Stelara 90 mg/1 mL Ustekinumab pre‑filled syringe × 1 (refrigerated)

Stelara contains the active substance USTEKINUMAB, a monoclonal antibody.

• • Monoclonal antibodies are proteins that recognize and bind to other specific proteins in the body.

• • Stelara belongs to a group of medicines called immunosuppressants.

• • These are drugs that inhibit parts of the immune system.

Stelara is used to treat the following inflammatory diseases:

• • Plaque psoriasis – in adults and children aged 6 years or older

• • Psoriatic arthritis – in adults

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

• • Moderate to severe ulcerative colitis – in adults

• • Flapper:

• • Plaque psoriasis is a skin disease that causes inflammation of the skin and nails.

• • Stelara suppresses inflammation and improves other symptoms of the disease.

• • Stelara is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate or phototherapy, or where these treatments have not worked.

• • Stelara is used in children and adolescents who are 6 years of age or older with moderate to severe plaque psoriasis, who cannot tolerate phototherapy or other systemic treatment, or where these treatments have not had an effect.

Psoriatic Arthritis:

• • Psoriatic arthritis is an inflammatory disease of the joints that is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will be given other medicines.

If you do not respond well enough to these medicines, you may be given Stelara to:

• • Reduce the symptoms of your disease.

• • Improve your physical function.

• • Slow down your joint damage.

Crohn’s disease:

• • Crohn’s disease is an inflammatory disease of the intestine.

• • If you have Crohn’s disease , you will first be given other medicines.

• • If you do not get a good enough effect or cannot tolerate these medicines, you can get Stelara to reduce the symptoms of your disease.

Ulcerative colitis:

• • Ulcerative colitis is an inflammatory disease of the intestine.

• • If you have ulcerative colitis , you will first receive other medicines.

• • If you do not get a good enough effect or cannot tolerate these medicines, you can get Stelara to reduce the symptoms of your disease.

How To Use:

• • Stelara is intended for use under the guidance and supervision of a doctor who has experience in the treatment of conditions for which Stelara is indicated.

• • Always use this medicine exactly as your doctor has told you.

• • Contact a doctor if you are unsure. Ask your doctor about when you should take injections and when you should have follow-up appointments.

How much Stelara should be given:

• • Your doctor will decide how much Stelara you need to use and how long to use it.

Adults who are 18 years of age or older:

Psoriasis or psoriatic arthritis:

• • The recommended starting dose is 45 mg Stelara.

• • Patients who weigh more than 100 kilograms (kg) can start with a dose of 90 mg instead of 45 mg.

• • After the initial dose, you will receive the next dose 4 weeks later, then every 12 weeks. The subsequent doses are usually the same as the starting dose.

Crohn’s disease or ulcerative colitis:

• • During treatment, the first dose with approx. 6 mg/kg Stelara will be given by your doctor through a drip into a vein in your arm ( intravenous infusion).

• • After the initial dose, you will receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks, as an injection under the skin ( subcutaneously ).

• • In some patients, 90 mg of Stelara can be given every 8 weeks after the first subcutaneous injection.

• • Your doctor will decide when you should receive the next dose.

• • Children and young people aged 6 or older

Psoriasis:

• • Your doctor will find the right dose for you, including the amount (volume) of Stelara to inject to get the right dose.

• • The right dose for you depends on your body weight at the time the individual dose is given.

• • There is a 45 mg vial if you need to get less than a full 45 mg dose.

• • If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg of body weight.

• • If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.

• • If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.

• • After the initial dose, you will receive the next dose 4 weeks later, then every 12 weeks.

How Stelara is given:

• • Stelara is given as an injection under the skin ( subcutaneously ).

• • At the start of treatment, your medical or nursing staff may inject Stelara for you.

• • You and your doctor can still decide that you inject Stelara yourself. If so, you will receive training on how to inject Stelara yourself.

• • Talk to your doctor if you have any questions about how to give yourself an injection.

• • If you take too much Stelara

• • If you have taken too much Stelara, contact your doctor or pharmacist immediately. Always take the outer packaging of the medicine with you, even if it is empty.

If you have forgotten to take Stelara:

• • If you miss a dose, contact your doctor or pharmacist.

• • Do not take a double dose to make up for a missed dose.

If you stop treatment with Stelara:

• • It is not dangerous to stop using Stelara. If you stop, the symptoms may return.

• • Ask your doctor or pharmacist if you have any questions about the use of this medicine.

• Do not shake the pre-filled syringe of Stelara. Prolonged shaking can damage the medicine.