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 subject to additional monitoring due to approval of an extension
of indications. 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. 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.
1. Why am I using Ultomiris?
Ultomiris contains the active ingredient ravulizumab rch.
2. What should I know before I use Ultomiris?
Ultomiris is a medicine that affects your body’s defence system and so can lower the
ability of your immune system to fight infections. Using this medicine increases your
risk of severe infection and sepsis (infection of the blood). You must be vaccinated
against meningococcal infection and be aware of the signs and symptoms of a meningococcal
infection. You should seek medical care immediately if you see any signs or symptoms
of meningococcal infection. You must always carry a “Patient Safety Card” with you.
Talk to your doctor if you have an infection or have had an allergic reaction to any
of the ingredients listed at the end of the CMI.
3. What if I am taking other medicines?
Talk to your doctor if you have any other medical conditions or are taking any other
medicines. The effect of using Ultomiris on other medicines has not been studied.
4. How do I use Ultomiris?
Ultomiris will be given to you directly into the vein (intravenously) by a doctor
or nurse. The infusion will take approximately 45 minutes but might take longer according
to your body weight.
5. What should I know while using Ultomiris?
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Things you should do
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Ensure that your (or your child’s) vaccinations are up to date.
If you forget or miss your appointment for an Ultomiris infusion, contact your doctor
immediately.
Remind any doctor, dentist, and pharmacist that you visit that you are using Ultomiris.
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Things you should not do
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Do not stop using Ultomiris without checking with your doctor.
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Looking after your medicine
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Ultomiris will be stored in refrigerated conditions (2°C to 8°C) in the hospital or
pharmacy.
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6. Are there any side effects?
This medicine is subject to additional monitoring due to approval of an extension
of indications. 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 Ultomiris blocks a part of your immune system it increases the risk of severe
infection and sepsis, especially by a type of bacteria called Neisseria meningitidis.
This can cause cases of meningitis, which is a major brain inflammation, or a severe
infection of the blood.
These infections require urgent and appropriate care as they may become rapidly serious
or fatal 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 “What I should know before I use Ultomiris ” below or refer
to your Patient Safety Card).
- You must be vaccinated against meningococcal infection before starting Ultomiris
.
If you initiate Ultomiris 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 need to be aware of the signs and symptoms of meningococcal infection (see “What
I should know before I use Ultomiris ” below or refer to your Patient Safety Card)
and notify your doctor immediately if any of the symptoms occur.
- If you cannot reach your doctor, go to the Emergency Department at your nearest
hospital. Show your Patient Safety Card to any doctor or nurse who treats you.
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Active ingredient(s):
ravulizumab rch [100 mg per 1mL]
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Ultomiris.
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 Ultomiris.
Where to find information in this leaflet:
1. Why am I using Ultomiris?
Ultomiris contains the active ingredient ravulizumab rch.
Ultomiris belongs to a class of medicines called monoclonal antibodies, that attach
to a specific target in the body. Ravulizumab rch has been designed to attach to the
C5 complement protein, which is a part of the body’s defence system called the ‘complement
system’.
Ultomiris is used to treat patients with a disease called Paroxysmal Nocturnal Haemoglobinuria
(PNH). It is also used to treat patients with a disease affecting the blood system
and kidneys called atypical haemolytic uraemic syndrome (aHUS). Ultomiris can also
be used to treat adult patients with generalized Myasthenia Gravis (gMG), a condition
which causes weakness of muscles throughout the body. People with gMG can experience
challenges with fatigue, drooping eyelids, speech, chewing, movement and breathing,
amongst other symptoms.
Ultomiris 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). In patients with NMOSD, the eye nerves, brain and
spinal cord are attacked and damaged by the immune system working incorrectly, which
can lead to loss of sight in one or both eyes, weakness, or loss of movement in the
legs or arms, painful spasms, loss of feeling, problems with bladder and bowel function
and marked difficulties with activities of daily living.
How it works
In patients with PNH, the complement system is overactive and attacks their red blood
cells, which can lead to blood clots, low blood cell counts (anaemia), tiredness,
difficulty in functioning, pain, abdominal pain, dark urine, shortness of breath,
difficulty swallowing and erectile dysfunction. By attaching to and blocking the C5
protein, this medicine can stop complement proteins from attacking red blood cells
and so control symptoms of the disease such as improving anaemia and tiredness.
In patients with aHUS, their complement system attacks vital organs (such as the kidney),
blood cells and blood vessels, which can lead to low blood counts (platelets and red
blood cells), reduced or lost kidney function, blood clots, tiredness and difficulty
in functioning. Ultomiris can block the body’s inflammatory response, and its ability
to attack and destroy its own vulnerable blood vessels and so control symptoms of
the disease including injury to the kidneys.
gMG is a disease where a patient’s immune system (which normally protects the body
from infection) attacks it instead. In gMG this autoimmune attack occurs at the connection
between nerves and muscles, causing the complement system to damage nerve tissue,
resulting in nerves which function poorly.
In patients with NMOSD Ultomiris is presumed to block the body's inflammatory response,
and its ability to attack and destroy its own eye nerves, brain and spinal cord, which
reduces the risk of relapse or attack of NMOSD. Ultomiris is not intended for acute
treatment of NMOSD relapse.
2. What should I know before I use Ultomiris?
Warnings
Ultomiris is a medicine that affects your immune system (your body’s defence system).
Ultomiris can lower the ability of your immune system to fight infections.
The use of Ultomiris increases your risk of meningococcal infection, a severe infection
that can affect the linings of the brain and can spread through the blood and body
(sepsis) as well as the risk of other infections (e.g. widespread gonorrhoea).
Because of the importance of rapidly identifying and treating meningococcal infection/sepsis
in patients who receive Ultomiris, you will be provided with a “Patient Safety Card”
to carry with you at all times, so that you are aware of the following signs and symptoms
of a meningococcal infection:
headache with nausea or vomiting
headache and a fever
headache with a stiff neck or stiff back
fever
fever and rash
confusion
muscle aches with flu-like symptoms
eyes sensitive to light
Call your doctor immediately and go to the Emergency department at your nearest hospital
if you have any of the symptoms listed above.
Patients less than 18 years of age must also be vaccinated against Haemophilus Influenzae and pneumococcal infections.
Ask your doctor for advice about gonorrhoea prevention before using this medicine.
When Ultomiris is given, you may experience reactions to the infusion (drip) (infusion
reaction) such as headache, lower back pain, and infusion-related pain. Some patients
may experience allergic or hypersensitivity reactions (including anaphylaxis, a serious
allergic reaction which causes difficulty breathing or dizziness).
Should you experience an infusion reaction, your doctor will interrupt the infusion
of Ultomiris and institute appropriate measures depending on the severity.
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 use Ultomiris if:
you have not been vaccinated against Neisseria meningitidis, a bacteria that causes meningococcal infection, or if it has been less than 2 weeks
after receiving your meningococcal vaccination and you are not taking antibiotics
to reduce the risk of infection
You should also be aware that vaccination may not prevent this type of infection.
You may need antibiotics to prevent infection. You should discuss with your doctor
the use of ongoing preventative antibiotics and if they are required.
you have unresolved meningococcal infection
you are allergic to ravulizumab rch, any other proteins of hamster 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.
Check with your doctor if you:
have any infections, or any other medical conditions
take any medicines for any other condition
experience any infusion related pain, when Ultomiris is given, you may experience
a reaction to the infusion such as a headache or lower back pain
are on a controlled sodium diet as Ultomiris contains sodium (main component of cooking/table
salt). Each 3mL vial contains 4.6 mg sodium and each 11mL vial contains 16.8 mg sodium.
This may need to be considered in calculating your salt/sodium intake.
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.
Ultomiris has not been studied in pregnant women. Women who may become pregnant should
use effective contraception methods during treatment, and for up to 8 months after
treatment.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether Ultomiris passes into breast milk. Since many medicines are
secreted into breast milk, breastfeeding should be discontinued during treatment,
and for up to 8 months after treatment.
Elderly
There are no special precautions needed for the treatment of patients aged from 65
years and over, although experience with Ultomiris in elderly patients with PNH and
aHUS, or NMOSD in clinical studies is limited.
3. What if I am taking other medicines?
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 Ultomiris on other medicines has not been studied
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Ultomiris.
4. How do I use Ultomiris?
How much to use
The doses administered are based on your body weight; your doctor will calculate this.
Ultomiris will be given to you directly into the vein (intravenously) by a doctor
or nurse. The infusion will take approximately 45 minutes but might take longer according
to your body weight.
Your first dose is called the loading dose. Two weeks after receiving your loading
dose, you will be given a maintenance dose of Ultomiris. This will be repeated every
8 weeks for patients above 20kg, and every 4 weeks for patients weighing less than
20kg.
If you were previously receiving another medicine for PNH, aHUS or NMOSD called Soliris®, the loading dose should be given 2 weeks after the last Soliris maintenance infusion
or 1 week after the last Soliris induction infusion.
If you forget to use Ultomiris
If you forget or miss your appointment for an Ultomiris infusion, contact your doctor
immediately for advice and see section below “Things you should not do” for information
about the risks of interrupting or stopping your Ultomiris treatment.
If you use too much Ultomiris
There have been no reported overdoses of Ultomiris. As Ultomiris is given to you under
the supervision of your doctor, it is unlikely that you will receive too much.
5. What should I know while using Ultomiris?
Things you should do
Always carry your Patient Safety Card with you and show it to any doctor or nurse
that treats you.
Ensure that your meningococcal vaccination is up to date.
You should also be aware that vaccination may not always prevent this type of infection.
Your doctor might consider that you need additional measures, such as antibiotics,
to prevent infection.
Ensure that your child’s vaccinations are up to date.
Remind any doctor, dentist or pharmacist you visit that you are using Ultomiris.
Things you should not do
Do not stop using this medicine without checking with your doctor.
Interrupting or stopping treatment with Ultomiris may cause your PNH, aHUS, gMG or
NMOSD symptoms to return. Your doctor will discuss the possible side effects with
you and explain the risks.
For PNH, the risks of stopping Ultomiris include an increase in the destruction of
your red blood cell which may cause:
- a large drop in your red blood cell count causing anaemia. Symptoms of anaemia may
include tiredness, headaches, dizziness and looking pale
-dark urine
-fatigue
-abdominal pain
-being short of breath
-difficulty swallowing
-erectile dysfunction (impotence)
-confusion or a change in how alert you are
-chest pain or angina
-blood clots
If you experience any of these symptoms, contact your doctor immediately
Your doctor will need to monitor you closely for at least 16 weeks after stopping
Ultomiris.
For aHUS, the risks of stopping Ultomiris include an increase in small blood vessel
damage, which may cause;
a large drop in your platelets (thrombocytopenia)
a large rise in destruction of your red blood cells
decreased urination (problems with your kidneys)
an increase in your serum creatinine levels (problems with your kidneys)
confusion or change in how alert you are
change in your vision
chest pain or angina
being short of breath
abdominal pain, diarrhoea
blood clots
If you experience any of these symptoms, contact your doctor immediately.
Your doctor will need to monitor you closely.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Ultomiris
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
Ultomiris will be stored in refrigerated conditions (2°C to 8°C) in the hospital or
pharmacy
6. Are there any side effects?
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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Sinus or throat infection
Common cold (nasopharyngitis)
Middle ear infection, tonsillitis
Cough
Diarrhoea, constipation
Abdominal pain or discomfort
Loss of appetite
Joint pain (arthralgia)
Back pain
Muscle pain (myalgia) and muscle spasms
Swelling of the hands, ankles or feet
Swollen glands (lymph nodes)
Feeling anxious
Feeling tired (fatigue)
Hair loss or thinning
High blood pressure (hypertension)
Urinary tract infections (infections of the bladder)
Headache
Vomiting
Nausea
Stomach discomfort after meals
Hives, rash, itchy skin (pruritus)
Fever (pyrexia)
Dizziness
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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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Meningococcal infection
headache
nausea or vomiting
headache with nausea or vomiting
headache with a fever
headache with a stiff neck or stiff back
fever
fever and rash
confusion
muscle aches with flu-like symptoms
sensitivity to light
rash or itchy skin
feeling tired
back pain, muscle spasms, aching muscles (not caused by exercise), pain in arms or
legs
looking pale
dizziness
Shortness of breath, difficulty in breathing, chest tightness
Pneumonia (severe lung infection)
Allergic reactions (swelling of the face, lips, tongue or other parts of the body,
itching or hives).
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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 Ultomiris contains
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Active ingredient
(main ingredient)
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ravulizumab rch
(100 mg/mL)
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Other ingredients
(inactive ingredients)
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monobasic sodium phosphate
dibasic sodium phosphate
polysorbate 80
L-arginine
Sucrose
Water for injections
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Potential allergens
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Proteins of hamster origin
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Do not take this medicine if you are allergic to any of these ingredients.
What Ultomiris looks like
Ultomiris 100 mg/mL is a translucent, clear to yellowish colour, practically free
from particles solution.
(Aust R 330566-300 mg/3mL)
(Aust R 336710-1100 mg/11mL).
Who distributes Ultomiris
In Australia Ultomiris is registered by:
Alexion Pharmaceuticals Australasia Pty Ltd
Level 4,
66 Talavera Road, Macquarie Park,
NSW 2113
Medical enquiries: 1800 788 189
This leaflet was prepared in January 2024.