Latanoprostene Bunod Ophthalmic Solution, 0.024%

FDA Drug Information • Also known as: Latanoprostene Bunod Ophthalmic Solution, 0.024%

Brand Names: Latanoprostene Bunod Ophthalmic Solution, 0.024%
Route: OPHTHALMIC
Dosage Form: SOLUTION/ DROPS
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION Latanoprostene bunod ophthalmic solution, 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. Latanoprostene bunod ophthalmic solution contains the active ingredient latanoprostene bunod 0.24 mg/mL, the preservative benzalkonium chloride 0.2 mg/mL, and the following inactive ingredients: polysorbate 80, glycerin, EDTA, and water. The formulation is buffered to pH 5.5 with citric acid/sodium citrate. Its chemical name is 4-(Nitrooxy)butyl (5Z)-7-{(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl}hept-5-enoate. Its molecular formula is C 27 H 41 NO 8 . Molecular weight: 507.62. Its chemical structure is Latanoprostene bunod is a colorless to pale yellow viscous oil. latanoprostene-bunod-spl-structure

What Is Latanoprostene Bunod Ophthalmic Solution, 0.024% Used For?

1 INDICATIONS AND USAGE Latanoprostene bunod ophthalmic solution, 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprostene bunod ophthalmic solution is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Dosage and Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the conjunctival sac of the affected eye(s) once daily in the evening. Do not administer latanoprostene bunod ophthalmic solution, 0.024% more than once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect. If latanoprostene bunod ophthalmic solution is to be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure, administer each drug product at least five (5) minutes apart. One drop in the affected eye(s) once daily in the evening.

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling:

Pigmentation [ see Warnings and Precautions (5.1) ]

Eyelash Changes [ see Warnings and Precautions (5.2) ]

Intraocular Inflammation [ see Warnings and Precautions (5.3) ]

Macular Edema [ see Warnings and Precautions (5.4) ]

Bacterial Keratitis [ see Warnings and Precautions (5.5) ]

Use with Contact Lens [ see Warnings and Precautions (5.6 )] 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 Gland Pharma at (609) 250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Latanoprostene bunod ophthalmic solution was evaluated in 811 patients in 2 controlled clinical trials of up to 12 months duration. The most common ocular adverse reactions observed in patients treated with latanoprostene bunod were: conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). Approximately 0.6% of patients discontinued therapy due to ocular adverse reactions including ocular hyperemia, conjunctival irritation, eye irritation, eye pain, conjunctival edema, vision blurred, punctate keratitis and foreign body sensation.

Contraindications

4 CONTRAINDICATIONS None. None.

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no available human data for the use of Latanoprostene bunod ophthalmic solution during pregnancy to inform any drug associated risks. Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits. Latanoprostene bunod was shown to be abortifacient and teratogenic when administered intravenously (IV) to pregnant rabbits at exposures ≥ 0.28 times the clinical dose. Doses ≥ 20 mcg/kg/day (23 times the clinical dose) produced 100% embryofetal lethality. Structural abnormalities observed in rabbit fetuses included anomalies of the great vessels and aortic arch vessels, domed head, sternebral and vertebral skeletal anomalies, limb hyperextension and malrotation, abdominal distension and edema. Latanoprostene bunod was not teratogenic in the rat when administered IV at 150 mcg/kg/day (87 times the clinical dose) [see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered latanoprostene bunod daily by intravenous injection on gestation days 7 through 19, to target the period of organogenesis. The doses administered ranged from 0.24 to 80 mcg/kg/day. Abortion occurred at doses ≥ 0.24 mcg/kg/day latanoprostene bunod (0.28 times the clinical dose, on a body surface area basis, assuming 100% absorption). Embryofetal lethality (resorption) was increased in latanoprostene bunod treatment groups, as evidenced by increases in early resorptions at doses ≥ 0.24 mcg/kg/day and late resorptions at doses ≥ 6 mcg/kg/day (approximately 7 times the clinical dose). No fetuses survived in any rabbit pregnancy at doses of 20 mcg/kg/day (23 times the clinical dose) or greater. Latanoprostene bunod produced structural abnormalities at...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING 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 68083-563-01 5 mL fill in a 7 mL Natural container - NDC 68083-564-01 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.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.