VYZULTA™ is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Do not use VYZULTA™ if you are hypersensitive to latanoprostene bunod or to any of the excipients
Special warnings and precautions of use
Pigmentation:
VYZULTA™ (latanoprostene bunod ophthalmic solution, 0.024%) may cause changes to pigmented tissues. The most frequently reported changes with prostaglandin analogs have been increased pigmentation of the iris and periorbital tissue (eyelid). Pigmentation is expected to increase as long as latanoprostene bunod ophthalmic solution is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of VYZULTA™, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in most patients. Patients who receive prostaglandin analogs, including VYZULTA™, should be informed of the possibility of increased pigmentation, including permanent changes.

The long-term effects of increased pigmentation are not known.
Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with VYZULTA™ (latanoprostene bunod ophthalmic solution), 0.024% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

Eyelash Changes:
VYZULTA™ may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and the number of lashes or hairs. Eyelash changes are usually reversible upon discontinuation of treatment.
Intraocular Inflammation:
VYZULTA™ should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation as it may exacerbate this condition.
Macular Edema:
Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. VYZULTA™ should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Bacterial Keratitis:
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Use with Contact Lenses:
Contact lenses should be removed prior to the administration of VYZULTA™ because this product contains benzalkonium chloride. Lenses may be reinserted 15 minutes after administration. It is known that it causes damaged colors of soft contact lenses.
Interaction with other medicinal products:
No specific interaction studies have been performed with VYZULTA™. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least five (5) minutes apart
Pregnancy and lactation
Women of child bearing potential/Birth control (Contraception):
There is no information on VYZULTA™ administration in women with child bearing potential or on the requirement of contraception in women using VYZULTA™. It should be careful when the product administered to women of child bearing potential.
Pregnancy:
There are no sufficient data with respect to effects on pregnancy of VYZULTA™. Investigations on animals showed that there is reproductive toxicity.
The potential risk for humans is unknown.
VYZULTA™ should not be used in pregnancy unless prescribed by your doctor.
Lactation:
There are no data on the presence of VYZULTA™ in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for VYZULTA™, and any potential adverse effects on the breastfed infant from VYZULTA™.

Reproduction/Fertility:
Fertility studies have not been conducted with latanoprostene bunod.
Pediatric population:
Use in pediatric patients aged 16 years and younger is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.
Effects on ability to drive and use machines
As with any eye drops, patients may experience temporary blurred vision or redness, pain, or itching of the treated eye (s). If blurred vision occurs at instillation, the patients should wait until their vision clears before driving or using machinery

Always take VYZULTA™ exactly as your doctor or health care provider has told you. You should check with your doctor, health care provider or pharmacist if you are not sure.
The recommended dose is one drop in the conjunctival sac of the affected eye(s) once daily in the evening. Do not administer VYZULTA™ (latanoprostene bunod ophthalmic solution, 0.24 mg/ml) more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
USE ONLY IF IMPRINTED NECKBAND IS INTACT.

Like all medicines, VYZULTA™ can cause side effects, although not everybody gets them.
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1.000 to < 1/100); rare (≥ 1/10.000 to < 1/1.000); very rare (< 1/10.000), not known (cannot be estimated from the available data).

Eye disorders
Common: Conjunctival hyperemia, eye irritation, eye pain, instillation site pain
Not known: Pigmentation, eyelash changes, intraocular inflammation, macular edema, bacterial keratitis, usage with contact lenses, ocular hyperemia, conjunctival irritation, conjunctival edema, vision blurred, punctuate keratisis and foreign body sensation.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.

Saudi Arabia:
The National Pharmacovigilance Centre (NPC)
o SFDA Call Center: 19999
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc

United Arab Emirates:
Pharmacovigilance & Medical Device section
P.O.Box: 1853
Tel: 80011111
Email : pv@mohap.gov.ae
Drug Department
Ministry of Health & Prevention
Dubai, UAE

Other GCC Countries:
Please contact the relevant competent authority.

Unopened bottle should be stored refrigerated at 2° to 8° C (36° to 46°F).
Once a bottle is opened it may be stored at 2° to 25°C (36° to 77°F) for 8 weeks
Protect from light
Protect from freezing
Keep out of reach of children
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.