Soliris®
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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.
Soliris contains the active ingredient eculizumab rmc. Soliris is used for the treatment
of patients with a disease that affects red blood cells called Paroxysmal Nocturnal
Haemoglobinuria (PNH).
Soliris is also used to treat patients with a condition called atypical Haemolytic
Uraemic Syndrome (aHUS).
Soliris is also used to treat adult patients with a disease of the central nervous
system that mainly affects the eye nerves and the spinal cord called Neuromyelitis
Optica Spectrum Disorder (NMOSD).
For more information, see Section 1. Why am I using Soliris? in the full CMI.
Do not use if you have ever had an allergic reaction to Soliris 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.
For more information, see Section 2. What should I know before I use Soliris? in the full CMI.
Some medicines may interfere with Soliris and affect how it works.
See 3. What if I am taking other medicines? in the full CMI.
Soliris will be given to you directly into the vein (intravenously) by a doctor or
nurse. Each infusion will take approximately 25 – 45 minutes in adults, and 1 to 4
hours in paediatric patients.
More instructions can be found in Section 4. How do I use Soliris? in the full CMI.
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Things you should do
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Remind any doctor, nurse, dentist or pharmacist you visit that you are using Soliris.
If you forget or miss a Soliris infusion, call your doctor immediately.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not stop taking Soliris without checking with your doctor.
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Looking after your medicine
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Soliris will be stored in refrigerated conditions (2°C to 8°C) in the hospital or
pharmacy.
Soliris vials in the original package may be removed from refrigerated storage (up
to 25°C) for only one single period of up to 3 days. At the end of this period unopened
product can be put back in the refrigerator.
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For more information, see Section 5. What should I know while using Soliris? in the full CMI.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
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WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
As Soliris blocks part of your immune system, it increases the risk of severe infection
and sepsis, especially by a type of bacteria called Neisseria meningitidis, which
can cause meningitis (major brain inflammation) or a severe infection of the blood
(sepsis).
These infections require urgent and appropriate care as it may become rapidly fatal
or life-threatening or lead to major disabilities. It is important to understand the
precautions to take to reduce the risk of these infections and what to do if you are
worried you may have an infection (see
2. What should I know before I start using Soliris
) section below or refer to your Patient Safety Information Card).
You must be vaccinated against meningococcal infection (Neisseria meningitidis) before
starting Soliris.
If you initiate Soliris treatment less than 2 weeks after receiving a meningococcal
vaccine you must take antibiotics until 2 weeks after you have been vaccinated to
reduce the risk of infection with Neisseria meningitidis.
You will need to be aware of the signs and symptoms of meningococcal infections (see
2. What should I know before I start using Soliris
section below or refer to your Patient Safety Information Card) and notify your doctor
immediately if any of the symptoms occur.
If you cannot reach your doctor, go to Accident and Emergency at your nearest hospital.
Show your Patient Safety Information Card to any doctor or nurse who treats you.
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Soliris®
(so-li-ris)
Active ingredient(s): Eculizumab rmc
Consumer Medicine Information (CMI)
This leaflet provides important information about using Soliris. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Soliris.
Where to find information in this leaflet:
1. Why am I using Soliris?
Soliris contains the active ingredient eculizumab rmc. Soliris is a monoclonal antibody.
Soliris is used for the treatment of patients with a disease that affects red blood
cells called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Soliris is also used to treat patients with a condition called atypical Haemolytic
Uraemic Syndrome (aHUS).
Soliris is also used to treat adult patients with a disease of the central nervous
system that mainly affects the eye nerves and the spinal cord called Neuromyelitis
Optica Spectrum Disorder (NMOSD).
Patients with PNH lack naturally occurring protective proteins on the surface of some
of their red blood cells. In unaffected individuals, these proteins protect red blood
cells from destruction by the body’s inflammatory response. PNH patients lack these
protective proteins and their red blood cells can be destroyed. This can lead to low
red blood cell counts (anaemia), tiredness, difficulty in functioning, pain, dark
urine, kidney failure, shortness of breath and blood clots.
Soliris can block the body’s inflammatory response, and its ability to attack and
destroy blood cells. In this way Soliris improves anaemia, fatigue, and other signs
and symptoms of PNH.
Patients with aHUS have an inflammatory condition which affects the blood system and
kidney. This can lead to reduced or lost function of the kidneys or other organs,
low blood counts (low platelets and anaemia), tiredness and difficulty functioning.
Soliris works by blocking the body’s inflammatory response and its ability to attack
and destroy its own vulnerable blood and kidney cells.
In patients with NMOSD, the eye nerves, brain and spinal cord are attacked and damaged
by the immune system. Soliris is presumed to block the body’s inflammatory response,
and its ability to attack and destroy its own eye nerves, brain and spinal cord.
Warnings
Soliris treatment may reduce your natural resistance to infections, especially against
certain bacteria that can cause meningococcal meningitis (severe infection of the
lining of the brain) and sepsis (infection in the blood), as well as other infections
caused by similar bacteria (e.g. widespread gonorrhoea).
Do not use Soliris if:
You are allergic to eculizumab rmc, or any of the ingredients listed at the end of
this leaflet
You have had an allergic reaction to any other proteins of mouse origin
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
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
you have not been vaccinated against Neisseria meningitidis, a bacteria that causes
meningococcal infection,
you are not up to date with your meningococcal vaccination
if it is less than 2 weeks after receiving your meningococcal vaccination and you
are not taking antibiotics to reduce the risk of infection
you have meningitis
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?
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.
Data in a limited number of pregnant women treated with Soliris do not indicate that
Soliris increases the risk of harm to the unborn baby; however, your doctor will discuss
the risks and benefits with you. Unless you are planning to become pregnant, you should
use adequate contraception whilst being treated with Soliris (and up to 5 months after
discontinuing treatment).
It is not known whether Soliris passes into breast milk; however, your doctor will
discuss the risks and benefits for you and your child if you breastfeed whilst on
Soliris treatment.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
The effect of using Soliris on other medicines has not been studied. Ask your doctor
or nurse if you have any questions.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Soliris.
How much to take / use
Soliris will be given to you directly into the vein (intravenously) by a doctor or
nurse. Each infusion will take approximately 25 – 45 minutes in adults, and 1 to 4
hours in paediatric patients.
Soliris has not been studied in children and adolescent patients with NMOSD. Soliris
is not for use in this patient population.
For adults, Soliris is given once a week for the first four weeks, on the fifth week,
the dose is increased and then Soliris is given every two weeks thereafter
For children and adolescents who weigh less than 40kg, Soliris will be given at a
frequency and dose that varies depending on their weight
Children and adolescents who weigh more than 40kg are treated with the adult dosing
If you are having plasma exchange or plasma infusion you may receive additional doses
of Soliris.
Follow the instructions provided and use Soliris until your doctor tells you to stop.
If you forget to use Soliris
If you forget or miss your appointment for a Soliris infusion, contact your doctor
immediately.
If you are given too much Soliris
There have been no reported overdoses of Soliris. As Soliris is given to you under
the supervision of your doctor, it is unlikely that you will receive too much.
Things you should do
Tell any other doctors, nurses, dentists, and pharmacists who treat you that you are
taking this medicine.
Keep appointments with your doctor or clinic.
It is important to have the infusion with Soliris at the appropriate time to make
sure the medicine has the best chance of providing treatment for the condition.
Have any tests when your doctor says to.
Your doctor may wish to test your body’s response to Soliris or may wish to test your
body’s response if you stop therapy.
Call your doctor straight away if you:
Have had an allergic reaction to Soliris, or any of the ingredients listed at the
end of this leaflet, or any other proteins of mouse origin.
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
Remind any doctor, nurse, pharmacist or dentist you visit that you are using Soliris.
Things you should not do
Do not stop using this medicine suddenly.
Do not stop taking Soliris without checking with your doctor.
If you forget or miss a Soliris infusion, call your doctor immediately.
If you have PNH, stopping treatment with Soliris may cause a sudden and serious breakdown
of your red blood cells.
Symptoms or problems from red blood cell breakdown include:
a large drop in your red blood cell count causing anaemia. Symptoms include tiredness,
headaches, being short of breath when exercising, dizziness and looking pale
confusion or change in how alert you are
chest pain or angina
dark urine
blood clots
If you experience any of these symptoms, contact your doctor immediately.
Your doctor will need to monitor you closely for at least 8 weeks after stopping Soliris.
If you have aHUS, stopping treatment with Soliris may cause small blood clots (known
as thrombotic microangiopathy or TMA). Your doctor will discuss the possible side
effects with you and explain the risks. Your doctor will want to monitor you closely.
Symptoms or problems from TMA may include:
low blood platelet count, leading to bruising or bleeding more easily than normal
a large drop in your red blood cell count causing anaemia. Symptoms include tiredness,
headaches, being short of breath when exercising, dizziness and looking pale
confusion or change in how alert you are
seizures
chest pain or angina
decreased urination (kidney problems)
shortness of breath
blood clots
If you experience any of these symptoms, contact your doctor immediately
Studies with Soliris did not examine the risk of relapse of NMOSD if treatment with
Soliris is discontinued. Hence, the risk of relapse of NMOSD is unknown.
If you have NMOSD and stop treatment with Soliris, your doctor will need to monitor
you closely for signs and symptoms of potential NMOSD relapse.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Soliris
affects you.
The effects of this medicine on a person’s ability to drive and use machines were
not assessed as part of its registration.
Looking after your medicine
Soliris will be stored in refrigerated conditions (2°C to 8°C) in the hospital or
pharmacy.
Soliris vials in the original package may be removed from refrigerated storage (up
to 25°C) for only one single period of up to 3 days. At the end of this period unopened
product can be put back in the refrigerator.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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.
Less serious side effects
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Less serious side effects
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What to do
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headache
runny or stuffy nose and colds
sore throat, mouth ulcers or inflammation of gums
cough
chest or lung infection
difficulty sleeping
being short of breath (especially when exercising)
tiredness , unusual weakness or fainting
flu-like symptoms such as fever, sore throat, cough and chills looking pale
abnormal dreams
difficulties or pain when urinating
dark urine or blood in the urine
nausea or vomiting
stomach pain or discomfort
constipation
indigestion or an uncomfortable feeling in the stomach or belching after eating
rash, dry, itchy and inflamed skin
hair loss
loss of appetite
loss of taste
pins and needles in your hands or feet
upper respiratory tract infection, cough, throat pain
ringing in the ears, vertigo,
cold sores (oral Herpes)
fatigue
depression, anxiety,mood swings or sleep disorder
diarrhoea
back or neck pain
spontaneous penile erection
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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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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severe infection (meningococcal infection, fungal infection (Aspergillus), infection
of the lung (pneumonia), kidney infection), sepsis -
high fever, chills, confusion, rapid breathing, dizziness, light headedness or shakes
serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic
reaction)
bleeding or bruising more easily than normal
confusion or change in how alert you are
difficulty breathing
chest tightness
chest pain or angina
fast or irregular heartbeats, also called palpitations
high blood pressure
muscle spasms or aching muscles, muscle tenderness or weakness not caused by exercise
joint pain
infusion site pain
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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.
This medicine is only available with a doctor's prescription.
What Soliris contains
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Active ingredient
(main ingredient)
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eculizumab rmc
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Other ingredients
(inactive ingredients)
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sodium chloride
monobasic sodium phosphate monohydrate
dibasic sodium phosphate heptahydrate
polysorbate 80
water for injections
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Potential allergens
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proteins of mouse origin
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Do not take this medicine if you are allergic to any of these ingredients.
