Lytenava injection for wet age-related macular degeneration

Lytenava is an injectable medicine used to treat neovascular (wet) age-related macular degeneration (nAMD), a condition that causes abnormal blood vessel growth in the eye leading to vision loss. It works by blocking vascular endothelial growth factor (VEGF), a protein that promotes the growth of these abnormal vessels.

Lytenava is prescribed for adult patients with neovascular (wet) age-related macular degeneration (nAMD). It is given as a monthly injection directly into the eye by a qualified physician to control disease progression.

Bevacizumab-vikg

Lytenava contains bevacizumab-vikg, a monoclonal antibody that binds to all isoforms of VEGF-A, preventing VEGF from activating its receptors on endothelial cells. This inhibition reduces abnormal blood vessel proliferation, leakage, and swelling in the retina, which are key contributors to vision loss in nAMD.

The recommended dose of Lytenava is 1.25 mg (0.05 mL of 25 mg/mL) administered by intravitreal injection once every approximately 28 days (monthly).

The injection must be performed under controlled aseptic conditions by a qualified physician using sterile gloves, a sterile drape, and an eyelid speculum or equivalent. Before injecting, the vial content is withdrawn using a 5-micron sterile filter needle attached to a 1 mL syringe, then the filter needle is discarded and replaced with a sterile 30-gauge x ½-inch injection needle to perform the injection.

Prior to injection and about 30 minutes after, intraocular pressure should be monitored using tonometry, and the optic nerve head perfusion should be checked when applicable.

Each single-dose vial is intended for use in one eye only. If both eyes require treatment, separate vials and sterile equipment must be used for each eye.

• Patients with ocular or periocular infections.
• Patients with active intraocular inflammation.
• Patients with known hypersensitivity to bevacizumab products or any ingredient in Lytenava, as hypersensitivity can lead to severe intraocular inflammation.

Serious risks to monitor include:

• Endophthalmitis and retinal detachments: These infections or complications may occur after injection. Patients should be monitored and instructed to report symptoms immediately.
• Increased intraocular pressure: Pressure in the eye can rise within 60 minutes after injection. Monitoring before and after injection is essential.
• Arterial thromboembolic events (ATEs): Although rare, there is a potential risk of serious events such as nonfatal stroke, myocardial infarction, or vascular death due to VEGF inhibition.

Strict aseptic injection technique must always be used to reduce infection risks.

The most common side effect reported in clinical trials (≥4%) was conjunctival hemorrhage (4%). Other common ocular side effects included eye pain and vitreous floaters (each about 2%). Less common adverse reactions (less than 1%) included corneal abrasion, dry eye, eye irritation, and increased intraocular pressure.

Pregnancy: No adequate studies in pregnant women. Based on its VEGF inhibition mechanism, Lytenava may harm fetal development. Use only if clearly needed.

Lactation: Unknown if bevacizumab-vikg is excreted in human milk. Caution advised when administering to nursing women.

Contraception: Females of reproductive potential should use effective contraception during treatment and for at least 3 months following the last dose.

Store Lytenava in single-dose glass vials. Inspect visually for particulate matter or discoloration before use. The vial is intended for single use only and must not be stored after opening.