Pagenax Dosage/Direction for Use

Dosage regimen: Single-use vial for intravitreal use only. Each vial should only be used for the treatment of a single eye.
Pagenax must be administered by a qualified physician.
General target population: The recommended dose for Pagenax is 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first three doses. Thereafter, Pagenax is administered every 12 weeks (3 months). The physician may individualize treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. The treatment interval could be as frequent as every 8 weeks (2 months) (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Special populations: Renal impairment: No dosage regimen adjustment is required in patients with renal impairment (see Pharmacology under Actions).
Hepatic impairment: No dosage regimen adjustment is required in patients with hepatic impairment (see Pharmacology under Actions).
Pediatric patients (below 18 years): The safety and efficacy of Pagenax in pediatric patients have not been established.
Geriatric patients (65 years or above): No dosage regimen adjustment is required in patients 65 years or above.
Method of administration: As with all medicinal products for intravitreal use, Pagenax should be inspected visually prior to administration (see Instructions for use under Patient Counselling Information).
The injection procedure must be carried out under aseptic conditions, which include 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. Patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see Contraindications). Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
For information on preparation of Pagenax, see Instructions for use under Patient Counselling Information.
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 center of the globe. The injection volume of 0.05 mL is then delivered slowly; a different scleral site should be used for subsequent injections.
The safety and efficacy of Pagenax administered to both eyes concurrently have not been studied.