2. What should I know before I am given SUSVIMO?
Do not use SUSVIMO if you have had an allergic reaction to ranibizumab or any of the
ingredients listed at the end of this CMI.
Do not use SUSVIMO if you have an infection in or around your eye, or inflammation
in your eye.
Do not use SUSVIMO if you have not received at least two prior injections in the eye
for treatment of your nAMD.
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 am given SUSVIMO? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with SUSVIMO and affect how it works.
4. How is SUSVIMO given?
SUSVIMO must only be given via the eye implant at a recommended dose of 2 mg.
The implant is refilled every 24 weeks (approximately 6 months) by your doctor.
5. What should I know while I am being given SUSVIMO?
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Things you should do
|
Avoid rubbing or touching your eye where the implant is located.
Women should use contraception during treatment and for at least 12 months after the
last refill.
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|
Things you should not do
|
Do not stop treatment with SUSVIMO unless your doctor tells you to.
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|
Driving or using machines
|
After the implant-related procedures and eye examinations, do not drive or use machines
until you receive confirmation from your doctor and your eyesight has returned to
normal.
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Looking after your medicine
|
It is unlikely that you will have to store SUSVIMO at home. If you have to store it,
keep it in the refrigerator at 2°C to 8°C (do not freeze) in the outer carton.
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6. Are there any side effects?
Common side effects: eye pain, irritation or discomfort or tenderness when you touch
the eye; cloudy vision or difficulty seeing at night; hazy circles around lights;
eye irritation; red, painful, swollen, itchy eyelids; pain or discomfort during the
procedure or at the procedure site or bruising around the eye; drooping of the eyelid;
headache; nausea; vomiting
Serious side effects: changes in vision, including moving spots, shadows or flashing
lights or blurred vision; increasing eye pain with increasing vision loss; redness
or blood in the eye; sudden sensation that something is in the eye; eye discharge
(including pus) or watery eyes; sensitivity to light; small bulge where the implant
was placed, exposure of the implant; abnormally shaped pupils.
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: ENDOPHTHALMITIS
The Contivue implant has been associated with endophthalmitis. Endophthalmitis is
an infection of the eyeball with inflammation inside of the eye that can cause permanent
damage to your eye including blindness. Call your healthcare provider right away if
you have worsening eye pain with vision loss, sensitivity to light or redness of the
white of the eye. Endophthalmitis requires urgent (same day) medical or surgical treatment.
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Active ingredient(s):
ranibizumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SUSVIMO. 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 SUSVIMO.
Where to find information in this leaflet:
1. Why am I being given SUSVIMO?
SUSVIMO contains the active ingredient ranibizumab.
Ranibizumab belongs to a group of medicines called anti- vascular endothelial growth
factor agents ("anti-VEGF"). SUSVIMO is specially formulated to be released into the
eye using a permanent eye implant (Contivue implant). The Contivue implant is surgically
inserted into your eye and is about the size of a grain of rice. It is filled and
refilled with SUSVIMO by your doctor. SUSVIMO is continuously released over time into
the back of your eye via the implant.
SUSVIMO is used to treat adults with a conditions called neovascular (wet) age-related
macular degeneration (nAMD), who have responded to anti-VEGF injections into the eye
(intravitreal). nAMD is caused when tiny, abnormal blood vessels grow in the back
of the eye (retina). The abnormal vessels leak blood or fluid in the macula (central
part of the retina responsible for sharp detailed vision) and can form scars that
cause vision to get worse and may result in permanent blind spots.
A specific protein called vascular endothelial growth factor (VEGF) is involved in
the formation and leakiness of these abnormal blood vessels. SUSVIMO binds to and
blocks the effects of VEGF and interrupts or slows the growth of the abnormal blood
vessels and slows leakage from the blood vessels in your eye.
SUSVIMO can help maintain your vision.
If you have any questions about SUSVIMO, how it works or why this medicine has been
prescribed for you, ask your doctor.
2. What should I know before I am given SUSVIMO?
Warnings
Do not use SUSVIMO if:
you are allergic to ranibizumab, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
If you have or suspect you have an infection in or around your eye.
If you have inflammation in your eye (may be indicated by pain and/or redness)
If you have not received at least two prior injections in the eye for treatment of
your nAMD
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
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
SUSVIMO should not be used during pregnancy unless the potential benefit outweighs
the potential risk to your unborn child.
Check with your doctor if you are pregnant or intend to become pregnant.
Should you become pregnant during treatment your doctor may replace SUSVIMO in the
implant with saline.
Talk to your doctor if you are breastfeeding or intend to breastfeed. SUSVIMO is not
recommended during breastfeeding because it is not known whether SUSVIMO passes into
human milk.
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.
If you are taking medicines that can cause bleeding (such as warfarin, aspirin, and
some pain killers), you may be at an increased risk of bleeding inside the eye. Talk to you doctor about stopping these medicines before your implant is inserted.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SUSVIMO.
4. How is SUSVIMO given?
How much SUSVIMO is given
The recommended dose is 2 mg continuously delivered via the implant.
The implant is refilled every 24 weeks (approximately 6 months) by your doctor.
Depending on how you respond to treatment with SUSVIMO, your doctor may give you additional
injection(s) into your eye (intravitreal injections) of a different form of ranibizumab
within the 24-week refill interval.
How you will be given SUSVIMO
SUSVIMO must only be given using the implant.
An eye surgeon trained in implant procedures will fill the implant with SUSVIMO prior
to surgically inserting the implant in your eye.
Afterwards, the implant will be refilled by your eye doctor at regular intervals.
Your doctor(s) will perform both of these procedures using a local anaesthetic to
numb the eye and will take steps to reduce the risk of infection.
When you will be given SUSVIMO
Your doctor will decide when you will be given SUSVIMO.
How long will you be given SUSVIMO
SUSVIMO is intended as a long-term treatment via the permanent eye implant. Your doctor
will regularly monitor your condition to check that the treatment is having the desired
effect.
While monitoring your condition, your doctor may determine it is necessary to stop
the SUSVIMO refills or to safely remove the implant via surgery.
If you miss a dose (refill) of SUSVIMO
If you miss a dose (refill), schedule a new appointment with your doctor to receive
the refill as soon as possible. Do not wait until the next planned refill.
Before stopping treatment with SUSVIMO
If you are considering stopping SUSVIMO, discuss this with your doctor.
Stopping treatment may increase your risk of vision loss and your vision may worsen.
Discuss suitable alternatives with your doctor, to determine the best treatment for
you.
If you are given too much SUSVIMO
Your doctor will ensure you are given the correct amount of SUSVIMO. If you think
that you have been given too much SUSVIMO, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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 being given SUSVIMO?
Things you should do
If you experience any problems during the treatment, tell your doctor.
Avoid rubbing your eye or touching the area of your eye where the implant is located
as much as possible. If necessary to do so however, make sure your hands are cleaned
prior to touching the eye.
Women who could become pregnant must use effective contraception during treatment
and for at least 12 months after the last time the implant was refilled with SUSVIMO.
Call your doctor straight away if you:
develop signs of inflammation and/or infection of the eye such as redness of the eye,
eye pain, light sensitivity and/or vision changes, seeing flashes of light with floaters
(seeing cobwebs), change in your vision, progressing to a loss of sight or blurred
vision or a red tint to your vision.
A serious eye infection, eye disorder or bleeding within the gel-like substance at
the back of your eye can sometimes develop after being given SUSVIMO.
notice a small bulge in the layer that covers the white part of the eye where the
implant was placed (this may be due to leakage of fluid from the inside of your eye)
which may present as a sudden sensation that something is in your eye or eye discharge
or watering.
notice any changes to your vision, including a decrease in your vision or a decrease
in the sharpness of your vision.
Temporary decrease in vision can occur after the implant insertion procedure.
notice wearing away of or an opening of the stitches leading to a gap in the layer
that covers the white part of your eye. This could lead to exposure of the implant.
Symptoms include a sudden sensation that there is something in your eye, eye discharge
or watering.
notice that the implant has moved out of place.
Remind any doctor or dentist you visit that you are using SUSVIMO.
Things you should not do
Do not stop treatment with SUSVIMO unless your doctor tells you to.
Monitoring and care during your treatment with SUSVIMO
Your doctor will monitor your condition throughout your treatment with SUSVIMO to
allow for prompt medical assistance if necessary. Follow your doctor’s instructions
for how to care for the treated eye. These instructions include but are not limited
to the following:
After the implant insertion procedure:
Keep your head above shoulder level for the rest of the day.
Sleep with your head raised on 3 or more pillows if lying down during the day and
night after your doctor has inserted the implant into your eye.
Do not remove the eye shield from your eye until you are instructed to by your doctor.
At bedtime, continue to wear an eye shield for at least 7 nights following the implant
insertion procedure.
Use all post-operative eye medications as directed by your doctor.
Do not push on or rub your eye, or touch the region of your eye where the implant
is located (i.e. underneath the eyelid in the upper and outer part of your eye) for
30 days following implant insertion
Do not participate in strenuous activities until 1 month after implant insertion or
after discussion with your doctor.
Current and future health care providers should be shown the implant card that you
have received. This is especially important if you need to undergo an MRI as you may
only receive an MRI under specific conditions which your healthcare provider can confirm
by reviewing the information on your implant card.
After the refill procedure:
Do not push on or rub your eye, or touch the region of the eye where the implant is
located (i.e. underneath the eyelid in the upper and outer part of your eye) for 7
days following the refill procedure.
Use antimicrobial eye drops as directed by your doctor.
After the implant removal procedure (if it is deemed medically necessary):
Keep your head above shoulder level for the rest of the day.
Sleep with your head raised on 3 or more pillows if lying down during the day and
night after your implant is removed.
Wear an eye shield for at least 7 nights following the implant removal procedure.
Do not participate in strenuous activities until 14 days following the implant removal
procedure.
Use all post-operative anti-inflammatory and antimicrobial drops, as directed by your
doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SUSVIMO
affects you.
You may not see as well after the implant is surgically inserted or removed from your
eye, after your implant is refilled with SUSVIMO, and after the eye examinations associated
with these procedures. Do not drive or use machines until you receive confirmation
from your doctor and until your eyesight has returned to normal.
Looking after your medicine
It is unlikely that you will have to store SUSVIMO at home. If you have to store it:
Store SUSVIMO in the refrigerator at 2°C to 8°C in the original carton to protect
from light.
Prior to use, the unopened vial may be kept below 30°C for up to 24 hours.
Do not freeze. Do not shake.
Do not use this medicine after the expiry date.
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.
The side effects associated with SUSVIMO may be due to the medicine itself or due
to the implant-related procedures.
Less serious side effects
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Less serious side effects
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What to do
|
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Eye-related:
a defect, scratches or swelling on the surface of the eye; symptoms include eye pain
or tenderness when you touch the eye, hazy circles or "halos" around light, or a gritty
feeling in the eye
bruising around the eye following surgery
redness, pain, swelling, and itching of the eyelids
eye irritation, including burning, stinging, itching, tearing, eye redness, eye pain,
eye discomfort, gritty or scratchy feeling
drooping of the upper eyelid
Procedure related:
pain or discomfort during the procedure or at the site of the procedure
pain, discomfort or swelling after the procedure
headache
nausea
vomiting
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Speak to your doctor if you have any of these 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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Eye related:
bleeding, inflammation or shrinking of the gel-like substance of the eye (vitreous);
symptoms include moving spots (floaters) or "spider webs" in your vision, shadows
in your vision or loss of vision
bleeding, tear or separation of the layer at the back of the eye (retina); symptoms
include blurred vision, a red tint to your vision, flashing lights, shadows in your
side vision, or loss of vision
infection of the eye with inflammation inside the eye; symptoms include worsening
eye pain (in and around the eye) with vision loss, sensitivity to light, or redness
in the white of the eye, eye discharge (including pus)
a sudden sensation that something is in your eye, eye discharge or watering. This
can mean that your implant has moved out of place
inflammation of the coloured part of the eye (iris) or attachment of the iris to other
structures in the eye; symptoms include eye pain, abnormally shaped pupils, loss of
vision, sensitivity to light
a small bulge in the layer that covers the white part of the eye where the implant
is placed
wearing away of the layer that covers the white part of the eye or gap in the layer
that covers the white of the eye near the incision edge (may cause exposure of the
implant)
cloudy vision or difficulty seeing at night
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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.
|
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 SUSVIMO contains
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Active ingredient
(main ingredient)
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ranibizumab
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Other ingredients
(inactive ingredients)
|
Histidine hydrochloride
Polysorbate 20
Sucrose
Water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What SUSVIMO looks like
SUSVIMO solution is in a vial and is a clear to slightly milky, colourless to pale
brown liquid.
SUSVIMO is a solution for injection in the ocular implant. (Aust R 510105).
Who distributes SUSVIMO
SUSVIMO is distributed in Australia by:
Roche Products Pty Ltd
ABN 70 000 132 865
Level 8, 30-34 Hickson Road
Sydney NSW 2000
Medical enquiries: 1800 233 950
This leaflet was prepared in September 2026.