For: Glaucoma (Open Angle), Intraocular Hypertension
Vyzulta (latanoprostene bunod) is a nitric oxide donating prostaglandin receptor agonist for the treatment of patients with open angle glaucoma or ocular hypertension. VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is supplied in low density polyethylene bottles with dropper tips and turquoise caps in the following sizes:
2.5 mL fill in a 4 mL white container - NDC 24208-504-02
5 mL fill in a 7.5 mL natural container - NDC 24208-504-05
Storage: Unopened bottle should be stored refrigerated at 2º to 8ºC (36º to 46ºF). Once a bottle is opened it may be stored at 2º to 25ºC (36º to 77ºF) for 8 weeks.
During shipment, bottles may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.
Protect from light. Protect from freezing. These highlights do not include all the information needed to use VYZULTA safely and effectively. See full prescribing information for VYZULTA.
VYZULTA® (latanoprostene bunod ophthalmic solution) 0.024%, for topical ophthalmic use
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2)
DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution: 0.24 mg/mL latanoprostene bunod (0.024%) (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
Pigmentation: Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent. (5.1)
•
Eyelash changes: Gradual changes to eyelashes including increased length, increased thickness and number of eyelashes. Usually reversible upon discontinuation of treatment. (5.2)
ADVERSE REACTIONS
Most common ocular adverse reactions with incidence ≥ 2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2019