Active Ingredient: Faricimab
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravitreal, 6 milligrams faricimab, once every 4 weeks, 4 doses in total, over the duration of 20 to 24 weeks. Afterwards, intravitreal, 6 milligrams faricimab, once every 16 weeks.
Regimen B: Intravitreal, 6 milligrams faricimab, once every 4 weeks, 4 doses in total, over the duration of 20 to 24 weeks. Afterwards, intravitreal, 6 milligrams faricimab, once every 8 weeks.
Regimen C: Intravitreal, 6 milligrams faricimab, once every 4 weeks, 4 doses in total, over the duration of 20 to 24 weeks. Afterwards, intravitreal, 6 milligrams faricimab, once every 12 weeks.
The recommended dose is 6 mg 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. 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. 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.
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 nAMD 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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