Difluprednate: FDA label

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Indications

Difluprednate ophthalmic emulsion is a corticosteroid indicated for:

The treatment of inflammation and pain associated with ocular surgery. ( 1.1 )
The treatment of endogenous anterior uveitis. ( 1.2 )

1.1Ocular Surgery

Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery.

1.2Endogenous Anterior Uveitis

Difluprednate ophthalmic emulsion is indicated for the treatment of endogenous anterior uveitis.

Contraindications

Difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, 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 disease of ocular structures. Difluprednate ophthalmic emulsion 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 )

Warnings and precautions

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. If difluprednate ophthalmic emulsion is used for 10 days or longer, IOP should be monitored. ( 5.1 )
Cataracts : Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 )
Delayed Healing : The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. ( 5.3 )

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on difluprednate ophthalmic emulsion use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic exposure to difluprednate ophthalmic emulsion following ocular administration is low [see Clinical Pharmacology (12.3) ] . Consequently, the systemic exposure of a pregnant woman to difluprednate is expected to be minimal following topical ocular administration.

In animal reproductive studies, subcutaneous administration of difluprednate to pregnant rabbits and rats throughout organogenesis produced maternal toxicity, embryo-fetal toxicity and teratogenicity in rabbits and fetotoxicity in rats. Administration of difluprednate to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryofetal development studies, subcutaneous administration of difluprednate to pregnant rats during the period of organogenesis decreased the placental weight, at doses greater than or equal to 10 mcg/kg/day (approximately 0.48-fold higher than the maximum recommended human ophthalmic dose [MRHOD] of 0.2 mg/day, on a mg/m 2 basis and assuming 100% absorption of the dose).

Decreased weight gain and delayed ossification of the fetus were observed at a dose of 100 mcg/kg/day (approximately 4.8-fold higher than the MRHOD). The no-observed-effect level (NOEL) for teratogenic effects was 10 mcg/kg/day. In rabbits, subcutaneous administration of difluprednate during the period of organogenesis produced maternal toxicity, embryofetal lethality, fetal growth retardation and teratogenicity (cleft palate, cerebral hernia, exencephaly, hypogenesis of the first digit of the forelimbs, club hand, umbilical hernia and others) at 10 mcg/kg/day (approximately 0.97-fold the MRHOD on a mg/m 2 basis and assuming 100% absorption of the dose).

The NOEL was 1 mcg/kg/day. In a peri- or pre-/postnatal study in rats, subcutaneous administration of difluprednate during late gestation through lactation resulted in no abnormalities in postnatal development, growth and behavior or reproductive potential. The NOEL was greater than or equal to 10 mcg/kg/day (the highest dose tested; approximately 0.48-fold higher than the MRHOD on a mg/m 2 basis and assuming 100% absorption of the dose).

Adverse reactions

The following serious reactions are found elsewhere in the labeling:

Intraocular Pressure (IOP) Increase [see Warnings and Precautions (5.1) ]
Cataracts [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) ] For treatment of inflammation and pain associated with ocular surgery, most common adverse reactions (incidence 5% to 15%) are corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. For treatment of endogenous anterior uveitis, most common adverse reactions (incidence 5% to 10%) are blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Ocular Surgery

Ocular adverse reactions occurring in 5% to 15% of subjects in clinical studies with difluprednate ophthalmic emulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1% to 5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis.

Ocular adverse reactions occurring in less than 1% of subjects included application-site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritus, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure.

6.2Endogenous Anterior Uveitis

A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to difluprednate ophthalmic emulsion. The most common adverse reactions of those exposed to difluprednate ophthalmic emulsion occurring in 5% to 10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis.

Adverse reactions occurring in 2% to 5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity.

Difluprednate

Indications

1.1Ocular Surgery

1.2Endogenous Anterior Uveitis

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Intraocular Pressure (IOP) Increase

5.2Cataracts

5.3Delayed Healing

5.4Corneal and Scleral Melting

5.5Bacterial Infections

5.6Viral Infections Use

5.7Fungal Infections

5.8Topical Ophthalmic Use

5.9Risk of Contamination Do

5.10Contact Lens Wear

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Ocular Surgery

6.2Endogenous Anterior Uveitis

Composition

Strengths and forms

Official product information

At a glance

Guidelines