45 mg solution
What Stelara is and what it is used for
What Stelara is
Stelara contains the active substance ustekinumab, which is a so-called monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind specifically to particular proteins in the body.
Stelara belongs to a group of medicines called ‘immunosuppressants’. These drugs work by inhibiting part of the immune system.
What Stelara is used for
Stelara is used to treat the following inflammatory diseases:
- Plaque psoriasis – in adults and children 6 years and older
- Psoriatic arthritis – in adults
- Moderate to severe Crohn’s disease – in adults
- Moderate to severe ulcerative colitis – in adults
Plaque psoriasis is a skin disease that causes inflammation that affects the skin and nails. Stelara will reduce inflammation and other signs of the disease.
Stelara is used in adult patients with moderate or severe plaque psoriasis who cannot use ciclosporin, methotrexate, or light therapy, or when these treatments have not worked.
Stelara is used in children and adolescents 6 years of age and older with moderate to severe plaque psoriasis who cannot tolerate light therapy or other systemic treatments or if these treatments have not worked.
Psoriatic arthritis is an inflammatory joint disease, which usually affects people with 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 deterioration of your joint injuries.
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Stelara to reduce the symptoms of your disease.
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first receive other medicines. If you do not get enough of these medicines or cannot tolerate them, you may be given Stelara to reduce the signs and symptoms of your disease.
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 that your doctor considers significant.
Warnings and precautions
Talk to your doctor or pharmacist before using Stelara. The doctor will check how well you are doing before each treatment. Tell the doctor if you have any other diseases before each treatment. Also tell the doctor if you have recently been in contact with someone who may have had tuberculosis. The doctor will examine you and do a tuberculosis test before you are treated with Stelara. If the doctor considers you to be at risk for tuberculosis, you will possibly be treated with anti-tuberculosis drugs .
Watch out for serious side effects
Stelara can cause serious side effects, including allergic reactions and infection. You need to be aware of certain signs of illness while taking Stelara. See “Serious side effects” in section 4 for a full list of these side effects.
Before using Stelara, tell the doctor:
- If you have ever had an allergic reaction to Stelara. Ask your doctor if you are unsure.
- If you have previously had any type of cancer – this is because immunosuppressive drugs such as Stelara weaken part of the immune system. This can increase the risk of cancer.
- If you have or have recently had an infection.
- If you have any new or changed lesions in the area of psoriasis or on intact skin.
- If you receive any other treatment for psoriasis and/or psoriatic arthritis – e.g. another immunosuppressant or light therapy (when your body is treated with a type of ultraviolet (UV) light). These treatments can also weaken part of the immune system. Concomitant use of these treatments with Stelara has not been studied. However, it may increase the risk of diseases related to a weaker immune system.
- If you receive or have ever received injections to treat allergies – it is not known whether Stelara can affect these.
- If you are over 65 – you may be more likely to get an infection.
Children and young people
Stelara is not recommended for children with psoriasis under 6 years of age or for use in children under 18 years of age with psoriatic arthritis, Crohn’s disease, or ulcerative colitis as there are no studies conducted in this age group.
Other medicines, vaccines, and Stelara
Tell your doctor or pharmacist:
- if you are taking, have recently taken, or maybe taking other medicines.
- if you have recently been vaccinated or are about to do so. Certain types of vaccines (live vaccines) should not be given at the same time as Stelara.
Pregnancy and breastfeeding
- Use of Stelara during pregnancy should be avoided. The effect of Stelara on pregnant women is not known. Women of childbearing potential must use effective contraception during treatment with Stelara and for at least 15 weeks after treatment has ended.
- Consult a doctor if you are pregnant, think you may be pregnant, or plan to have a baby.
- Ustekinumab can be excreted in breast milk. Consult a doctor if you are breastfeeding or if you plan to breastfeed. You and your doctor decide whether you should breastfeed or use Stelara – do not do both.
Driving ability and use of machinery
How to use Stelara
Stelara is intended to be used under the guidance and supervision of a physician experienced in treating the conditions for which Stelara is intended.
Always use this medicine exactly as directed by your doctor. Consult a doctor if you are unsure. Talk to the doctor about when you should take the injections and when you should come for a follow-up visit.
How much Stelara is given
The doctor will decide how much Stelara you need to use and for how long.
Adults 18 years and older
Psoriasis or psoriatic arthritis
- The recommended starting dose is 45 mg of Stelara. Patients who weigh more than 100 kilograms (kg) can start with a dose of 90 mg instead of 45 mg.
- After the starting dose, you will receive the next dose after 4 weeks and then every 12 weeks. Your subsequent dose is usually the same as the starting dose.
Crohn’s disease or ulcerative colitis
- During treatment, the first dose of approximately 6 mg/kg of Stelara will be given to you by your doctor by drip through a vein in your arm ( intravenous infusion ). After you receive the first dose, you will receive the next dose of 90 mg Stelara after 8 weeks and then every 12 weeks by injection under the skin ( subcutaneously ).
- In some patients, 90 mg of Stelara can be given every 8 weeks, after the first injection under the skin. Your doctor will decide when you should receive your next dose.
Children and young people 6 years and older
- The doctor will calculate the dose that suits you, including the amount (volume) of Stelara to be injected to give the right dose. The right dose for you depends on your body weight at the time each dose is given.
- If you weigh less than 60 kg, the recommended dose of Stelara is 0.75 mg per kg of body weight.
- If you weigh between 60 kg and 100 kg, the recommended dose of Stelara is 45 mg.
- If you weigh more than 100 kg, the recommended dose of Stelara is 90 mg.
- After the starting dose, you will receive the next dose after 4 weeks and then every 12 weeks.
How Stelara is given
- Stelara is given as an injection under the skin ( subcutaneously ). At the start of treatment, Stelara is normally injected by healthcare professionals.
- However, you can inject Stelara yourself if the doctor, in consultation with you, thinks it is appropriate. If so, you will be taught how to inject Stelara.
- For instructions on how to inject Stelara, see “Instructions for administration” at the end of this leaflet.
If you have used too much Stelara
If you forget to use Stelara
If you forget to take a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a missed dose.
If you stop using Stelara
It is not dangerous to stop using Stelara. However, your symptoms may return if you stop.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may need emergency care. Tell your doctor or seek emergency medical attention if you notice any of the following symptoms.
- Serious allergic reactions ( anaphylaxis ) are rare in people taking Stelara (may affect up to 1 in 1,000 people). Symptoms include:
- difficulty breathing or swallowing
- low blood pressure, which can cause dizziness or lightheadedness
- 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 pneumonia have been reported in patients receiving ustekinumab. Tell your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.
If you have a severe allergic reaction, your doctor may decide not to use Stelara again.
Infections – these may need urgent care. Tell your doctor immediately if you notice any of the following signs.
- Nose or throat infection and the common cold are common (affects up to 1 in 10 users)
- Respiratory tract infections are uncommon (may affect up to 1 in 100 users)
- Inflammation of tissue under the skin ( cellulitis ) is less common (may affect up to 1 in 100 people)
- Shingles (a type of painful rash with blisters) are less common (may affect up to 1 in 100 people)
Stelara can impair your ability to fight infection. Some infections can be serious and can include infections caused by viruses, fungi, or bacteria, including infections that mainly occur in people with a weakened immune system (opportunistic infections ).
You must pay attention to signs of infection while using Stelara. These include:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough that does not go away
- hot, red, and painful skin, or a painful rash with blisters
- burning when you pee
Tell the doctor immediately if you notice any of these signs of infection. It can be a sign of infection such as infection in the respiratory tract, skin infections, or shingles which can cause serious complications. Tell the doctor if you have any kind of infection that does not go away or keeps coming back. Your doctor may decide not to use Stelara until the infection clears. Also, tell your doctor if you have any open cuts or sores as these can become infected.
Skin peeling – increased redness and skin peeling over a large area of the body can be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. You should tell your doctor immediately if you notice any of these signs.
Other side effects:
Common side effects ( may affect up to 1 user in 10)
- Feeling of fatigue
- Itching ( pruritus )
- Back, muscle, or joint pain
- Sore throat
- Redness and pain at the injection site.
Uncommon side effects ( may affect up to 1 user in 100):
- Dental infections
- Vaginal yeast infection
- Stuffy nose
- Bleeding, bruising, hardness, swelling, itching at the injection site.
- Feeling of weakness
- Drooping eyelids and sunken muscles on one side of the face (“facial palsy” or “Bell’s palsy”), which is usually temporary.
- A change in psoriasis one with redness and new small, yellow or white skin blisters, sometimes with a fever ( pustular psoriasis )
- Skin peeling (skin exfoliation)
Rare side effects ( may affect up to 1 in 1,000 users)
- Redness and peeling of the skin over a large area of the body, which may itch or be painful (exfoliative dermatitis ). Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis ).
- Inflammation of small blood vessels that can lead to skin redness with small, red, or purple bumps, fever, or joint pain ( vasculitis ).
Very rare side effects ( may affect up to 1 in 10,000 users)
- Blisters on the skin that may be red, itchy, and painful (bullous pemphigoid ).
How Stelara should be stored
- Keep this medicine out of the sight and reach of children.
- Store in a refrigerator (2°C – 8°C). Do not freeze.
- Store the vial in the outer carton. Light sensitive.
- Do not shake the Stelara vials. If the medicine is shaken vigorously for a long time, it can be destroyed.
Do not use this medicine:
- After the expiry date stated on the label and carton after “EXP”. The expiration date is the last day of the specified month.
- If the liquid is discolored, cloudy, or contains visible foreign particles (for more information, see section 6, “Appearance of the medicinal product and package sizes”).
- If you know or suspect that the medicine has been exposed to extreme temperatures (eg accidentally frozen or heated).
- If the medicine has been shaken vigorously.
- If the seal is broken.
Stelara is for single use only. Unused medicine in the vial and syringe must be thrown away.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is ustekinumab. One vial contains 45 mg ustekinumab in 0.5 ml.
- Other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injections.
Appearance and package sizes of the medicine
Stelara is a clear to slightly opalescent (has a pearlescent luster), colorless to slightly yellowish solution for injection. The solution may contain a few small clear or white protein particles. The medicine is supplied in a cardboard package with a 2 ml glass vial for single use. One vial contains 45 mg ustekinumab in 0.5 ml solution for injection.
Marketing Authorisation Holder
Janssen-Cilag International NV
Janssen Biologics BV
NL-2333 CB Leiden