Stelara
ustekinumab
ustekinumab
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Stelara is and what it is used for
What you need to know before you use Stelara
How Stelara will be given
Possible side effects
How to store Stelara
Contents of the pack and other information
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.
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 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 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.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Stelara.
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.
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.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
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.
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.
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.
Stelara has no or negligible influence on the ability to drive and use machines.
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.
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.
Your doctor will decide how much Stelara you need to receive and for how long.
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.
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 or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment.
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.
Some patients may have serious side effects that may need urgent treatment.
Serious allergic reactions (‘anaphylaxis’) are rare in people taking Stelara (may affect up to 1 in 1,000 people). Signs include:
difficulty breathing or swallowing
low blood pressure, which can cause dizziness or light-headedness
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).
If you have a serious allergic reaction, your doctor may decide that you should not use Stelara again.
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.
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
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
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)
Blistering of the skin that may be red, itchy, and painful (Bullous pemphigoid).
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 thenationalreportingsystem listedinAppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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.
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.
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.
B-2340 Beerse Belgium
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:
UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88
„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00
Janssen-Cilag NV Tél/Tel: +32 14 64 94 11
Janssen-Cilag A/S Tlf: +45 4594 8282
AM MANGION LTD Tel: +356 2397 6000
Janssen-Cilag GmbH Tel: +49 2137 955 955
Janssen-Cilag B.V. Tel: +31 76 711 1111
UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410
Janssen-Cilag AS Tlf: + 47 24 12 65 00
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000
Janssen-Cilag Pharma GmbH Tel: +43 1 610 300
Janssen-Cilag, S.A. Tel: +34 91 722 81 00
Janssen-Cilag Polska Sp. z o.o. Tel.: + 48 22 237 60 00
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700
Johnson & Johnson România SRL Tel: +40 21 207 1800
Janssen Sciences Ireland UC Tel: +353 1 800 709 122
Johnson & Johnson d.o.o. Tel. +386 1 401 18 00
Janssen_safety_slo@its.jnj.com
Janssen-Cilag AB c/o Vistor hf.
Sími: +354 535 7000
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ Tηλ: +357 22 207 700
Janssen-Cilag AB Tfn: +46 8 626 50 00
UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561
Janssen Sciences Ireland UC Tel: +44 1 494 567 444
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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.
Instructionsfordilution:
STELARA concentrate for solution for infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.
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.
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).
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.
Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discoloration or foreign particles are observed.
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.
Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
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.