STELARA 45 mg Injectable Solution

Наталія Бессоліцина

Наталія Бессоліцина — лікарка-ревматолог вищої категорії з великим клінічним досвідом. Вона спеціалізується на діагностиці, лікуванні та довгостроковому супроводі пацієнтів із захворюваннями суглобів, хребта та системними аутоімунними порушеннями. Проводить онлайн-консультації відповідно до міжнародних стандартів і принципів доказової медицини.

З якими симптомами та діагнозами звертаються:

Біль у суглобах (гострий, хронічний, рецидивний).
Запальні артрити: ревматоїдний артрит, псоріатичний артрит, поліартрит.
Обмінні порушення: подагра, подагричний артрит.
Захворювання хребта: анкілозуючий спондиліт (хвороба Бехтерєва).
Дегенеративні зміни: остеоартроз, гонартроз, коксартроз, плечолопатковий періартрит.
Системні захворювання: червоний вовчак, склеродермія, васкуліти.
Остеопороз та підвищена ламкість кісток.

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Інструкція із застосування STELARA

Зміст інструкції

STELARA 130 mg concentrate for solution for infusion
STELARA 45 mg injectable solution
STELARA 45 mg solution for injection in pre-filled syringe
STELARA 90 mg solution for injection in pre-filled syringe
STELARA 45 mg injectable solution in pre-filled pen
Stelara
STELARA 90 mg solution for injection in pre-filled pen
Stelara

STELARA 130 mg concentrate for solution for infusion

ustekinumab

Read this leaflet carefully before using this medicine as it contains important
information for you.
This leaflet is 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Stelara and what is it used for

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

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

moderate to severe Crohn’s disease in adults and children weighing at least 40 kg;
moderate to severe ulcerative colitis in adults.

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

Ulcerative Colitis
Ulcerative colitis is an inflammatory bowel disease. If you suffer from ulcerative colitis, you will be treated
first with other medications. If you do not respond well enough or are intolerant to these medicines,
you may be given Stelara to reduce the signs and symptoms of your disease.

2. What you need to know before using Stelara

Do not use Stelara

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

If you are not sure whether any of the above conditions apply to you, talk to your doctor or pharmacist before using Stelara.

Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your health status before treatment. Make sure to tell your doctor about any illnesses you have before treatment. Also, tell your doctor if you have recently been in contact with people who may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before giving you Stelara. If your doctor believes you are at risk of tuberculosis, they may give you medicines to treat tuberculosis.

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

Contact your doctor before using Stelara

If you have ever had an allergic reactionto Stelara. Ask your doctor if you are not sure.
If you have ever had any type of cancer- this is because immunosuppressants like Stelara partially weaken the immune system. This can increase the risk of cancer.
If you have been treated for psoriasis with other biologic 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 had a recent infection or if you have abnormal openings in the skin (fistulas).
If you have ever had any new or changed skin lesionwithin the area of psoriasis or on normal skin.
If you are taking any other type of 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 can also partially reduce the activity of the immune system. The simultaneous use of these therapies with Stelara has not been studied. However, it is possible that it may increase the possibility 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 Stelara may have an effect on them.
If you are 65 years of age or older- you may have a greater chance of getting infections.

If you are not sure whether any of the conditions mentioned above may apply to you, talk to your doctor or pharmacist before undergoing treatment with Stelara.
During treatment with ustekinumab, some patients have developed reactions similar to lupus, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker edge, in areas of skin exposed to the sun or with joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with Stelara, heart attack and stroke were observed. Your doctor will regularly check risk factors for heart disease and stroke to ensure they are treated appropriately. Seek immediate medical attention if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision abnormalities.

Children and adolescents
Stelara is not recommended for the treatment of children weighing less than 40 kg with Crohn’s disease, nor in children and adolescents under 18 years of age with ulcerative colitis because it has not been studied in this age group.

Other medicines, vaccines and Stelara
Tell 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 Stelara.
if you received Stelara during pregnancy, inform your child’s pediatrician about the Stelara treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received Stelara during pregnancy, live vaccines are not recommended for your child in the first twelve months after birth, unless your child’s pediatrician recommends otherwise.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
No increased risk of birth defects has been observed in newborns exposed to Stelara in the womb. However, there is limited experience with Stelara in pregnant women. Therefore, it is preferable to avoid the use of Stelara during pregnancy.
If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during use of Stelara and for at least 15 weeks after stopping treatment with Stelara.
Ustekinumab can reach the newborn through the placenta. If you received Stelara during pregnancy, your child may have an increased risk of contracting an infection.
If you received Stelara during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received Stelara during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first twelve months after birth, unless your pediatrician recommends otherwise.
Ustekinumab can be excreted in small amounts in breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use Stelara. You cannot do both.

Driving and using machines
Stelara does not alter or negligibly alters the ability to drive vehicles or use machines.

Stelara contains sodium
Stelara contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially “sodium-free”.
However, before Stelara is administered, it is mixed with a solution containing sodium. Talk to your doctor if you are on a low-salt diet.

Stelara contains polysorbate 80
STELARA contains 10.8 mg of polysorbate 80 (E433) per dose, equivalent to 0.40 mg/mL. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergies.

3. How Stelara will be used

Stelara is intended for use under the guidance and supervision of a physician experienced in the diagnosis and
treatment of Crohn's disease or ulcerative colitis.
Stelara 130 mg concentrate for solution for infusion will be administered to you by the physician, through
an intravenous drip in the arm vein (intravenous infusion) for at least one hour. Discuss with your physician
when you will need to undergo injections and subsequent follow-up visits.

How much Stelara is administered
The physician will decide how much Stelara you need and for how long.

Adults starting from 18 years

The physician 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 take the next dose of 90 mg of Stelara with an injection under the skin (subcutaneous injection) and then continue every 12 weeks.

Children with Crohn's disease weighing at least 40 kg

The physician 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 take the next dose of 90 mg of Stelara with an injection under the skin (subcutaneous injection) and then continue every 12 weeks.

How Stelara is administered
The first dose of Stelara for the treatment of Crohn's disease or ulcerative colitis is
administered by the physician through an intravenous drip in a vein in the arm (intravenous infusion).
Inform your physician if you have any questions about the use of Stelara.

If you forget to use Stelara
If you forget or miss the appointment for administering the dose, contact your physician to
schedule a new appointment.

If you stop using Stelara
It is not dangerous to stop using Stelara. However, if you stop treatment, the symptoms
may reappear.
If you have further questions about the use of this medicine, ask your physician or
pharmacist.

4. Possible side effects

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

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

Allergic reactions – these may require urgent medical attention, so contact your doctor or seek urgent medical help if you notice any of the following signs.

Severe allergic reactions (“anaphylaxis”) are rare in patients taking Stelara (affecting up to 1 in 1,000 patients). Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or feeling lightheaded

o swelling of the face, lips, mouth or throat.

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

Infusion-related reactions – If you are being treated for Crohn’s disease or ulcerative colitis, the first dose of Stelara is given through a drip (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. Tell your doctor immediately if you develop
symptoms such as cough, shortness of breath and fever.
If you have a severe allergic reaction, your doctor may decide that you should not use Stelara
again.

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

Infections of the nose and throat and the common cold are common (affecting up to 1 in 10 patients).
Chest infections are uncommon (can 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).

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

fever, flu-like symptoms, night sweats, weight loss
feeling tired or short of breath, persistent cough
warm, red and painful skin, or a painful blistering rash
burning when urinating
diarrhoea
blurred vision or loss of vision
headache, stiff neck, sensitivity to light, nausea or confusion

Tell your doctor immediately if you notice any of these signs of infection. These
may be signs of infection such as chest infections, skin infections, herpes zoster or
opportunistic infections that may have serious complications. See your doctor if you have
any type of infection that persists or keeps coming back. Your doctor may decide to
stop Stelara until the infection has resolved. Also tell your doctor if you have
any cuts or open wounds that may 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
should tell your doctor immediately.
Other side effects
Common side effects(affecting up to 1 in 10 patients)

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

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

Dental infection
Fungal vaginal infection
Depression
Blocked or runny nose
Bleeding, bruising, stiffness, swelling and itching at the place where the injection is given
Feeling weak
Drooping eyelid and muscle weakness on one side of the face (“facial palsy” or “Bell’s palsy”), which is usually temporary
A change of psoriasis with redness and small, yellow or white pustules, sometimes accompanied by fever (pustular psoriasis)
Skin peeling (shedding of the skin)
Acne

Rare side effects(affecting 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 can lead to a rash with small red or purple bumps, fever or joint pain (vasculitis)

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

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

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

5. How to store Stelara

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

Do not use this medicine

After the expiry date that is stated on the label and the carton after “Exp.”. The expiry date refers to the last day of the month.
If the liquid has a discolored appearance, is cloudy or if you see foreign particles floating (see section 6 “Description of Stelara 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.

Stelara is for single use. Any unused diluted solution for infusion remaining in the vial and the
syringe must be disposed of in accordance with local regulations.

6. Contents of the pack and other information

What Stelara contains

The active ingredient is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
The excipients are: Disodium edetate dihydrate (E385), L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose, water for injections.

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

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: + 32 14 64 94 11
[email protected]

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]

Malta
AM MANGION LTD.
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: + 47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: + 48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle
Latvijā
Tel: +371 678 93561
[email protected]

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
[email protected]
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 for healthcare professionals only.
Traceability
In order to improve the traceability of biological medicinal products, the trade name and batch number
of the administered product must be clearly recorded.
Instructions for dilution.
STELARA 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 STELARA vials needed based on the patient's weight (see section 3, Table 1, Table 2). Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
2. Withdraw and discard a volume of 9 mg/mL (0.9%) sodium chloride solution from the 250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL of sodium chloride for each vial of STELARA needed, for 2 vials discard 52 mL, for 3 vials discard 78 mL, for 4 vials discard 104 mL).
3. Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Gently mix.
4. Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, discoloration or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within eight hours of dilution in the infusion bag.
6. Use only one sterile, non-pyrogenic, low protein-binding in-line filter infusion set (pore size 0.2 micrometers).
7. Each vial is for single use and unused medicinal product must be disposed of in accordance with local regulations.

Storage
If required, the diluted infusion solution may be stored at room temperature.
The infusion must be completed within 8 hours of dilution in the infusion bag. Do not
freeze.

STELARA 45 mg injectable solution

ustekinumab

Read this leaflet carefully before using this medicine as it contains important
information for you.
This leaflet is written for people who are taking this medicine. If you are the parent or
carer of a child to whom Stelara is to be administered, 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Stelara and what is it used for

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

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

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation of the skin and nails.
Stelara will reduce the inflammation and other signs of the disease.
Stelara is used in adults with moderate to severe plaque psoriasis who cannot use
cyclosporine, methotrexate or phototherapy, or in whom these treatments do not work.
Stelara is used in children and adolescents starting 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 disease of the joints, usually accompanied by
psoriasis. If you have active psoriatic arthritis you will first be treated with other medicines. If you should
not respond adequately to these medicines, you may take Stelara to:

reduce the signs and symptoms of the disease
improve physical function
slow down damage to the joints.

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

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you suffer from ulcerative colitis, you will be treated
first with other medicines. If you do not respond well enough or are intolerant to these medicines,
you may be given Stelara to reduce the signs and symptoms of your disease.

2. What you need to know before using Stelara

Do not use Stelara

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

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

Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your health before each treatment. Make sure to tell your doctor about any illnesses you have before each treatment. Also, tell your doctor if you have recently been in contact with people who may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before giving you Stelara. If your doctor believes you are at risk of tuberculosis, they may give you medicines to treat tuberculosis.

Before using Stelara, contact your doctor:

If you have ever had an allergic reactionto Stelara. Ask your doctor if you are not sure.
If you have ever had any type of cancer- this is because immunosuppressants like Stelara partially weaken the immune system. This can increase the risk of cancer.
If you have been treated for psoriasis with other biologic medicines (a medicinal productderived from a biological source and usually administered by injection)- the risk of cancer may be higher.
If you have or have had a recent infection.
If you have ever had any new or changed lesionwithin the area of psoriasis or on normal skin.
If you are taking any other type of 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 can also partially reduce the activity of the immune system. The simultaneous use of these therapies with Stelara has not been

studied. However, it is possible that it may increase the possibility 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 Stelara may have an effect on them.
If you are 65 years of age or older- you may have a higher chance of getting infections.

If you are not sure if any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before undergoing treatment with Stelara.
During treatment with ustekinumab, some patients have experienced reactions similar to lupus, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, and scaly rash, sometimes with a darker edge, in areas of skin exposed to the sun or with joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with Stelara, heart attack and stroke were observed. Your doctor will regularly check your risk factors for heart disease and stroke to ensure they are treated appropriately. Contact a doctor immediately if you develop chest pain, weakness or an unusual sensation on one side of your body, facial drooping, or speech or vision abnormalities.

Children and adolescents
Stelara is not recommended for the treatment of children with psoriasis under the age of 6 years, children with Crohn's disease weighing less than 40 kg, or for the treatment of children under the age of 18 years with psoriatic arthritis or ulcerative colitis because it has not been studied in this age group.

Other medicines, vaccines and Stelara
Tell 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 Stelara.
if you received Stelara during pregnancy, inform your child’s pediatrician about the Stelara treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received Stelara during pregnancy, live vaccines are not recommended for your child in the first twelve months after birth, unless your child’s pediatrician recommends otherwise.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
No increased risk of birth defects has been observed in newborns exposed to Stelara in the womb. However, there is limited experience with Stelara in pregnant women. Therefore, it is preferable to avoid using Stelara during pregnancy.
If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during use of Stelara and for at least 15 weeks after stopping treatment with Stelara.
Ustekinumab can reach the newborn through the placenta. If you received Stelara during pregnancy, your child may have an increased risk of infection.
If you received Stelara during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received Stelara during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first twelve months after birth, unless your pediatrician recommends otherwise.
Ustekinumab may be excreted in small amounts in breast milk. If you are breastfeeding or

breastfeeding, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use Stelara. You cannot do both.

Driving and using machines
Stelara does not impair or negligibly impairs the ability to drive vehicles or use machines.

Stelara contains polysorbate 80
STELARA contains 0.02 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use Stelara

Stelara is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Stelara is indicated.
Use this medicine following the doctor's instructions exactly at all times. If you have any doubts, consult your
doctor. Discuss with your doctor when you will need to undergo the injections and subsequent follow-up
visits.

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

Adults starting from 18 years of age
Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Stelara. Patients with a weight greater than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
4 weeks after the initial dose, you will take the next dose and then continue every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn's disease or ulcerative colitis

During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by the doctor via an intravenous infusion in the arm (intravenous infusion). 8 weeks after the initial dose, you will receive the next dose of 90 mg of Stelara and then continue every 12 weeks with an injection under the skin (subcutaneous route).
In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. The doctor will decide when the next dose needs to be administered.

Children and adolescents starting from 6 years of age
Psoriasis

The doctor will calculate the correct dose, including the amount (volume) of Stelara that must be injected to ensure the administration of the correct dose. The correct dose will depend on the child's body weight at the time of administration of each dose.
If the body weight is less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg of body weight.
If the body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Stelara.
If the weight exceeds 100 kg, the recommended dose is 90 mg of Stelara.
4 weeks after the initial dose, you will need to receive the next dose and then continue every 12 weeks.

Children weighing at least 40 kg
Crohn's disease

During treatment, the first dose of approximately 6 mg/kg of Stelara is administered by the doctor via an intravenous infusion in the arm (intravenous infusion). 8 weeks after the dose

initial, you will receive the next dose of 90 mg of Stelara and then continue every 12 weeks with
an injection under the skin (subcutaneous route).

In some patients, after the first subcutaneous injection, the 90 mg dose of Stelara may be administered every 8 weeks. The doctor will decide when the next dose needs to be administered.

How Stelara is administered
Stelara is administered by a subcutaneous injection (“by the subcutaneous route”). At the beginning of
treatment, medical or nursing staff may inject Stelara for you.

However, you and your doctor can decide whether you can inject Stelara yourself. In this case, you will be taught how to inject Stelara yourself.
For instructions on how to inject Stelara, see “Instructions for Administration” at the end

Inform your doctor if you have any questions about the injection to be performed yourself.

If you use more Stelara than you should
If you have used or received too much Stelara, 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 Stelara
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for
the missed dose.

4. Possible side effects

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

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

Allergic reactions – these may require urgent treatment, so contact your doctor or seek urgent medical attention if you notice any of the following signs.

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

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Tell your doctor immediately if you develop symptoms such as cough, shortness of breath and fever.
If you have a severe allergic reaction, your doctor may decide that you should not use Stelara again.

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

Infections of the nose and throat and the 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 skin rash with blisters) is uncommon (affects up to 1 in 100 patients).

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

fever, flu-like symptoms, night sweats, weight loss
feeling tired or short of breath, persistent cough
warm, red and painful skin, or a painful rash with blisters
burning when urinating
diarrhea
blurred vision or loss of vision
headache, stiff neck, sensitivity to light, nausea or confusion

Tell 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 that can have serious complications. See your doctor if you have any type of infection that persists or keeps coming back. Your doctor may decide to stop Stelara until the infection resolves. Also tell your doctor if you have any cuts or open wounds that may 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 should tell your doctor immediately.
Other side effects
Common side effects(affect up to 1 in 10 patients)

Diarrhea
Nausea
Vomiting
Feeling tired
Feeling dizzy
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 infection
Vaginal fungal infection
Depression
Stuffy or runny nose
Bleeding, bruising, stiffness, swelling and itching at the place where the injection is given
Feeling weak
Drooping eyelid and muscle weakness on one side of the face (“facial palsy” or “Bell’s palsy”), which is usually temporary
A change in psoriasis with redness and small, yellow or white bumps, sometimes accompanied by fever (pustular psoriasis)
Skin peeling (shedding 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 can lead to a skin rash with small red or purple bumps, fever or joint pain (vasculitis)

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

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

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

5. How to store Stelara

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

Do not use this medicine

After the expiry date that is stated on the label and the outer packaging after “Exp.”. The expiry date refers to the last day of the month.
If the liquid has a discolored appearance, is cloudy, or if you see foreign particles floating (see section 6 “Description of Stelara 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.

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

6. Contents of the pack and other information

What Stelara contains

The active ingredient is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 mL.
The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Stelara and contents of the pack
Stelara is a solution for injection from clear to slightly opalescent (pearlescent appearance), from colourless to light yellow. The solution may contain some small translucent or white protein particles. It is supplied in a carton containing 1 single-dose vial, made of glass, with a volume of 2 mL. Each vial contains a dose of ustekinumab 45 mg in 0.5 mL of solution for injection.