Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Lemtrada?
Lemtrada contains the active ingredient alemtuzumab. Lemtrada is used to treat relapsing
forms of multiple sclerosis (MS) in adults with active disease who are not stable
on current therapy.
2. What should I know before I use Lemtrada?
Do not use if you have ever had an allergic reaction to Lemtrada or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Lemtrada and affect how it works.
4. How do I use Lemtrada?
Lemtrada will be given to you as an infusion into a vein. Each infusion will take
approximately 4 hours.
5. What should I know while using Lemtrada?
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Things you should do
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If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking Lemtrada.
Woman of childbearing potential should use effective contraceptive methods during
treatment with Lemtrada and for 4 months after each course of treatment.
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Things you should not do
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Do not take Lemtrada if you have an allergy to alemtuzumab (the active ingredient)
or proteins of mouse origin, or any of the ingredients listed at the end of this leaflet.
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Driving or using machines
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Lemtrada does not directly affect your ability to drive or use machines. However,
you may experience a side-effect during the treatment course which could make this
unsafe, for example dizziness. If affected, stop these activities until the side-effect
resolves.
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Looking after your medicine
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Lemtrada is stored in the pharmacy or clinic at 2°C to 8°C.
The Doctor, Nurse or Pharmacist will dispose of any unused Lemtrada.
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6. Are there any side effects?
Tell your doctor, pharmacist or nurse as soon as possible if you do not feel well
while you are taking Lemtrada. There have been reports of a rare but serious brain
infection called PML (progressive multifocal leucoencephalopathy) in patients receiving
some medicines for MS. PML can cause severe disability or even death. Symptoms of
PML can be similar to those of MS.
Active ingredient:
alemtuzumab
Consumer Medicine Information (CMI)
This leaflet provides important information about using Lemtrada. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about Lemtrada.
Where to find information in this leaflet:
1. Why am I using Lemtrada?
Lemtrada contains the active ingredient alemtuzumab.
Lemtrada is used to treat relapsing forms of multiple sclerosis (MS) in adults with
active disease who are not stable on current therapy.
Lemtrada slows down the progression of physical disability in people with relapsing
forms of MS and decreases the number of flare-ups (relapses).
In MS your immune system mistakenly attacks the protective layer (myelin) around the
nerve fibres of your brain and spinal cord, causing inflammation.
Lemtrada works on your immune system so that it may reduce the impact of the disease
on your nervous system.
Your doctor, however, may have prescribed Lemtrada for another purpose.
Ask your doctor if you have any questions about why it has been prescribed for you.
This medicine is only available with a doctor's prescription.
2. What should I know before I use Lemtrada?
Before treatment your doctor should have discussed the risks and benefits of Lemtrada
and the need for you to commit to 48-months of follow-up after the last infusion of
Lemtrada.
Warnings
Do not use Lemtrada if:
you are allergic to alemtuzumab (the active ingredient) or proteins of mouse origin,
or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Symptoms that may indicate an allergic reaction 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
These symptoms may also occur as a non-allergic reaction
to Lemtrada infusion. Tell your doctor if you are experiencing these symptoms.
Lemtrada should not be used after the expiry date (exp) printed on the pack.
Lemtrada should not be used if the packaging is torn or shows signs of tampering.
Check with your doctor if you have:
allergies to any of the ingredients listed at the end of this leaflet
received a vaccination in the last 6 weeks
bleeding, thyroid or kidney problems
a recent history of infection
a malignancy (cancer)
had a positive HIV, Hepatitis B or C blood test
uncontrolled hypertension
ever had a stroke
ever had angina or a heart attack
a condition where your blood’s ability to form clots is impaired, or are taking any
medicine to help your blood clot normally
received an organ transplant
taken or are taking other medicines to reduce the function of your immune system
taken any medicines for any other condition
other illness in addition to your Multiple Sclerosis.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Use in Children
Lemtrada is not intended to be used in children and adolescents as it has not been
studied in MS patients below 18 years old.
Pregnancy and Breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Woman of childbearing potential should use effective contraceptive methods during
treatment with Lemtrada and for 4 months after each course of treatment.
If you become pregnant after treatment with Lemtrada and experience thyroid problems
during pregnancy, extra caution is needed. The thyroid problems could be harmful to
the baby.
It is unknown if Lemtrada can be transferred to a baby through breast milk, but there
could be a risk. You should not breast-feed during each course of treatment with Lemtrada
and for 4 months after each treatment course.
Important Information
Talk to your doctor before Lemtrada is given. After having a course of treatment you
may be at risk of developing autoimmune conditions (see below) or experiencing serious
infections. It is important you understand these risks and how to monitor for them.
You will be given a Patient Wallet Card and Patient Guide with further information.
It is important you keep the Patient Wallet Card with you during treatment and for
4 years after your last infusion, because side effects may occur many years after
treatment. If you have medical treatment, even if not for your MS, show the Patient
Wallet Card to your doctor.
Autoimmune Conditions
Treatment with Lemtrada may increase the risk for autoimmune conditions. These are
conditions where your immune system mistakenly attacks certain cells of your body.
Information about some specific conditions is provided below.
These autoimmune conditions can occur many years after treatment with Lemtrada.
You will need to have a blood test and a urine test before starting treatment and
every month until 4 years after your last Lemtrada infusion even if you are feeling
well and your MS symptoms are under control.
In addition, there are certain signs and symptoms that you should look out for yourself.
Details are described under Side Effects. More helpful information about these conditions
and testing for them can be found in the Lemtrada Patient Guide.
Immune Thrombocytopenic Purpura
Approximately 2% of patients may develop an autoimmune bleeding disorder called Immune
Thrombocytopenic Purpura (ITP). This must be diagnosed and treated promptly, as otherwise
the effects can be serious or even fatal. ITP can cause bleeding (that may be hard
to stop) and/or easy bruising, and/or small scattered spots on your skin that are
red, pink or purple.
Your blood will be checked before starting your treatment with Lemtrada, and every
month after your initial treatment course until 4 years after your last infusion.
This should allow a problem to be detected early and treatment to begin right away.
Your doctor will explain symptoms for you to look out for so that you can seek urgent
medical help if you experience them.
Thrombotic Thrombocytopenic Purpura
Some patients may develop a bleeding disorder called Thrombotic Thrombocytopenic Purpura
(TTP). This must be diagnosed and treated promptly, as otherwise the effects can be
serious or even fatal. TTP can cause blood clots form in small blood vessels throughout
the body. The clots can limit or block the flow of oxygen-rich blood to the body's
organs, such as the brain, kidneys, and heart.
Kidney Disease (such as anti-GBM disease)
Approximately 1 in 250 patients have experienced autoimmune related problems with
their kidneys, such as anti-glomerular basement membrane disease (anti-GBM disease).
If untreated it can cause kidney failure requiring dialysis or transplantation and
may lead to death. Your blood and urine will be checked before starting your treatment
with Lemtrada, and every month after your initial treatment course until 4 years after
your last infusion. This should allow a problem to be detected early and treatment
to begin right away.
Thyroid Disorders
More than a third of patients have experienced an autoimmune disorder of the thyroid
gland affecting its ability to make or control hormones that are important for your
metabolism. This can result in many different symptoms such as excessive sweating,
unexplained weight loss, eye swelling, nervousness, or fast heartbeat. Let your doctor
know if you experience any such symptoms.
If you develop a thyroid disorder, in most cases you will need to be treated for the
rest of your life with medication to control your thyroid disorder, or in some cases
your thyroid may have to be removed. Your blood will be checked before starting your
treatment with Lemtrada, and every 3 months after your initial treatment course until
4 years after your last infusion.
Should you develop a thyroid disorder, it is very important that you are properly
treated for it, especially if you become pregnant after using Lemtrada. Having an
untreated thyroid disorder could harm your unborn baby, or harm your baby after birth.
Liver Inflammation
Some patients have developed liver inflammation after receiving Lemtrada. If you develop
one or more of the following symptoms report this to your doctor: nausea, vomiting,
abdominal pain, fatigue, loss of appetite, yellow skin or eyes, dark urine, or bleeding
or bruising more easily than normal.
Organ Inflammation
Lemtrada treatment may potentially be associated with an immune disorder (sarcoidosis)
that can cause inflammation of one or more organs including lungs, lymph nodes, skin
or heart. If you develop one or more of the following symptoms, report this to your
doctor: fatigue, swollen lymph nodes, weight loss, pain and swelling in joints, persistent
dry cough, shortness of breath, chest pain, changes in heartbeat, blurred vision,
eye pain, sensitivity of light, rash or sores on or under your skin.
Lemtrada treatment may be associated with inflammation of the colon (colitis). Tell
your doctor if you have any of the following symptoms: diarrhoea (loose stools) or
more frequent bowel movements than usual; stools that are black or sticky or have
blood or mucus; severe stomach area (abdomen) pain or tenderness.
Autoimmune Encephalitis
This condition may include symptoms such as behaviour and psychiatric changes, movement
disorders, short term memory loss or seizures as well as other symptoms resembling
an MS relapse.
Other Autoimmune Conditions
Uncommonly patients have experienced autoimmune conditions with the red blood cells
or white blood cells. This can be diagnosed from the blood tests that you will be
having after Lemtrada treatment. If you develop one of these conditions your doctor
will take appropriate measures to treat it.
Summary of Recommended Testing for Autoimmune Conditions
Blood test – Before treatment starts and every month until 4 years after your last
Lemtrada infusion.
Urine test – Before treatment starts and every month until 4 years after your last
Lemtrada infusion.
Liver function test - before treatment starts and every month until 4 years after
your last Lemtrada infusion.
Infusion Reactions
Most patients treated with Lemtrada will experience side-effects at the time of the
infusion or within 24 hours after the infusion. All of these reactions are described
in the Side Effects section of this leaflet.
Most infusion reactions are mild but some serious reactions are possible such as change
in heart rate, headache, low blood pressure, nausea, chest discomfort, fever or hives.
Allergic reactions are possible.
In order to try to reduce these effects, your doctor will give you medication (corticosteroids)
prior to the first 3 infusions of a treatment course. Other treatments to limit these
reactions can also be given before the infusion or when you experience symptoms. In
addition, you will be observed during the infusion and after the infusion has been
completed. In case of serious reactions, it is possible that the infusion may be slowed
down or even stopped.
Other Serious Reactions Occurring Shortly After Lemtrada Infusion
Some patients have had serious or life-threatening reactions after Lemtrada infusion,
including bleeding in the lung, heart attack, stroke or tears in blood vessels supplying
the brain. Reactions may occur following any of the doses during the treatment course.
In the majority of cases reactions occurred within 1-3 days of the infusion. Your
doctor will monitor vital signs, including blood pressure, before and during the infusion.
Get help right away if you have any of the following symptoms: trouble breathing,
chest pain, facial drooping, sudden severe headache, weakness on one side of the body,
difficulty with speech or neck pain.
Haemophagocytic Lymphohistiocytosis
Treatment with Lemtrada may increase the risk of excessive activation of white blood
cells associated with inflammation (haemophagocytic lymphohistiocytosis), which can
be fatal if not diagnosed and treated early.
If you experience multiple symptoms such as fever, swollen glands, bruising, or skin
rash, contact your doctor immediately.
Adult Onset Still’s disease (AOSD)
AOSD is a rare condition that has the potential to cause multi-organ inflammation,
with several symptoms such as fever >39°C or 102.2°F lasting more than 1 week, pain,
stiffness with or without swelling in multiple joints and/or a skin rash. If you experience
a combination of these symptoms contact your healthcare provider immediately.
Infections
Patients treated with Lemtrada may be at a higher risk for getting a serious infection.
If you are suffering from an infection before the initiation of your Lemtrada treatment,
your doctor will consider delaying the treatment until the infection is under control
or resolved.
Most infections seen in clinical trials were mild to moderate and most often included
airway infections such as colds, bronchitis and sinus infections, cystitis, cold sores,
or influenza (flu). However serious infections like appendicitis, gastric flu, pneumonia,
chicken pox or shingles and tooth infection have also occurred.
If you have had a herpes infection (e.g., a cold sore) in the past it is possible
that this will flare up after treatment with Lemtrada, or you could develop a herpes
infection for the first time. It is recommended that your doctor prescribes treatment
with a medicine against infections like this, which should be taken during the days
that you receive infusions, and for one month following the infusion, in order to
reduce the chance of developing a herpes infection.
In addition, infections which can result in abnormalities of the cervix (the neck
of the womb) are possible. Therefore, it is recommended that all female patients have
annual screening performed, such as a pap smear. Your doctor will explain to you what
testing will be done to you.
Patients who receive Lemtrada have an increased chance of getting an infection caused
by the bacteria, Listeria. Avoid foods that may be a source for Listeria (for example,
deli or processed meats, unpasteurized milk and cheese products, or undercooked meat,
seafood or poultry) or make sure that the food you eat which may contain Listeria
is heated well if you receive treatment with Lemtrada.
You may be tested for tuberculosis according to your doctor’s decision.
Fungal (yeast) infections of the mouth (oral thrush), and vagina (vaginal thrush)
have also been seen.
If you are a carrier of hepatitis B or hepatitis C infection (these affect the liver),
extra caution is needed before you receive Lemtrada treatment as it is unknown if
treatment could lead to activation of the hepatitis infection which could subsequently
damage your liver.
Inflammation of the Gallbladder
Lemtrada may increase your chance of getting inflammation of the gallbladder. This
may be a serious medical condition that can be life threatening. You should report
to your doctor if you have symptoms such as stomach pain or discomfort, fever, nausea
or vomiting.
Previously Diagnosed Cancer
If you have been diagnosed with cancer in the past, please inform your doctor about
it.
Vaccines
It is unknown if Lemtrada has an impact on your ability to raise a response to a vaccine.
If you have not completed the standard required vaccinations, your doctor will consider
whether you should have them before your Lemtrada treatment. In particular, your doctor
will consider vaccinating you against chicken-pox if you have never had it. Any vaccination
will need to be completed at least 6 weeks prior to starting a Lemtrada treatment
course.
After your treatment course with Lemtrada, consult your healthcare provider if you
require vaccination. Your healthcare provider will determine if it is safe for you
to do so. You must not receive certain types of vaccines (live viral vaccines) if
you have recently received Lemtrada.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
vaccinations, medicines, vitamins, or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
Besides Lemtrada, there are other treatments (including those for MS, or to treat
other conditions) which could affect your immune system and so could affect your ability
to fight infections. If you have used another MS treatment in the past, your doctor
may ask you to stop the other medicine in advance of starting treatment with Lemtrada.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Lemtrada.
4. How do I use Lemtrada?
How much to take
Follow the instructions provided and use Lemtrada until your doctor tells you to stop.
When to take Lemtrada
Lemtrada will be given to you as an infusion into a vein. Each infusion will take
approximately 4 hours.
The initial treatment you will receive will consist of one infusion (12mg) per day
on 5 days (course 1) and one infusion (12mg) per day for 3 days one year later (course
2). There is no Lemtrada treatment between the two courses.
Some patients, if they have symptoms or signs of MS disease activity after the initial
two courses may receive one or two additional treatment courses. In case you need
an additional treatment course you will receive one infusion per day for three days
administered at least a year after the prior treatment.
Once you have received Lemtrada, you will need to undergo regular tests to ensure
that any potential side-effects can be diagnosed and treated promptly. Monitoring
must continue for 4 years after the last infusion.
If you use too much Lemtrada
As Lemtrada is given to you under the supervision of a doctor or nurse, it is very
unlikely that you will receive too much. However, if you experience any unexpected
or worrying side effects after being given Lemtrada tell your doctor, pharmacist,
or nurse as soon as possible.
You should immediately:
by calling
13 11 26 in Australia, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Lemtrada?
Things you should do
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking Lemtrada.
Woman of childbearing potential should use effective contraceptive methods during
treatment with Lemtrada and for 4 months after each course of treatment.
Remind any doctor, dentist or pharmacist you visit that you are using Lemtrada.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Lemtrada
affects you.
Lemtrada does not directly affect your ability to drive or use machines. However,
you may experience a side-effect during the treatment course which could make this
unsafe, for example dizziness. If affected, stop these activities until the side-effect
resolves.
Looking after your medicine
Lemtrada is stored in the pharmacy or clinic at 2°C to 8°C.
When to discard your medicine
The Doctor, Nurse or Pharmacist will dispose of any unused Lemtrada.
6. Are there any side effects?
Tell your doctor, pharmacist, or nurse as soon as possible if you do not feel well
while you are taking Lemtrada.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
There have been reports of a rare, serious brain infection called PML (progressive
multifocal leukoencephalopathy) in patients receiving some medicines for MS. PML can
cause severe disability or even death. Symptoms of PML can be similar to those of
MS.
Tell your partner or carer about your Lemtrada treatment, especially if you have received
other medicines to treat MS before. They might notice symptoms that you do not, such
as changes in movement or behaviour, that your doctor may need to investigate further.
Less serious side effects
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Less serious side effects
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What to do
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Side effects that can happen during, or within 24 hours, of the infusion including:
headache, rash, fever, feeling sick, hives, itching, reddening of the face and neck,
feeling tired
General:
chills
chest pain
dizziness
strange taste
difficulty sleeping
difficulty breathing or shortness of breath
muscular or joint pain
sore mouth or gums
feeling weak
trembling
burning or prickling sensation
swelling of arms or legs
excessive sweating
nose bleeds
bruising
Skin-related:
red skin
rash
vitiligo (patches of skin that have lost colour)
hair loss
Heart-related:
change in heart rate
Gynecological:
prolonged or irregular menstruation
Gut-related:
indigestion,
vomiting
diarrhoea
stomach pain
gastric flu
heartburn
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
Refer to your Lemtrada patient guide for further information.
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Serious side effects
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Serious side effects
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What to do
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General:
unexplained weight gain
feeling cold
worsening tiredness, unexplained or excessive tiredness
neck pain
excessive sweating
unexplained weight loss
sore throat
sudden severe headache nervousness
fast heartbeat
trouble breathing
chest pain
pressure, tightness, pain, or a squeezing or aching sensation in your chest or arms
that may spread to your neck, jaw or back
lightheadedness or sudden dizziness
pulsing sound in the ear
pain in your scalp, face or neck
Gut-related:
stomach pain or discomfort
nausea or vomiting
new constipation
stool that is black, has blood or mucus
Eye-related:
eye swelling
eye pain
Neurological disorder:
sudden weakness or numbness on one side of the body
drooping of the skin on your face
sudden difficulty with speech or blurred vision
Infection:
signs of infection such as fever and/or chills, swollen glands, mouth or skin ulcers,
abscesses, or wounds that take a long time to heal
swollen glands in the neck or armpits
fever
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Skin related:
small scattered spots on your skin that are red, pink or purple
paleness or jaundice (a yellowish colour of the skin or whites of the eyes)
purplish bruises on the skin or mucous membranes (such as the mouth)
Bleeding
any bleeding that is heavier than usual or harder to stop than expected, easy bruising
blood in the urine, coughing up blood and swelling in your legs or feet
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Lemtrada contains
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Active ingredient
(main ingredient)
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Each vial of Lemtrada contains 10mg/mL of alemtuzumab
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Other ingredients
(inactive ingredients)
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sodium chloride
dibasic sodium phosphate heptahydrate
potassium chloride
monobasic potassium phosphate
polysorbate 80
disodium edetate
water for injections
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Potential allergens
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-
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Do not take this medicine if you are allergic to any of these ingredients.
What Lemtrada looks like?
Lemtrada is a clear colourless to yellowish solution.
AUST R 200941
Who distributes Lemtrada?
Australian Sponsor:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Australia
This leaflet was prepared in September 2024.
lem-ccdsv22-cmiv16-26sep24