byqlovi
Pharmaranks rates Byqlovi 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Byqlovi (Clobetasol Propionate) is a corticosteroid used to treat Dermatitis, Facial Dermatoses, Foot Dermatoses, Hand Dermatoses.
Clobetasol Propionate · by Harrow Eye
Available as a generic: Clobetasol Propionate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Clobetasol Propionate
- Drug class
- Corticosteroid
- Strength
- Clobetasol Propionate 0.05%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- dermatitis, facial dermatoses, foot dermatoses
- Manufacturer
- Harrow Eye
- FDA application
- NDA218158
What is Byqlovi?
From the FDA label:BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, that has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β- methylpregna- 1,4-diene-3,20-dione 17-propionate and it has the following structural formula: Clobetasol propionate has the empirical formula C25H32CIFO5 and a molecular weight of 467. BYQLOVI contains a sterile, anti-inflammatory corticosteroid for topical ophthalmic use. Each mL of BYQLOVI contains: ACTIVE: clobetasol propionate 0.5 mg (0.05%) INACTIVES: sodium chloride, hydrogenated soybean lecithin, citric acid, glycerin, poloxamer 407, polyvinyl alcohol, boric acid, edetate disodium dihydrate, methylcellulose, trisodium citrate, and water for injection PRESERVATIVE: benzalkonium chloride 0.0036%. Structural Formula
How to use
Instill one drop of BYQLOVI into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. ( 2.1 ) Wash hands well before each use. ( 2.2 ) 2.1 Recommended Dosage Instill one drop of BYQLOVI into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. 2.2 Administration Instructions Wash hands well before each use. If using other eye drops in addition to BYQLOVI, wait at least 5 minutes between instillation of BYQLOVI and other eye drops.
Side effects
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…
Warnings
Important safety information
Intraocular Pressure (IOP) Increase : Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts : Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed Healing : The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. ( 5.3 ) Corneal and Scleral Melting : In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. ( 5.4 ) Bacterial Infections : Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. ( 5.5 ) Viral Infections : Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.6 ) Fungal Infections : Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. ( 5.7 ) 5.1 Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If BYQLOVI is used for 10 days or longer, IOP should be monitored. 5.2 Cataracts Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. 5.3 Delayed Healing The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. 5.4 Corneal and Scleral Melting In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. 5.5 Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. 5.6 Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). 5.7 Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long- term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal culture should be taken when appropriate. 5.8 Risk of Contamination Do not allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension. 5.9 Contact Lens Wear BYQLOVI should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of BYQLOVI. The preservative in BYQLOVI may be absorbed by soft contact lenses. Lenses may be reinserted after 15 minutes following administration of BYQLOVI.
Who should not take Byqlovi
BYQLOVI is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. BYQLOVI is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ( 4 )
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Byqlovi ranks — best-rated corticosteroid for:
Ways to save
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Use copay cards
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Frequently asked questions
- What does Byqlovi treat?
- Byqlovi (Clobetasol Propionate) may be used to treat dermatitis, facial dermatoses, foot dermatoses, hand dermatoses, inflammation, leg dermatoses, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Byqlovi work?
- Byqlovi is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How is Byqlovi rated?
- pharmaranks gives Byqlovi a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Byqlovi?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Byqlovi. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Byqlovi?
- Byqlovi is marketed by Harrow Eye. You can see Harrow Eye's full profile, rating, and other products on pharmaranks.
- Is Byqlovi a brand-name or generic drug?
- Byqlovi is a brand-name product with the active ingredient Clobetasol Propionate. Lower-cost generic equivalents containing Clobetasol Propionate are available — ask your pharmacist.
- Is Byqlovi available over the counter?
- No. Byqlovi is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What class of drug is Byqlovi?
- Byqlovi is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Byqlovi FDA-registered?
- Byqlovi is on record with the U.S. FDA under application number NDA218158. You can verify this on its official FDA label.
- Has Byqlovi been recalled by the FDA?
- Byqlovi has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Byqlovi safe?
- There's no single safe-or-not verdict. pharmaranks gives Byqlovi a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Byqlovi?
- Byqlovi's side effects are taken directly from its FDA label. From the label: 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 M… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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byqlovi
70/100