RoActemra 20 mg/ml concentrate for solution for infusionPati - United Kingdom[英国药品]

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RoActemra 20 mg/ml concentrate for solution for infusionPati

2014-06-08 23:37:59 来源: 作者: 【大中小】浏览:336次评论:0条

For doctors

What is it and how is it used?

RoActemra contains the active substance tocilizumab, a monoclonal antibody that blocks the action of a specific protein (cytokine) called interleukin-6. This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.

RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough. RoActemra helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks. RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.

RoActemra is usually given in combination with methotrexate. However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.

What do you have to consider before using it?

Do not use RoActemra

Take special care with RoActemra

infections and may make an existing infection worse or increase the chance of getting a new infection.

Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.

RoActemra is not recommended for use in children or adolescents under 18 years of age.

Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. RoActemra can affect the way some medicines work, and the dose of these may require adjustment. You should tell your doctor if you are using medicines containing any of the following active substances:

Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA.

Pregnancy and breast-feeding
Talk to your doctor if you are pregnant, may be pregnant, intend to become pregnant or if you are breast-feeding. Women of childbearing potential must use effective contraception during and up to 3 months after treatment. RoActemra should not be used during pregnancy unless clearly necessary.

It is not known whether RoActemra is excreted in breast milk. If you are a nursing mother, you should stop breast-feeding if you are to be given RoActemra. Before starting breast-feeding, your last treatment with RoActemra should be at least 3 months ago.

Driving and using machines
There are no studies on the effects of RoActemra on the ability to drive and use machines. However, if you experience dizziness, a common side effect, then you should not drive or use machines.

Important information about some of the ingredients of RoActemra
This medicinal product contains 26.55 mg sodium per maximum dose of 1200 mg (8.85 mg sodium per 400 mg vial). To be taken into consideration by patients on a controlled sodium diet. Doses below 1025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium free’.

How is it used?

The usual dose of RoActemra is 8 mg per kg of body weight. Depending on your response, your doctor may decrease your dose to 4 mg/kg then increase back to 8 mg/kg when appropriate.

You will receive RoActemra once every 4 weeks through a drip in your vein (intravenous infusion) over one hour.

After dilution, RoActemra will be given to you by a doctor or nurse, who will also monitor you during and after administration.

If you use more RoActemra than you should
Since RoActemra is given by a doctor or nurse, it is unlikely that you will be given too much. However, if you are worried, talk to your doctor.

If you forget to use RoActemra
Since RoActemra is given by a doctor or nurse, it is unlikely that you will miss a dose. However, if you are worried, talk to your doctor.

If you stop using RoActemra
You should not stop using RoActemra without discussing with your doctor first.

If you have any further questions on the use of RoActemra, then please ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, RoActemra can cause side effects, although not everybody gets them. Side effects could occur at least up to 3 months after your last dose of RoActemra.

The most common side effects of RoActemra are upper respiratory tract infections, with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache.

Possible serious side effects include serious infections and allergic (hypersensitivity) reactions, that may, in a small number of cases, be life-threatening.
If you notice any of the following signs of:

allergic reactions during or after infusion, tell your doctor immediately:

infections, tell your doctor as soon as possible:

The symptoms described above can be signs of the side effects listed below, all of which have been observed with RoActemra in clinical studies.

Side effects may occur with certain frequencies, which are defined as follows:

Very common side effects:upper respiratory tract infections like coughs and colds, and high cholesterol levels.

Common side effects:lung infection (pneumonia),cold sores (oral herpes simplex), blisters, shingles (herpes zoster), skin infection sometimes with fever and chills, low white blood cell counts shown by blood tests (neutropenia, leucopenia), headache, dizziness, high blood pressure,mouth ulceration, stomach pain, abnormal liver function tests (increased transaminases), increased bilirubin shown by blood tests, rash and itching, hives, fluid retention (oedema) in the lower legs, cough, shortness of breath, weight increase, eye infection (conjunctivitis) and allergic (hypersensitivity) reactions

Uncommon side effects:diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain), red swollen (inflamed) areas in the mouth, high blood fat (triglycerides), stomach ulcer, kidney stones and underactive thyroid.

Very rare side effects: low blood measurements for white blood cells, red blood cells and platelet count.

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 vial in the outer carton in order to protect from light.

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For doctors

What is it?

RoActemra is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance tocilizumab.

What is it used for?

RoActemra is used to treat adults (aged 18 years or over) with moderate to severe active rheumatoid arthritis (an immune system disease causing inflammation of the joints). It is used in combination with methotrexate (another medicine used in rheumatoid arthritis) in patients who have not responded adequately to or who could not tolerate other treatments, including conventional medicines for rheumatoid arthritis (such as methotrexate) or tumour necrosis factor (TNF) blockers. RoActemra can be used on its own in patients who cannot take methotrexate.

When used with methotrexate, RoActemra can slow down the damage to the joints and improve physical function (the ability to perform everyday tasks).

The medicine can only be obtained with a prescription.

How is it used?

Treatment with RoActemra should be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.

RoActemra is given once every four weeks as an infusion lasting an hour. The recommended dose is 8 mg per kilogram body weight, but doses above 800 mg per infusion are not recommended. Doses above 1,200 mg have not been tested. The dose of RoActemra or methotrexate may need to be adjusted or treatment interrupted in patients who develop liver or blood problems. Doctors should monitor the kidneys carefully in patients with moderate or severe kidney problems.

Patients who receive RoActemra should be given the special alert card that summarises the safety information about the medicine.

How does it work?

The active substance in RoActemra, tocilizumab, 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) that is found in the body. Tocilizumab has been designed to attach to the receptor for a messenger molecule or ‘cytokine’ in the body called interleukin-6. This messenger is involved in causing inflammation and is found at high levels in patients with rheumatoid arthritis. By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of rheumatoid arthritis.

How has it been studied?

RoActemra has been studied in five main studies involving a total of over 4,000 adults with moderate to severe rheumatoid arthritis.

Four of the studies compared RoActemra with placebo (a dummy treatment). In three of these, the medicines were given as an add-on to failing treatment with methotrexate or other conventional rheumatoid arthritis medicines in a total of over 3,000 patients. In the fourth study, the medicines were given in combination with methotrexate in 498 patients who had an inadequate response to previous treatment with TNF blockers. The fifth study compared RoActemra given on its own with methotrexate in a total of 673 patients.

In all five studies, the main measure of effectiveness was the number of patients who had responded to treatment after six months. A response was defined as a reduction in symptom scores of 20% or more as measured using a standard scale for rheumatoid arthritis. One of the studies, which involved 1,196 patients, also looked at the effect of the combination of RoActemra and methotrexate on joint damage and physical function after one and two years of treatment.

Almost 4,000 patients from these studies went on to enter studies looking at the long-term effects of RoActemra treatment.

What benefits has it shown during the studies?

RoActemra was more effective than the comparator medicines at reducing the symptoms of rheumatoid arthritis.

In the studies of patients with an inadequate response to conventional treatments, patients adding RoActemra were around four times more likely to respond to treatment than those adding placebo. In the patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around nine times more likely to respond than those receiving placebo. The fifth study showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own.

The combination of RoActemra and methotrexate also slowed down the damage to the joints and improved physical function after up to two years, when compared with the combination of placebo and methotrexate.

The long-term studies showed that the response to RoActemra is maintained for at least two years.

What is the risk associated?

The most common side effect with RoActemra (seen in more than 1 patient in 10) is upper respiratory tract infections (colds). For the full list of all side effects reported with RoActemra, see the Package Leaflet.

RoActemra should not be used in people who may be hypersensitive (allergic) to tocilizumab or any of the other ingredients. It must not be used in patients who have an active, severe infection. Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis (a disease affecting the gut) or diabetes.

Why has it been approved?

The CHMP decided that RoActemra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?

The company that makes RoActemra will supply packs containing information for doctors, nurses and patients prior to the medicine’s launch in each Member State. These packs will include information on RoActemra’s safety and on how it should be given to patients.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for RoActemra to Roche Registration Limited on 16 January 2009. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with RoActemra, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2010.

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Name

RoActemra 20 mg/ml concentrate for solution for infusion

Composition

Each ml concentrate contains 20 mg tocilizumab*.

Each vial contains 80 mg of tocilizumab* in 4 ml (20 mg/ml).
Each vial contains 200 mg of tocilizumab* in 10 ml (20 mg/ml).
Each vial contains 400 mg of tocilizumab* in 20 ml (20 mg/ml).

*humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

Excipients:
Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.

For a full list of excipients, see section 6.1.