Stelara - patient leaflet, side effects, dosage

1. What Stelara is and what it is used for

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 is used to treat the following inflammatory diseases:

• Moderate to severe Crohn’s disease – in adults
• Moderate to severe ulcerative colitis – in adults

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.

2. What you need to know before you use Stelara

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 treatment. Make sure you tell your doctor about any illness you have before 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 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 or have had a recent infection or if you have any abnormal skin openings

(fistulae).

• If you have any new or changing lesions within psoriasis areas or on normal skin.
• 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.

Children and adolescents

Stelara is not recommended for use in children under 18 years of age with Crohn’s disease 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 had or are going to have a vaccination. Some types of vaccines (live

vaccines) should not be given while using Stelara.

Pregnancy and breast-feeding

• It is preferable to avoid the use of Stelara in pregnancy. The effects of Stelara in pregnant

women are not known. 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.

• Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a

baby.

• Ustekinumab may pass into breast milk. 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 sodium

Stelara contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. However, before Stelara is given to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet.

• 3. How Stelara will be given

Stelara is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn’s disease or ulcerative colitis.

Stelara 130 mg concentrate for solution for infusion will be given to you by your doctor, through a drip in the vein of your arm (intravenous infusion) over at least one hour. 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 receive and for how long.

Adults aged 18 years or older

• The doctor will work out the recommended intravenous infusion dose for you based on your

body weight.

Your body weight	Dose
<55 kg	260 mg
> 55 kg to < 85 kg	390 mg
>85 kg	520 mg

• After the starting intravenous dose, you will have the next dose of 90 mg Stelara by an injection

under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks therafter.

How Stelara is given

• The first dose of Stelara for treatment of Crohn’s disease or ulcerative colitis is given by a

doctor as a drip in the vein of an arm (intravenous infusion).

Talk to your doctor if you have any questions about receiving Stelara.

If you forget to use Stelara

If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment.

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.

4. Possible side effects

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).

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 into a vein (intravenous infusion). Some patients have experienced serious allergic reactions during the infusion.

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, or bacteria, including infections that mainly occur in people with a weakened immune system (opportunistic infections).

You must look out for signs of infection while you are using Stelara. These include:

• fever, flu-like symptoms, night sweats
• 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.

Tell your doctor straight away if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, shingles 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 1000 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).

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.

5. How to store Stelara

• Stelara 130 mg concentrate for solution for infusion is given in a hospital or clinic and patients

should not need to store or handle 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 carton in order to protect from light.
• Do not shake the Stelara vials. 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.
• If the seal is broken.

Stelara is for single use only. Any diluted infusion solution or unused product remaining in the vial and the syringe should be thrown away in accordance with local requirements.

6. Contents of the pack and other information

What Stelara contains

• The active substance is ustekinumab. Each vial contains130 mg ustekinumab in 26 mL.
• The other ingredients are EDTA disodium salt dihydrate, L-histidine, L-histidine

monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose and water for injection.

What Stelara looks like and contents of the pack

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

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

Deutschland

Janssen-Cilag GmbH

Tel: +49 2137 955 955

Eesti

UAB „JOHNSON & JOHNSON“ Eesti filiaal

Tel: +372 617 7410

EXÀàôa

Janssen-Cilag OappaKsuTiK^ A.E.B.E.

Tql: +30 210 80 90 000

España

Janssen-Cilag, S.A.

Tel: +34 91 722 81 00

France

Janssen-Cilag

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Hrvatska

Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700

Ireland

Janssen Sciences Ireland UC

Tel: +353 1 800 709 122

Ísland

Janssen-Cilag AB c/o Vistor hf.

Sími: +354 535 7000

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Janssen-Cilag SpA

Tel: 800.688.777 /+39 02 2510 1

Kùnpoç

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Latvija

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Tel: +371 678 93561

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:.

The following information is intended for healthcare professionals only:

Traceability:

In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should 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 patient weight (see section 3, Table 1). Each 26 mL vial of STELARA contains 130 mg of ustekinumab.

• 2. Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 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).

• 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 should be 250 mL. Gently mix.

• 4. Visually inspect the diluted solution before infusion. Do not use if visibly 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 should be completed within eight hours of the dilution in the infusion bag.

• 6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).

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