MabCampath
alemtuzumab
Alemtuzumab
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.
What MabCampath is and what it is used for
Before you use MabCampath
How to use MabCampath
Possible side effects
How to store MabCampath
Further information
Medicinal product no longer authorised
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.
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”).
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.
The dosage of MabCampath will not be increased until the effects are reduced. MabCampath treatment may reduce your natural resistance to infections
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.
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.
Medicinal product no longer authorised
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.
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.
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.
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.
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.
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.
Medicinal product no longer authorised
MabCampath treatment may continue for up to 12 weeks depending on your progress.
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.
Your doctor will treat you, as appropriate, if you have any side effects.
Like all medicines, MabCampath can cause side effects, although not everybody gets them.
In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.
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.
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
Medicinal product no longer authorised
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
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.
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 (2C-8C). 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.
Medicinal product no longer authorised
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.
The active substance is alemtuzumab.
One ml contains 10 mg of alemtuzumab. Each ampoule 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.
MabCampath is a concentrate for solution for infusion that comes in a glass ampoule. Each pack of MabCampath contains 3 ampoules.
Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Genzyme Srl (Italia/Italja), Tel: +39 059 349 811
Джензайм ЕООД Тел. +359 2 971 1001
Genzyme Europe B.V. Képviselet Tel: +36 1 310 7440
Genzyme Czech s.r.o. Tel: +420 221 722 511
Genzyme Europe B.V., Tel: +31 35 699 1200
Genzyme A/S, (Danmark/Tanska/Danmörk), Tlf/Puh./Sími: + 45 32712600
Genzyme Austria GmbH, Tel: + 43 1 774 65 38
Medicinal product no longer authorised
Tel: + 48 22 246 0900
Genzyme Hellas Ltd. (Ελλάδα)
Τηλ: +30 210 99 49 270
Genzyme Portugal S.A. Tel: +351 21 422 0100
sanofi-aventis, S.A. Tel: +34 93 485 94 00
Genzyme Biopharma SRL Tel: +40 212 43 42 28
Genzyme S.A.S,
Tél: + 33 (0) 825 825 863
Tel: +44 1865 405200
During the first week, 3 mg of MabCampath is given on Day 1, then 10 mg on Day 2 and then 30 mg on Day 3, depending on tolerability. MabCampath will be given at 30 mg three times per calendar week on alternate days, for up to 12 weeks.
The ampoule contents should be inspected for particulate matter and discolouration prior to administration. If particulate matter is present or the solution is coloured, then the ampoule should not be used.
MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light. The required amount of the ampoule contents should be added, via a sterile, low-protein binding, non-fibre 5 μm filter, to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion. The bag should be inverted gently to mix the solution. Care should be taken to ensure the sterility of the prepared solution particularly as it contains no antimicrobial preservatives.
Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused though the same intravenous line.
Caution should be exercised in the handling and preparation of the MabCampath solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the ampoule or other accidental spillage. Women who are pregnant or trying to become pregnant should not handle MabCampath.
Medicinal product no longer authorised
Procedures for proper handling and disposal should be observed. Any spillage or waste material should be disposed of by incineration.