If contralateral eye requires treatment, a new prefilled syringe or vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter needle (vial only), and injection needles should be changed before administration to the other eye Single-use vial Inspect solution do not use if particulates, cloudiness, or discoloration are visibleĮach prefilled syringe or vial should only be used for the treatment of a single eye Solution should appear colorless to pale yellow

Prior to and 30 minutes following intravitreal injection, monitor for elevation in intraocular pressure using tonometry Risks involved outweigh potential benefits. D: Use in LIFE-THREATENING emergencies when no safer drug available. Animal studies show risk and human studies not available or neither animal nor human studies done. C: Use with caution if benefits outweigh risks. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. Controlled studies in pregnant women show no evidence of fetal risk.

There are no data available on presence of ranibizumab in human milk effects of ranibizumab on breastfed infant or effects of ranibizumab on milk production/excretion developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from ranibizumab Pregnancy CategoriesĪ: Generally acceptable. Ranibizumab should be given to a pregnant woman only if clearly needed Lactation There are no adequate and well-controlled studies in pregnant womenĪdministration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels ) after a single eye treatment at the recommended clinical dose No studies on effects of ranibizumab on fertility conducted not known whether ranibizumab can affect reproduction capacity based on anti-VEGF mechanism of action for ranibizumab, therapy may pose risk to reproductive capacity Potential for adverse thromboembolic events (eg, nonfatal stroke, nonfatal MI, vascular death)įatal events occurred more frequently in patients with diabetic macular edema and diabetic retinopathy at baseline, who were treated monthly compared with control Possibility of IOP increase within 60 min of intravitreal injection monitor intraocular pressure prior to and following intravitreal injection with drug and manage appropriately Risk of endophthalmitis or retinal detachment with intravitreous injections proper aseptic injection technique should always be used when administering therapy patients should be monitored following the injection to permit early treatment should an infection occur Hypersensitivity reactions may manifest as severe intraocular inflammation May retreat if needed, based on assessment of mean baseline change in visual acuity (BCVA) Dosage Modifications Renal impairment Indicated for treatment of myopic choroidal neovascularization (mCNV)Ġ.5 mg (0.05 mL of 10 mg/mL solution) intravitreal injection qMonth initially, for up to 3 months Indicated for treatment of diabetic retinopathy in patients with or without diabetic macular edema (DME)Ġ.3 mg (0.05 mL of 6 mg/mL solution) intravitreally qMonth (~q28 days) Myopic Choroidal Neovascularization Indicated for diabetic macular edema (DME)Ġ.3 mg (0.05 mL of 6 mg/mL solution) intravitreally qMonth (~q28 days) Diabetic Retinopathy Indicated for macular edema following retinal vein occlusionĠ.5 mg (0.05 mL of 10 mg/mL solution) intravitreal injection qMonth (~q28 days) 圆 months Diabetic Macular Edema

Over 9 months after 3 initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain.

Although not as effective, patients may be treated with initial 3 once monthly doses followed by less frequent dosing with regular assessment.

Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD)Ġ.5 mg (0.05 mL of 10 mg/mL solution) intravitreal qMonth (~q28 days) Less frequent dosing Neovascular (Wet) Age-related Macular Degeneration

10mg/mL (0.05mL ) (Lucentis, Byooviz, Cimerli).

Dosage Forms & Strengths intravitreal injectable preservative-free solution

Mistat injection to the eye