VYZULTA Οphthalmic solution (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch & Lomb Incorporated

Λέξεις κλειδιά

24208-504

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1. Indications and Usage

VYZULTA (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

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 VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% more than once ...

3. Dosage Forms and Strengths

VYZULTA is a topical ophthalmic solution containing latanoprostene bunod, 0.24 mg/mL.

4. Contraindications

None.

5. Warnings and Precautions

5.1 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 ...

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 ...

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 ...

8.1. Pregnancy

Risk Summary There are no available human data for the use of VYZULTA during pregnancy to inform any drug associated risks. Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits. ...

8.2. 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 ...

8.4. 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.

8.5. Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

11. Description

VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. VYZULTA contains the active ingredient latanoprostene bunod 0.24 ...

12.1. 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 ...

12.2. 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.

12.3. 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 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Latanoprostene bunod was not mutagenic in bacteria and did not induce micronuclei formation in the in vivo rat bone marrow micronucleus assay. Chromosomal aberrations were observed in vitro ...

13.2. Animal Toxicology and/or Pharmacology

A 9-month toxicology study administered topical ocular doses of latanoprostene bunod to one eye of cynomolgus monkeys: control (vehicle only), one drop of 0.024% bid, one drop of 0.04% bid and two drops ...

14. Clinical Studies

In clinical studies up to 12 months duration, patients with open-angle glaucoma or ocular hypertension with average baseline intraocular pressures (IOPs) of 26.7 mmHg, the IOP-lowering effect of VYZULTA ...

16.1. How Supplied

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 ...

16.2. Storage and Handling

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 ...

17. 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 ...