Active Ingredient: Faricimab
Branch RVO or central RVO.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravitreal, 6 milligrams faricimab, once every 4 weeks, 3 doses in total. Afterwards, intravitreal, 6 milligrams faricimab, once every 4 to 16 weeks.
The recommended dose is 6 mg administered by intravitreal injection every 4 weeks (monthly); 3 or more consecutive, monthly injections may be needed.
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 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. Treatment intervals shorter than 4 weeks and longer than 4 months 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. Safety data in RVO patients over 85 years is limited.
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. 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 is then delivered slowly; a different scleral site should be used for subsequent injections.
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.
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