NEODOSE

INDICATIONS

Retinopathy of Prematurity (ROP)

FDA APPROVED INDICATION

Safety and effectiveness have not been established in pediatric patients.

CONTRAINDICATIONS

Ocular or periocular infections

PRECAUTIONS

• Cardiovascular: Arterial thromboembolic events (nonfatal stroke, nonfatal myocardial infarction, or vascular death) have occurred
• Ophtalmic:
  • Endophthalmitis and retinal detachments have been reported; monitor.
  • Intraocular pressure increase has been observed prior to injection and within 60 minutes after injection; monitor

ADVERSE EFFECTS

• • Ophthalmic Effects:
  The most commonly reported adverse effects in adult patients were conjunctivalhemorrhage, eye pain, vitreous floaters, and increased intraocular pressure .

• Adverse events suspected to be related to intravitreal ranibizumab were conjuctival hemorrhage, retinal detachment, injection site hemorrhage with the 0.12 mg dose (5 out of 10 infants) and conjunctival hemorrhage, corneal edema, retinal hemorrhage, and retinal vascular disorder with the 0.2 mg dose (4 out of 9 infants). Serious retinal detachment was suspected of to be related to intravitreal ranibizumab 0.12 mg (1 out of 10 infants) .

• A large avascular area in zone II and zone III were present in 8 eyes (3%) at 24 weeks after intravitreal ranibizumab . These eyes had abnormal vessel shunting and branching on fundus photography .

• More high myopia was seen in eyes treated with bevacizumab (14.6%) than those treated with ranibizumab (0%) at 1 year of age in a retrospective study (n=37 infants).

Cataract (0.7%) and vitreous and preretinal hemorrhage in 1 eye (0.4%) occurred in a retrospective case series of 145 premature infants of retinopathy of prematurity
• Non-ophthalmic Effects: Respiratory failure and hypotension occurred in 1 infant with ROP administered intravitreal ranibizumab 0.2 mg (1 out of 9 infants).

ADMINISTRATION

• Preparation
  • Syring
    • Only open the sealed tray under aseptic conditions
    • Snap off the syringe cap without turning or twisting
    • Remove any air bubbles
  • Vial
    • Under aseptic conditions, withdraw all of the ranibizumab vial contents (0.2 mL) through a 19-gauge x 1.5- inch, 5-micron filter needle attached to a 1-mL Luer lock syringe.
    • After withdrawal, discard the filter needle.
    • Do not use the filter needle for intravitreal injection.
    • Remove any air bubbles.
• Administration
  • In pediatric patients a sterile 30-gauge, 31-gauge , or 32-gauge 4-mm needle injected ranibizumab 0.75 mm to 1 mm or 1.5 mm posterior to the temporal limbus into the vitreous cavity.
  • To treat the contralateral eye, use a new vial or prefilled syringe and change the sterile field, gloves, drapes, eyelid speculum, filter needle (vial only), and injection needles before administration.

MONITORING

• Monitor the treated eye for increased intraocular pressure with tonometry before and 30 minutes after intravitreal injection..
• Assess for perfusion of the optic nerve head immediately after intravitreal injection.
• Monitor the treated eye for signs and symptoms of endophthalmitis (redness, sensitivity to light, pain, vision changes) following intravitreal injection.