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 particular full CMI for further information.

Why am I being given VABYSMO?

VABYSMO contains the active ingredient faricimab. VABYSMO is used to treat the following eye disorders:

neovascular (wet) age-related macular degeneration (nAMD).

diabetic macular oedema (DMO)

What should I know before I am given VABYSMO?

You must not be given VABYSMO if you have ever had an allergic reaction to faricimab or any of the ingredients listed at the end of this CMI.

You must not be provided VABYSMO if you have an infection in or around your eye, or even inflammation in your vision.

Talk to your doctor if you have any other medical conditions, take any kind of other medicines, or are pregnant or plan in order to become pregnant or are breastfeeding.

Exactly what if We are taking other medicines?

Some medicines may interfere with VABYSMO and affect how it works.

How is VABYSMO given?

VABYSMO must be injected into your attention every month for the first 4 months. Thereafter, the particular frequency from the ongoing injections will be determined by your own doctor.

What should We know while I am being given VABYSMO?

Things you should do

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

Women who could become pregnant should use effective contraception during treatment and for in least 3 months after the last injection of VABYSMO.

Driving or even using machines

A person may not really see as well after you are given VABYSMO and after the associated eye examinations. This is temporary. Do not drive or make use of 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, keep it in the refrigerator from 2°C to 8°C (do not freeze) in the outer carton.

Are there any side effects?

Common negative effects may include eye pain, watery eyes, moving spots (floaters) or shadows in your vision

Serious unwanted effects might include gradual or sudden decrease or changes in your vision, unexpected onset of eye pain, a higher number of spots in the front of the vision (floaters), increased sensitivity to light, red tint in order to your vision, blood or even redness of your eye, small marks or scratches on the eye surface with discomfort or tenderness when you touch the eye, gritty feeling within the eye.

This medicine is subject to additional monitoring. This will allow quick identification associated with new safety information. You can help by reporting any kind of side effects you may get. You can report side results to your doctor, or directly at www.tga.gov.au/reporting-problems  .

Active ingredient(s): faricimab

Consumer Medicine Information (CMI)

This leaflet provides important information about using VABYSMO. You should also speak to your doctor or even pharmacist if you would like further information or if you have any concerns or questions about using VABYSMO.

Where to find info in this booklet:

Why am I being given VABYSMO?

VABYSMO contains the active ingredient faricimab.

Faricimab belongs to a group of medicines called antineovascularisation agents.

VABYSMO is injected into the attention by your own doctor to treat adults with the particular following eyesight disorders:

neovascular (wet) age-related macular degeneration (nAMD).

diabetic macular oedema (DMO)

Both these conditions affect the macula, the central part of the retina (the light-sensitive layer at the back of the eye) that is responsible for sharp, detailed vision.

nAMD is caused when tiny, abnormal blood vessels grow in the particular retina. The abnormal vessels leak bloodstream or fluid in the macula and can form scars that cause eyesight to get worse and may result in permanent blind places.

DMO will be caused by leaky blood vessels that will cause swelling from the macula.

How VABYSMO works

VABYSMO specifically recognises and blocks the activity associated with proteins known as angiopoietin-2 and vascular endothelial growth factor A. When these proteins are present in higher levels than normal, they can cause the growth of abnormal bloodstream and damage to the normal vessels, with leakage in to the retina. This causes swelling of the retina or damage in order to the layers from the retina, which can negatively affect vision. By attaching to these proteins, VABYSMO can block their actions and may improve disease and/or slow down worsening associated with the disease, thereby maintaining your eyesight.

If you have any queries about VABYSMO, how it works or why this medicine has been prescribed with regard to you, ask your physician.

What ought to I know before I am given VABYSMO?

Warnings

Do not use VABYSMO if:

you are allergic to faricimab, or any of the particular ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medication.

Some symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; inflammation of the face, lips, tongue or other parts from the body; rash, itching or even hives around the skin.

In case you have or suspect you have an infection in or around your eye.

For those who have inflammation in or around your eye (may be indicated by pain and/or redness)

Check with your doctor if a person:

have any other medical conditions

take any medicines for any kind of other condition

have glaucoma (an eyes condition usually brought on by high pressure within the eye)

have a history of seeing flashes of light or floaters (dark floating spots) or if you have a sudden increase in the size and number of floaters

have had eye surgery in the last four weeks or even if eye surgery is usually planned in the next four weeks.

have ever had any eye diseases or vision treatments

have had a stroke or experienced any signs of a stroke, such as weakness or paralysis associated with limbs or even face, problems speaking

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 part effects ?

Pregnancy and breastfeeding

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

Check with your doctor if you are pregnant or intend to become pregnant.

Should a person get pregnant during treatment along with VABYSMO, tell your physician.

Women who are able to become expecting should use effective contraception during treatment and for in least 3 months after your own last injection of VABYSMO.

Talk to your doctor if you are breastfeeding a baby or intend to breastfeed. VABYSMO is not recommended throughout breastfeeding because it is definitely not known whether VABYSMO passes into human milk.

What if We are taking some other medicines?

Tell your doctor or pharmacist in case you are taking any other medicines, including any medications, vitamins or even supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Seek advice from your physician or pharmacist if you are not sure about what medicines, vitamins or supplements a person are taking and in case these affect VABYSMO.

How is VABYSMO given?

How much VABYSMO is given

The recommended dose is 6 mg (0. 05 mL) of VABYSMO, injected into your attention every month regarding the first 4 months.

Thereafter, you may receive injections into your eye up to every 4 weeks.

The frequency of shots will be determined by your own doctor.

How you will end up being given VABYSMO

VABYSMO can be injected directly into your eyesight (intravitreal injections) by the doctor skilled in giving eye injections.

When you will certainly be given VABYSMO

VABYSMO is shot into your eye each month for the first 4 months.

Thereafter, you may receive shots into the eyes up to every single 4 a few months.

The rate of recurrence of injections will be determined by your physician.

Depending on how you respond to therapy with VABYSMO, your doctor may inquire you in order to change to a more or less frequent dose.

How long will you be given VABYSMO

VABYSMO is intended as a long-term treatment. Your doctor may regularly keep track of your condition in order to check that the treatment is having the desired effect.

If you miss a dose of VABYSMO

If you miss the dose, schedule a new appointment with your physician as soon as possible. Do not wait until the next planned dose.

Before stopping treatment with VABYSMO

If you are considering stopping treatment with VABYSMO, discuss this along with your doctor.

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

Discuss suitable alternatives together with your physician, to determine the best treatment for you.

If you are given too much VABYSMO

Your doctor will ensure you are given the correct amount of VABYSMO. If you think that you have been given too much VABYSMO, a person may need urgent medical attention.

You should immediately:

phone the particular Poisons Information Centre
( by calling 13 11 26 ), or

contact your doctor, or

go to the Emergency Department at your nearest hospital.

You ought to do this even if there are no indications of discomfort or even poisoning.

What should I know while being given VABYSMO?

Things you should do

If you experience any problems during the therapy, tell your medical doctor.

Call your own doctor straight away or visit the emergency department if an individual:

develop sudden vision reduction or change in eyesight

develop signs of a possible eye infection or inflammation, such as worsening redness of the eye or blood in and around typically the eye, eye pain, increased eye discomfort, blurred or perhaps decreased perspective, an improved quantity of floaters (small particles) within your eye-sight, increased sensitivity to light

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

Things need to not do:

Do not stop remedy with VABYSMO unless your current doctor tells you to.

Stopping treatment method may increase your risk associated with vision damage and the vision might worsen.

It is important for you to know that:

there is no information about injecting VABYSMO into both eyes in the same time. Use in this way may lead to an increased risk of experiencing side effects.

injections using VABYSMO may possibly cause a temporary increase in eye pressure (intraocular pressure) in some patients within 60 minutes regarding the injection. Your medical professional will monitor this after each shot.

• your health practitioner will check whether you have other risk factors that may well increase the chance of a tear as well as detachment of one of this layers from the back of the eye, in which case VABYSMO must be given having caution.

There is the risk involving blood clots blocking bloodstream vessels, which may lead to a heart attack or stroke with intravitreal injections connected with VABYSMO. However, this is a theoretical risk. Go to your own personal nearest emergency room immediately if you experience signs of a stroke, such as weakness or paralysis with limbs or even face or perhaps difficulty speaking.

Monitoring and care during your cure with VABYSMO

Your doctor will monitor your personal condition throughout your treatment with VABYSMO to allow for prompt medical assistance if necessary. Follow your doctor’s instructions for how to care for often the treated vision. These instructions include but are not really limited to your following:

Driving or using machines

Be careful before you drive or use any machines or tools until you know how VABYSMO affects a person.

You may not see as well after VABYSMO is injected into your eye and after the attention examinations associated with VABYSMO. Usually do not drive or maybe use devices until your own eyesight has returned to normal.

Looking after your medicine

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

Store VABYSMO in the refrigerator at 2°C to 8°C in the exact original carton to protect from light.

Prior to use, the unopened vial may be kept with 20°C to be able to 25°C for up to 24 hours.

Tend not to freeze. Never shake.

Do not use this medicine after the expiry date.

Any kind of side effects?

All medicines can have side results. If you do encounter any part effects, most of them are minor plus temporary. Nevertheless, some aspect effects may need medical attention.

See the information below in addition to, if an individual need for you to, ask your current doctor as well as pharmacist in case you have any further questions about side effects.

Less serious area effects

Serious side outcomes

Tell your health care provider or pharmacist if anyone notice anything else that could be making you feel unwell.

Other negative effects not listed here may occur in some people.

Reporting unwanted effects

After you have received medical advice for any side affects you experience, you can report side effects to help the Therapeutic Goods Administration online on www.tga.gov.au/reporting-problems  . By reporting negative effects, you can help provide more information on the safety of this medicine.

Always make sure you confer with your doctor or pharmacologist before you decide to stop taking any kind of the medicines.

Product details

This medicine is only available with a doctor’s prescription.

What VABYSMO contains

Active ingredient

(main ingredient)

faricimab

Other ingredients

(inactive ingredients)

Histidine

Acetic acid

Methionine

Polysorbate 20

Sodium chloride

Sucrose

Water for injections

Usually do not take this particular medicine if you usually are allergic to any of these ingredients.

What VABYSMO looks like

VABYSMO solution is in a vial and is a clear to slightly milky, colourless to pale brown liquid.

Each VABYSMO carton consists of one glass vial and even one sterile 5 µm blunt transfer filter needle (18-gauge x 1½ inch, 1. 2 mm x 40 mm).

VABYSMO is a solution with regard to injection regarding intravitreal make use of (Aust R 369935).

Who distributes VABYSMO

VABYSMO 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 08 August 2022.

Leave a Reply

Your email address will not be published.