What is in this leaflet

This leaflet answers some common questions about MabCampath.
It does not contain all the available information. It does not take the place of talking to your Doctor or Pharmacist.
All medicines have risks and benefits. Your Doctor has weighed the risks of you using MabCampath against the benefits they expect it will have for you.
Keep this leaflet with the medicine.
You may need to read it again. 

What MabCampath is used for

This medicine is an anti-cancer drug used to treat a form of leukaemia known as B cell chronic lymphocytic leukaemia (B-CLL). This is a cancer of the type of white blood cells called lymphocytes.
Patients with B-CLL have too many abnormal lymphocytes, which displace healthy cells in the bone marrow (where most new blood cells are formed) in addition to the blood stream and other organs. Without enough healthy blood cells, infections, anaemia, bruising, excessive bleeding or even organ failure can result.

How it works

MabCampath is a monoclonal antibody that specifically recognises and binds to a unique protein located on the surface of abnormal lymphocytes.
After binding, MabCampath destroys the abnormal lymphocytes, which are then gradually removed from the body by normal biological processes.
Ask your Doctor if you have any questions about why MabCampath has been prescribed for you.
Your doctor may have prescribed it for another reason.
There is not enough information to recommend the use of this medicine for children.
There is not enough information to recommend the use of this medicine in patients who have kidney or liver disorders.

Before you are given MabCampath

When you must not be given it

Do not use MabCampath if you have an allergy to:
any medicine containing alemtuzumab or murine proteins
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not have treatment with MabCampath if you have any of the following medical conditions:
an active infection which is spread around the body
HIV
an active secondary cancer
Do not have treatment with MabCampath if you are pregnant.
It may affect your developing baby if you have it during pregnancy.
Do not breast-feed if you are taking this medicine. Do not begin breast-feeding again until at least 4 weeks after you have finished your treatment and after you have consulted your doctor.
It is possible that your baby may be affected if you breast-feed.
If you are not sure whether you should start using this medicine, talk to your Doctor.

Before you are given it

Tell your doctor or pharmacist if you have allergies to any other medicines, or substances such as foods, preservatives or dyes.
Tell your Doctor if you have or have had heart disease, chest pains and/or are receiving treatment to reduce high blood pressure, as MabCampath may make these conditions worse, your doctor will need to monitor you carefully.
Tell your doctor if you have been treated in the past with chemotherapies or general medications that may have a high risk of causing heart damage.
Your doctor may wish to monitor your heart function whilst receiving this medicine.
If you have not told your doctor about any of the above, tell him/her before you are given MabCampath.

Taking other medicines

Tell your Doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and MabCampath may interfere with each other. These include:
Anti-cancer agents. It is recommended that MabCampath is not given within 3 weeks of other chemotherapeutic agents.
Live viral vaccines. It is recommended that patients do not receive live viral vaccines at least 12 months following MabCampath therapy.
There medicines may be affected by MabCampath or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Speak to your doctor before receiving any vaccinations.
Your doctor may have more information on medicines to be careful with or avoid while taking this medicine.

How MabCampath is given

MabCampath is given under the supervision of a specialist doctor experienced in the treatment of your disease.
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 is given and when?

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 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 what are the appropriate amounts of MabCampath to give during your treatment period.

How long is it given?

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

If you receive too much (overdose)

The doctor will treat you as appropriate if you have any ill effects from having been given too much of MabCampath.
In cases of overdose, it is advisable to contact the Poisons Information Centre (Australia: 13 11 26; New Zealand: 0800 POISON or 0800 764 766) for recommendations on the management of overdose.
Symptoms of an overdose may include a severe fever, tiredness, headaches, being short of breath when exercising, dizziness and looking pale.

While you are undergoing treatment with MabCampath

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking MabCampath.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you are a fertile male or female of childbearing potential, ensure that you use reliable form of birth control during treatment and for at least 6 months after treatment. If you do become pregnant while taking this medicine, tell your doctor immediately.
The effects of this medicine on reproduction are unknown.
If you are about to have any blood tests, tell all your doctors that you are being treated with this medicine.
If may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Some side effects (for example, blood disorders) can only be found when your doctor does tests on a regular basis.
If you have pre-existing medical conditions (such as 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.
Take all medications as prescribed by your doctor.
MabCampath causes suppression of the immune system, which affects the natural ability of the body to fight infection for up to six months after treatment. Therefore, you may require antibiotics and antivirals to provide you with extra protection until your immune system has recovered.
Your doctor may also prescribe other additional medication to help alleviate possible side effects.

Things to be careful of

Be careful driving or operating machinery until you know how MabCampath affects you.
Confusion and sleepiness have been reported with this medicine.

Side effects

Tell your Doctor as soon as possible if you do not feel well while you are undergoing treatment with MabCampath.
This medicine helps most people with B cell chronic lymphocytic leukaemia (B-CLL), but is may have unwanted side effects. All medicines can have side effects. Sometimes we are serious, most of the time they are not.
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 reduce any side effects. You may need medical attention if you get some of the side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your Doctor or Pharmacist to answer any questions you may have.
Tell your doctor if you notice any of them and they worry you:
discharge with itching of the eyes and crusty eyelids
bleeding or bruising more easily than normal
tiredness, headaches, being short of breath when exercising, dizziness and looking pale
Weight loss, loss of appetite
anxiety, confusion, depression, drowsiness, trouble sleeping, unusually overactive
fainting, dizziness
tremor, pins and needles, decreased feeing or sensitivity, headache, taste loss
bluish discoloration of skin, flushing
abnormal heart beat (fast or slow)
difficulty in breathing, pressure, chest tightness, coughing,
nausea, vomiting, stomach pain, diarrhoea, indigestion, constipation, wind
rash (itchy or not), excessive sweating, redness of the skin
aching muscles, muscle tenderness or weakness (not caused by exercise), back pain, joint pain, chest pain
fever, chills, tiredness, unusual weakness
feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes with a throbbing ache, fever, stuffy nose and loss of the sense of smell
sore throat and discomfort when swallowing
symptoms of low calcium levels in the blood which includes muscle spasm or twitching, numbness or tingling in fingers and toes
depression, irritability, confusion, disorientation
dehydration or excessive thirst
blisters and/or ulcers in the mouth or genitalia
symptoms of pneumonia such as fever, chills, shortness of breath, cough and phlegm that may be blood stained
flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
burning or pain upon urination, increased frequency to urinate
sore, creamy-yellow, raised patches in the mouth
itching, burning and a thick, white, "cottage cheese" discharge
unexplained weight gain, feeling cold, worsening tiredness, new constipation
weight loss, excessive sweating, intolerance to heat, increased bowel movements.
The above list includes the more common side effects of your medicine. They are often mild or moderate problems that are short-lived and diminish during the course of treatment.
However, if you believe the side effect is of a more severe nature, tell your doctor as soon as possible.
Tell your doctor immediately if you notice any of the following:
vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
unusually swollen glands in the neck, armpit or groin
loss of hearing
loss of control of your bladder or bowels
The above list includes serious side effects that may require medical attention.
Serious side effects are usually uncommon or rare.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
signs of heart attack such as central crushing chest pain, aching sensation in your chest or arms that may spread to your neck, jaw or back, pain in left arm, increased sweating
signs of a stroke such as drooping of the skin on your face or sudden weakness or numbness on one side of the body or sudden difficulty with speech or your vision
signs of tumour lysis syndrome such as pain in one side of the body under the rib cage, little or no urine, drowsiness, nausea, vomiting, breathlessness, irregular heart beat, loss of memory, loss of consciousness
Signs of haemophagocytic lymphohistiocytosis (excessive activation of white blood cells) such as fever, swollen glands, bruising, or skin rash. Haemophagocytic lymphohistiocytosis can be fatal if not diagnosed and treated early
Signs of glomerulonephritis such as pink or cola-colored urine, or foam in the urine, or noticeable swelling face, hands, feet and abdomen.
signs of Guillain-Barre syndrome, which is a temporary inflammation of the nerves, causing pain, weakness, and paralysis in the extremities and often progressing up to the chest and face
abnormally fast or irregular heart beat
extreme difficulty breathing, shortness of breath, sharp chest pains which are worse when breathing in, frequent fainting
severe bleeding or bruising more than usual (e.g. persistent nose bleeds)
signs of intracranial haemorrhage such as severe headache, nausea and vomiting, alertness changes, problems with speech, balance, coordination or focusing the eyes
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are usually uncommon or rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Keep all doctors appointments so your progress can be checked.
Some side effects (for example, blood disorders) can only be found when your doctor does tests on a regular basis.

After using MabCampath

Storage

MabCampath will be stored by your doctor. Storage conditions are outlined below for your information.
MabCampath vials: Store at 2-8°C (in a refrigerator). Do not freeze. Protect from light.
MabCampath reconstituted solution:
Should be used immediately after dilution or within 8 hours after dilution. Solutions may be stored at 15-300C 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.
MabCampath contains no antimicrobial preservative.

Product description

What it looks like

MabCampath is diluted for administration via intravenous drip.
Each pack of MabCampath contains three 2 mL clear glass vials. Each vial contains 1 mL colourless to slightly yellow concentrate.

Ingredients

Each MabCampath vial contains
30 mg of alemtuzumab as the active ingredient which is equivalent to 1 mL of a 30 mg/mL solution.
It also contains:
disodium edentate
phosphate buffered saline. This consists of polysorbate 80, potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate and water for injections to make up 1mL

Sponsor

MabCampath is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No: 1800 818 806
In New Zealand this product is distributed by:
sanofi-aventis new zealand limited
Level 8, James and Wells Tower
56 Cawley Street, Ellerslie,
Auckland
New Zealand
Freecall No:0800 283 684

Australian Registration Numbers:

AUST R 116622 
mabcampath-ccdsv18-cmiv3- 10jan20
This leaflet was prepared in January 2020