BYQLOVI
Generic: CLOBETASOL PROPIONATE
Basic Information
Manufacturer
Harrow Eye, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
31ca5a0f-812e-491d-aa00-d8ed424ba322
Indications & Usage
1 INDICATIONS AND USAGE BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery.
BYQLOVI is a corticosteroid indicated for the treatment of post- operative inflammation and pain following ocular surgery.
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BYQLOVI is a corticosteroid indicated for the treatment of post- operative inflammation and pain following ocular surgery.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: Intraocular Pressure (IOP) Increase [see Warnings and Precautions ( 5.1 )] Posterior Subcapsular Cataract Formation [see Warnings and Precautions ( 5.2 )] Delayed Healing [see Warnings and Precautions ( 5.3 )] Corneal and Scleral Melting [see Warnings and Precautions ( 5.4 )] Bacterial Infections [see Warnings and Precautions ( 5.5 )] Viral Infections [see Warnings and Precautions ( 5.6 )] Fungal Infections [see Warnings and Precautions ( 5.7 )] Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%).
Many of these reactions may have been the consequence of the surgical procedure ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) 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.
Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%).
Many of these reactions may have been the consequence of the surgical procedure.
Many of these reactions may have been the consequence of the surgical procedure ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) 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.
Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%).
Many of these reactions may have been the consequence of the surgical procedure.