MabCampath 30 mg/ml concentrate for solution for infusion
Alemtuzumab
Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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.
In this leaflet:
- 1. What MabCampath is and what it is used for
- 2. Before you are given MabCampath
- 3. How MabCampath is used
- 4. Possible side effects
- 5. How to store MabCampath
- 6. Further information
What Mabcampath Is And What It Is Used For
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.
Before You Are Given Mabcampath
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 to 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 and/or 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.
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 of childbearing potential, then you should avoid becoming pregnant by using 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 Mabcampath Is Used
MabCampath goes 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 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.
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 dosage to help to 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, autoimmune phenomena, low red blood cell and low blood platelet levels, infections, bleeding in the brain (intracranial haemorrhage) have occurred with fatal outcome. 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, shivering/chills, sweating, nausea (feeling sick), vomiting, low blood pressure, low white/red blood cell levels, infections including pneumonia and blood poisoning, irritation and/or 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):
- high blood pressure, fast or slow heart rate, feeling your heart racing, blood vessel spasm
- becoming red in the face, bruising of the skin
- taste changes
- decreased sense of touch
- dizziness, sensation of spinning, fainting, shaking or trembling movements, feeling restless
- eye inflammation (e.g. conjunctivitis)
- pins and needles or burning sensation of the skin
- abnormal liver function, constipation, indigestion, passing abdominal gas
- inflammation, irritation and/or tightness of the lungs, throat and/or sinuses, too little oxygen reaching the body organs, coughing, coughing up of blood
- abdominal bleeding (e.g. in the stomach and intestine)
- injection site reactions including redness, swelling, pain, bruising, inflammation
- generally feeling unwell, weakness, pain in various parts of the body (muscle, back, chest, bones, joints, stomach and intestine)
- weight loss, dehydration, thirst, swelling of the lower legs, temperature change sensation, low calcium or sodium blood levels
- flu-like symptoms
- abscess, skin redness or allergic skin reaction, blistering of the skin
- confusion, anxiety, depression, sleeplessness
Uncommon side effects (affects 1 to 10 in every patients in 1,000 patients treated in clinical trials):
- bone marrow disorders
- heart disorders (heart stopping, heart attack, heart congestion, irregular heart rate)
- blood disorders (abnormal clotting, decreased protein, low potassium levels)
- high blood sugar, worsening diabetes
- bleeding and inflammation of the gums, blisters on the tongue, nosebleeds
- fluid in the lungs, difficulty breathing, harsh sound when breathing, runny nose, abnormal findings in the lungs, lymph gland disorders
- nervousness, abnormal thinking
- swelling around the eye
- ringing sound in the ears, deafness
- hiccups, burping
- hoarseness
- abnormal kidney function
- paralysis of the small bowel
- impotence
- unsteadiness, increased muscle tone
- unusual increased or altered sensitivity to touch’
- abnormal sensation/feeling or movement
- 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 To Store Mabcampath
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 vial label.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original packaging in order to protect from light.
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.
Further Information
What MabCampath contains
The active substance is alemtuzumab.
One ml contains 30 mg of alemtuzumab. Each vial contains 30 mg of alemtuzumab.
The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate and water for injections.
What MabCampath looks like and contents of the pack
MabCampath is a concentrate for solution for infusion that comes in a glass vial.
Each pack of MabCampath contains 3 vials.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom/Ireland
This leaflet was last approved in 11/2009
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
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