EYSUVIS- loteprednol etabonate suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LOTEPREDNOL ETABONATE (UNII: YEH1EZ96K6) (LOTEPREDNOL - UNII:Z8CBU6KR16)

Available from:

ALCON LABORATORIES, INC.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS, as with other ophthalmic corticosteroids, 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. Risk Summary There are no adequate and well controlled studies with loteprednol etabonate in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rat when administered orally during pregnancy. Loteprednol etabonate produced malformations when administered orally to pregnant rabbits at doses 1.4 times the recommended human ophthalmic dose (RHOD) and to pregnant rats at doses 34 times the RHOD. In pregnant rats receiving oral doses of loteprednol etabonate during the period equivalent to the last trimester of pregnancy through lactation in humans, survival of offspring was reduced at doses 3.4 times the RHOD. Maternal toxicity was observed in rats at doses 347 times the RHOD, and a maternal no observed adverse effect level (NOAEL) was established at 34 times the RHOD. The background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered loteprednol etabonate by oral gavage on gestation days 6 to 18, to target the period of organogenesis. Loteprednol etabonate produced fetal malformations at 0.1 mg/kg (1.4 times the recommended human ophthalmic dose (RHOD) based on body surface area, assuming 100% absorption). Spina bifida (including meningocele) was observed at 0.1 mg/kg, and exencephaly and craniofacial malformations were observed at 0.4 mg/kg (5.6 times the RHOD). At 3 mg/kg (41 times the RHOD), loteprednol etabonate was associated with increased incidences of abnormal left common carotid artery, limb flexures, umbilical hernia, scoliosis, and delayed ossification. Abortion and embryofetal lethality (resorption) occurred at 6 mg/kg (83 times the RHOD). A NOAEL for developmental toxicity was not established in this study. The NOAEL for maternal toxicity in rabbits was 3 mg/kg/day. Embryofetal studies were conducted in pregnant rats administered loteprednol etabonate by oral gavage on gestation days 6 to 15, to target the period of organogenesis. Loteprednol etabonate produced fetal malformations, including absent innominate artery at 5 mg/kg (34 times the RHOD); and cleft palate, agnathia, cardiovascular defects, umbilical hernia, decreased fetal body weight and decreased skeletal ossification at 50 mg/kg (347 times the RHOD). Embryofetal lethality (resorption) was observed at 100 mg/kg (695 times the RHOD). The NOAEL for developmental toxicity in rats was 0.5 mg/kg (3.4 times the RHOD). Loteprednol etabonate was maternally toxic (reduced body weight gain) at 50 mg/kg/day. The NOAEL for maternal toxicity was 5 mg/kg. A peri-/postnatal study was conducted in rats administered loteprednol etabonate by oral gavage from gestation day 15 (start of fetal period) to postnatal day 21 (the end of lactation period). At 0.5 mg/kg (3.4 times the clinical dose), reduced survival was observed in live-born offspring. Doses ≥ 5 mg/kg (34 times the RHOD) caused umbilical hernia/incomplete gastrointestinal tract. Doses ≥ 50 mg/kg (347 times the RHOD) produced maternal toxicity (reduced body weight gain, death), decreased number of live-born offspring, decreased birth weight, and delays in postnatal development. A developmental NOAEL was not established in this study. The NOAEL for maternal toxicity was 5 mg/kg. There are no data on the presence of loteprednol etabonate in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for EYSUVIS and any potential adverse effects on the breastfed infant from EYSUVIS. Safety and effectiveness in pediatric patients have not been established. No overall differences in safety and effectiveness have been observed between elderly and younger adult patients. INSTRUCTIONS FOR USE EYSUVIS [eye-SU-vis] (loteprednol etabonate ophthalmic suspension) 0.25% for topical ophthalmic use This Instructions for Use contains information on how to properly administer EYSUVIS. Important Information You Need to Know Before Using EYSUVIS - EYSUVIS is for use in the eye. - Wash your hands before using EYSUVIS. - Do not use if the tamper-evident seal is not intact. - Do not let the EYSUVIS dropper tip touch your eye, fingers, or any other surfaces to avoid contamination or injury to your eye. - Use EYSUVIS exactly as your doctor tells you to. - If you are using EYSUVIS with other eye (ophthalmic) medicines, you should wait at least 5 minutes between using EYSUVIS and the other medicine. - If you wear contact lenses, remove them before using EYSUVIS. - Put the pink cap back on EYSUVIS after each use. Before you use EYSUVIS for the first time: There are two caps on your bottle of EYSUVIS. Hold the bottle firmly by its neck. Remove the white cap by twisting it clockwise (See Figure A) . Throw away the white cap. EYSUVIS is now ready to use. Figure A Follow Steps 1 to 6 each time you use EYSUVIS. - Wash your hands well. - Shake the EYSUVIS bottle for 2 to 3 seconds before using (See Figure B) . Figure B Figure B - Remove the pink cap from the top of the EYSUVIS dropper by turning it counterclockwise (See Figure C) . Keep the pink cap. Do not let the EYSUVIS dropper tip touch your eye, fingers, or any other surface. Figure C Figure C - Turn the EYSUVIS bottle upside down (See Figure D) . Figure D Figure D - Tilt your head back. Hold the bottle directly above your affected eye. Squeeze the middle of the EYSUVIS bottle gently to put 1 to 2 drops (follow your doctor's instruction) into the affected eye (See Figure E) . Figure E Figure E - Place the pink cap back onto the EYSUVIS bottle and tighten by turning clockwise (See Figure F) . Figure F Figure F If you use contact lenses, wait for 15 minutes before placing them back in. How should I store EYSUVIS? - Store EYSUVIS upright between 59ºF to 77ºF (15ºC to 25ºC). - Do not freeze. - After opening, EYSUVIS can be used until the expiration date (EXP) on the bottle. The expiration date can be found on the lower right side of the label on the bottle. Keep EYSUVIS and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Kala Pharmaceuticals, Inc. Watertown, MA 02472 Approved: 10/2020

Product summary:

EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is a sterile ophthalmic suspension. It is supplied in a white, low-density polyethylene dropper bottle with a linear low-density polyethylene tip, a pink high-density polyethylene cap, and a white low-density polyethylene tamper-evident overcap in the following size: 8.3 mL in a 10 mL bottle (NDC 71571-333-83) Storage and Handling Do not use if tamper-evident overcap seal is not intact. The white tamper-evident overcap can be thrown away. Retain the pink cap and keep the bottle tightly closed when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, EYSUVIS can be used until the expiration date on the bottle.

Authorization status:

New Drug Application

Summary of Product characteristics

EYSUVIS- LOTEPREDNOL ETABONATE SUSPENSION/ DROPS
ALCON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EYSUVIS™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EYSUVIS.
EYSUVIS (LOTEPREDNOL ETABONATE OPHTHALMIC SUSPENSION) 0.25%,
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
EYSUVIS is a corticosteroid indicated for the short-term (up to two
weeks) treatment of the signs and
symptoms of dry eye disease. (1)
DOSAGE AND ADMINISTRATION
Shake for two to three seconds before using. (2)
Instill one to two drops of EYSUVIS into each eye four times daily.
(2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic suspension containing 2.5 mg/mL of loteprednol etabonate.
(3)
CONTRAINDICATIONS
EYSUVIS, as with other ophthalmic corticosteroids, 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. (4)
WARNINGS AND PRECAUTIONS
Delayed Healing and Corneal Perforation:The initial prescription and
each 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. (5.1)
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. Renewal of the medication order
should be made by a physician only after examination of the patient
and evaluation of the IOP.(5.2)
Cataracts: Use of corticosteroids may result in posterior subcapsular
cataract formation. (5.3)
Bacterial Infections: Use of corticosteroids may suppress the host
response and thus increase the
hazard of secondary ocular infections. In acute purulent conditions,
corticosteroids may mask infection
or enhance ex