Susvimo
·
- Prescription status not stated
- Eyes and ears
- Active substance
- Ranibizumab
- Used in
- Eyes and ears
- Made by
- Roche Registration GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
nAMD happens when:
- What Susvimo is Susvimo is a medicine that contains the active substance ranibizumab. This belongs to a group of medicines called ‘anti-neovascularisation agents’.
- Susvimo is released into the eye using an eye (ocular) implant.
- What Susvimo is used for Susvimo is used to treat adults with neovascular (wet) age-related macular degeneration (nAMD), who have responded to medicine that attaches to and blocks ‘vascular endothelial growth factor’ (VEGF).
- tiny, abnormal blood vessels grow in the back of the eye (retina).
- these blood vessels leak blood or fluid in the middle part of the retina (the macula) that gives you sharp detailed vision.
- these blood vessels and their bleeding can eventually form scars that can lead to permanent blind spots in the centre of your vision.
- How Susvimo works Susvimo works by attaching to and blocking ‘VEGF’, a protein that can cause the growth of abnormal blood vessels in your eye. This medicine stops or slows the growth and leaking of these blood vessels.
- Susvimo can help maintain and in some cases, improve your vision.
- The medicine is gradually released from the implant into the back of your eye. The implant is inserted in the eye with surgery, and is about the size of a grain of rice. It is filled and refilled with Susvimo by your doctor.
- Where the implant is placed The diagram below shows the refill needle (1) and the implant position in the eye (2). This diagram is not to scale.
From the package leaflet in EMA’s product information, p. 31–32 · 2026-09-24
Do not take it if
- if you are allergic (hypersensitive) to ranibizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have or think you have an infection in or around your eye.
- if you have an inflamed eye - indicated by pain or redness.
- You must not be given Susvimo if any of the above apply to you. If you are not sure, talk to your doctor before having Susvimo.
From the package leaflet in EMA’s product information, p. 32.
How to take it
These directions are for this exact strength and form. Another one is different.
- Before you are given Susvimo your doctor will check that you respond to medicine that attaches to and blocks ‘VEGF’.
- How much and how often Susvimo is given The recommended dose is 2 mg given gradually by the implant.
- The implant is refilled every 24 weeks - roughly 6 months - by your doctor.
- Based on how you respond to treatment with Susvimo, your doctor may give additional injections into your eye in the 24-week refill period.
- How you will be given Susvimo An eye surgeon trained in the implant procedures will fill the implant with Susvimo before inserting the implant in your eye. After, the implant will be refilled by your eye doctor (trained in the refill procedure) at regular times.
- Your doctor(s) will inject medicine, to numb the eye for both of these procedures.
- Your doctor will perform an aseptic or sterile procedure to reduce the risk of infection. See section 2 ‘Monitoring and care during your treatment with Susvimo’.
- Susvimo must only be given using the implant meant for this medicine.
- How long you will keep the implant The implant is intended to remain in the eye, unless removed for medical reasons. Your doctor will keep track of your illness to check the treatment is working properly. They may need to stop the refills of Susvimo or safely remove the implant using surgery (if medically necessary).
- If you miss a dose (refill) of Susvimo If you miss a refill, book a new appointment with your doctor to get 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, make sure you discuss this with your doctor, as they will need to discuss with you about monitoring your eye and the need to retain or remove the implant. Your doctor will discuss other treatments to determine the best one for you. Stopping all treatment may increase your risk of vision loss and your vision may get worse.
- If you have any further questions on the use of this medicine, ask your doctor.
From the package leaflet in EMA’s product information, p. 35.
Warnings and precautions
- Tell your doctor immediately if you have any of these signs during treatment with Susvimo. You may need urgent medical or surgical treatment, or a delay before your next refill:
- more moving spots or “spider webs” in your vision (vitreous haemorrhage).
- a sudden feeling that something is in your eye, eye discharge or watering (conjunctival bleb / conjunctival bleb leak / conjunctival erosion / conjunctival retraction).
- worsening eye pain or vision loss, sensitivity to light or redness in the white of the eye (endophthalmitis).
- flashing lights, a change or loss of vision (retinal tear or detachment).
- clouding of the lens due to injury (traumatic cataract).
- the implant has moved out of place (device dislocation).
- If you get any of the side effects listed above, tell your doctor immediately. You may need urgent medical or surgical treatment, or a pause before your next refill. See section 4, ‘Possible side effects’.
- It is also important for you to know that the safety and efficacy of Susvimo when given in both eyes has not been studied.
- The systemic use of VEGF inhibitors is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events) which may lead to heart attack or stroke, especially if you have certain existing medical conditions.
- Monitoring and care during your treatment with Susvimo Your doctor will monitor your illness and the condition of the implant throughout your treatment with this medicine, to make sure they can quickly give medical assistance if needed. Follow your doctor's instructions for how to care for the treated eye to allow the eye to heal. These instructions include, but are not limited to:
- After the surgery to insert the implant Keep your head above shoulder level for the rest of the day.
- Sleep with your head raised on 3 or more pillows when lying down, that day and night.
- Do not remove the eye shield from the eye, until you are told to by your doctor. At bedtime, continue to wear the eye shield for at least 7 nights after the surgery.
- Take all eye medicines your doctor tells you to.
- Do not push on the eye, rub the eye or touch the area of the eye where the implant is located (for example underneath the eyelid in the upper and outer part of your eye) for 30 days after the implant is inserted.
- Do not participate in strenuous activities, such as running or lifting weights, until 1 month after the implant is inserted, or until your doctor says you can.
- Patient implant card and Magnetic Resonance Imaging (MRI) scan Get the patient implant card from your doctor and keep this card in a safe place for future reference - it has important information about the implant.
- If you need to have an MRI scan, show your healthcare providers the implant card that you have been given.
- You can only have an MRI scan under very specific conditions.
- After the refill procedure Do not push on the eye, rub the eye or touch the area of the eye where the implant is located (for example underneath the eyelid in the upper and outer part of your eye) for 7 days following the refill.
- Take all eye medicines your doctor tells you to.
- After the implant removal procedure (if removal 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 when lying down that day and night.
- Wear an eye shield for at least 7 nights following the removal.
- Do not participate in strenuous activities, such as running or lifting weights, until 14 days after the implant removal procedure.
- Take all eye medicines your doctor tells you to.
- Throughout treatment with Susvimo Do not rub your eye, or touch the area of your eye where the implant is, as much as possible. If you need to, make sure you clean your hands before touching your eye.
- Implant damage During your treatment with Susvimo, the implant may become damaged. If this damage prevents the proper filling of the implant, your nAMD may be inadequately treated and your physician may remove the implant from your eye and/or change your treatment.
- Children and adolescents Susvimo has not been studied in children and adolescents, because nAMD only happens in adults.
From the package leaflet in EMA’s product information, p. 32–34.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. There is no information currently available about using this medicine when you are pregnant. This medicine could harm an unborn baby. If you become pregnant during treatment, your doctor may replace the medicine with preservative-free sodium chloride solution in the implant. Your doctor will discuss this with you. They will only continue your treatment with this medicine if the potential benefits to you outweighs the potential risks to your unborn baby.
- Do not use this medicine while you are breast-feeding because it is not known whether Susvimo passes into human milk. Ask your doctor for advice before treatment.
From the package leaflet in EMA’s product information, p. 34.
Other medicines
- Before you receive Susvimo, tell your doctor if you are taking, have recently taken or might take any other medicines.
- In particular tell your doctor if you are taking any of the following medicines, as their use would be an important consideration for surgery:
- medicines that reduce the formation of blood clots, such as warfarin or low dose acetyl salicylic acid.
- nonsteroidal anti-inflammatory medicines, such as ibuprofen or naproxen.
- If any of the above apply to you (or you are not sure), talk to your doctor before you are given Susvimo.
- Contraception Women who could become pregnant should use effective contraception:
- when being given this medicine, and for at least 12 months after the last time the implant was refilled.
From the package leaflet in EMA’s product information, p. 34.
Driving and using machines
- You may have worse vision for a while after the implant is inserted, removed, refilled with medicine, or after eye examinations.
- Do not drive or use machines until your doctor tells you to remove the eye shield - and the reduced vision is better.
- Susvimo contains polysorbate 20 This medicine contains 0.002 mg polysorbate 20 per 0.02 mL dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
From the package leaflet in EMA’s product information, p. 34–35.
Side effects
- Like all medicines, this medicine can cause side effects, although not everybody gets them.
- The list of possible side effects includes those related to Susvimo, the implant in the eye and the procedures to place, refill and remove the implant.
- Some side effects may be serious Tell your doctor immediately if you notice any of the following serious side effects – you may need urgent medical or surgical treatment, or a delay before your next refill:
- Very common: may affect more than 1 in 10 people.
- Common: may affect up to 1 in 10 people.
- Uncommon: may affect up to 1 in 100 people.
- more moving spots or “spider webs” in your vision. You may have bleeding in the gel-like substance at the back of the eye (vitreous haemorrhage) - common a sudden feeling that something is in your eye, eye discharge or watering. This feeling may mean:
- a small bulge in the layer that covers the white part of the eye (conjunctival bleb) - very common
- fluid leaking creating a blister-like bulge on the surface of the eye (conjunctival bleb leak) - very common
- the layer that covers the white part of your eye is wearing away (conjunctival erosion), which can expose the implant - common
- stitches are opening to make a gap in the layer that covers the white of the eye (conjunctival retraction). This could expose the implant - common worsening eye pain with vision loss, sensitivity to light, or redness in the white of the eye. This might be an infection of the eyeball with inflammation inside of the eye (endophthalmitis) - common flashing lights, a change or loss of vision. This may mean:
- You have a hole or tear in the layer (the retina) in the back of the eye that senses light (retinal tear) - uncommon
- You have separation of the layer (the retina) in the back of the eye where light is sensed (retinal detachment) - common clouding of the lens of the eye due to injury (traumatic cataract) - uncommon the implant has moved out of place (device dislocation) - common If you notice any of the serious side effects above, tell your doctor immediately.
- Other side effects Most of the side effects are mild to moderate.
- Tell your doctor if any of the following side effects become severe:
- Very common: may affect more than 1 in 10 people blood in the layer that covers the white of the eye (conjunctival haemorrhage)
- redness in the layer that covers the white of the eye (conjunctival hyperaemia)
- inflammation of the coloured part of the eye (iritis)
- eye pain clouding of the lens of the eye (cataract)
- moving spots in the vision (vitreous floaters)
- headache implant damage Common: may affect up to 1 in 10 people bleeding at the back of the eye sensation that something is in the eye eye irritation or discomfort - burning, stinging, itching, tearing, redness nausea, vomiting lowered pressure inside the eye when the gel-like substance at the back of the eye (vitreous) shrinks and separates from the layer (retina) at the back of the eye that senses light (vitreous detachment)
- vision blurred or less sharp swelling of the eyelid, clear part at the front of the eye or the layer that covers the white part of the eye inflammation of the eyelid - redness, pain, swelling and itching of the eyelids or eyelid scales scratched eye surface (corneal abrasion)
- drooping of the upper eyelid itchy eyes thinning of the white part of the eye defect of the clear part (cornea) at the front of the eye eye discharge, increased production of tears, or watering eyes eyes feeling more sensitive to light infection of the layer that covers the white of the eye (conjunctivitis)
- pain during the procedure inflammation of the gel-like substance at the back of the eye (vitritis)
- separation of the layer of blood vessels from underneath the white part of the eye (choroidal detachment)
- bruising around the eye following surgery blood in front of the coloured part (the iris) of the eye inflammation of the coloured part of the eye (the iris) and its nearby tissue thinning of the layer that covers the white part of the eye attachment of the coloured part of the eye (the iris) to other structures in the eye (iris adhesions)
- defect of the layer that covers the white part of the eye Uncommon: may affect up to 1 in 100 people cloudiness of the implant redness in the white part of the eye exposed stitches – or other problems after the implant procedure discomfort after a refill at or near where the implant is, or discomfort after the procedure scar tissue formation where the implant was inserted (fibrosis)
- a reaction (for example swelling) at or near where the implant is foreign object in the eye swelling after the procedure If any of these side effects become severe, please tell your doctor.
- Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.
- By reporting side effects, you can help provide more information on the safety of this medicine.
From the package leaflet in EMA’s product information, p. 35–37.
How to store it
- The following information is intended for healthcare professionals.
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
- Store in a refrigerator (2 °C – 8 °C).
- Do not freeze.
- Keep the vial in the outer carton in order to protect from light.
- Prior to use, the unopened vial may be kept at 9 °C to 30 °C for up to 24 hours.
From the package leaflet in EMA’s product information, p. 37–38.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Roche Registration GmbH |
|---|---|
| Active substance | Ranibizumab |
| Used in | Eyes and ears |
| Classification | S01LA04 · Eyes and ears |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2026-09-18 |
| Last updated by the regulator | 2026-09-24 |
| EMA product number | EMEA/H/C/006527 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.