Patizra 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 contamination and subsequent infection.
Patizra must be administered by a qualified ophthalmologist experienced in intravitreal injections.
The recommended dose for Patizra 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 1 month.
The recommended dose for Patizra in preterm infants is 0.2 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.02 mL. Treatment of ROP is initiated with a single dose and can be given bilaterally on the same day. Further treatment may be administered if there are signs of disease activity. The interval between two doses injected into the same eye should not be shorter than one month.
Treatment of wet AMD: Patizra treatment in adults is initiated with a loading phase of one injection per month for three consecutive months, followed by a maintenance phase in which patients should be monitored for visual acuity on a monthly basis. If the patient experiences a loss of greater than 5 letters in visual acuity (ETDRS or one Snellen line equivalent), Patizra should be administered.
Although less effective, treatment may be reduced to one injection every three months after the first four injections if monthly injections are not feasible. Compared to continued monthly dosing, dosing every 3 months will lead to an approximate 5 letter (1-line) loss of visual acuity benefit, on average, over the following 9 months. Patients should be evaluated regularly.
Alternative dose: 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.
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 anatomic parameters.
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, for example, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by two weeks at a time. If disease activity recurs, the treatment interval should be shortened accordingly.
Treatment of visual impairment due to DME: 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.
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 anatomic parameters.
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, for example, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by two weeks at a time. If disease activity recurs, the treatment interval should be shortened accordingly.
Patizra and laser photocoagulation in DME: Patizra can be safely administered concomitantly with laser photocoagulation as well as in patients who have received previous laser photocoagulation. When given on the same day, Patizra should be administered at least 30 minutes after laser photocoagulation.
Treatment of PDR: 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.
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 anatomic parameters.
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, for example, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. If disease activity recurs, the treatment interval should be shortened accordingly.
Treatment of visual impairment due to CNV secondary to PM: Treatment in adults is initiated with a single injection.
If monitoring reveals signs of disease activity, further treatment is recommended.
Monitoring for disease activity may include clinical examination, optical coherence tomography (OCT) or fluorescein angiography (FA). The frequency of monitoring should be determined by the treating physician.
In the treatment of visual impairment due to CNV secondary to PM, many patients may only need one or two injections during the first year, while some patients may need more frequent treatment (see Pharmacology: Clinical studies under Actions).
Treatment of visual impairment due to macular edema secondary to RVO: Treatment in adults is given monthly and continued until maximum visual acuity is achieved, confirmed by stable visual acuity for three consecutive monthly assessments performed while on Patizra treatment.
Thereafter patients should be monitored monthly for visual acuity.
Treatment is resumed with monthly injections when monitoring indicates a loss of visual acuity due to macular edema secondary to RVO and continued until stable visual acuity is reached again for three consecutive monthly assessments.
Patizra and laser photocoagulation in Branch RVO (BRVO): Patizra can be safely administered concomitantly with laser photocoagulation. When given on the same day, Patizra should be administered at least 30 minutes after laser photocoagulation.
Treatment of ROP in preterm infants: Treatment in preterm infants is initiated with a single injection. Further treatment may be administered if there are signs of diseases activity.
Special populations: Renal impairment: Dose adjustment is not needed in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Patizra has not been studied in patients with hepatic impairment. However, as systemic exposure is negligible, no special measures are considered necessary in this population.
Pediatric Patients (below 18 years): Patizra is not recommended for use in children and adolescents due to a lack of data on safety and efficacy in these sub-populations.
Geriatric patients (65 years or above): No dose adjustment is required in the elderly.
Mode of administration: As with all medicinal products for parenteral use, Patizra 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.
For information on preparation of Patizra, 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 centre of the globe. The injection volume of 0.05 mL is then delivered; the scleral site should be rotated for subsequent injections.
The patient's intraocular pressure must be monitored after the injection. Monitoring should consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes and ophthalmoscopy 2-7 days later. Patients must be instructed to report any signs of endophthalmitis to their doctor immediately (See Precautions).
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.