MabCampath 10 mg/ml concentrate for solution for infusion Al - United Kingdom[英国药品]

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MabCampath 10 mg/ml concentrate for solution for infusion Al

2013-10-30 00:35:10 来源: 作者: 【大中小】浏览:468次评论:0条

For doctors

What is it and how is it used?

MabCampath is used to treat patients with chronic lymphocytic leukaemia (CLL), a cancer of the lymphocytes (a type of white blood cell). It is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.

The active substance in MabCampath, alemtuzumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body. In CLL, too many lymphocytes are produced. Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with sugar molecules) that is found on the surface of lymphocytes. As a result of this binding, the lymphocytes die, and this helps to control the CLL.

What do you have to consider before using it?

Do not use MabCampath if you:

are allergic to alemtuzumab or to proteins of a similar origin or to any of the other ingredients of MabCampath see section 6 Further Information. Your doctor will inform you accordingly have an infection have HIV have an active second malignancy are pregnant see also Pregnancy.

Take special care with MabCampath:

When you first receive MabCampath, you may experience side effects soon after the first infusions (see section 4 “Possible side effects”). These effects will gradually reduce as treatment is continued.

You may also be given

steroids, antihistamines or analgesics treatment for fever to help reduce some of the side effects.

The dosage of MabCampath will not be increased until the effects are reduced.

MabCampath treatment may reduce your natural resistance to infections

antibiotics and antivirals may be given to provide you with extra protection.

You will be examined for symptoms of a certain type of viral infection called CMV (cytomegalovirus) during your MabCampath therapy and for at least 2 months afterwards.

Your doctor will monitor you carefully if you

have heart disease or chest pains andor you are receiving treatment to reduce high blood pressure, as MabCampath may make these conditions worse. Patients with these conditions may be at higher risk of a heart attack.

have been treated in the past with chemotherapies or general medications that have a high risk of causing heart damage, your doctor may wish to monitor your cardiac function ECG, heart rate, body weight while receiving MabCampath.

have other side effects, most often blood disorders from taking MabCampath. Your doctor will be monitoring the effects of treatment and your progress carefully by examining you and by taking blood samples for analysis on a regular basis.

are over 65 years of age as you may be more intolerant to the medicine than other patients.

You may experience an allergic or hypersensitivity reaction to MabCampath solution, especially against the protein contained in it, while the infusion is given to you. Your doctor will treat you for this, if this happens.

Because of the potential for a fatal reaction to transfusion of any blood products following treatment with MabCampath, it is recommended that you speak to your doctor regarding the irradiation of blood products prior to receiving the transfusion. You should inform your doctor if you experience any unusual symptoms after a transfusion.

MabCampath is not recommended in children below 17 years of age or in patients who have kidney or liver disorders.

Taking other medicines

You should inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.

In particular, you should not be given MabCampath within 3 weeks of taking any other anti-cancer agents.

Also, you should not be vaccinated with live viral vaccines during treatment and for at least 12 months after you have finished your treatment. Speak to your doctor before receiving any vaccinations.

Pregnancy

MabCampath must not be administered to patients who are pregnant, therefore if you:

are pregnant or you think you may be pregnant, you should tell your doctor immediately. are a woman of childbearing potential or a fertile man, then you should use effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.

Breast-feeding

You should stop breast-feeding when you start your treatment and you should not begin breast-feeding again until at least 4 weeks after you have finished your treatment and you have consulted your doctor on the matter.

Driving or using machines

No studies of the effects of MabCampath on the ability to drive and use machines have been performed. However you should be cautious as confusion and sleepiness have been seen. You should ask your doctor for advice.

How is it used?

MabCampath is administered into one of your veins via a drip (see also ‘information intended for medical or healthcare professionals’).

Each time you are given MabCampath, it will take about 2 hours for all the solution to enter your blood.

MabCampath treatment may continue for up to 12 weeks depending on your progress.

During the first week, your doctor will increase the dose of MabCampath slowly to reduce the possibility of you having side effects and to allow your body to tolerate MabCampath better.

If you experience early side effects the initial smaller doses may be repeated until the effects go away or reduce. The doctor will carefully monitor you and decide what are the appropriate amounts of MabCampath to give you during your whole treatment period.

If more MabCampath is given than recommended

Your doctor will treat you, as appropriate, if you have any side effects.

What are possible side effects?

Like all medicines, MabCampath can cause side effects, although not everybody gets them.

Your doctor may give you other medicines or change your dose to help reduce any side effects (see section 2 “ Take Special care ”).

Serious side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, low red blood cell and low blood platelet levels, infections, bleeding in the brain (intracranial haemorrhage) have occurred with fatal outcome. Diseases related to an overactive immune system where your immune system attacks your own body can lead to low red blood cells, low blood platelets and/or low white blood cells, and nerve disorders, and these can also be fatal. Tell your doctor immediately if you experience any of these side effects.

In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.

Very common side effects (seen in at least 1 in every 10 patients treated in clinical trials):

Usually one or more of these effects happen during the first week after the start of treatment:

fever, shiveringchills, sweating, nausea feeling sick, vomiting, low blood pressure, low whitered blood cell levels, infections including pneumonia and blood poisoning, irritation andor blistering of the mouth region, low blood platelet levels, tiredness, rash, itching, red raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.

They are usually only mild or moderate problems and they gradually diminish during the course of treatment.

Common side effects (affects 1 to 10 patients in every 100 patients treated in clinical trials):

Uncommon side effects (affects 1 to 10 patients in every 1,000 patients treated in clinical trials):

pain when urinating, decreases in urine flow, increased frequency in urination, blood in urine, incontinence tumour lysis syndrome a metabolic disorder, which may begin with pains in the side and blood in the urine

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 your pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the ampoule label. The expiry date refers to the last day of that month.

Store in a refrigerator (2-C-8-C).

Do not freeze.

Store in the original packaging in order to protect from light.

MabCampath should be used within 8 hours after dilution. During that time the solution may be stored at 15°C-30°C or refrigerated.

Do not use MabCampath if you notice any signs of particulate matter or discolouration prior to administration.

Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will dispose of medicines no longer required. These measures will help protect the environment.

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For doctors

What is it?

MabCampath is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance alemtuzumab (10 mg/ml or 30 mg/ml).

What is it used for?

MabCampath is used to treat patients with B-cell chronic lymphocytic leukaemia (B-CLL), a cancer of a type of white blood cell called B lymphocytes. MabCampath is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.

The medicine can only be obtained with a prescription.

How is it used?

MabCampath treatment should be supervised by a doctor experienced in the use of cancer treatments. Patients should be given steroids, an antihistamine and a painkiller before the first dose and before any increase in dose. They should also receive antibiotics and antiviral medicines during and after treatment.

MabCampath is given as an infusion lasting about two hours. During the first week of treatment, MabCampath should be given in increasing doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3, as long as each dose is well tolerated. This is called ‘dose escalation’. After this, the recommended dose is 30 mg three times a week (every other day) for a maximum of 12 weeks.

Patients should be monitored during treatment to see how they respond, but also to check their blood levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that fights infection): if these are too low the treatment should be interrupted or stopped. See the summary of product characteristics (also part of the EPAR) for full details.

How does it work?

The active substance in MabCampath, alemtuzumab, 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 certain cells in the body. In CLL, too many lymphocytes are produced. Alemtuzumab has been designed to attach to a glycoprotein (a protein that is coated with sugar molecules) called CD52 that is found on the surface of lymphocytes. As a result, the lymphocytes die, and this helps to control the CLL.

How has it been studied?

MabCampath has been looked at in four main studies involving a total of 446 patients with CLL. One study included 297 patients who had not received treatment before. It compared a 12-week course of MabCampath with a year-long course of chlorambucil (another anticancer medicine). The main measure of effectiveness was how long it took until the disease got worse or the patient died.

The other three studies looked at a total of 149 patients who had already received other treatments. In these studies, MabCampath was not compared with any other treatment. One of these studies included 93 patients in whom previous treatment with fludarabine had stopped working. The main measure of effectiveness was the overall response to treatment.

What benefits has it shown during the studies?

In patients who had not received treatment before, MabCampath was more effective than chlorambucil. In the patients receiving MabCampath, it took an average of 14.6 months for the disease to get worse or for the patient to die, compared with 11.7 months in those taking chlorambucil.

In the study of patients who had been treated with fludarabine before, 33% responded partially or completely to treatment with MabCampath. Similar results were seen in the other two studies of previously treated patients.

What is the risk associated?

The most frequent side effects with MabCampath are: infusion reactions (fever, chills, low blood pressure, itching, feeling sick, hives, increased heart rate, breathlessness), low counts of blood cells (white blood cells, platelets and red blood cells), infections (signs of cytomegalovirus in the blood, cytomegalovirus infection or other infections), gastrointestinal symptoms (feeling sick, vomiting, abdominal pain) and neurological symptoms (insomnia, anxiety). The most frequent serious adverse reactions are low counts of blood cells, infusion reactions, and infections or immunosuppression (reduced activity of the immune system). For the full list of all side effects reported with MabCampath, see the package leaflet.

MabCampath should not be used in people who may be hypersensitive (allergic) to alemtuzumab, mouse proteins, or any of the other ingredients. MabCampath must not be used in patients:

with HIV infection

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who have an active, second cancer

who are pregnant.

Why has it been approved?

The CHMP noted that the effectiveness of MabCampath had been demonstrated, but that there is no information from studies directly comparing MabCampath with treatment combinations including fludarabine, which are widely used to treat patients with CLL. Therefore, the Committee concluded that MabCampath’s benefits are greater than its risks for the treatment of patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate. The Committee recommended that MabCampath be given marketing authorisation.

MabCampath was originally authorised under ‘exceptional circumstances’, because, for scientific reasons, it had not been possible to obtain complete information on the medicine. As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 04 July 2008.

How has it been studied?

The company that makes MabCampath will provide a brochure containing information on the medicine’s safety to all doctors in all Member States who prescribe the medicine.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for MabCampath on 6 July 2001. The marketing authorisation is valid for an unlimited period. The marketing authorisation holder is Genzyme Europa BV. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with MabCampath, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011.

MabCampath Page

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Name

MabCampath 10 mg/ml concentrate for solution for infusion

Composition

One ml contains 10 mg of alemtuzumab.
Each ampoule contains 30 mg of alemtuzumab.

Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52). The antibody is produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.

For a full list of excipients, see section 6.1.