STELARA 45mg solution for injection in pre-filled syringePat - United Kingdom[英国药品]

TOP

STELARA 45mg solution for injection in pre-filled syringePat

2015-02-03 00:55:09 来源: 作者: 【大中小】浏览:399次评论:0条

For doctors

What is it and how is it used?

STELARA belongs to a group of medicines called immunosuppressants (medicines that inhibit your immune system). STELARA contains the active substance ustekinumab, a monoclonal antibody.Monoclonal antibodies are proteins that recognise and bind to other specific proteins in the body.

STELARA is used to treat moderate to severe plaque psoriasis in adultpatients who cannot use or did not respond to other medicines and phototherapy. This disease causes inflammation of skin and nails. STELARA will reduce the inflammation and other signs of the disease.

What do you have to consider before using it?

Do not use STELARA
-If you are allergic (hypersensitive) to ustekinumab or to any of the other ingredients of STELARA (listed in section 6 ‘What STELARA contains’).
-If you have an active infection which your doctor considers important (see also below ‘Take specialcare with STELARA’).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using STELARA.

Take special care with STELARA
Your doctor will assess your health before each treatment. Make sure you tell your doctorabout any illness you have before each treatment. Check with your doctor before using STELARA if you have:

Latex sensitivity The container of this medicinal product contains latex rubber. This may cause severe allergic reactions in people who are sensitive to latex. Tell your doctor if you have ever had an allergic reaction to latex or developed any allergic reaction to STELARA injection

Cancer. Immunosuppressants like STELARA decrease the activity of the immune system. This may increase the risk of cancer. Tell your doctor if you have ever had any type of cancer

Vaccinations. Tell your doctor if you have recently had or are going to have a vaccine

Other therapies for psoriasis. Tell your doctor if you are receiving any other immunosuppressant or phototherapy when your body is treated with specific ultraviolet UV light while using STELARA, which may also decrease the activity of your immune system. The combination of these therapies has not been investigated and it may increase the risk of diseases related to a weakened immune system

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using STELARA.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You should not be given certain types of vaccines while on treatment with STELARA.

Pregnancy and breastfeeding
Talk to your doctor before using STELARA:
-If you are pregnant or are planning to become pregnant while using STELARA. The effects of this medicine 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 STELARA and for at least 15weeks after the last STELARA treatment.
-If you are breastfeeding or if you plan to breastfeed while using STELARA. Your doctor will decide whether you should use this medicine.

Driving and using machines
It is not known if STELARA can affect the ability to drive or use machines.

How is it used?

Always use STELARA exactly as your doctor has told you. You should check with your doctor if you are not sure. Make sure you discuss with your doctor when you will have your injections and your follow-up appointments.

How much STELARA is given
-Your doctor will decide how much STELARA you need and for how long
-This may depend on your weight

The usual starting dose is 45 mg ustekinumab. After the starting dose, you will receive the next dose 4 weeks later, and then every 12 weeksPatients who weigh more than 100 kg may be given 90 mg instead of 45 mg

Children and adolescents (under 18years)
STELARA is not recommended for children and adolescents (under 18 years old) because it has not been studied in this age group.

How STELARA is given
-STELARA is given by injection under your skin (subcutaneously)
-At the start, medical or nursing staff may inject STELARA. However, you and your doctor may decide that you may inject STELARA yourself. In this case you will get training on how to inject STELARA yourself.
Talk to your doctor if you have any questions about giving yourself an injection. See below in section ‘Instructions for administration’for further information about how to inject STELARA.

If you use more STELARA than you should
If you have used or been given too much STELARA, talk to a doctor or pharmacist straight away. Always have the outer carton of the medicine with you, even if it is empty.

If you forget to use STELARA
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose.

If you stop using STELARA
It is not dangerous to stop using STELARA. However, the symptoms for which STELARA was prescribed may come back.

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

What are possible side effects?

Like all medicines, STELARA can cause side effects, although not everybody gets them.Most side effects are mild to moderate. However, some patients may experience serious side effects and may require treatment.

Tell your doctor straight away if you notice any of the following serious side effects –you may need urgent medical treatment:

Signs of an allergic reaction such as swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe skin rash hives swelling of the hands, feet or anklesSigns of infection including tuberculosis such as fever, feeling tired or short of breath, cough which will not go away, flu-like symptoms, night sweats, diarrhoea, wounds, dental problems and burning when urinating

Side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 user in 10common affects 1 to 10 users in 100uncommon affects 1 to 10 users in 1,000rare affects 1 to 10 users in 10,000very rare affects less than 1 user in 10,000not known frequency cannot be estimated from the available data

The following side effects have been observed with STELARA:

Very common:
-Infection of the throat or airways.

Common DepressionFeeling dizzyHeadacheSore throatBlocked or stuffy noseDiarrhoeaItchingRashItchy bumpsBack or muscle painFeeling tiredRedness of the injection siteInflammation of tissue under the skin. The signs include warmth, swelling, redness and pain

Uncommon:
-Pain, swelling, itching, hardness, bleeding, bruising and irritation where the injection is given.

Rare:
-

Serious allergic reactions including anaphylaxis, angioedema. Symptoms of serious allergic reaction may include wheezing, dizziness and swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the pre-filled syringein the outer carton in order to protect from light.

Do not shake STELARA pre-filled syringes. Prolonged vigorous shaking may damage the medicine.

Do not use STELARA
-After the expiry date which is stated on the label and the carton after “EXP”. The expiry date refers to the last day of that month
-If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see further section 6 ‘What STELARA looks like and contents of the pack’)
-If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated)
-If the product has been shaken vigorously
STELARA is for single use only. Any unused product remaining in the syringe should be disposed of.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

↑ back to table of contents ↑

For doctors

What is it?

Stelara is a solution for injection that contains the active substance ustekinumab. It is available in a vial or in a prefilled syringe. Each vial or syringe contains either 45 or 90 mg ustekinumab.

What is it used for?

Stelara is used to treat adults with moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in patients who failed to respond to or cannot use other systemic (whole-body) treatments for psoriasis, including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A). PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen’ before being exposed to ultraviolet light.
The medicine can only be obtained with a prescription.

How is it used?

Stelara is given under the supervision of a doctor who has experience in diagnosing and treating psoriasis.
It is given as an injection under the skin at a dose of 45 mg. This is followed by a further injection four weeks later, and then an injection every three months (12 weeks). The doctor should consider stopping treatment if there is no response after 28 weeks. Patients weighing over 100 kg should be given Stelara in 90-mg doses.
Patients may inject themselves once they have been trained, if their doctor thinks that this is appropriate.

How does it work?

The active substance in Stelara, ustekinumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Ustekinumab has been designed to attach to a protein called ‘IL-12/23p40’. This protein forms part of two of the cytokines (messenger molecules) in the immune system called interleukin-12 and interleukin-23. These cytokines are involved in causing the inflammation and other processes that cause psoriasis. By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.

How has it been studied?

Stelara has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,996 adults with moderate to severe plaque psoriasis. Over half of the patients had failed one or more other treatments for psoriasis or could not receive them. Both studies looked at two doses of Stelara (45 and 90 mg). The main measure of effectiveness was the number of patients who ‘responded’ to treatment after 12 weeks, meaning that symptom scores improved by 75% or more. The studies were still ongoing at the time of the medicine’s assessment and are scheduled to last for up to five years. The company also provided some of the longer-term results of one of the studies (after 18 months of treatment), and the early results of an ongoing study comparing Stelara with etanercept (another medicine for psoriasis).

What benefits has it shown during the studies?

Stelara was more effective than placebo at improving the symptoms of psoriasis. Looking at the results of the two main studies taken together, around 69% of the patients receiving Stelara responded to treatment after 12 weeks, compared with around 3% of the patients receiving placebo. There was no difference in response rates between the two doses of Stelara in patients weighing below 100 kg. Patients weighing over 100 kg had a better response to the 90-mg dose. The longer-term results showed that with continuous treatment, the response to Stelara is maintained for at least 18 months. The ongoing comparative study has shown that Stelara is more effective than etanercept after 12 weeks of treatment.

What is the risk associated?

The most common side effects with Stelara (seen in more than 1 patient in 10) are upper respiratory tract infection (colds) and nasopharyngitis (inflammation of the nose and throat). For the full list of all side effects reported with Stelara, see the Package Leaflet.
Stelara should not be used in people who may be hypersensitive (allergic) to ustekinumab or any of the other ingredients. It must not be used in patients who have an active infection that the doctor considers important. The doctor may interrupt treatment in patients who develop a serious infection.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that Stelara has a new mode of action, blocking the activity of two messenger molecules (interleukin-12 and interleukin-23) rather than only one. The Committee also noted that unexpected increases in problems affecting the heart and blood vessels and psychiatric problems such as depression were seen in some studies and that these might be related to Stelara. Therefore, based on the information currently available, the CHMP decided to restrict the use of the medicine to patients in whom other treatments had failed or who could not receive them. The Committee decided that Stelara’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?

The company that makes Stelara will provide educational programmes for healthcare providers and patients. These will focus on the safety of Stelara, particularly the risks of developing tuberculosis, other infections and cancers. The patient programme will also include details of how Stelara should be injected.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Stelara to Janssen-Cilag International NV on 16 January 2009. The marketing authorisation is valid for five years, after which it can be renewed.

↑ back to table of contents ↑

Name

STELARA 45mg solution for injection in pre-filled syringe

Composition

Each single-use pre-filled syringe contains 45mg ustekinumab in 0.5ml.

Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin(IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology.

For a full list of excipients, see section 6.1.