Stelara 45 mg/0.5 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.

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.

Ingredients:

• • The active substance is ustekinumab. Each pre-filled syringe contains 45 mg ustekinumab in 0.5 ml.

What Stelara looks like and the contents of the pack:

• • Stelara is a clear to slightly opaque (has a pearly sheen), colorless to pale yellow solution for injection.

• • The solution may contain a few small transparent or white protein particles.

• • It is supplied as a box with a single dose in a 1 ml pre-filled syringe.

• Each syringe contains 45 mg ustekinumab in 0.5 ml solution for injection.