Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, Grenzach-Wyhlen, 79639, Germany
Vabysmo is indicated for the treatment of adult patients with:
This medicinal product must be administered by a qualified physician experienced in intravitreal injections. Each vial should only be used for the treatment of a single eye.
The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 4 doses.
Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 20 and/or 24 weeks after treatment initiation so that treatment can be individualised. In patients without disease activity, administration of faricimab every 16 weeks (4 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) or 12 weeks (3 months) should be considered. There is limited safety data on treatment intervals of 8 weeks or less between injections. Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion, but there is no requirement for monthly monitoring between injections.
The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 4 doses.
Thereafter, treatment is individualised using a treat-and-extend approach. Based on the physician’s judgement of the patient’s anatomic and/or visual outcomes, the dosing interval may be extended up to every 16 weeks (4 months), in increments of up to 4 weeks. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate (see section 5.1). Treatment intervals shorter than 4 weeks between injections have not been studied. Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion, but there is no requirement for monthly monitoring between injections.
This medicinal product is intended for long-term treatment. If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, treatment should be discontinued.
If a dose is delayed or missed, the patient should return to be assessed by physician at the next available visit and continue dosing depending on physician’s discretion.
No dose adjustment is required in patients aged 65 years or above (see section 5.2). Safety data in nAMD patients over 85 years is limited (see section 4.4).
No dose adjustment is required in patients with renal impairment (see section 5.2).
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
There is no relevant use of this medicinal product in the paediatric population for the indications of nAMD and DME.
For intravitreal use only.
Vabysmo should be inspected visually for particulate matter and discoloration prior to administration, and if present, the vial should not be used.
The intravitreal injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, a sterile drape and a sterile eyelid speculum (or equivalent). The patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.8). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
The injection needle should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 mL is then delivered slowly; a different scleral site should be used for subsequent injections.
After injection, any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, sterile equipment for paracentesis should be available.
Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g. vision loss, eye pain, redness of the eye, photophobia, blurring of vision) without delay.
For instructions on handling of the medicinal product before administration, see section 6.6.
Overdosing with greater than recommended injection volume may increase intraocular pressure. In the event of overdose, IOP should be monitored and, if deemed necessary by the treating physician, appropriate treatment should be initiated.
30 months.
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 room temperature, 20°C to 25°C, for up to 24 hours.
Ensure that the injection is given immediately after preparation of the dose.
0.24 mL sterile, solution in a glass vial with a coated rubber stopper sealed with an aluminum cap with a yellow plastic flip-off disk.
Pack size of 1 vial and 1 blunt transfer filter needle (18-gauge x 1½ inch, 1.2 mm x 40 mm, 5 µm).
Do not shake.
The vial contains more than the recommended dose of 6 mg. The fill volume of the vial (0.24 mL) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the vial results in overdose. The injection dose must be set to the 0.05 mL dose mark, i.e. 6 mg faricimab.
Vabysmo should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the vial must not be used.
The contents of the vial and the transfer filter needle are sterile and for single use only. Do not use if the packaging, vial and/or transfer filter needle are damaged or expired. Detailed instructions for use are provided in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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