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RANIBIZUMAB
Aug 21, 06 FDA ApprovalsLUCENTIS® (Genentech, Inc) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment for intraocular treatment.
DOSING INFORMATION:
The recommended dose is 0.5 milligram (0.05 milliliter) administered by intravitreal injection once monthly. If monthly injections are not feasible, after the first 4 consecutive monthly injections, may reduce treatment to one injection every 3 months; however, this treatment approach will be less effective.PHARMACOKINETICS:
Peak serum concentrations of 1.5 ng/mL are estimated to occur at approximately 24 hours after an intravitreal administration of ranibizumab 0.5 mg/eye; vitreal concentrations are estimated to be 90,000-fold higher than serum concentrations. It has an estimated average vitreous elimination half-life of 9 days.CAUTIONS:
Ranibizumab may cause endophthalmitis and retinal detachments. Increases in intraocular pressure are commonly reported and may occur within 60
minutes of intravitreal injection. There is also a theoretical risk of developing arterial thromboembolic events. Most common adverse effects reported
are ocular in nature and include conjunctival hemorrhage, eye pain, vitreous floaters, and intraocular inflammation.FDA APPROVED INDICATIONS:
Ranibizumab is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration.The information above is for use only by healthcare professionals in conjunction with clinical data and their professional judgment.
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