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 reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dompé U.S.
at 1-833-366-7387 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In two clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks.
The mean age of the population was 61 to 65 years of age (18 to 95).
The majority of the treated patients were female (61%).
The most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients.
Eye pain may arise as corneal healing occurs.
Other adverse reactions occurring in 1% to 10% of OXERVATE patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache.
5 WARNINGS AND PRECAUTIONS Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion.
( 5.1 ) 5.1 Use with Contact Lens Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion.
Lenses may be reinserted 15 minutes after administration.
5.2 Eye Discomfort OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment.
The patient should be advised to contact their doctor if a more serious eye reaction occurs.
Like all medications, Oxervate 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: