Stelara 130 mg Ustekinumab concentrate for infusion – 26 mL vial (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.

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 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 diagnosis and treatment of Crohn’s disease or ulcerative colitis .

• • Stelara 130 mg concentrate for infusion, solution will be given to you by your doctor, through a drip into a vein in your arm ( intravenous infusion) over at least 1 hour.

• • 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 receive and how long to receive it.

Adults who are 18 years of age or older

• • The doctor calculates the recommended intravenous infusion dose for you based on your body weight.

• • After the intravenous starting dose, you will receive the next dose of 90 mg Stelara as an injection under the skin ( subcutaneous injection) 8 weeks later, then every 12 weeks.

How Stelara is given:

• • The first dose of Stelara to treat Crohn’s disease or ulcerative colitis is given by a doctor as a drip into a vein in an arm ( intravenous infusion).

• • Talk to your doctor if you have any questions about how to get Stelara.

• • If you have forgotten to take Stelara

• • If you forget or do not make it to the doctor’s appointment when you are supposed to receive the dose, contact the doctor to get a new appointment.

• • 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.

Before using Stelara, tell your doctor:

• • If you have ever had an allergic reaction to Stelara. Talk to your doctor if you are unsure.

• • If you have ever had some form of cancer – this is because immunosuppressive drugs such as Stelara inhibit parts of the immune system. This can increase the risk of cancer .

• • If you have or have recently had an infection or if you have abnormal skin openings (fistulas).

• • If you have any new sores or changing sores in psoriasis areas or on normal skin.

• • If you receive another form of treatment for psoriasis and/or psoriatic arthritis – such as other immunosuppressive medicines or phototherapy (when your body is treated with a type of ultraviolet (UV) light).

• • These treatments can also inhibit parts of the immune system.

• • Use of these treatments at the same time as Stelara has not been studied.

• • It is nevertheless possible that the probability of diseases increases due to a weaker immune system.

• • If you have or have had injections to treat allergies – it is not known whether Stelara can affect this.

• • If you are 65 or older – you may be more likely to get infections .

• • If you are unsure whether any of the above applies to you, contact your doctor or pharmacist before taking Stelara.

Ingredients:

• • The active substance is USTEKINUMAB.

• • Each vial contains 130 mg USTEKINUMAB in 26 ml.

What Stelara looks like and the contents of the pack:

• • Stelara is a clear, colorless to light yellow concentrate for infusion.

• • It is supplied as a box with a single dose in a 30 ml vial.

• Each glass contains 130 mg of USTEKINUMAB in 26 ml of concentrate for infusion, solution.