Accentrix Dosage/Direction for Use

Dosage regimen: Single-use vial (adults and preterm infants) for intravitreal use only. Use of more than one injection from a vial can lead to product contamination and subsequent ocular infection.
Accentrix must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Posology: Adults: The recommended dose for Accentrix in adults is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 mL. The interval between two doses injected into the same eye should not be shorter than one month.
Treatment in adults is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity i.e. no change in visual acuity and in other signs and symptoms of the disease under continued treatment. In patients with wet AMD, DME, PDR, and RVO, initially, three or more consecutive, monthly injections may be needed.
Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters.
If, in the physician's opinion, visual and anatomic parameters indicate that the patient is not benefiting from continued treatment, Accentrix should be discontinued.
Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME. For PDR and RVO, treatment intervals may also be gradually extended, however there are insufficient data to conclude on the length of these intervals. If disease activity recurs, the treatment interval should be shortened accordingly.
The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity. Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection. For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year (see PHARMACOLOGY under Actions).
Ranibizumab and laser photocoagulation in DME and in macular oedema secondary to BRVO: There is some experience of ranibizumab administered concomitantly with laser photocoagulation (see Pharmacology: PHARMACODYNAMICS under Actions). When given on the same day, ranibizumab should be administered at least 30 minutes after laser photocoagulation. ranibizumab can be administered in patients who have received previous laser photocoagulation.
Ranibizumab and verteporfin photodynamic therapy in CNV secondary to PM: There is no experience of concomitant administration of ranibizumab and verteporfin.
Preterm infants: The recommended dose for Accentrix in preterm infants is 0.2 mg given as an intravitreal injection. This corresponds to an injection volume of 0.02 ml. In preterm infants treatment of ROP is initiated with a single injection per eye and may be given bilaterally on the same day.
In total, up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity. Most patients (78%) in the clinical study received one injection per eye. The administration of more than three injections per eye has not been studied. The interval between two doses injected into the same eye should be at least four weeks.
Special populations: Hepatic impairment: Ranibizumab has not been studied in patients with hepatic impairment. However, no special considerations are needed in this population.
Renal impairment: Dose adjustment is not needed in patients with renal impairment (see Pharmacology: PHARMACOKINETICS under Actions).
Elderly: No dose adjustment is required in the elderly. There is limited experience in patients older than 75 years with DME.
Pediatric population: The safety and efficacy of ranibizumab in children and adolescents below 18 years of age for indications other than retinopathy of prematurity have not been established. Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in Pharmacology: Pharmacodynamics: CLINICAL STUDIES under Actions but no recommendation on a posology can be made.
Method of administration: As with all medicinal products for parenteral use, Accentrix should be inspected visually for particulate matter and discoloration prior to administration.
The 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 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, in accordance with local practice.
For information on preparation of Accentrix, see INSTRUCTIONS FOR USE AND HANDLING under Cautions for Usage.
In adults, 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; the scleral site should be rotated for subsequent injections.
In preterm infants, the injection needle should be inserted 1.0 to 2.0 mm posterior to the limbus with the needle pointing towards the optic nerve. The injection volume of 0.02 mL is then delivered.