Inveltys Drug Information
Generic name: LOTEPREDNOL ETABONATE
Uses of Inveltys
is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Dosage & Administration of Inveltys
Dosage Information Instill one to two drops of
INVELTYS into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.
Administration Instructions Instruct patient to wash hands well before each use. Shake
for one to two seconds before using. If the patient is using other eye drops in addition to INVELTYS, advise the patient to wait at least 5 minutes between instillation of INVELTYS and other eye drops.
Side Effects of Inveltys
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. The most common adverse drug reactions in the clinical trials with INVELTYS were eye pain and posterior capsular opacification, both reported in 1% of patients. These reactions may have been the consequence of the surgical procedure.
Warnings & Cautions for Inveltys
Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma
with damage to the optic nerve, as well as 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, intraocular pressure should be monitored.
Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. 5.3
Delayed Healing Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. 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.
Bacterial Infections Prolonged use of corticosteroids may suppress the host response and
thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
Viral Infections Use of 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).
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 cultures should be taken when appropriate.
Risk of Contamination Do not to allow the dropper tip to touch
any surface, as this may contaminate the suspension.
Contact Lens Wear
The preservative in INVELTYS may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of INVELTYS and may be reinserted 15 minutes following administration.
Pregnancy Safety for Inveltys
Pregnancy Risk Summary INVELTYS is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug.
Pediatric Use of Inveltys
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Contraindications for Inveltys
is contraindicated in most 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. INVELTYS is contraindicated in most 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.
Clinical Studies of Inveltys
Clinical efficacy was evaluated in 2 multi-centered, randomized, double-masked, placebo-controlled trials in which patients with an anterior cell grade greater than or equal to "2" (a cell count of 6 or higher using a slit-lamp biomicroscope) after cataract surgery were assigned to INVELTYS or placebo (vehicle) following surgery (NCT # 02163824 and NCT # 02793817). One to two drops of INVELTYS or vehicle was self-administered twice a day for 14 days, beginning the day after surgery. Complete resolution of inflammation (a cell count of 0 maintained through day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through day 15 without rescue medication) was assessed 4, 8, and 15 days post-surgery. In the intent-to-treat analysis of both studies, a significant benefit was seen in the INVELTYS -treated group for complete resolution of ocular inflammation at Days 8 and 15, and complete resolution of pain at Days 4, 8, and 15, when compared with placebo.
The consolidated clinical trial results are provided below. Figure 1 Consolidated Clinical Trial Data: Percent of Patients with Complete Resolution of Anterior Chamber Cells (Cell Count = 0) at Days 8 and 15 * p-values < 0.01 for treatment comparisons Figure 2 Consolidated Clinical Trial Data: Percent of Patients Who Were Pain Free at Days 4, 8, and 15 * p-values < 0.01 for treatment comparisons Figure 1 Figure 2
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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