Stelara 45 mg solution for injection in pre-filled pen: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

STELARA 45 mg solution for injection in pre-filled pen

ustekinumab

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

This leaflet has been written for the person using the medicine.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Stelara is and what it is used for
What you need to know before using Stelara
How to use Stelara
Possible side effects
How to store Stelara
Contents of the pack and other information

1. What Stelara is and what it is used for

What Stelara is

Stelara contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically identify and bind to certain proteins in the body.

Stelara belongs to a group of medicines called “immunosuppressants”. These medicines work by weakening part of the immune system.

What Stelara is used for

Stelara administered with the pre-filled pen is used to treat the following inflammatory diseases:

Plaque psoriasis – in adults
Psoriatic arthritis – in adults
Moderate to severe Crohn’s disease – in adults
Moderate to severe ulcerative colitis – in adults

Plaque psoriasis

Plaque psoriasis is a skin disease that causes inflammation affecting the skin and nails. Stelara reduces inflammation and other signs of the disease.

Stelara administered with the pre-filled pen is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or when these treatments have not worked.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease, which is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond well to these medications, you may be treated with Stelara to:

Reduce the signs and symptoms of your disease.
Improve your physical function.
Reduce joint damage.

Crohn’s disease

Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be given other medications. If you do not respond adequately or cannot tolerate these medications, you may be given Stelara to reduce the signs and symptoms of your disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be given other medications. If you do not respond sufficiently or cannot tolerate these medications, you may be given Stelara to reduce the signs and symptoms of your disease.

2. What you need to know before using Stelara

Do not use Stelara

If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
If you have an active infection that your doctor considers significant.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before using Stelara.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Stelara. Your doctor will assess your condition before each treatment. Make sure to inform your doctor about any illness you may have before each treatment. Your doctor will also ask whether you have recently been in contact with someone who might have tuberculosis. Your doctor will examine you and perform a test for tuberculosis before you start using Stelara. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Watch for serious side effects

Stelara may cause serious side effects, including allergic reactions and infections. You should be aware of certain signs of illness while using Stelara. See the complete list of these side effects in “Serious side effects” in section 4.

Before using Stelara, tell your doctor:

If you have ever had an allergic reaction to Stelara. Consult your doctor if you are unsure.
If you have ever had any type of cancer – because immunosuppressants like Stelara weaken part of the immune system, which may increase the risk of developing cancer.
If you have previously received treatment for psoriasis with other biologics (a medicine produced from a biological source and usually administered by injection) – the risk of developing cancer may be higher.
If you currently have or have recently had an infection.
If you have any new skin lesions or changes in existing lesions within the psoriasis-affected area or on intact skin.
If you have ever had an allergic reaction to latex or to Stelara injection – the container of this medicine contains latex rubber, which may cause severe allergic reactions in people sensitive to latex. See “Watch for serious side effects” in section 4 for signs of an allergic reaction.
If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as other immunosuppressants or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. The use of these treatments together with Stelara has not been studied, but it may increase the likelihood of developing illnesses related to a weakened immune system.
If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether Stelara may affect these treatments.
If you are 65 years of age or older – you may be more likely to develop infections.

If you are unsure whether you have any of these conditions, speak with your doctor or pharmacist before using Stelara.

Some patients have experienced lupus-like reactions during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in sun-exposed areas of skin, or if it is accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of patients with psoriasis treated with Stelara. Your doctor will periodically check your risk factors for heart disease and stroke to ensure they are properly managed. Seek immediate medical attention if you experience chest pain, weakness or numbness on one side of the body, facial paralysis, or speech or vision disturbances.

Children and adolescents

The use of the Stelara pre-filled pen is not recommended in children and adolescents under 18 years of age with psoriasis, as it has not been studied in this age group. For children aged 6 years and older and adolescents with psoriasis, the pre-filled syringe or vial should be used instead.

The use of Stelara is not recommended in children and adolescents under 18 years of age with psoriatic arthritis, Crohn’s disease, or ulcerative colitis, as it has not been studied in this age group.

Use of Stelara with other medicines, vaccines

Inform your doctor or pharmacist:

If you are currently using, have recently used, or might use any other medicines.
If you have recently been vaccinated or are scheduled to receive a vaccine. Certain types of vaccines (live vaccines) must not be administered while using Stelara.
If you received Stelara during pregnancy, inform your infant’s doctor about your Stelara treatment before the infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your infant within the first six months after birth if you received Stelara during pregnancy, unless otherwise advised by your infant’s doctor.

Pregnancy and breastfeeding

It is preferable to avoid using Stelara during pregnancy. The effects of Stelara in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use adequate contraception while using Stelara and for at least 15 weeks after the last dose of Stelara.
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
Stelara may pass through the placenta to the fetus. If you received Stelara during pregnancy, your infant may have an increased risk of infection.
It is important to inform your infant’s doctors and other healthcare professionals if you received Stelara during pregnancy before the infant receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your infant within the first six months after birth if you received Stelara during pregnancy, unless otherwise recommended by your infant’s doctor.
Ustekinumab may be excreted in breast milk in very small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether to breastfeed or use Stelara. Do not do both at the same time.

Driving and using machines

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

3. How to use Stelara

Stelara should be used under the guidance and supervision of a physician experienced in the treatment of the conditions for which Stelara is indicated.

Always follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor. Ask your doctor when your injections should be given and about follow-up appointments.

How much Stelara is administered

Your doctor will decide the amount of Stelara you need to use and the duration of treatment.

Adults aged 18 years and older

Psoriasis or psoriatic arthritis

The recommended starting dose is 45 mg of Stelara. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
After the initial dose, the next dose will be given 4 weeks later, and subsequently every 12 weeks. The following doses are usually the same as the starting dose.

Crohn’s disease or ulcerative colitis

During treatment, your doctor will administer the first dose of approximately 6 mg/kg of Stelara as an intravenous infusion (through a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Stelara 8 weeks later, and then every 12 weeks, as an injection under the skin (“subcutaneously”).
In some patients, after the first subcutaneous injection, 90 mg of Stelara will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

How Stelara is administered

Stelara is administered by subcutaneous injection (“under the skin”). At the beginning of your treatment, medical or nursing staff may administer Stelara to you.
However, you and your doctor may decide that you will self-inject Stelara. In that case, you will be trained on how to self-administer Stelara injections.
For instructions on how to inject Stelara, see “Administration instructions” at the end of this leaflet.

Consult your doctor if you have any questions about how to self-inject.

If you use more Stelara than you should

If you have used or been administered too much Stelara, speak immediately with your doctor or pharmacist. Always carry the medicine carton with you, even if it is empty.

If you forget to use Stelara

If you miss a dose, speak with your doctor or pharmacist. Do not take a double dose to make up for missed doses.

If you stop treatment with Stelara

Stopping Stelara is not dangerous. However, if you discontinue treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Serious adverse effects

Some patients may experience serious adverse effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment. Contact your doctor or seek immediate medical help if you notice any of the following signs.

Severe allergic reactions ("anaphylaxis") are rare in the population using Stelara (may affect up to 1 in 1,000 people). Signs include:
difficulty breathing and swallowing
low blood pressure, which may cause dizziness or mild headaches
swelling of the face, lips, mouth, or throat.
Common signs of an allergic reaction include rash and hives (these may affect up to 1 in 100 people).

In rare cases, lung-related allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you experience symptoms such as cough, difficulty breathing, and fever.

If you have a severe allergic reaction, your doctor may decide that you should not use Stelara again.

Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of these signs.

Infections of the nose or throat and the common cold are common (may affect up to 1 in 10 people).
Chest infections are uncommon (may affect up to 1 in 100 people).
Inflammation of the tissues beneath the skin ("cellulitis") is uncommon (may affect up to 1 in 100 people).
Herpes (a type of painful blistering rash) is uncommon (may affect up to 1 in 100 people).

Stelara may affect your ability to fight infections. Some of these infections could become serious and may be caused by viruses, fungi, bacteria (including tuberculosis), or parasites. They include infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving ustekinumab treatment.

You should monitor for signs of infection while using Stelara. These include:

fever, flu-like symptoms, night sweats, weight loss
feeling tired or having difficulty breathing; persistent cough
skin that feels warm, red, and painful, or a painful blistering skin rash
burning sensation when urinating
diarrhea
visual deterioration or vision loss
headache, neck stiffness, light sensitivity, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate serious infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to severe complications. You should also inform your doctor if you have any infection that does not go away or keeps recurring. Your doctor may decide that you should not use Stelara until the infection resolves. Also contact your doctor if you have any open cuts or ulcers that could become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin disorders. If you notice any of these symptoms, you must inform your doctor immediately.

Other adverse effects

Common adverse effects (may affect up to 1 in 10 people):

Diarrhea
Nausea
Vomiting
Feeling tired
Dizziness
Headache
Itching ("pruritus")
Back, muscle, or joint pain
Sore throat
Redness and pain at the injection site
Sinusitis

Uncommon adverse effects (may affect up to 1 in 100 people):

Dental infections
Vaginal yeast infections
Depression
Nasal congestion or stuffiness
Bleeding, bruising, hardness, swelling, and itching at the injection site
Feeling weak
Drooping eyelid and sinking of the muscles on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
Skin peeling (skin exfoliation)
Acne

Rare adverse effects (may affect up to 1 in 1,000 people):

Redness and peeling of the skin over a large area of the body, which may cause itching or pain (exfoliative dermatitis). Similar symptoms may develop as a natural change in psoriasis symptoms (erythrodermic psoriasis)
Inflammation of small blood vessels, which may cause a skin rash with small red or purple raised spots, fever, or joint pain (vasculitis)

Very rare adverse effects (may affect up to 1 in 10,000 people)

Blisters on the skin, which may be red, itchy, and painful (bullous pemphigoid).
Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash in areas of skin exposed to sunlight, possibly accompanied by joint pain).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Stelara

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C to 8 °C). Do not freeze.
Keep the prefilled pen in the outer packaging to protect it from light.
If necessary, individual Stelara prefilled pens may also be stored at room temperature up to 30°C for a single period of up to 30 days, keeping them in their original carton to protect them from light. Write the date when the prefilled pen is first removed from the refrigerator and the date when it must be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiration date printed on the carton. Once a syringe or prefilled pen has been stored at room temperature (up to a maximum of 30°C), it must not be returned to the refrigerator. Discard the syringe or prefilled pen if it has not been used within 30 days of storage at room temperature, or if it has expired according to the original expiration date, whichever occurs first.
Do not shake Stelara prefilled pens. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

After the expiry date stated on the label and packaging after “EXP”. The expiry date refers to the last day of the month indicated.
If the solution changes colour, becomes cloudy, or contains foreign particles floating in it (see section 6 “What Stelara looks like and contents of the pack”).
If you know or suspect it has been exposed to extreme temperatures (such as accidental overheating or freezing).
If the product has been shaken vigorously.

Stelara is for single use only. Any unused product remaining in the syringe or prefilled pen must be discarded. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Stelara

The active substance is ustekinumab. Each pre-filled pen contains 45 mg of ustekinumab in 0.5 ml.
The other components are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injections.

Appearance of Stelara and contents of the pack

Stelara is a slightly opalescent (with a pearly sheen), injectable solution that is colourless to pale yellow. The solution may contain a few translucent or white protein particles. It is supplied in a pack containing 1 single-dose 1 ml glass pre-filled pen. Each pre-filled pen contains 45 mg of ustekinumab in 0.5 ml of injectable solution.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium

Janssen-Cilag NV

Tel/Tel: +32 14 64 94 11