Overview
11 DESCRIPTION BYOOVIZ (ranibizumab-nuna) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-nuna binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-nuna, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ranibizumab products bind to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF 110 . 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, and macular edema following RVO. The binding of ranibizumab products 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. 12.2 Pharmacodynamics Increased retinal thickness (i.e.
Indications
- 1 INDICATIONS AND USAGE BYOOVIZ is indicated for the treatment of patients with: BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) Myopic Choroidal Neovascularization (mCNV) ( 1.3 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Myopic Choroidal Neovascularization (mCNV)
Common Doses
- 0.5 mg
- 0.05 mL
- 10 mg
- 1 mL
Dosage
2 DOSAGE AND ADMINISTRATION For ophthalmic intravitreal injection only ( 2.1 ) Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 2.2 ) : BYOOVIZ 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. - Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Patients should be assessed regularly.
Contraindications
- 4 CONTRAINDICATIONS Ocular or periocular infections ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1 Ocular or Periocular Infections BYOOVIZ is contraindicated in patients with ocular or periocular infections. 4.2 Hypersensitivity BYOOVIZ is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in BYOOVIZ. Hypersensitivity reactions may manifest as severe intraocular inflammation.
Side Effects
- 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis and Retinal Detachments [ see Warnings and Precautions (5.1) ] Increases in Intraocular Pressure [ see Warnings and Precautions (5.2) ] Thromboembolic Events [ see Warnings and Precautions (5.3) ] The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP ( 6.2 ).
Interactions
- 7 DRUG INTERACTIONS Drug interaction studies have not been conducted with ranibizumab products. Ranibizumab intravitreal injection has been used adjunctively with Photodynamic Therapy (PDT). Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when ranibizumab was administered 7 days (± 2 days) after PDT.