BYDUREON 2 mg powder and solvent for prolonged-releasesuspen - United Kingdom[英国药品]

TOP

BYDUREON 2 mg powder and solvent for prolonged-releasesuspen

2014-11-09 14:44:42 来源: 作者: 【大中小】浏览:410次评论:0条

For doctors

What is it and how is it used?

BYDUREON is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus.

BYDUREON is used in combination with the following diabetes medicines: metformin, sulphonylureas and thiazolidinediones. Your doctor is now prescribing BYDUREON as an additional medicine to help control your blood sugar. Continue to follow your food and exercise plan.

You have diabetes because your body does not make enough insulin to control the level of sugar in your blood or your body is not able to use the insulin properly. BYDUREON helps your body to increase the production of insulin when your blood sugar is high.

What do you have to consider before using it?

Do not use BYDUREON

Take special care with BYDUREON

Using other medicines

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

The use of BYDUREON with insulins, and other medicines that are used to treat type 2 diabetes that work like BYDUREON (for example:liraglutide and Byetta [exenatide twice daily]), is not recommended.

Using BYDUREON with food and drink

Use BYDUREON at any time of day, with or without meals.

Pregnancy and breast-feeding

Women of childbearing potential should use contraception during treatment with BYDUREON. It is not known if BYDUREON may harm your unborn child. Tell your doctor if you are, you think you might be, or are planning to become pregnant as BYDUREON should not be used during pregnancy and for at least three months before a pregnancy.

It is not known if BYDUREON passes into your milk. BYDUREON should not be used if breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you use BYDUREON in combination with a sulphonylurea, low blood sugar (hypoglycaemia) can occur. Hypoglycaemia may reduce your ability to concentrate. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machines).

Important information about some of the ingredients of BYDUREON

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

How is it used?

Always use BYDUREON exactly as your doctor or diabetes nurse has told you. You should check with your doctor, diabetes nurse or pharmacist if you are unsure.

BYDUREON 2 mg should be injected once a week, at any time of day, with or without meals.

BYDUREON is injected into the skin (subcutaneous injection) of your stomach area (abdomen), upper leg (thigh), or the back of your upper arm.
Each week you can use the same area of your body. But be sure to choose a different injection site in that area.

Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.

Follow the Instructions for the User provided in the carton to inject BYDUREON

Your health care professional should teach you how to inject BYDUREON before you use it for the first time.

Check that the liquid in the syringe is clear and free of particles before you begin. After mixing use the suspension only if the mixture is white to off white and cloudy. If you see clumps of dry powder on the sides or bottom of the vial, the medicine is NOT mixed well. Shake vigorously again until well mixed.

BYDUREON should be injected immediately after mixing the powder and the solvent.

Use a new injection needle for each injection and dispose of it after each use.
If you are not sure you have taken the full dose of BYDUREON:

If you are not sure if you have taken all your dose, do not inject another dose of BYDUREON, just take it next week as planned.

If you use more BYDUREON than you should

If you use too much BYDUREON you may need medical treatment. Too much BYDUREON can cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).

If you forget to use BYDUREON

You might like to choose a day that you always plan to make your BYDUREON injection. If you miss your injection that day, take your injection as soon as possible after you notice. For your next injection you can return to your chosen injection day as long as the next injection is at least one day (24 hours) later. You can also change your chosen injection day. Do not take two injections on the same day.

If you stop using BYDUREON

If you feel you should stop using BYDUREON please consult your doctor first. If you stop using BYDUREON this can affect your blood sugar levels.
If you have any further questions on the use of this medicine, ask your doctor, diabetes nurse or pharmacist.

What are possible side effects?

Like all medicines, BYDUREON can have side effects although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).

Severe allergic reactions (anaphylaxis) have been reported very rarely in patients receiving a product that has the same active ingredient as BYDUREON.

You should see your doctor immediately if you experience symptoms such as

Cases of inflammation of the pancreas (pancreatitis) have been reported rarely in patients receiving a product that has the same active ingredient as BYDUREON. Pancreatitis can be a serious, potentially life-threatening medical condition.

Very common side effects of BYDUREON:

Common side effects of BYDUREON:

In addition, some other side effects have been seen in patients using a product that has the same active ingredient as BYDUREON:

Common:

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.

Do not use BYDUREON after the expiry date, which is stated on the label and the carton after EXP.

Store in a refrigerator. Do not freeze.
However, the kit may be kept for up to 4 weeks below 30 ºC prior to use.
Store in the original package in order to protect from light.
Throw away any BYDUREON kit that has been frozen.

Medicines should not be disposed of via waste water 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?

Bydureon is a medicine that contains the active substance exenatide. It is available as a powder and solvent to be made up into a prolonged-release suspension for injection that provides 2 mg of exenatide. Prolonged-release means that the active substance is released slowly over a few weeks after being injected.

What is it used for?

Bydureon is used to treat type 2 diabetes. It is used together with other antidiabetes medicines in adult patients whose blood glucose (sugar) levels are not adequately controlled with the maximum tolerated doses of the other medicines. It can be used with metformin, a sulphonylurea, a thiazolidinedione, metformin and a sulphonylurea, or metformin and a thiazolidinedione.

The medicine can only be obtained with a prescription.

How is it used?

Bydureon is given as one injection under the skin once a week on the same day each week in the abdomen, thigh or back of the upper arm. Patients inject themselves using a kit supplied with the medicine. They should be given appropriate training and should follow the user instructions.

When adding Bydureon to a sulphonylurea, the doctor may need to reduce the dose of the sulphonylurea because there is a risk of hypoglycaemia (low blood sugar levels). Adding Bydureon to metformin or a thiazolidinedione is not associated with this risk.

How does it work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Bydureon, exenatide, is an ‘incretin mimetic’. This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food. This helps with the control of blood glucose levels.

How has it been studied?

The effects of Bydureon were first tested in experimental models before being studied in humans.

Bydureon was investigated in four main studies lasting six months or more involving a total of 1,525 patients with type 2 diabetes. Two of the studies (555 patients) compared Bydureon with a medicine containing exenatide given twice daily, as add-on treatment to oral antidiabetes medicines or diet and exercise alone. One study (514 patients) compared Bydureon with sitagliptin or pioglitazone (a thiazolidinedione) as add-on treatment to metformin. The other study (456 patients) compared Bydureon with insulin glargine as add-on treatment to metformin with or without a sulphonylurea.

In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is being controlled. At the start of the studies, the patients’ HbA1c levels were around 8.4%.

What benefits has it shown during the studies?

In all four studies, Bydureon was more effective than the comparator treatments at reducing the levels of HbA1c in the blood. In the first study, Bydureon reduced HbA1c levels by an average of 1.9% after 30 weeks of treatment, compared with an average reduction of 1.5% with exenatide given twice daily. In the second study, the average reduction was 1.6% after 24 weeks of treatment with Bydureon, compared with an average reduction of 0.9% with exenatide given twice daily. In the third study, Bydureon reduced HbA1c levels by an average of 1.4% after 26 weeks of treatment, compared with an average reduction of 0.8% or 1.1% with sitagliptin or pioglitazone respectively. In the fourth study, the average reduction with Bydureon was 1.5% after 26 weeks, compared with an average reduction of 1.3% with insulin glargine.

What is the risk associated?

The most common side effects seen with Bydureon were mainly problems affecting the stomach and gut (nausea (feeling sick), vomiting, diarrhoea and constipation). Nausea was the most common single side effect, which was mainly seen at the start of treatment and decreased over time. In addition, reactions at the site of injection (itching), low blood sugar levels (when used with a sulphonylurea) and headache occurred. Most side effects were mild to moderate in intensity. For the full list of all side effects reported with Bydureon, see the package leaflet.

Bydureon should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.

Bydureon Page

Why has it been approved?

The CHMP noted that the benefits of Bydureon, such as its effect on reducing the levels of HbA1c, compare well with those of comparator medicines and that its side effects are manageable. The CHMP therefore decided that Bydureon’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Bydureon to Eli Lilly Nederland B.V. on 17 June 2011. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Bydureon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2011. Bydureon Page

↑ back to table of contents ↑