Medsafe Logo


INFORMATION FOR CONSUMERS

Home  |  Consumers  |  Health Professionals  |  Regulatory  |  Other  |  Hot Topics  |  Search

Consumer Medicine Information

MabCampath®

Concentrated Solution for Infusion - alemtuzumab 30 mg/mL

What is in this leaflet

This leaflet answers some common questions about MabCampath.

This leaflet does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you receiving MabCampath against the benefits they expect it will have for you. Only your doctor is able to weigh up all the relevant facts and you should consult him/her about all aspects of this medicine as it relates to you.

MabCampath is a prescription medicine. It should only be used under medical supervision.

If you have any concerns about receiving this medicine, ask your doctor.

Keep this leaflet. You may need to read it again.

What MabCampath is used for

MabCampath is used for the treatment of patients with chronic lymphocytic leukaemia (CLL), a malignant disease of white blood cells, when other treatments have not been successful or have only been successful for a short period (less than 6 months).

MabCampath is a monoclonal antibody. Monoclonal antibodies are proteins which specifically recognise and bind to a unique other protein called an antigen. MabCampath binds to an antigen on the surface of certain white blood cells, called lymphocytes.

Patients with CLL have too many abnormal lymphocytes, which displace healthy cells in the bone marrow where most new blood cells are formed. This replacement of healthy cells also happens in the blood stream and other organs. After binding to the abnormal lymphocytes, MabCampath destroys them, and they are gradually removed from the body by normal biological processes.

Before you have MabCampath

When you must not have it

You must not be given MabCampath if:

When special care with MabCampath is needed

When you first receive MabCampath, you may experience side effects soon after the first infusions. These effects will gradually reduce as treatment is continued. If the effects are severe, then you may be given antihistamines and 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 causes potent and prolonged suppression of the immune system, which affects the ability of the body to fight infection for up to six months after treatment. Therefore, you will require antibiotics to prevent infection until your immune system has recovered.

If you have heart disease or chest pains and/or you are receiving treatment to reduce high blood pressure, your doctor will monitor you carefully as MabCampath may make these conditions worse.

MabCampath may also cause other side effects, most often blood disorders. For this reason, 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.

If you are over 65 years of age, you will be monitored very closely because you may be more intolerant to the medicine than other patients.

If you are a male or female of childbearing potential, then you should ensure that you use a reliable form of birth control during and for at least 6 months after treatment.
This is because MabCampath effects on reproduction are unknown.

The safety and efficacy of MabCampath has not been tested in children (below 17 years of age) or in patients who have kidney or liver disorders.

Pregnancy

MabCampath must not be administered to patients who are pregnant.
Therefore:

Breast-feeding

MabCampath must not be administered to patients who are 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.

If you have not told your doctor about any of the above, do so before you start taking MabCampath.

Taking other medicines

You should inform your doctor if you are taking or have recently taken any other medicines, whether provided on a prescription or bought from a pharmacy, supermarket or health food shop including any over-the-counter medicines, vitamins or herbal medicines.

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.

Other medicines may be affected by MabCampath or may affect how well MabCampath works. You may need to use different amounts of your medicine or a different medicine. Your doctor will be able to advise you.

How to use MabCampath

How MabCampath is prepared for administration

MabCampath is contained in solution in a glass vial. The vial contents are extracted and added to a sodium chloride or glucose solution contained in a drip bag. The lines from the drip bag are then connected directly into one of your veins.

How MabCampath is given

MabCampath is given in the form of a solution directly in to the blood stream through a vein. This is known as intravenous infusion. Each time you are given MabCampath, it will take about 2 hours for all the solution to enter your blood.

How much MabCampath is given

During the first week, 3 mg of MabCampath in the solution is given on Day 1, then 10 mg on Day 2 and then 30 mg on Day 3. MabCampath will continue to be given at 30 mg on each of 3 alternate days each week.

You may experience early side effects and then the initial smaller doses may be repeated until the effects go away or reduce. The idea is to increase amounts of MabCampath slowly to reduce the possibility of having side effects and allow your body to tolerate it better. The doctor will carefully monitor you and decide the appropriate amounts of MabCampath to give during your whole treatment period.

For how long is MabCampath given

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

If you are given too much (overdose)

The doctor will treat you as appropriate if you have any particular ill effects. In cases of overdose, it is advisable to contact the National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for recommendations on the management and treatment of overdosage.

Side effects

Like all medicines, MabCampath can have side effects. The side effects mentioned below are usually due to MabCampath because it affects the body's immune system in general and reduces resistance to infection. Some infections may be serious and sometimes fatal. Your doctor may give you other medicines or change your dosage to help to reduce any side effects.

If you are not sure what the side effects below are, ask your doctor to explain them to you.
Also, if you notice any effects not mentioned below, tell your doctor or your pharmacist.

Very common side effects due to MabCampath, which may happen early in your treatment, include:-

Usually, one or more of these effects happen during the first week after the start of treatment. They are usually only mild or moderate problems and they gradually diminish during the course of treatment.

Pneumonia can occur very commonly during treatment. Your doctor may give you additional antibiotic and/or antiviral treatment to reduce the risk of development of this and other infections.

Common side effects due to MabCampath include:

Heart and blood disorders: high blood pressure, fast heart rate, feeling your heart racing, blood vessel spasm, becoming red in the face, bruising of the skin.

Nervous system and special senses: taste changes, decreased sense of touch, dizziness, sensation of spinning, shaking or trembling movements, feeling restless, eye inflammation, pins and needles or burning sensation of skin.

Gastrointestinal and liver system: pain in the abdomen, bleeding of the stomach and intestine, swelling, irritation and/or ulceration of the mouth region, abnormal liver function, constipation, indigestion, passing abdominal gas.

Respiratory system: inflammation and/or tightness of the lungs, throat and/or sinuses, too little oxygen reaching the body organs, coughing, coughing up of blood.

General disorders: pain, redness or swelling at the site of injection, generally feeling unwell, weakness, pain in various parts of the body (muscle, back, chest, bones, joints), weight loss, dehydration, thirst, excess fluid in the body, low calcium or sodium levels, temperature change sensation, flu-like symptoms, abscess, skin rash, blistering of the skin, confusion, anxiety, depression, sleepiness, sleeplessness.

Common Infections include: pneumonias (bacterial), candidal (fungal), herpes and shingles (viral) and respiratory, urinary, gastro-intestinal and other general bacterial infections.

Uncommon side effects due to MabCampath may be more serious in nature and include:

One rare side effect is a special disorder (called tumour lysis syndrome) which may begin with flank pain and blood in the urine. Another rare side effect (called intracranial haemorrhage) may lead to bleeding in the brain.

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 platelet levels, have occurred with fatal outcome in rare cases.

Be careful driving or operating machinery until you know how MabCampath affects you.
No studies of the effects of MabCampath have been performed. You should ask for advice from your doctor.

Product description

Storage

MabCampath vials will be stored by your doctor, however the storage conditions are outlined below for your information.

MabCampath should be stored at 2 - 8°C (in a refrigerator). Do not freeze. Protect from light.

Reconstituted solution: MabCampath contains no antimicrobial preservative. MabCampath should be used immediately after dilution or within 8 hours after dilution. Solutions may be stored at 15 - 30°C or refrigerated. This can only be accepted if preparation of the solution takes place under strictly aseptic conditions and the solution is protected from light.

What it looks like

MabCampath is a concentrated solution in a glass vial. The total amount of the active substance, alemtuzumab, in each vial is 30 mg and is equivalent to 1 mL of a 30 mg/mL solution.

MabCampath is diluted for administration via intravenous drip.

Each pack of MabCampath contains 3 vials.

Ingredients

Active ingredients

Inactive ingredients

Manufacturer

MabCampath is made in Germany.

Supplier

MabCampath is distributed in New Zealand by:

Bayer New Zealand Limited
3 Argus Place
Hillcrest
North Shore
AUCKLAND 0627

This leaflet was prepared on 7 November 2007.

Reference: MabCampath Data Sheet dated 5 November 2007.

® = Registered Trademark