ustekinumab: package leaflet

number of STELARA vials needed based on patient weight (see section 4.2, Table 1 and Table 3 in the Summary of Product Characteristics) or for paediatric patients who weigh less than 40 kg, calculate the dose and number of vials needed based on the patient’s body surface area (BSA) (see section 4.2, Table 2 in the Summary of Product Characteristics). Each 26 mL vial of STELARA contains 130 mg of ustekinumab.

250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL 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).

The final volume in the infusion bag should be 250 mL. Gently mix.

dose is based on the patient’s BSA as a single intravenous (IV) dose of STELARA. Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 100 mL infusion bag equal to the volume of STELARA to be added. Withdraw the appropriate volume of STELARA from each vial needed and add it to the 100 mL infusion bag. The final volume in the infusion bag should be 100 mL. Gently mix.

particles, discolouration or foreign particles are observed.

should be completed within eight hours of the dilution in the infusion bag.
7.
Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometre).
8.
Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.

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

Take the vial(s) out of the refrigerator. Let the vial stand for about half an hour. This will let the liquid come to a comfortable temperature for injection (room temperature).
Check the vial(s) to make sure
 the number of vials and strength is correct o
If your dose is 45 mg or less, you will get one 45 mg vial of Stelara o
If your dose is more than 45 mg you will get two 45 mg vials of Stelara and you will need to give yourself two injections. Choose two different sites for these injections (e.g. one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other. Use a new needle and syringe for each injection.
 it is the right medicine
 it has not passed its expiry date
 the vial is not damaged and the seal is not broken
 the solution in the vial is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow  the solution is not discoloured or cloudy and does not contain any foreign particles  the solution is not frozen.
Children with plaque psoriasis weighing less than 60 kg need a dose lower than 45 mg and children with Crohn’s disease or ulcerative colitis weighing less than 40 kg need a dose less than 90 mg. Make sure you know the proper amount (volume) to remove from the vial(s) and type of syringe(s) needed for dosing. If you don’t know the amount or type of syringe needed, contact your healthcare provider for further instruction.
Get everything together that you need and lay out on a clean surface. This includes a syringe, needle, antiseptic wipes, a cotton ball or gauze, and a sharps container (see Figure 1).
Figure 1

Choose an injection site (see Figure 2)

Stelara is given by injection under the skin (subcutaneously)


Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button)  If possible, do not use areas of skin that show signs of psoriasis  If someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site Figure 2 Prepare the injection site  Wash your hands very well with soap and warm water  Wipe the injection site on the skin with an antiseptic wipe  Do not touch this area again before giving the injection


Take the cap off the top of the vial (see Figure 3)
Figure 3

Do not remove the stopper

Clean the stopper with an antiseptic swab

Put the vial on a flat surface.

Pick up the syringe and remove the needle cover

Do not touch the needle or let the needle touch anything

Push the needle through the rubber stopper

Turn the vial and the syringe upside down

Pull on the syringe plunger to fill the syringe with the amount of liquid prescribed by your doctor  It is important that the needle is always in the liquid. This stops air bubbles forming in the syringe (see Figure 4) *Areas in gray are recommended injection sites.

Figure 4

Remove the needle from the vial

Hold the syringe with the needle pointing up to see if it has any air bubbles inside  If there are air bubbles, tap the side gently until the air bubbles go to the top of the syringe (see Figure 5) Figure 5  Then press the plunger until all of the air (but none of the liquid) has been removed  Do not lay the syringe down or allow the needle to touch anything.


Gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly  Push the needle into the pinched skin  Push the plunger with your thumb as far as it will go to inject all of the liquid. Push it slowly and evenly, keeping the skin gently pinched  When the plunger is pushed as far as it will go, take out the needle and let go of the skin


There may be a small amount of blood or liquid at the injection site. This is normal  Press a cotton ball or gauze over the injection site and hold for 10 seconds  Do not rub the skin at the injection site. You may cover the injection site with a small adhesive bandage, if necessary.


Used syringes and needles should be placed in a puncture-resistant container, like a sharps container. Never re-use needles and syringes, for your safety and health, and for the safety of others. Dispose of your sharps container according to your local regulations  Empty vials, antiseptic wipes, and other supplies can be disposed of in your garbage.

Preparing for use of the pre-filled syringe

Take the pre-filled syringe(s) out of the refrigerator. Let the pre-filled syringe stand outside the box for about half an hour. This will let the liquid come to a comfortable temperature for injection (room temperature). Do not remove the syringe’s needle cover while allowing it to reach room temperature  Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward  Do not hold by the plunger head, plunger, needle guard wings, or needle cover  Do not pull back on the plunger at any time  Do not remove the needle cover from the pre-filled syringe until instructed to do so  Do not touch the needle guard activation clips (as indicated by asterisks * in Figure 1) to prevent prematurely covering the needle with the needle guard.
Check the pre-filled syringe(s) to make sure
 the number of pre-filled syringes and strength is correct o
If your dose is 45 mg you will get one 45 mg pre-filled syringe of Stelara o
If your dose is 90 mg you will get two 45 mg pre-filled syringes of Stelara and you will need to give yourself two injections. Choose two different sites for these injections (e.g.
one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
 it is the right medicine
 it has not passed its expiry date
 the pre-filled syringe is not damaged
 the solution in the pre-filled syringe is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow  the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any foreign particles  the solution in the pre-filled syringe is not frozen.

Get everything together that you need and lay out on a clean surface. This includes antiseptic wipes, a cotton ball or gauze, and a sharps container.

Choose an injection site (see Figure 2)

Stelara is given by injection under the skin (subcutaneously)

Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button)  If possible, do not use areas of skin that show signs of psoriasis  If someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site Figure 2 Prepare the injection site  Wash your hands very well with soap and warm water  Wipe the injection site on the skin with an antiseptic wipe  Do not touch this area again before giving the injection


The needle cover should not be removed until you are ready to inject the dose

Pick up the pre-filled syringe, hold the body of the syringe with one hand

Pull the needle cover straight off and throw it away. Do not touch the plunger while you do this Figure 3  You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle. These are both normal and do not need to be removed  Do not touch the needle or allow it to touch any surface  Do not use the pre-filled syringe if it is dropped without the needle cover in place. If this happens, please contact your doctor or pharmacist  Inject the dose promptly after removing the needle cover.
*Areas in gray are recommended injection sites.


Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly  Do not pull back on the plunger at any time  In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 4) Figure 4  Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings (see Figure 5) Figure 5  When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see Figure 6) Figure 6  Slowly take your thumb off the plunger head to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by Figure 7:

Figure 7


There may be a small amount of blood or liquid at the injection site. This is normal.

Press a cotton ball or gauze over the injection site and hold for 10 seconds.

Do not rub the skin at the injection site. You may cover the injection site with a small adhesive bandage, if necessary.


Used syringes should be placed in a puncture-resistant container, like a sharps container (see Figure 8). Never re-use a syringe, for your safety and health and for the safety of others.
Dispose of your sharps container according to your local regulations

Antiseptic wipes and other supplies can be disposed of in your garbage.
Figure 8

Preparing for use of the pre-filled syringe

Take the pre-filled syringe(s) out of the refrigerator. Let the pre-filled syringe stand outside the box for about half an hour. This will let the liquid come to a comfortable temperature for injection (room temperature). Do not remove the syringe’s needle cover while allowing it to reach room temperature  Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward  Do not hold by the plunger head, plunger, needle guard wings, or needle cover  Do not pull back on the plunger at any time  Do not remove the needle cover from the pre-filled syringe until instructed to do so  Do not touch the needle guard activation clips (as indicated by asterisks * in Figure 1) to prevent prematurely covering the needle with the needle guard.
Check the pre-filled syringe(s) to make sure
 the number of pre-filled syringes and strength is correct o
If your dose is 90 mg you will get one 90 mg pre-filled syringe of Stelara.
 it is the right medicine
 it has not passed its expiry date
 the pre-filled syringe is not damaged
 the solution in the pre-filled syringe is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow  the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any foreign particles  the solution in the pre-filled syringe is not frozen.
Get everything together that you need and lay out on a clean surface. This includes antiseptic wipes, a cotton ball or gauze, and a sharps container.

Choose an injection site (see Figure 2)

Stelara is given by injection under the skin (subcutaneously)

Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button)  If possible, do not use areas of skin that show signs of psoriasis  If someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site Figure 2 Prepare the injection site  Wash your hands very well with soap and warm water  Wipe the injection site on the skin with an antiseptic wipe  Do not touch this area again before giving the injection


The needle cover should not be removed until you are ready to inject the dose

Pick up the pre-filled syringe, hold the body of the syringe with one hand

Pull the needle cover straight off and throw it away. Do not touch the plunger while you do this Figure 3  You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle. These are both normal and do not need to be removed  Do not touch the needle or allow it to touch any surface  Do not use the pre-filled syringe if it is dropped without the needle cover in place. If this happens, please contact your doctor or pharmacist  Inject the dose promptly after removing the needle cover.


Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly  Do not pull back on the plunger at any time  In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 4) *Areas in gray are recommended injection sites.

Figure 4

Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings (see Figure 5) Figure 5  When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see Figure 6) Figure 6  Slowly take your thumb off the plunger head to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by Figure 7:

Figure 7


There may be a small amount of blood or liquid at the injection site. This is normal.

Press a cotton ball or gauze over the injection site and hold for 10 seconds.

Do not rub the skin at the injection site. You may cover the injection site with a small adhesive bandage, if necessary.


Used syringes should be placed in a puncture-resistant container, like a sharps container (see Figure 8). Never re-use a syringe, for your safety and health and for the safety of others.
Dispose of your sharps container according to your local regulations

Antiseptic wipes and other supplies can be disposed of in your garbage.
Figure 8

What Stelara is
Stelara contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
Stelara belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system.
What Stelara is used for
Stelara administered using the pre-filled pen is used to treat the following inflammatory diseases:

Plaque psoriasis - in adults

Psoriatic arthritis - in adults

Moderate to severe Crohn’s disease - in adults

Moderate to severe ulcerative colitis - in adults
Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. Stelara will reduce the inflammation and other signs of the disease.
Stelara administered using the pre-filled pen is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Stelara to:

Reduce the signs and symptoms of your disease.

Improve your physical function.

Slow down the damage to your joints.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given 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.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given 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.

Do not use Stelara

If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6).

If you have an active infection which your doctor thinks is important.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check how well you are before each treatment. Make sure you tell your doctor about any illness you have before each treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis.
Your doctor will examine you and do a test for tuberculosis, before you have Stelara. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.
Look out for serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Stelara. See ‘Serious side effects’ in section 4 for a full list of these side effects.
Before you use Stelara tell your doctor:

If you ever had an allergic reaction to Stelara. Ask your doctor if you are not sure.

If you have an allergy to alpha-gal or have been diagnosed with alpha-gal syndrome (a type of food allergy to certain meats or meat products).

If you have ever had any type of cancer – this is because immunosuppressants like Stelara weaken part of the immune system. This may increase the risk of cancer.

If you have been treated for psoriasis with other biologic medicines (a medicine produced from a biological source and usually given by injection) – the risk of cancer may be higher.

If you have or have had a recent infection.

If you have any new or changing lesions within psoriasis areas or on normal skin.

If you have ever had an allergic reaction to latex or Stelara injection – the container of this medicinal product contains latex rubber, which may cause severe allergic reactions in people who are sensitive to latex. See ‘Look out for serious side effects’ in section 4 for the signs of an allergic reaction.

If you are having any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. Using these therapies together with Stelara has not been studied. However it is possible it may increase the chance of diseases related to a weaker immune system.

If you are having or have ever had injections to treat allergies – it is not known if Stelara may affect these.

If you are 65 years of age or over – you may be more likely to get infections.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Some patients have experienced lupus-like reactions including skin lupus or lupus-like syndrome during treatment with ustekinumab. Talk to your doctor right away if you experience a red, raised, scaly rash sometimes with a darker border, in areas of the skin that are exposed to the sun or with joint pains.
Heart attack and strokes
Heart attack and strokes have been observed in a study in patients with psoriasis treated with Stelara.
Your doctor will regularly check your risk factors for heart disease and stroke in order to ensure that they are appropriately treated. Seek medical attention right away if you develop chest pain, weakness or abnormal sensation on one side of your body, facial droop, or speech or visual abnormalities.
Children and adolescents
The Stelara pre-filled pen is not recommended for use in children and adolescents under 18 years of age with psoriasis, Crohn’s disease or ulcerative colitis, because it has not been studied in this age group. The pre-filled syringe or vial should be used instead for children 6 years of age and older and adolescents with psoriasis. The solution for infusion, vial or pre-filled syringe should be used instead for children 2 years of age and older with Crohn's disease or ulcerative colitis.
Stelara is not recommended for use in children and adolescents under 18 years of age with psoriatic arthritis, or in children under the age of 6 years with psoriasis or children under 2 years of age with Crohn’s disease or ulcerative colitis, because it has not been studied in these age groups.
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 had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using Stelara.

If you received Stelara while pregnant, tell your baby’s doctor about your Stelara treatment before the baby receives any vaccine, including live vaccines, such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your baby in the first twelve months after birth if you received Stelara during the pregnancy unless your baby’s doctor recommends otherwise.
Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

A higher risk of birth defects has not been seen in babies exposed to Stelara in the womb.
However, there is limited experience with Stelara in pregnant women. It is therefore preferable to avoid the use of Stelara in pregnancy.

If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Stelara and for at least 15 weeks after the last Stelara treatment.

Stelara can pass across the placenta to the unborn baby. If you received Stelara during your pregnancy, your baby may have a higher risk for getting an infection.

It is important that you tell your baby’s doctors and other health care professionals if you received Stelara during your pregnancy before the baby receives any vaccine. Live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your baby in the first twelve months after birth if you received Stelara during the pregnancy unless your baby’s doctor recommends otherwise.

Ustekinumab may pass into breast milk in very small amounts. Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you should breast-feed or use Stelara - do not do both.

Driving and using machines
Stelara has no or negligible influence on the ability to drive and use machines.
Stelara contains polysorbate 80
Stelara contains 0.02 mg of polysorbate 80 (E433) in each dosage unit which is equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Stelara is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which Stelara is intended.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Talk to your doctor about when you will have your injections and follow-up appointments.
How much Stelara is given
Your doctor will decide how much Stelara you need to use and for how long.
Adults aged 18 years or older
Psoriasis or psoriatic arthritis

The recommended starting dose is 45 mg Stelara. Patients who weigh more than 100 kilograms (kg) may start on a dose of 90 mg instead of 45 mg.

After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The following doses are usually the same as the starting dose.
Crohn’s disease or ulcerative colitis

During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor through a drip in a vein in your arm (intravenous infusion). After the starting dose, you will receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks thereafter by an injection under the skin (‘subcutaneously’).

In some patients, after the first injection under the skin, 90 mg Stelara may be given every 8 weeks. Your doctor will decide when you should receive your next dose.
How Stelara is given

Stelara is given as an injection under the skin (‘subcutaneously’). At the start of your treatment, medical or nursing staff may inject Stelara.

However, you and your doctor may decide that you may inject Stelara yourself. In this case you will get training on how to inject Stelara yourself.

For instructions on how to inject Stelara, see ‘Instructions for administration’ at the end of this leaflet.
Talk to your doctor if you have any questions about giving yourself an injection.
If you use more Stelara than you should
If you have used or been given too much Stelara, talk to a doctor or pharmacist straight away. Always have the outer carton 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 a forgotten dose.
If you stop using Stelara
It is not dangerous to stop using Stelara. However, if you stop, your symptoms may come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Some patients may have serious side effects that may need urgent treatment.
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs.

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Stelara (may affect up to 1 in 1,000 people). Signs include:
o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or light-headedness o swelling of the face, lips, mouth or throat.

Common signs of an allergic reaction include skin rash and hives (these may affect up to 1 in 100 people).
In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab. Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever.
If you have a serious allergic reaction, your doctor may decide that you should not use Stelara again.
Infections – these may need urgent treatment. Tell your doctor straight away if you notice any of the following signs.

Infections of the nose or throat and common cold are common (may affect up to 1 in 10 people)  Infections of the chest are uncommon (may affect up to 1 in 100 people)  Inflammation of tissue under the skin (‘cellulitis’) is uncommon (may affect up to 1 in 100 people)  Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 100 people) Stelara may make you less able to fight infections. Some infections could become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that mainly occur in people with a weakened immune system (opportunistic infections).
Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eye have been reported in patients receiving treatment with ustekinumab.
You must look out 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; cough which will not go away
 warm, red and painful skin, or a painful skin rash with blisters
 burning when passing water
 diarrhoea
 visual disturbance or vision loss
 headache, neck stiffness, light sensitivity, nausea or confusion.
Tell your doctor straight away if you notice any of these signs of infection. These may be signs of infections such as chest infections, or skin infections or shingles or opportunistic infections that could have serious complications. Tell your doctor if you have any kind of infection that will not go away or keeps coming back. Your doctor may decide that you should not use Stelara until the infection goes away. Also tell your doctor if you have any open cuts or sores as they might get infected.
Shedding of skin – increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin

conditions. You should tell your doctor straight away if you notice any of these signs.
Other side effects
Common side effects (may affect up to 1 in 10 people):

Diarrhoea

Nausea

Vomiting

Feeling tired

Feeling dizzy

Headache

Itching (‘pruritus’)

Back, muscle or joint pain

Sore throat

Redness and pain where the injection is given

Sinus infection
Uncommon side effects (may affect up to 1 in 100 people):

Tooth infections

Vaginal yeast infection

Depression

Blocked or stuffy nose

Bleeding, bruising, hardness, swelling and itching where the injection is given

Feeling weak

Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s palsy’), which is usually temporary  A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis)  Peeling of the skin (skin exfoliation)  Acne Rare side effects (may affect up to 1 in 1,000 people):

Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change 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 (may affect up to 1 in 10,000 people):

Blistering of the skin that may be red, itchy, and painful (Bullous pemphigoid).

Skin lupus or lupus-like syndrome (red, raised scaly rash on areas of the skin exposed to the sun possibly with joint pains).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


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 pen in the outer carton in order to protect from light.


If needed, individual Stelara pre-filled pens may also be stored at room temperature up to 30 °C for a maximum single period of up to 30 days in the original carton in order to protect from light. Record the date when the pre-filled pen is first removed from the refrigerator and the discard date in the space provided on the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once a pre-filled pen has been stored at room temperature (up to 30 °C), it should not be returned to the refrigerator. Discard the pre-filled pen if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier.

Do not shake the pre-filled pen. Prolonged vigorous shaking may damage the medicine.
Do not use this medicine:

After the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date refers to the last day of that month.

If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 ‘What Stelara looks like and contents of the pack’).

If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated).

If the product has been shaken vigorously.
Stelara is for single use only. Any unused product remaining in the pre-filled pen should be thrown away. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Stelara contains

The active substance is ustekinumab. Each pre-filled pen contains 45 mg ustekinumab in 0.5 mL.

The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections.
What Stelara looks like and contents of the pack
Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution for injection. The solution may contain a few small translucent or white particles of protein. It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled pen. Each pre-filled pen contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: 0800 93 377 info_belux@its.jnj.com
Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com
България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: 800 29 504 info_belux@its.jnj.com
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955 medinfo-de@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: 0800 242 42 42 info_nl@its.jnj.com
Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
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 contacto@its.jnj.com
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 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com
Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400
Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com
Latvija
UAB "JOHNSON & JOHNSON" filiāle
Latvijā
Tel: +371 678 93561 lv@its.jnj.com
This leaflet was last revised in.
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Instructions for use
Stelara
(ustekinumab) injection, for subcutaneous use
Pre-filled pen
This “Instructions for Use” contains information on how to inject Stelara.
Important
Stelara comes in a single-dose pre-filled pen containing one 45 mg dose or one 90 mg dose.
During injection, push handle all the way down until purple body is not visible to inject the full dose. DO NOT LIFT PRE-FILLED PEN during injection! If you do, the pre-filled pen will lock and you will not get the full dose.
If your doctor decides that you or a caregiver may be able to give your injections of Stelara at home, you should receive training on the right way to prepare and inject Stelara using the pre-filled pen. Do not try to inject yourself until you have been trained by your doctor.
Each pre-filled pen can only be used one time. Throw it away (see Step 3) after use even if there is medicine left in it.
Do not reuse the pre-filled pen.
Read these Instructions for Use before using the Stelara pre-filled pen and each time you get a new pre-filled pen. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
If you cannot give yourself the injection:
 ask your doctor or nurse to help you, or
 ask someone who has been trained by a doctor or nurse to give your injections.
To reduce the risk of accidental needle sticks, each pre-filled pen has a needle guard that automatically covers the needle and locks after you have given your injection and the injector is lifted. Do not lift the pre-filled pen during the injection until the injection is complete.
The needle cover inside the bottom cap of the pre-filled pen contains latex. Do not handle the needle cover if you are allergic to latex.
Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.

Storage information
Store in refrigerator at 2 ° to 8 °C. If needed, store at room temperature up to 30 °C for up to 30 days in the original carton. Do not return to refrigerator once stored at room temperature.
Do not freeze the pre-filled pen.
Keep the pre-filled pen and all medicines out of reach of children.
Do not shake the pre-filled pen. Shaking may damage the Stelara medicine. If the pre-filled pen has been shaken, do not use it. Get a new pre-filled pen.
Keep the pre-filled pen in the original carton to protect from light and physical damage.
Need help?
Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.

1. Preparing to Inject Stelara
Gather carton(s)
If refrigerated, remove the pre-filled pen carton(s) from the refrigerator and place on a flat surface.
Leave at room temperature for at least 30 minutes before use.
Do not warm any other way.
If your dose is 45 mg, you will receive one 45 mg pre-filled pen.
If your dose is 90 mg, you will receive one 90 mg or two 45 mg pre-filled pens. If you receive two 45 mg pre-filled pens, follow Steps 1-3 for both injections.

Choose a different injection site for the second injection.
Check the expiry date (‘EXP’) and seals on the carton(s)
Do not use the pre-filled pen if the seals on the carton are broken or if the expiry date has passed.
Do not use the pre-filled pen if it has been kept at room temperature for longer than 30 days or if it has been stored above 30 °C. Call your doctor or pharmacist for a new pre-filled pen.
Choose injection site
Select from the following areas for your injection:

Front of thighs

Lower stomach area (lower abdomen), except for a 5-centimetre area right around your navel (belly-button) If someone else is giving you the injection, they may also use:

Back of upper arms
Do not inject into skin that is tender, bruised, red, or hard.
Use a different injection site for each injection.

Wash hands
Wash your hands well with soap and warm water.
Clean injection site
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan, or blow on the injection site after you have cleaned it.
Inspect liquid in window
Choose a well-lit, clean, flat work surface.
Take the pre-filled pen out of the carton and check for damage.
Check the liquid in the viewing window. It should be clear to slightly opalescent and colourless to light yellow and may contain tiny white or clear particles and one or more air bubbles. This is normal.
Do not inject if the liquid is frozen, cloudy, discoloured, or has large particles. Call your doctor or pharmacist for a new pre-filled pen.
2. Injecting Stelara
Pull off bottom cap
Keep hands away from the needle guard after the cap is removed. It is normal to see a few drops of liquid.
Inject Stelara within 5 minutes of removing the cap.
Do not put the cap back on. This could damage the needle.
Do not use a pre-filled pen if it is dropped after removing the cap. Call your doctor or pharmacist for a new pre-filled pen.

Place straight on skin. Push handle all the way down until purple body is not visible.
You may hear a click when the injection begins. Keep pushing.
If you feel resistance, keep pushing. This is normal.
The medication injects as you push. Do this at a speed that is comfortable for you.
Confirm your injection is complete
Your injection is complete when:

The purple body is not visible.

You cannot press the handle down anymore.

You may hear a click.
Lift straight up
The yellow band indicates that the needle guard is locked into place.
DO NOT LIFT PRE-FILLED PEN during injection!
If you do, the needle guard will lock, showing a yellow band, and you will not get the full dose.
click

3. After your injection
Dispose of the pre-filled pen
Put the used pre-filled pen in a sharps disposal container right away after use.
Do not throw away (dispose of) the pre-filled pens in the household trash.
Do not recycle your used sharps disposal container.
Check injection site
There may be a small amount of blood or liquid at the injection site. This is normal. Press a cotton ball or gauze pad to the injection site until any bleeding stops.
Do not rub the injection site.
If needed, cover the injection site with a bandage.
If you receive two 45 mg pre-filled pens for a 90 mg dose, repeat Steps 1-3 with the second pre-filled pen. Choose a different injection site for the second injection.

What Stelara is
Stelara contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
Stelara belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system.
What Stelara is used for
Stelara administered using the pre-filled pen is used to treat the following inflammatory diseases:

Plaque psoriasis - in adults

Psoriatic arthritis - in adults

Moderate to severe Crohn’s disease - in adults

Moderate to severe ulcerative colitis - in adults
Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. Stelara will reduce the inflammation and other signs of the disease.
Stelara administered using the pre-filled pen is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Stelara to:

Reduce the signs and symptoms of your disease.

Improve your physical function.

Slow down the damage to your joints.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given 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.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given 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.

Do not use Stelara

If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6).

If you have an active infection which your doctor thinks is important.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check how well you are before each treatment. Make sure you tell your doctor about any illness you have before each treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis.
Your doctor will examine you and do a test for tuberculosis, before you have Stelara. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.
Look out for serious side effects
Stelara can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Stelara. See ‘Serious side effects’ in section 4 for a full list of these side effects.
Before you use Stelara tell your doctor:

If you ever had an allergic reaction to Stelara. Ask your doctor if you are not sure.

If you have an allergy to alpha-gal or have been diagnosed with alpha-gal syndrome (a type of food allergy to certain meats or meat products).

If you have ever had any type of cancer – this is because immunosuppressants like Stelara weaken part of the immune system. This may increase the risk of cancer.

If you have been treated for psoriasis with other biologic medicines (a medicine produced from a biological source and usually given by injection) – the risk of cancer may be higher.

If you have or have had a recent infection.

If you have any new or changing lesions within psoriasis areas or on normal skin.

If you have ever had an allergic reaction to latex or Stelara injection – the container of this medicinal product contains latex rubber, which may cause severe allergic reactions in people who are sensitive to latex. See ‘Look out for serious side effects’ in section 4 for the signs of an allergic reaction.

If you are having any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. Using these therapies together with Stelara has not been studied. However it is possible it may increase the chance of diseases related to a weaker immune system.

If you are having or have ever had injections to treat allergies – it is not known if Stelara may affect these.

If you are 65 years of age or over – you may be more likely to get infections.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Some patients have experienced lupus-like reactions including skin lupus or lupus-like syndrome during treatment with ustekinumab. Talk to your doctor right away if you experience a red, raised, scaly rash sometimes with a darker border, in areas of the skin that are exposed to the sun or with joint pains.
Heart attack and strokes
Heart attack and strokes have been observed in a study in patients with psoriasis treated with Stelara.
Your doctor will regularly check your risk factors for heart disease and stroke in order to ensure that they are appropriately treated. Seek medical attention right away if you develop chest pain, weakness or abnormal sensation on one side of your body, facial droop, or speech or visual abnormalities.
Children and adolescents
The Stelara pre-filled pen is not recommended for use in children and adolescents under 18 years of age with psoriasis, Crohn’s disease or ulcerative colitis, because it has not been studied in this age group. The pre-filled syringe or vial should be used instead for children 6 years of age and older and adolescents with psoriasis. The solution for infusion, vial or pre-filled syringe should be used instead for children 2 years of age and older with Crohn's disease or ulcerative colitis.
Stelara is not recommended for use in children and adolescents under 18 years of age with psoriatic arthritis, or in children under the age of 6 years with psoriasis or children under 2 years of age with Crohn’s disease or ulcerative colitis, because it has not been studied in these age groups.
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 had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using Stelara.

If you received Stelara while pregnant, tell your baby’s doctor about your Stelara treatment before the baby receives any vaccine, including live vaccines, such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your baby in the first twelve months after birth if you received Stelara during the pregnancy unless your baby’s doctor recommends otherwise.
Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

A higher risk of birth defects has not been seen in babies exposed to Stelara in the womb.
However, there is limited experience with Stelara in pregnant women. It is therefore preferable to avoid the use of Stelara in pregnancy.

If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Stelara and for at least 15 weeks after the last Stelara treatment.

Stelara can pass across the placenta to the unborn baby. If you received Stelara during your pregnancy, your baby may have a higher risk for getting an infection.

It is important that you tell your baby’s doctors and other health care professionals if you received Stelara during your pregnancy before the baby receives any vaccine. Live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your baby in the first twelve months after birth if you received Stelara during the pregnancy unless your baby’s doctor recommends otherwise.

Ustekinumab may pass into breast milk in very small amounts. Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you should breast-feed or use Stelara - do not do both.

Driving and using machines
Stelara has no or negligible influence on the ability to drive and use machines.
Stelara contains polysorbate 80
Stelara contains 0.04 mg of polysorbate 80 (E433) in each dosage unit which is equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Stelara is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which Stelara is intended.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Talk to your doctor about when you will have your injections and follow-up appointments.
How much Stelara is given
Your doctor will decide how much Stelara you need to use and for how long.
Adults aged 18 years or older
Psoriasis or psoriatic arthritis

The recommended starting dose is 45 mg Stelara. Patients who weigh more than 100 kilograms (kg) may start on a dose of 90 mg instead of 45 mg.

After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The following doses are usually the same as the starting dose.
Crohn’s disease or ulcerative colitis

During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor through a drip in a vein in your arm (intravenous infusion). After the starting dose, you will receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks thereafter by an injection under the skin (‘subcutaneously’).

In some patients, after the first injection under the skin, 90 mg Stelara may be given every 8 weeks. Your doctor will decide when you should receive your next dose.
How Stelara is given

Stelara is given as an injection under the skin (‘subcutaneously’). At the start of your treatment, medical or nursing staff may inject Stelara.

However, you and your doctor may decide that you may inject Stelara yourself. In this case you will get training on how to inject Stelara yourself.

For instructions on how to inject Stelara, see ‘Instructions for administration’ at the end of this leaflet.
Talk to your doctor if you have any questions about giving yourself an injection.
If you use more Stelara than you should
If you have used or been given too much Stelara, talk to a doctor or pharmacist straight away. Always have the outer carton 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 a forgotten dose.
If you stop using Stelara
It is not dangerous to stop using Stelara. However, if you stop, your symptoms may come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Some patients may have serious side effects that may need urgent treatment.
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs.

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Stelara (may affect up to 1 in 1,000 people). Signs include:
o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or light-headedness o swelling of the face, lips, mouth or throat.

Common signs of an allergic reaction include skin rash and hives (these may affect up to 1 in 100 people).
In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab. Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever.
If you have a serious allergic reaction, your doctor may decide that you should not use Stelara again.
Infections – these may need urgent treatment. Tell your doctor straight away if you notice any of the following signs.

Infections of the nose or throat and common cold are common (may affect up to 1 in 10 people)  Infections of the chest are uncommon (may affect up to 1 in 100 people)  Inflammation of tissue under the skin (‘cellulitis’) is uncommon (may affect up to 1 in 100 people)  Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 100 people) Stelara may make you less able to fight infections. Some infections could become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that mainly occur in people with a weakened immune system (opportunistic infections).
Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eye have been reported in patients receiving treatment with ustekinumab.
You must look out 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; cough which will not go away
 warm, red and painful skin, or a painful skin rash with blisters
 burning when passing water
 diarrhoea
 visual disturbance or vision loss
 headache, neck stiffness, light sensitivity, nausea or confusion.
Tell your doctor straight away if you notice any of these signs of infection. These may be signs of infections such as chest infections, or skin infections or shingles or opportunistic infections that could have serious complications. Tell your doctor if you have any kind of infection that will not go away or keeps coming back. Your doctor may decide that you should not use Stelara until the infection goes away. Also tell your doctor if you have any open cuts or sores as they might get infected.
Shedding of skin – increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin

conditions. You should tell your doctor straight away if you notice any of these signs.
Other side effects
Common side effects (may affect up to 1 in 10 people):

Diarrhoea

Nausea

Vomiting

Feeling tired

Feeling dizzy

Headache

Itching (‘pruritus’)

Back, muscle or joint pain

Sore throat

Redness and pain where the injection is given

Sinus infection
Uncommon side effects (may affect up to 1 in 100 people):

Tooth infections

Vaginal yeast infection

Depression

Blocked or stuffy nose

Bleeding, bruising, hardness, swelling and itching where the injection is given

Feeling weak

Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s palsy’), which is usually temporary  A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis)  Peeling of the skin (skin exfoliation)  Acne Rare side effects (may affect up to 1 in 1,000 people):

Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change 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 (may affect up to 1 in 10,000 people):

Blistering of the skin that may be red, itchy, and painful (Bullous pemphigoid).

Skin lupus or lupus-like syndrome (red, raised scaly rash on areas of the skin exposed to the sun possibly with joint pains).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


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 pen in the outer carton in order to protect from light.


If needed, individual Stelara pre-filled pens may also be stored at room temperature up to 30 °C for a maximum single period of up to 30 days in the original carton in order to protect from light. Record the date when the pre-filled pen is first removed from the refrigerator and the discard date in the space provided on the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once a pre-filled pen has been stored at room temperature (up to 30 °C), it should not be returned to the refrigerator. Discard the pre-filled pen if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier.

Do not shake the pre-filled pen. Prolonged vigorous shaking may damage the medicine.
Do not use this medicine:

After the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date refers to the last day of that month.

If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 ‘What Stelara looks like and contents of the pack’).

If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated).

If the product has been shaken vigorously.
Stelara is for single use only. Any unused product remaining in the pre-filled pen should be thrown away. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Stelara contains

The active substance is ustekinumab. Each pre-filled pen contains 90 mg ustekinumab in 1 mL.

The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections.
What Stelara looks like and contents of the pack
Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution for injection. The solution may contain a few small translucent or white particles of protein. It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled pen. Each pre-filled pen contains 90 mg ustekinumab in 1 mL of solution for injection.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: 0800 93 377 info_belux@its.jnj.com
Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88 lt@its.jnj.com

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: 800 29 504 info_belux@its.jnj.com
Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227
Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858 janssenhu@its.jnj.com
Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282 jacdk@its.jnj.com
Malta
AM MANGION LTD
Tel: +356 2397 6000
Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955 medinfo-de@its.jnj.com
Nederland
Janssen-Cilag B.V.
Tel: 0800 242 42 42 info_nl@its.jnj.com
Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410 ee@its.jnj.com
Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00 jacno@its.jnj.com
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 contacto@its.jnj.com
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 medisource@its.jnj.com
Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600
Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
România
Johnson & Johnson România SRL
Tel: +40 21 207 1800
Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122 medinfo@its.jnj.com
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
JNJ-SI-safety@its.jnj.com
Ísland
Janssen-Cilag AB c/o Vistor ehf.
Sími: +354 535 7000 janssen@vistor.is
Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com
Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300 jacfi@its.jnj.com
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700
Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00 jacse@its.jnj.com
Latvija
UAB "JOHNSON & JOHNSON" filiāle
Latvijā
Tel: +371 678 93561 lv@its.jnj.com
This leaflet was last revised in.
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Instructions for use
Stelara
(ustekinumab) injection, for subcutaneous use
Pre-filled pen
This “Instructions for Use” contains information on how to inject Stelara.
Important
Stelara comes in a single-dose pre-filled pen containing one 45 mg dose or one 90 mg dose.
During injection, push handle all the way down until purple body is not visible to inject the full dose. DO NOT LIFT PRE-FILLED PEN during injection! If you do, the pre-filled pen will lock and you will not get the full dose.
If your doctor decides that you or a caregiver may be able to give your injections of Stelara at home, you should receive training on the right way to prepare and inject Stelara using the pre-filled pen. Do not try to inject yourself until you have been trained by your doctor.
Each pre-filled pen can only be used one time. Throw it away (see Step 3) after use even if there is medicine left in it.
Do not reuse the pre-filled pen.
Read these Instructions for Use before using the Stelara pre-filled pen and each time you get a new pre-filled pen. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
If you cannot give yourself the injection:
 ask your doctor or nurse to help you, or
 ask someone who has been trained by a doctor or nurse to give your injections.
To reduce the risk of accidental needle sticks, each pre-filled pen has a needle guard that automatically covers the needle and locks after you have given your injection and the injector is lifted. Do not lift the pre-filled pen during the injection until the injection is complete.
The needle cover inside the bottom cap of the pre-filled pen contains latex. Do not handle the needle cover if you are allergic to latex.
Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
Storage information
Store in refrigerator at 2° to 8 °C. If needed, store at room temperature up to 30 °C for up to 30 days in

the original carton. Do not return to refrigerator once stored at room temperature.
Do not freeze the pre-filled pen.
Keep the pre-filled pen and all medicines out of reach of children.
Do not shake the pre-filled pen. Shaking may damage the Stelara medicine. If the pre-filled pen has been shaken, do not use it. Get a new pre-filled pen.
Keep the pre-filled pen in the original carton to protect from light and physical damage.
Need help?
Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.

1. Preparing to Inject Stelara
Gather carton(s)
If refrigerated, remove the pre-filled pen carton(s) from the refrigerator and place on a flat surface.
Leave at room temperature for at least 30 minutes before use.
Do not warm any other way.
If your dose is 45 mg, you will receive one 45 mg pre-filled pen.
If your dose is 90 mg, you will receive one 90 mg or two 45 mg pre-filled pens. If you receive two 45 mg pre-filled pens, follow Steps 1-3 for both injections.
Choose a different injection site for the second injection.

Check the expiry date (‘EXP’) and seals on the carton(s)
Do not use the pre-filled pen if the seals on the carton are broken or if the expiry date has passed.
Do not use the pre-filled pen if it has been kept at room temperature for longer than 30 days or if it has been stored above 30 °C. Call your doctor or pharmacist for a new pre-filled pen.
Choose injection site
Select from the following areas for your injection:

Front of thighs

Lower stomach area (lower abdomen), except for a 5-centimetre area right around your navel (belly-button) If someone else is giving you the injection, they may also use:

Back of upper arms
Do not inject into skin that is tender, bruised, red, or hard.
Use a different injection site for each injection.
Wash hands
Wash your hands well with soap and warm water.

Clean injection site
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Do not touch, fan, or blow on the injection site after you have cleaned it.
Inspect liquid in window
Choose a well-lit, clean, flat work surface.
Take the pre-filled pen out of the carton and check for damage.
Check the liquid in the viewing window. It should be clear to slightly opalescent and colourless to light yellow and may contain tiny white or clear particles and one or more air bubbles. This is normal.
Do not inject if the liquid is frozen, cloudy, discoloured, or has large particles. Call your doctor or pharmacist for a new pre-filled pen.
2. Injecting Stelara
Pull off bottom cap
Keep hands away from the needle guard after the cap is removed. It is normal to see a few drops of liquid.
Inject Stelara within 5 minutes of removing the cap.
Do not put the cap back on. This could damage the needle.
Do not use a pre-filled pen if it is dropped after removing the cap. Call your doctor or pharmacist for a new pre-filled pen.

Place straight on skin. Push handle all the way down until purple body is not visible.
You may hear a click when the injection begins. Keep pushing.
If you feel resistance, keep pushing. This is normal.
The medication injects as you push. Do this at a speed that is comfortable for you.
Confirm your injection is complete
Your injection is complete when:

The purple body is not visible.

You cannot press the handle down anymore.

You may hear a click.
Lift straight up
The yellow band indicates that the needle guard is locked into place.
DO NOT LIFT PRE-FILLED PEN during injection!
If you do, the needle guard will lock, showing a yellow band, and you will not get the full dose.
click

3. After your injection
Dispose of the pre-filled pen
Put the used pre-filled pen in a sharps disposal container right away after use.
Do not throw away (dispose of) the pre-filled pens in the household trash.
Do not recycle your used sharps disposal container.
Check injection site
There may be a small amount of blood or liquid at the injection site. This is normal. Press a cotton ball or gauze pad to the injection site until any bleeding stops.
Do not rub the injection site.
If needed, cover the injection site with a bandage.
If you receive two 45 mg pre-filled pens for a 90 mg dose, repeat Steps 1-3 with the second pre-filled pen. Choose a different injection site for the second injection.