Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 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 ) 5.1 Pigmentation Latanoprostene bunod ophthalmic solution, 0.024% may cause changes to pigmented tissues.
Like all medications, Latanoprostene Bunod Ophthalmic Solution, 0.024% can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: