Latanoprostene bunoid ophthal sol (Vyzulta) -@- 2017
Drug Name:Latanoprostene bunoid ophthal sol (Vyzulta) -@- 2017
List Of Brands:
Indication Type Description:
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Indication:
U.S. FDA APPROVED DRUGS DURING 2017
Sr.No- 36
Name of the Drug- Vyzulta
Active Ingredient- Latanoprestene bunod ophthalmic solution
Pharmacological Classification-
To treat intraocular pressure in patients with open angle hypertension
Date of Approval- 11-2-2017
(Ref- FDA approved List 2017)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VYZULTA safely and effectively.
See full prescribing information for VYZULTA. -
CONTRAINDICATIONS -
None.
WARNINGS AND PRECAUTIONS
VYZULTA (latanoprostene bunod ophthalmic solution) 0.024%, for Pigmentation: Increased pigmentation of the iris and periorbital tissue 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.
Adverse Reaction:
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%).
Contra-Indications:
CONTRAINDICATIONS -
None.
WARNINGS AND PRECAUTIONS
VYZULTA (latanoprostene bunod ophthalmic solution) 0.024%, for Pigmentation: Increased pigmentation of the iris and periorbital tissue topical ophthalmic use
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening.
DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution: 0.24 mg/mL latanoprostene bunod (0.024%) (3) (eyelid) can occur. Iris pigmentation is likely to be permanent.
Eyelash changes: Gradual changes to eyelashes including increased length, increased thickness and number of eyelashes. Usually reversible upon discontinuation of treatment.
Patient Information:
PATIENT COUNSELING INFORMATION
Potential for Pigmentation
Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent.
Patients should also be informed about the possibility of eyelid skin darkening, which is usually reversible after discontinuation of VYZULTA.
Potential for Eyelash Changes
Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with VYZULTA. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.
Handling the Container
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.
When to Seek Physician Advice
Advise patients that if they develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of VYZULTA.
Use with Contact Lenses
Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of VYZULTA.
Use with Other Ophthalmic Drugs
If more than one topical ophthalmic drug is being used, the drugs should be administered with at least five (5) minutes between applications.
VYZULTA is a trademark of Bausch & Lomb Incorporated or its affiliates.
© Bausch & Lomb Incorporated
Distributed by: Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Latanoprostene bunod is thought to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Intraocular pressure is a major modifiable risk factor for glaucoma progression. Reduction of intraocular pressure reduces risk of glaucomatous visual field loss.
2. Pharmacodynamics
Reduction of the intraocular pressure starts approximately 1 to 3 hours after the first administration with the maximum effect reached after 11-13 hours in eyes with elevated intraocular pressure.
3. Pharmacokinetics
Absorption
The systemic exposure of latanoprostene bunod and its metabolites latanoprost acid and butanediol mononitrate were evaluated in one study with 22 healthy subjects after topical ocular administration of VYZULTA 0.024% once daily (one drop bilaterally in the morning) for 28 days.
There were no quantifiable plasma concentrations of latanoprostene bunod (lower limit of quantitation, LLOQ, of 10.0 pg/mL) or butanediol mononitrate (LLOQ of 200 pg/mL) post dose on Day 1 and Day 28.
The mean maximal plasma concentrations (Cmax) of latanoprost acid (LLOQ of 30 pg/mL) were 59.1 pg/mL and 51.1 pg/mL on Day 1 and Day 28, respectively. The mean time of maximal plasma concentration (Tmax) for latanoprost acid was approximately 5 min post administration on both Day 1 and Day 28
Distribution
There were no ocular distribution studies performed in humans.
Metabolism
After topical ocular administration, latanoprostene bunod is rapidly metabolized in the eye to latanoprost acid (active moiety), an F2a prostaglandin analog, and butanediol mononitrate.
After latanoprost acid reaches the systemic circulation, it is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid ß-oxidation.
Butanediol mononitrate is metabolized to 1,4-butanediol and nitric oxide. The metabolite 1,4-butanediol is further oxidized to succinic acid and enters the tricarboxylic acid (TCA) cycle.
Elimination
The elimination of latanoprost acid from human plasma is rapid as latanoprost acid plasma concentration dropped below the LLOQ (30 pg/mL) in the majority of subjects by 15 min following ocular administration of VYZULTA 0.024% in humans
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy Risk Summary
There are no available human data for the use of VYZULTA during pregnancy to inform any drug associated risks.
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.
2. Lactation Risk Summary
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.
3. Pediatric Use
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.
4. Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
