Miscellaneous ocular agents:

Indications for: VABYSMO

Neovascular (wet) age-related macular degeneration (nAMD). Diabetic macular edema (DME).

Adult Dosage:

See full labeling. Give by intravitreal inj. nAMD: 6mg (0.05mL) once every 4 weeks (approx. every 28 ± 7 days, monthly) for the 1st 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to determine whether to give a 6mg (0.05mL) dose on one of the following 3 regimens: (1) Weeks 28 and 44; (2) Weeks 24, 36 and 48; or (3) Weeks 20, 28, 36 and 44. DME (Regimen 1): 6mg (0.05mL) once every 4 weeks for at least 4 doses, then may be adjusted by up to 4 week interval increments or reductions of up to 8 week interval increments based on CST and visual acuity evaluations; or (Regimen 2): 6mg (0.05mL) once every 4 weeks for the 1st 6 doses, followed by 6mg (0.05mL) every 8 weeks. 

Children Dosage:

Not established.

VABYSMO Contraindications:

Ocular or periocular infection. Active intraocular inflammation.

VABYSMO Warnings/Precautions:

Must be administered by a qualified physician. Monitor for endophthalmitis, retinal detachments, elevation in IOP, and perfusion of optic nerve head following inj. Potential risk of arterial thromboembolic events (eg, nonfatal stroke or MI, vascular death). Advise females of reproductive potential to use effective contraception prior to initial dose, during and for at least 3 months after the last dose. Pregnancy. Nursing mothers.

VABYSMO Classification:

Vascular endothelial growth factor (VEGF) inhibitor/angiopoietin-2 (Ang-2) inhibitor.

Adverse Reactions:

Conjunctival hemorrhage, vitreous floaters, increased IOP, eye pain, intraocular inflammation, eye irritation, ocular discomfort, retinal pigment epithelial tear (nAMD only).

Metabolism:

Expected to be catabolized in lysosomes to small peptides, amino acids.

Drug Elimination:

Renal. Half-life: 7.5 days.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1 (w. needle)