in the pre-filled syringe.
• Do not use the syringe if the medicine is frozen, cloudy, discoloured, or if you see floating foreign particles.

3b Check the expiry date (Exp.) and inspect the pre-filled syringe.

Expiry
date

• Do not use the syringe if the expiry date has passed.
• Do not use the pre-filled syringe in the following situations:
  • the needle cap is missing or loose;
  • there are cracks or broken parts;
  • the syringe has been dropped onto a hard surface.
• Make sure you have the correct medicine and strength.

3c Administer the injection at one of the following sites.

Upper arm
Abdomen
Thigh

• Administer the injection in the thigh or abdomen (avoiding the area within 5 cm around the navel).
• Choose a different site for each injection.
• If another person administers the injection, the medicine may be injected into the thigh, abdomen, or outer area of the upper arm.

Important: Avoid areas with scars, stretch marks, or where the skin is tender, bruised, red, or hardened. If possible, do not use skin areas showing signs of psoriasis.
3d Wash your hands thoroughly with soap and water.
3e Clean the injection site with an alcohol wipe.

• Allow the skin to dry.
• Do not touch this area again before administering the injection.

4 Inject WEZENLA
4a Remove the needle cap in a straight motion by holding the barrel of the pre-filled syringe.
Important: Remove the needle cap only when you are able to administer the injection
immediately (within 5 minutes), to prevent the medicine from drying.

• Do not twist or bend the needle cap.
• Never recap the needle, as this may damage the needle.
• After removing the needle cap, the needle must not come into contact with anything.
• After removing the needle cap, do not place the uncapped pre-filled syringe on any surface.
• Do not attempt to remove air bubbles from the pre-filled syringe. The presence of air bubbles is normal.
• Oozing of a small drop of medicine is normal.

4b Pinch the skin around the injection site between two fingers before injecting.
PINCH

• Hold the skin between your thumb and index finger to create a skin fold for the injection.
• If possible, this skin fold should be about 5 cm wide.

Important: Continue holding the skin fold until the injection is complete.
4c Insert the needle into the skin fold.
INSERT

• Insert the needle into the skin fold at a 45-degree angle.
• Do not place your finger on the plunger rod while inserting the needle, as this may cause medicine leakage.

4d Slowly press the plunger head down until it is fully seated between the needle shield clips.
INJECT

• Do not pull back on the plunger.
• Do not remove the pre-filled syringe before all the medicine has been administered.

4e Continue pressing on the plunger head and withdraw the needle from the skin.
LIFT

• Continue pressing on the plunger head and withdraw the needle from the skin.
• After removing the needle, release the skin.
• Slowly remove your thumb from the plunger head. This will cause the empty syringe to move backward until the entire needle is fully covered by the safety shield.

If a second injection is required…
4f If a second injection is required, repeat steps 2a–4e.

• Check the prescribed dose on your prescription. If your dose is 90 mg, you will receive either one 90 mg pre-filled syringe or two 45 mg pre-filled syringes.
  • If you receive two 45 mg pre-filled syringes for a 90 mg dose, you will need to administer a second injection immediately after the first.
• Repeat steps 2a–4e for the second injection using a new pre-filled syringe. Choose a different injection site for the second injection.

5 Complete the procedure and dispose of WEZENLA
Important: Never recap the needle.
5a Dispose of the used pre-filled syringe and needle cap in the sharps disposal container.

• Do not reuse the pre-filled syringe.

Do not dispose of the pre-filled syringe in household waste.
5b Check the injection site.

• Do not rub the injection site.
• If bleeding occurs, apply pressure with a cotton ball or gauze. Apply a plaster if needed.

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.

Package leaflet: Information for the user

WEZENLA 45 mg solution for injection in pre-filled pen, 90 mg solution for injection in pre-filled pen

ustekinumab
This medicinal product is subject to additional monitoring. This will allow 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 using this medicine as 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.
• 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What WEZENLA is and what it is used for

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

• plaque psoriasis (in adults)
• 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.
WEZENLA will reduce inflammation and other signs of the disease.
WEZENLA is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate or phototherapy, or in whom these treatments are ineffective.
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 WEZENLA 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, WEZENLA may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using WEZENLA

Do not use WEZENLA

• 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, consult your doctor or
pharmacist before using WEZENLA.
Warnings and precautions
Talk to your doctor or pharmacist before using WEZENLA. 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. Additionally, tell your doctor if you have recently been in contact with someone who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering WEZENLA. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
WEZENLA can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking WEZENLA. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using WEZENLA, contact your doctor

• If you have ever had an allergic reaction to WEZENLA – Ask your doctor if you are unsure.
• If you have ever had any type of cancer – This is because immunosuppressants like WEZENLA partially weaken the immune system, which 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, usually administered by injection) – The risk of cancer may be higher.
• If you currently 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 WEZENLA 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 injections – It is not known whether WEZENLA 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, consult your doctor or
pharmacist before starting treatment with WEZENLA.
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 areas of skin, or if you experience joint pain.
Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, 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 a strange sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
The WEZENLA pre-filled pen is not recommended for use in children and adolescents under 18 years of age with psoriasis or Crohn’s disease, as it has not been studied in this age group. For children aged 6 years and older (and adolescents) with psoriasis, the pre-filled syringe or vial should be used instead. For children with Crohn’s disease weighing at least 40 kg, the infusion solution, vial, or pre-filled syringe should be used instead.
WEZENLA is not recommended for the treatment of children and adolescents under 18 years of age with psoriatic arthritis or for children with Crohn’s disease weighing less than 40 kg, as it has not been studied in these populations.
Other medicines, vaccines, and WEZENLA
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 due to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using WEZENLA.
• if you received WEZENLA during pregnancy, inform your child’s paediatrician about the WEZENLA treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received WEZENLA during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise advised by your 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.
• In newborns exposed to WEZENLA in the womb, no increased risk of congenital malformations has been observed. However, experience with WEZENLA in pregnant women is limited. Therefore, it is preferable to avoid using WEZENLA 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 WEZENLA and for at least 15 weeks after stopping treatment with WEZENLA.
• Ustekinumab may pass to the unborn child through the placenta. If you received WEZENLA during pregnancy, your child may have an increased risk of developing an infection.
• If you received WEZENLA during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received

WEZENLA 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 advised by your child’s paediatrician.

• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine. You and your doctor will decide whether you should breastfeed or use WEZENLA. You cannot do both.

Driving and using machines
WEZENLA has no or negligible effect on the ability to drive vehicles and use machinery.
WEZENLA contains polysorbate 80
WEZENLA contains 0.02 mg (45 mg/0.5 mL) or 0.04 mg (90 mg/1.0 mL) of polysorbate 80 (E 433) per single dose, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions.
Inform your doctor if you have any known allergies.

3. How to use WEZENLA

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

How much WEZENLA is administered

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

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of WEZENLA. 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 WEZENLA is administered by your doctor as an intravenous infusion into your arm (intravenous infusion). After the initial dose, you will receive the next dose of 90 mg of WEZENLA after 8 weeks, then every 12 weeks via subcutaneous injection (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of WEZENLA may be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Use in children and adolescents from 6 years of age

Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of WEZENLA to be injected to ensure the correct dose is administered. The correct dose will depend on the child's body weight at the time of each dose administration.
• The pre-filled pen has not been studied in children aged between 6 and 11 years and its use is not recommended in children within this age group.
• A 45 mg vial is available if a dose lower than 45 mg is required.
• If body weight is below 60 kg, the recommended dose is 0.75 mg of WEZENLA per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of WEZENLA.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of WEZENLA.
• After the initial dose, you will receive the next dose after 4 weeks, and then every 12 weeks.

How WEZENLA is administered

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

If you use more WEZENLA than you should

If you have used or received too much WEZENLA, 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 WEZENLA

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 WEZENLA

It is not dangerous to stop using WEZENLA. However, if you stop treatment, your symptoms may return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 ustekinumab (occurring in up to 1 in 1,000 patients). Signs include:
  • difficulty breathing or swallowing
  • low blood pressure, which may cause dizziness or a feeling of lightheadedness
  • swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (occurring in 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 WEZENLA again.
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 (occurring in 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 (occurring in up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (occurring in up to 1 in 100 patients).

WEZENLA may reduce your ability to fight infections. Some infections may become severe and may include those caused by viruses, fungi, bacteria (including those causing tuberculosis) or parasites, including infections that primarily 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 the signs of infection while using WEZENLA. 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 have serious complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop WEZENLA 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 (occurring in 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 (occurring in 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 (occurring in 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 spots, fever or joint pain (vasculitis)

Very rare side effects (occurring in 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 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 WEZENLA

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2°C - 8°C). Do not freeze.
• Keep the pre-filled pen in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled pens of WEZENLA 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 pen is first removed from the refrigerator and the date when it should be discarded. The discard date must not exceed the original expiry date printed on the packaging. Once a pre-filled pen has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the pre-filled pen if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake WEZENLA pre-filled pens. Prolonged vigorous 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 that month.
• If you notice that the liquid has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of WEZENLA 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.

WEZENLA is for single use only. Any unused product remaining in the pre-filled pen 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. Package contents and other information

What WEZENLA contains

• The active substance is ustekinumab. Each pre-filled pen contains 45 mg of ustekinumab in 0.5 mL or 90 mg of ustekinumab in 1 mL.
• The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E 433), sucrose, water for injections.

Description of the appearance of WEZENLA and contents of the pack
WEZENLA is an injectable solution ranging from clear to opalescent, colourless to pale yellow. It is supplied
in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled pen. Each pre-filled pen contains one dose of ustekinumab 45 mg in 0.5 mL or ustekinumab 90 mg in 1 mL
of injectable solution.
Marketing Authorisation Holder and Manufacturer
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Marketing Authorisation Holder
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
s.a. Amgen n.v. Amgen Switzerland AG Vilniaus filialas
Tél/Tel: +32 (0)2 7752711 Tel: +370 5 219 7474
България Luxembourg/Luxemburg
Амджен България ЕООД s.a. Amgen
Тел.: +359 (0)2 424 7440 Belgique/Belgien
Tél/Tel: +32 (0)2 7752711
Česká republika Magyarország
Amgen s.r.o. Amgen Kft.
Tel: +420 221 773 500 Tel.: +36 1 35 44 700
Danmark Malta
Amgen, filial af Amgen AB, Sverige Amgen S.r.l.
Tlf.: +45 39617500 Italy
Tel: +39 02 6241121
Deutschland Nederland
Amgen GmbH Amgen B.V.
Tel: +49 89 1490960 Tel: +31 (0)76 5732500
Eesti Norge
Amgen Switzerland AG Vilniaus filialas Amgen AB
Tel: +372 586 09553 Tlf: +47 23308000
Ελλάδα Österreich
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Amgen GmbH
Τηλ: +30 210 3447000 Tel: +43 (0)1 50 217
España Polska
Amgen S.A. Amgen Biotechnologia Sp. z o.o.
Tel: +34 93 600 18 60 Tel.: +48 22 581 3000
France Portugal
Amgen S.A.S. Amgen Biofarmacêutica, Lda.
Tél: +33 (0)9 69 363 363 Tel: +351 21 4220606
Hrvatska România
Amgen d.o.o. Amgen România SRL
Tel: +385 (0)1 562 57 20 Tel: +4021 527 3000
Ireland Slovenija
Amgen Ireland Limited AMGEN zdravila d.o.o.
Tel: +353 1 8527400 Tel: +386 (0)1 585 1767
Ísland Slovenská republika
Vistor Amgen Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 321 114 49
Italia Suomi/Finland
Amgen S.r.l. Amgen AB, sivuliike Suomessa/Amgen AB, filial
Tel: +39 02 6241121 i Finland
Puh/Tel: +358 (0)9 54900500
Kύπρος Sverige
C.A. Papaellinas Ltd Amgen AB
Τηλ: +357 22741 741 Tel: +46 (0)8 6951100
Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

INSTRUCTIONS FOR USE

These Instructions for Use contain information on how to inject WEZENLA with a pre-filled pen (ConfiPen).
This pre-filled pen delivers WEZENLA via an injection under the skin (subcutaneous).
For information about the medicine, please consult the package leaflet.
Presentation of the pre-filled pen

Expiry date
Plunger tip (may be
visible in the window;
position may vary)
Medicine window
Yellow safety device
under the cap (needle
inside)
Cap
Important information you should know before injecting WEZENLA
Dosage:

• WEZENLA is available in two different doses: 45 mg/0.5 mL and 90 mg/1.0 mL. Check your prescription to ensure you have the correct dose.
• The label colour and size of the pre-filled pen window will vary depending on the dose. The amount of medicine in the pre-filled pen will also differ depending on the dose.

45 mg/0.5 mL 90 mg/1.0 mL
Important:

• If your dose is 90 mg, you will receive either one 90 mg pre-filled pen or two 45 mg pre-filled pens.
  • If you receive two 45 mg pre-filled pens for a 90 mg dose, you must administer a second injection immediately after the first.
  • Repeat steps 1–14 for the second injection using a new pre-filled pen.
  • Choose a different injection site for the second injection. Using the WEZENLA pre-filled pen:
• It is important that you or your caregiver do not attempt to administer the injection unless you have received adequate training from your doctor or healthcare professional.
• Do not use the pre-filled pen if the carton is damaged or the seal is broken.
• Do not use the pre-filled pen after the expiry date printed on the label.
• Do not shake the pre-filled pen.
• Do not remove the cap from the pre-filled pen until you are ready to perform the injection.
• Do not use the pre-filled pen if it has been frozen.
• Do not use the pre-filled pen if it has fallen on a hard surface. Part of the pre-filled pen may be damaged even if the damage is not visible. If available, use a new pre-filled pen and contact your doctor or healthcare professional.

Important: Keep the pre-filled pen and the sharps disposal container out of sight and reach of children.
Prepare the necessary items for administering the WEZENLA injection
1 Wait 30 minutes to allow the pre-filled pen to reach room temperature.
WAIT
30
minutes

• Remove the required number of pre-filled pens for the injection from the refrigerator.
• Allow the pre-filled pen to warm up naturally.
• Do not warm it with hot water, in a microwave, or in direct sunlight.
• Do not return the pre-filled pen to the refrigerator once it has reached room temperature.
• Do not shake the pre-filled pen at any time.
• Using the pre-filled pen at room temperature ensures the full dose is delivered and provides a more comfortable injection.

Medicine
2 Inspect the medicine. It should be from clear to opalescent, colourless to slightly yellow.

• It is normal to see air bubbles.
• Do not use WEZENLA if the medicine is frozen, cloudy, discoloured, or if you see floating foreign particles.

Expiry date
3 Check the expiry date (Exp.) and inspect the pre-filled pen for any damage.

• Do not use the pre-filled pen if the expiry date has passed.
• Do not use the pre-filled pen if:
  • the cap is missing or loose;
  • there are cracks or broken parts;
  • the pen has fallen on a hard surface.
• Make sure you have the correct medicine and dose.

Prepare for the WEZENLA injection

Alcohol wipe
Plaster
Sharps disposal
Cotton ball or
container
gauze
4 Gather and place the following items needed for the injection on a clean, flat, well-lit surface:

• WEZENLA pre-filled pen (at room temperature)
• Sharps disposal container
• Alcohol wipe
• Plaster
• Cotton ball or gauze

Abdomen
Thigh
5 Choose one of these sites for the injection.

• Choose the front of the thigh or the abdomen (avoiding the area within 5 cm of the navel).
• If another person administers the injection, the medicine can be injected into the thigh or abdomen.

Important: Avoid areas with scars, stretch marks, or where the skin is tender, bruised, red, or hardened. If possible, do not use areas of skin showing signs of psoriasis.
6 Wash your hands thoroughly with water and soap.
7 Clean the injection site with an alcohol wipe.

• Allow the skin to dry.
• Do not touch the cleaned area again before administering the injection.

Injecting WEZENLA
Important: Remove the cap only when you are ready to administer the injection immediately (within 5 minutes), as the medicine may dry out. Do not re-cap the pen.

The window must be visible
8 Hold the pre-filled pen so that the window is visible. Pull firmly to remove the cap. To assist removal, you may rotate the cap.

• Never re-cap the pen. This may damage the needle.
• It is normal to see a drop of medicine at the tip of the needle or yellow safety device.

Important: Do not touch or press the yellow safety device. Do not insert fingers into the yellow safety device.

9 Grasp the skin to create a taut skin fold at the injection site.
Place the yellow safety device directly against the skin.

• Continue holding the skin fold until the injection is complete.
• Ensure the window is visible.
• Ensure the pre-filled pen is positioned vertically at the injection site (forming a 90-degree angle).

PUSH AND HOLD
against the skin to start the injection

10 Firmly press the pre-filled pen until the yellow safety device stops moving.
Keep pressing the pre-filled pen; do not lift it.

• The needle will automatically insert and the injection will begin.
• You may hear or feel a click.
• Keep the pre-filled pen straight and steady against the skin.

OBSERVE
the window turning completely yellow

11 Continue pressing down on the pre-filled pen. Wait for the window to turn completely yellow.

• The injection may take up to 15 seconds to complete. You may hear or feel a click.
• When the window turns completely yellow, lift the pre-filled pen away from the skin.

Checking the injection site and disposing of the pre-filled pen
CONFIRM

The window is completely yellow
No leakage of
medicine (a small drop is normal)
12 Confirm that a full dose of medicine has been injected.

• Do not touch the yellow safety device.
• A small amount of liquid at the injection site is normal.

Important: If the window has not turned completely yellow, if you think the medicine is still being delivered, or if you see multiple drops of medicine, this indicates that you have not received a complete dose. Contact your healthcare professional immediately.

13 Check the injection site.

• Do not rub the injection site.
• If bleeding occurs, apply pressure with a cotton ball or gauze.
• Apply a plaster if needed.

14 Place the used pre-filled pen and cap into the sharps disposal container.
Important: Do not dispose of the pre-filled pen in household waste.

• Do not reuse the pre-filled pen.
• Do not touch the yellow safety device.

Any unused product remaining in the pre-filled pen must be discarded. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.