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 most common adverse reaction was instillation site pain (50%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc.
at 1-800-757-9780, 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.
In patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States.
The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%).
Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.
5 WARNINGS AND PRECAUTIONS To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces.
( 5.1 ) 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces.
5.2 Use with Contact Lenses TRYPTYR should not be administered while wearing contact lenses.
If contact lenses are worn, they should be removed prior to administration of the solution.
Lenses may be reinserted 15 minutes following administration of TRYPTYR.
Like all medications, Tryptyr 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: