MabCampath - patient leaflet, side effects, dosage

MabCampath 10 mg/ml concentrate for solution for infusion

Read all of this leaflet carefully before you start using 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.

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

WHAT MABCAMPATH IS AND WHAT IT IS USED

MabCampath is used to treat patients with chronic lymphoc aemia (CLL), a cancer of the lymphocytes (a type of white blood cell). It is used in patienwhom 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 helpntrol the CLL.

are allergic t tuzumab 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

e HIV

e an active second malignancy

pregnant (see also “Pregnancy”).

ake 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 (cytomegalovir 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 fr Your doctor will be monitoring the effects of treatme 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.

edicines

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 b performed. However you should be cautious as confusion and sleepiness have been seen ask your doctor for advice.

3. HOW TO USE MABCAMPATH

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

Each time you are given MabCampath, it will take about 2 hou blood.

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

During the first week , your doctor will increase th 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

4. POSSI

s, MabCampath can cause side effects, although not everybody gets them.

r doctor may give you other medicines or change your dose to help reduce any side effects section 2 “

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.

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

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.

5. 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 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 parti administration.

Medicines should not be disposed of via wastew will dispose of medicines no longer required. These measures will help protect the environment.

• 6. FURTHER INFORMATION

What MabCampath contains

The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate and water for injections.

ath looks like and contents of the pack

MabCampath is a concentrate for solution for infusion that comes in a glass ampoule.

Each pack of MabCampath contains 3 ampoules.

Marketing Authorisation Holder

Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands

Manufacturer

Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom

Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

België/Belgique/Belgien/

Genzyme Belgium N.V.,

Tél/Tel: + 32 2 714 17 11

Magyarorszag

Genzyme Europe B.V. Képviselet

Tel: +36 1 310 7440

Česká Republika/Slovenská Republika/

Genzyme Czech s.r.o.

Tel: +420 221 722 511

Nederland

Genzyme Europe B.V., Tel: +31 35 699 1200

Danmark/Norge/Sverige/Suomi/Finland/ Ísland

Genzyme A/S, (Danmark/Tanska/Dan­mörk),

Tlf/Puh./Sími: + 45 32712600

Deutschland

Genzyme GmbH, Tel: +49 610236740

vija/Lietuva

Sp. z o.o. lija/Lenkija), 22 246 0900

EÀÀàôa/Kùnpoç

Genzyme Hellas Ltd. (EXXáSa)

Tql: +30 210 99 49 270

España

sanofi-aventis, S.A.

Tel: +34 93 485 94 00

Portugal

Genzyme Portugal S.A.

Tel: +351 21 422 0100

Romania

Genzyme Biopharma SRL

Tel: +40 212 43 42 28

United Kingdom/Ireland

Genzyme Therapeutics Ltd. (United

Kingdom),

Tel: +44 1865 405200

The following information is intended for medical or healthcare professionals only:

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 MabCampa should be prepared for intravenous infusion using aseptic techniques and that the diluted solution 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 bindin 5 gm filter, to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucosi 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 latex gloves and safety glasses is recommended to avoid exposure i or other accidental spillage. Women who are pregnant or trying to MabCampath.

Procedures for proper handling and disposal should be obs should be disposed of by incineration.