Bevacizumab-vikg · intravitreal injection
Injections & Implants
LYTENAVA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD).
Contraindications
- Ocular or periocular infections
- Active intraocular inflammation
- Known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA (hypersensitivity reactions may manifest as severe intraocular inflammation)
1.25 mg (0.05 mL of 25 mg/mL) in a single-dose glass vial
Bevacizumab is a human vascular endothelial growth factor (VEGF) inhibitor. Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. LYTENAVA binds to all isoforms of VEGF-A, thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, LYTENAVA suppresses endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of such activity targets a pathophysiologic process that contributes to vision loss.
The recommended dose for LYTENAVA is 1.25 mg (0.05 mL of 25 mg/mL) administered by intravitreal injection once monthly (approximately 28 days).
Warnings & Precautions
- Endophthalmitis and Retinal Detachments: Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur.
- Increases in Intraocular Pressure: Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately.
- Thromboembolic Events: Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
Common Side Effects
Most common adverse reaction (≥ 4%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%).
Pregnancy: Based on the anti-VEGF mechanism of action for bevacizumab products, treatment with LYTENAVA may pose a risk to human embryofetal development. There are no adequate and well-controlled studies of LYTENAVA administration in pregnant women or pregnant animals. LYTENAVA should be given to a pregnant woman only if clearly needed.
Lactation: There are no data available on the presence of bevacizumab-vikg in human milk, the effects of bevacizumab-vikg on the breastfed infant or the effects of bevacizumab-vikg on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when LYTENAVA is administered to a nursing woman.
Contraception: Females of reproductive potential should use effective contraception during treatment with LYTENAVA and for at least 3 months after the last dose when stopping treatment with LYTENAVA.
The safety and effectiveness of LYTENAVA in pediatric patients have not been established.