Bevacizumab gamma: clinical use

Prescribing considerations

• Administration is restricted to qualified healthcare professionals experienced in intravitreal injections, using appropriate aseptic technique.
• Record the product name and batch number to maintain biological-medicine traceability.
• Use particular caution with poorly controlled glaucoma, retinal pigment epithelial detachment, recent arterial thromboembolic events, and recent or planned intraocular surgery.
• Safety and efficacy of simultaneous bilateral administration have not been established and systemic and ocular exposure may be greater.
• Do not administer concurrently with another ocular or systemic anti-VEGF medicine.

Contraindications and cautions

• Hypersensitivity to bevacizumab gamma or an excipient
• Active or suspected ocular or periocular infection
• Active intraocular inflammation

Monitoring

• Assess disease activity using visual acuity, clinical examination and appropriate retinal imaging.
• Measure intraocular pressure and assess optic nerve-head perfusion before and after injection.
• Monitor for endophthalmitis, intraocular inflammation, retinal tears or detachment and retinal pigment epithelial tears.
• Review thromboembolic history and withhold treatment when clinically required by the product information.
• Ensure patients know which post-injection symptoms require immediate assessment.

Clinical pharmacology

Bevacizumab gamma is a recombinant humanised IgG1 monoclonal antibody that binds VEGF-A and prevents signalling through VEGFR-1 and VEGFR-2. This suppresses pathological endothelial proliferation, neovascularisation and vascular permeability. Intravitreal administration produces local ocular effects with substantially lower systemic exposure than intravenous administration.

Formulation and product differences

• Lytenava is a sterile solution specifically authorised for intravitreal injection and supplied in a single-use vial.
• The vial contains excess solution for preparation; it must not be injected in full. Excess solution and air bubbles are removed during specialist preparation.
• The product must not be mixed with other medicinal products. Injection and filter devices are not supplied with the vial.

Injection

Route: Parenteral

Strengths: 25 mg/mL