Visual impairment due to diabetic macular oedema (DME)

Active Ingredient: Faricimab

Indication for Faricimab

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

For this indication, competent medicine agencies globally authorize below treatments:

6 mg every 4 weeks for the first 4 doses, thereafter the dosing interval may be extended up to every 16 weeks in increments of up to 4 weeks

For:

Dosage regimens

Intravitreal, 6 milligrams faricimab, once every 4 weeks, 4 doses in total. Afterwards, intravitreal, 6 milligrams faricimab, once every 4 to 16 weeks.

Detailed description

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. 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.

Duration of treatment

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.

Delayed or missed dose

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.

Elderly

No dose adjustment is required in patients aged 65 years or above.

Dosage considerations

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.

Active ingredient

Faricimab

Faricimab is a humanised bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of two distinct pathways by neutralisation of both angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A). By dual inhibition of Ang-2 and VEGF-A, faricimab reduces vascular permeability and inflammation, inhibits pathological angiogenesis and restores vascular stability.

Read more about Faricimab

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