Posology : מינונים

4.2    Posology and method of administration

Beovu must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Posology
The recommended dose is 6 mg brolucizumab (0.05 ml solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. Thereafter, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. A disease activity assessment is suggested 16 weeks (4 months) after treatment start. In patients without disease activity, treatment every 12 weeks (3 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) should be considered (see sections 4.4 and 5.1).

If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, BEO API July 24 V4_IL country specific              Page 1 of 14
Beovu should be discontinued.

Special populations
Elderly
No dosage adjustment is required in patients aged 65 years or above (see section 5.2).

Renal impairment
No dosage adjustment is required in patients with renal impairment (see section 5.2).
Hepatic impairment
Brolucizumab has not been studied in patients with hepatic impairment. No dosage adjustment is required in patients with hepatic impairment (see section 5.2).

Paediatric population
The safety and efficacy of brolucizumab in children and adolescents below 18 years of age have not been established. No data are available.

Method of administration

Beovu is for intravitreal use only.
The solution for injection should be inspected visually prior to administration (see section 6.6).

The intravitreal injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent). Sterile paracentesis equipment should be available as a precautionary measure. The patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.3). 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.

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. eye pain, redness of the eye, photophobia, blurring of vision) without delay.

Pre-filled syringe
The pre-filled syringe is for single use only. Each pre-filled syringe should only be used for the treatment of a single eye.

Since the volume contained in the pre-filled syringe (0.165 ml) is greater than the recommended dose (0.05 ml), a portion of the volume contained in the pre-filled syringe must be discarded prior to administration.

Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the air bubble along with excess medicinal product, the plunger should be slowly depressed until the edge below the dome of the rubber stopper is aligned with the 0.05 ml dose mark (equivalent to 50 µl, i.e. 6 mg brolucizumab).

Vial
The vial is for single use only. Each vial should only be used for the treatment of a single eye.

BEO API July 24 V4_IL country specific         Page 2 of 14
Since the volume contained in the vial (0.23 ml) is greater than the recommended dose (0.05 ml), a portion of the volume contained in the vial must be discarded prior to administration.

Injecting the entire volume of the vial could result in overdose. To expel the air bubble along with excess medicinal product, the air should be carefully expelled from the syringe and the dose adjusted to the 0.05 ml mark (equivalent to 50 µl, i.e. 6 mg brolucizumab).

For instructions on preparation of the medicinal product before administration, see section 6.6.