A vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: ? Neovascular (Wet) Age-Related Macular Degeneration (AMD) ? Macular Edema Following Retinal Vein Occlusion (RVO) ? Diabetic Macular Edema (DME)
Drugs for Age-Related Macular Degeneration (AMD)
Ranibizumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD, mCNV, DR, DME and macular edema following RVO. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
For Ophthalmic Intravitreal Injection Only Neovascular (Wet) Age-Related Macular Degeneration (AMD) it 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days). Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. In the nine 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. Patients should be assessed regularly. Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Compared with continued monthly dosing, dosing every 3 months over the next 9 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average. Patients should be assessed regularly. Macular Edema Following Retinal Vein Occlusion (RVO) (2.3) ? it 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days). In the RVO clinical studies, patients received monthly injections of it for 6 months. In spite of being guided by optical coherence tomography and visual acuity re-treatment criteria, patients who were then not treated at Month 6 experienced on average, a loss of visual acuity at Month 7, whereas patients who were treated at Month 6 did not. Patients should be treated monthly. Diabetic Macular Edema ? It is recommended to be administered by intravitreal injection once a month (approximately 28 days).
Drug interaction studies have not been conducted with Ranibizumab.
? Ocular or periocular infections ? Hypersensitivity
Conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available
Store between 2-8°C. Protect from light. Keep out of reach of children.
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