Stelara 130 Mg/26 ml - 1 Vial (Refrigerator)

Product Description:

• 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.

Warnings and precautions:

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 important.


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


• Talk to your doctor or pharmacist before using Stelara.


• Your doctor will examine your health before treatment.


• Make sure you tell your doctor about any illnesses you have before treatment.


• Also tell your doctor if you have recently been close to someone who may have tuberculosis.


• Your doctor will examine you and take a test for tuberculosis before you receive Stelara. 


• If your doctor thinks you are at risk of getting tuberculosis , you may be given medicine to treat it.

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.

Children and youth:

• Stelara is not recommended for use in children under 18 years of age with Crohn's disease or ulcerative colitis , as it has not been studied in this age group.


• Other medicines, vaccines and Stelara

Talk to your doctor or pharmacist:

• If you use, have recently used or plan to use other medicines.


• If you have recently had or are about to have a vaccination. 


• Some vaccine types (live vaccines) should not be given during treatment with stelara.

Pregnancy and breastfeeding:

• It is preferable to avoid the use of Stelara during pregnancy. 


• The effect of Stelara in pregnant women is not known.


• If you are a woman of childbearing age, you are advised not to become pregnant, and you must use safe contraception during treatment with Stelara and for at least 15 weeks after the last treatment.


• Talk to your doctor if you are pregnant, think you may be pregnant or plan to become pregnant.


• USTEKINUMAB can pass into breast milk. 


• Talk to your doctor if you are breastfeeding or plan to breastfeed. You and your doctor must decide whether you should breastfeed or use Stelara. Don't do both.

Driving and using machines:

• Stelara has no or negligible influence on the ability to drive and use machines.

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.

Product Details:

• Brand: Stelara
• Product Form: Vials
• Product Type: Vials