how to use stelara how to use stelara

how to use
stelara®
crohn’s disease

Instructions for administration4

If you and your healthcare team decide that self-injecting Stelara® is right for you, then one of the Homecare nurses will train you on how to administer the medicine.

Please see the video below for instructions on how to administer Stelara® by injection under the skin (‘subcutaneously’). Alternatively, instructions can also be found towards the end of the Patient Information Leaflet (PIL): Stelara® 90 mg for Crohn's disease.

instructions for administration

How often to take Stelara®3

The first dose for the treatment of moderate to severely active Crohn’s disease is administered by an intravenous infusion by your healthcare professional. The dose is determined by your body weight.

The next dose is 90 mg, administed by a subcutaneous injection (under the skin) 8 weeks later, then a 90 mg dose every 8 or 12 weeks, depending on how well you respond to your medication.3

At week 16, your doctor will assess whether you should receive a dose every 8 weeks or 12 weeks.3

If you are on a 12-weekly dose after this point and your symptoms are returning before your next dose, you may be given a 90 mg dose every 8 weeks instead after a consultation with your doctor.3

The dosing schedule for a patient with Crohn’s disease receiving their first Stelara® dose on 1st January is displayed below.

Week

January

0

February

8

March

April

16

May

20

June

24

July

August

32

September

October

40

November

44

December

48

= Intravenous infusion

= Injection due (patients requiring a 90 mg dose every 12 weeks after the subcutaneous dose at week 8)

= Injection due (patients requiring a 90 mg dose every 8 weeks after the subcutaneous dose at week 8)

Do you have questions about your dose?

Speak to your doctor or nurse if:

  • You are unsure when your next dose is due
  • You use more medication than you should have, such as receiving a larger dose or using it sooner than planned
  • You forget to administer a dose
  • You would like to stop using Stelara®; your symptoms may return if you stop treatment

The Stelara® treatment journey:
Year one

If you have moderate to severely active Crohn’s disease and you have been prescribed Stelara®, you may be wondering how often you will be given it and what might happen during the course of treatment. If so, read below to view the treatment journey, informed by research on how Stelara® has helped other patients.

week 0: the starter dose

Your first dose will be through intravenous infusion, given by a healthcare professional trained in the diagnosis and treatment of Crohn’s disease at your hospital. The dose is determined by your body weight.

week 8: the first maintenance dose

By week 8, approximately 58% of patients in a clinical trial experienced significant improvement in symptoms and 40% experienced remission. Symptom improvements included lower abdominal pain and reduced liquid or soft stools.15

From week 8 onwards, you will receive Stelara® as a subcutaneous injection (under the skin) by a healthcare professional at your hospital or by a nurse visiting your home, who may also train you to inject yourself if the clinical team agree. For more information on receiving your medication at home, please refer to the Homecare section or download the Homecare booklet.

As with any clinical trial, patients are selected based upon strict criteria, such as not having another progressive or uncontrolled medical condition, to avoid the data being influenced by their effects.

In real-world practice, patients taking Stelara® may have other medical conditions or other factors not allowed in the clinical trials. This means clinical trial data does not necessarily reflect real-world treatment, and so your response may differ to patients in these trials.

syringe-pink-purple

week 16

If your Crohn’s disease hasn’t responded to Stelara® by now or your symptom improvements are fading, your doctor may decide to give you a second maintenance dose of 90 mg and give you a maintenance dose every 8 weeks instead of every 12 weeks.3 Alternatively, your doctor may consider other treatment options.

week 16

week 20

If you responded well to your starter dose and first maintenance dose, you should now receive your medication once every 12 weeks.3

week 32

In clinical trials, 40% of patients who did not respond well or for long enough to Stelara® were changed to receive it every 8 weeks and experienced symptom improvements or remission 16 weeks later.3,15 If you have received your medication every 8 weeks from week 16, there is a good chance you will experience improvements or remission by this point.

Questions about your treatment?

Stay in contact with your healthcare team throughout your treatment and ask them any questions you have about your treatment or condition.

week 44 or 48*

*depending on your dosing schedule

The last dose of your first year on Stelara®!3

week 52: one year in

Your first year on Stelara® is complete! You will continue to have check-ups with your healthcare professional, to make sure your Crohn’s disease is still responding well to treatment and you’re happy with your medication.

If you have concerns or questions at any point, contact your healthcare professional.

after year one

Available data beyond the first-year show symptom improvements are generally maintained through 3 years.3,16

What you need to know before you use Stelara®

Do not use Stelara®4 - +

  • If you are allergic to ustekinumab or any of the other ingredients of this medicine
  • If you have an active infection which your doctor thinks is important

Warnings and precautions4 - +

Talk to your doctor, pharmacist or nurse before using Stelara®.

  • Make sure you tell your doctor about any illness you have before each treatment
  • Tell your doctor if you have recently been near anyone who might have tuberculosis
  • Your doctor will examine you and do a test for tuberculosis, before you receive this treatment. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it
  • Stelara® can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness whilst taking this treatment

Before you use Stelara® tell your doctor4 - +

  • If you ever had an allergic reaction to Stelara®. Ask your doctor if you are not sure
  • If you have ever had any type of cancer – this is because immunosuppressants like Stelara® weaken part of the immune system. This may increase the risk of cancer
  • If you have or have had a recent infection
  • If you have any new or changing lesions within psoriasis areas or on normal skin
  • If you are having any other treatment for Crohn’s disease - such as another immunosuppresant. these treatments may also weaken part of the immune system. Using these therapies together with Stelara® has not been studied. However it is possible it may increase the chance of diseases related to a weaker immune system
  • If you are having or have ever had injections to treat allergies – it is not known if this treatment may affect these
  • If you are 65 years of age or over – you may be more likely to get infections

Other medicines, vaccines and Stelara®4 - +

Tell your doctor or pharmacist:

  • If you are taking, have recently taken or might take any other medicines
  • If you have recently had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using this treatment

Pregnancy and breast-feeding4 - +

  • It is preferable to avoid the use of Stelara® in pregnancy. The effects of this treatment in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using this treatment and for at least 15 weeks after the last Stelara® dose
  • Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby
  • Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should discuss this to decide if therapy should be discontinued taking into account the benefit of breast-feeding to the child and the benefit of the treatment to you

Driving and using machines4 - +

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

Possible side effects4

Reporting side effects

In the UK, you can report side effects directly via the Yellow Card Scheme at: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

What are the side effects?

All medicines can cause side effects, but not everyone gets them. If you do experience side effects these are usually mild to moderate.
If you get any side effects, talk to your doctor or pharmacist.

Common side effects:4

(may affect up to 1 in 10 people)

  • Diarrhoea
  • Nausea
  • Vomiting
  • Feeling tired
  • Feeling dizzy
  • Headache
  • Itching (‘pruritus’)
  • Back, muscle or joint pain
  • Sore throat
  • Redness and pain where the injection is given

Uncommon side effects:4

(may affect up to 1 in 100 people)

  • Tooth infections
  • Vaginal yeast infection
  • Depression
  • Blocked or stuffy nose
  • Bleeding, bruising, hardness, swelling and itching where the injection is given
  • Feeling weak
  • Drooping eyelid and sagging muscles on one side of the face (‘facial palsy’ or ‘Bell’s palsy’), which is usually temporary
  • A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis)
  • Peeling of the skin (skin exfoliation)
  • Acne

Rare side effects:4

(may affect up to 1 in 1000 people)

  • Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis)

If you experience the following serious side effects, you should tell your doctor or seek medical help straight away, as you may need urgent treatment:4

Serious allergic reactions (‘anaphylaxis’), indicated by:4

  • Difficulty breathing or swallowing
  • Low blood pressure
  • Dizziness or light-headedness
  • Swelling of the face, lips, mouth or throat
  • Common signs of less serious allergic reactions include skin rash and hives

Shedding of the skin, indicated by:4

  • An increase in redness and shedding of skin over a larger area of the body - this could be a sign of a more serious skin condition

Signs of infection. Infections may be located in the nose, throat, chest, skin or elsewhere, indicated by:4

  • Fever
  • Flu-like symptoms
  • Night sweats
  • Feeling tired or short of breath
  • Cough which will not go away
  • Warm, red and painful skin
  • Painful skin rash with blisters
  • Burning when passing urine
  • Diarrhoea