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WHAT IS VABYSMO? | VABYSMO

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What Is VABYSMOPatient ResourcesCommunity SupportContact UsHealthcare
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What Is VABYSMOPatient ResourcesCommunity SupportContact USHealthcare
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WHAT IS VABYSMO® ?

VABYSMO is a registered medicine in New Zealand that your doctor injects into
your eye, in order to treat eye diseases called:

 * neovascular age-related macular degeneration (nAMD or wet AMD)
 * diabetic macular oedema (DME)

Ask your doctor if VABYSMO is right for you

 * VABYSMO specifically recognises and blocks the activity of two proteins known
   as vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2).
   High levels of these proteins can lead to leakage and swelling in the eye.
 * VABYSMO has shown promising results in improving vision and maintaining
   vision gains through the first year in both nAMD and DME*
 * After initial starting doses, it's possible to go up to 4 months
   injection-free.

* In clinical trials, patients with nAMD gained an average of 5 letters on a
visual acuity test at 1 month after treatment with VABYSMO. On average, patients
gained and maintained 6 letters over 1 year 1. Patients with DME gained an
average of 6 letters on a visual acuity test at 1 month after treatment with
VABYSMO. On average, patients gained 11 letters over 1 year 2.

For further information on VABYSMO, please talk to your health professional or
visit www.medsafe.govt.nz for VABYSMO Consumer Medicine Information.


HOW DO I ACCESS VABYSMO IN NEW ZEALAND?

VABYSMO is not a PHARMAC funded medicine. This means you will need to pay for it
privately.

If you have health insurance, carefully check what is covered under your policy
- every health insurance provider and policy has different benefits that cover
various treatments and procedures.

Roche also offers support through a Cost Share Programme. The VABYSMO Cost Share
Programme provides the opportunity to understand VABYSMO's benefits by assisting
with the cost of your medicine.

For more information, please ask your doctor about the cost of the medicine and
other fees that may apply.


EYE AFFECTED WITH WET AMD


EYE AFFECTED WITH DME

For more information on VABYSMO, please talk to your healthcare professional.


HOW DOES VABYSMO WORK?

VABYSMO specifically recognizes and blocks the activity of proteins known as
Ang-2 and VEGF-A.

In conditions like wet AMD and DME, these proteins can be present at high
levels, and this can cause the growth of abnormal blood vessels and/or damage to
the normal vessels.

The abnormal and damaged blood vessels leak into the retina causing swelling or
damage to the retina. This can make your vision worse.

VABYSMO attaches to these proteins and can block their actions, and prevent
abnormal vessel growth, leakage and swelling.


ASK YOUR DOCTOR IF VABYSMO IS RIGHT FOR YOU


IS THERE ANYTHING I SHOULD TELL MY DOCTOR BEFORE TREATMENT WITH VABYSMO?

If any of the following apply to you, tell your doctor as you should not be
given VABYSMO:

 * You have an active or suspected infection in or around the eye.
 * You have pain or redness in your eye (eye inflammation).
 * You are allergic to faricimab or any of the other ingredients in VABYSMO.

To help avoid side effects and ensure proper use, you should talk to your
healthcare professional before you take VABYSMO. Talk about any health
conditions you have, including if you:

 * have glaucoma (an eye condition usually caused by high pressure in the eye);

 * have a history of seeing flashes of light or floaters (dark floating spots)
   and if you have a sudden increase in the size and number of floaters;
 * have had eye surgery in the last four weeks or if eye surgery is planned in
   the next four weeks;
 * have ever had any eye diseases or eye treatments;
 * have had a stroke or experienced transient signs of stroke (weakness or
   paralysis of limbs or face, difficulty speaking or understanding);
 * are pregnant or planning to become pregnant;
 * are breastfeeding.

Tell your healthcare professional about all the medicines you take, including
any drugs, vitamins, minerals, natural supplements or alternative medicines.


WHAT ARE POSSIBLE SIDE EFFECTS FROM USING VABYSMO?

All medicines, including VABYSMO, 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 ask your
doctor if you have any further questions about the risk of side effects,
including any that are not listed here.

Possible common side effects include:
 * eye pain
 * burning, stinging, itching, redness, gritty or scratchy feeling
 * blurred, cloudy or decreased sharpness of vision or yellowing of colours
 * increased production of tears or watering eyes or eye discharge
 * a sensation that something is in your eye
 * moving spots (floaters) or shadows in your vision
 * small or distorted pupil

Speak to your doctor if you have any of these side effects and they worry you.

Serious side effects
 * Pain, redness or blood around the colored part of the eye bleeding into the
   eye causing a red tint to your vision
 * blood or redness in the white part of the eye
 * increase in eye pressure – symptoms include severe headache, eye pain, nausea
   and vomiting, blurred vision, eye redness
 * scratch to the clear part at the front of the eye
 * inflammation of the gel-like substance at the back of the eye – symptoms
   include hazy vision or a marked increase in floaters
 * sudden onset of the following: eye pain, increased discomfort, worsening eye
   redness, a higher number of floaters in your vision, or increased sensitivity
   to light – these are signs of a possible eye infection or inflammation
 * decrease or change in your vision which can be sudden or gradual, including
   dim vision, difficulty with vision at night, fading sudden, brief flashes of
   light which is more likely to occur when you move your eye, heavy feeling in
   the eye.

Call your doctor immediately, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.


WHAT SHOULD I KNOW WHILE BEING GIVEN VABYSMO?

Things you should do:

 * If you experience any problems during the treatment, tell your doctor.

Call your doctor straight away if you:

 * develop sudden vision loss or change in vision
 * develop signs of a possible eye infection or inflammation, such as worsening
   redness of the eye, eye pain, increased eye discomfort, blurred or decreased
   vision, an increased number of floaters (small particles) in your vision,
   increased sensitivity to light

Remind any doctor or dentist you visit that you are using VABYSMO.

Things you should not do:

 * Do not stop treatment with VABYSMO unless your doctor tells you to.

Stopping treatment may increase your risk of vision loss and your vision may
worsen.

It is important for you to know that:

 * there is no information about injecting VABYSMO into both eyes at the same
   time. Use in this way may lead to an increased risk of experiencing side
   effects.
 * injections with VABYSMO may cause a temporary increase in eye pressure
   (intraocular pressure) in some patients within 60 minutes of the injection.
   Your doctor will monitor this after each injection.
 * your doctor will check whether you have other risk factors that may increase
   the chance of a tear or detachment of one of the layers at the back of the
   eye, in which case VABYSMO must be given with caution.
 * There is a risk of blood clots blocking blood vessels, which may lead to a
   heart attack or stroke with intravitreal injections of VABYSMO. However, this
   is a theoretical risk.

Go to your nearest emergency room immediately if you experience signs of a
stroke, such as weakness or paralysis of limbs or face or difficulty speaking.

Monitoring and care during your treatment with VABYSMO

Your doctor will monitor your condition throughout your treatment with VABYSMO
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:

Driving or using machines

You may not see as well after Vabysmo is injected into your eye and after the
eye examinations associated with Vabysmo. Do not drive or use machines until
your eyesight has returned to normal

Looking after your medicine

It is unlikely that you will have to store VABYSMO at home. If you have to store
it:

 * Store VABYSMO 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 at 20°C to 25°C for up to 24
   hours.
 * Do not freeze. Do not shake.
 * Do not use this medicine after the expiry date.


THIS WEBSITE HAS

A VABYSMO Patient/Caregiver Guide that you can download

VIEW NOW

An audio version of the VABYSMO Patient/Caregiver Guide

LISTEN NOW
See Patient Resources
The website contains information for educational purposes only. It is not
intended to replace the advice of your doctor or other healthcare professionals.
If you have questions about your treatment or condition, please talk to your
doctor.

REFERENCES

 1. Heier, J. S., Khanani, A. M., Quezada Ruiz, et al. Efficacy, durability, and
    safety of intravitreal faricimab up to every 16 weeks for neovascular
    age-related macular degeneration (TENAYA and LUCERNE): two randomised,
    double-masked, phase 3, non-inferiority trials. Lancet 2022: 399(10326):
    729–740.
 2. Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of
    intravitreal faricimab with extended dosing up to every 16 weeks in patients
    with diabetic macular oedema (YOSEMITE and RHINE): two randomised,
    double-masked, phase 3 trials. Lancet 2022: 399(10326): 741–755.

VABYSMO® (faricimab) 120 mg/mL solution for injection for intravitreal use is a
Prescription Medicine for the treatment of neovascular (wet) age-related macular
degeneration (nAMD) and diabetic macular oedema (DMO).

VABYSMO has risks and benefits. Possible common side effects include: eye pain,
burning, stinging, itching, redness, gritty or scratchy feeling; blurred, cloudy
or decreased sharpness of vision or yellowing of colours; increased production
of tears or watering eyes or eye discharge; a sensation that something is in
your eye; moving spots (floaters) or shadows in your vision; small or distorted
pupil.

Do not use VABYSMO if: you are allergic to faricimab. 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 or around
your eye (may be indicated by pain and/or redness).

Tell your doctor if you: experience any problems during the treatment.

You may not see as well after you are given VABYSMO and after the associated eye
examinations. This is temporary. Do not drive or use machines until your
eyesight has returned to normal.

VABYSMO should not be used during pregnancy unless the potential benefit
outweighs the potential risk to your unborn child.

Call your doctor straight away or go to your nearest Accident and Emergency
Centre if you notice any of the following: sudden vision loss or change in
vision; signs of a possible eye infection or inflammation, such as worsening
redness of the eye or blood in and around the eye, eye pain, increased eye
discomfort, blurred or decreased vision, an increased number of floaters (small
particles) in your vision, increased sensitivity to light; you experience signs
of a stroke, such as weakness or paralysis of limbs or face or difficulty
speaking.

Use only as directed. If symptoms continue or you have side effects, see your
healthcare professional.

For more information about VABYSMO talk to your health professional; or visit
medsafe.govt.nz for VABYSMO Consumer Medicine Information; or visit roche.co.nz
or call Roche on 0800 276 243.

Ask your doctor if VABYSMO is right for you.

VABYSMO is an unfunded medicine for nAMD and DMO. Ask your health professional
about the cost of the medicine and other fees that may apply.

^TOP
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© 2023, Roche Products (New Zealand) Limited, Auckland. For more information
about Roche, please visit www.roche.co.nz. This site contains information on
VABYSMO which is intended for New Zealand audiences.
Please be aware that we do not take any responsibility for accessing such
information which may not comply with any legal process, regulation,
registration or use in the country of your origin. Access to this site is
subject to the terms in our Legal and Privacy Statement. You accept these terms
by continuing to access this site.

M-NZ-00000742/MR9719/NOV2023. This site was last updated NOV 2023.



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