omidenepag isopropyl ophthalmic (Rx)

Brand and Other Names:Omlonti
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 0.002% (2.5 mL)

Glaucoma or Ocular Hypertension

Indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

1 drop in affected eye(s) qDay in the evening

Safety and efficacy not established

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Interactions

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                    Adverse Effects

                    1-10%

                    Hyperemia (9%)

                    Photophobia (5%)

                    Vision blurred (4%)

                    Dry eye (3%)

                    Instillation site pain (3%)

                    Eye pain (2%)

                    Ocular hyperemia (2%)

                    Punctate keratitis (2%)

                    Headache (2%)

                    Eye irritation (1%)

                    Visual impairment (1%)

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                    Warnings

                    Contraindications

                    None

                    Cautions

                    May gradually change eyelashes and vellus hair in treated eye; changes include increased length, thickness, and the number of lashes or hairs; eyelash changes are usually reversible upon discontinuing treatment

                    Ocular inflammation has been reported; use with caution in patients with active ocular inflammation, including iritis/uveitis

                    Macular edema, including cystoid macular edema, has been reported; use with caution in aphakic patients, in pseudophakic patients, or in patients with known risk factors for macular edema

                    Advise patients to avoid touching tip of the bottle to eye or any surface, as this may contaminate solution

                    Advise patients to not touch tip to their eye to avoid the potential for injury to eye

                    Pigmentation changes

                    • Pigmentation changes are expected to occur and increase if omidenepag isopropyl ophthalmic solution is administered
                    • Pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes
                    • Iris color change may not be noticeable for several months to years
                    • Long term effects of pigmentation are not known
                    • The brown pigmentation around the pupil may spread concentrically towards the periphery ofthe iris and the entire iris or parts of the iris become more brownish
                    • Neither nevi nor freckles of the iris appear to be affected by treatment; while treatment can be continued in patients who develop noticeably increased iris pigmentation, examine regularly
                    • After discontinuing therapy, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in most patients
                    • Inform patient who are receiving prostaglandin analogs of the possibility of increased pigmentation, including permanent changes
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                    Pregnancy & Lactation

                    Pregnancy

                    Data are unavailable on use in pregnant females

                    Animal data

                    • SC administration of omidenepag isopropyl to pregnant rabbits throughout organogenesis produced fetal skeletal anomalies at a dose of 24x the clinical dose, based on estimated peak plasma concentration
                    • Omidenepag isopropyl was not teratogenic in rats when administered SC at 1 mg/kg/day, 2,452x the clinical dose

                    Lactation

                    There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production

                    However, systemic exposure to omidenepag following topical ocular administration is low, and it is unknown whether measurable levels of omidenepag would be present in maternal milk following topical ocular administration

                    Pregnancy Categories

                    A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                    B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                    C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                    D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                    X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                    NA: Information not available.

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                    Pharmacology

                    Mechanism of Action

                    Relatively selective EP2 receptor agonist decreases intraocular pressure (IOP)

                    Currently, exact mechanism of action is unknown

                    Elevated IOP represents a major risk factor for glaucomatous field loss

                    Higher the IOP, the greater the likelihood of optic nerve damage and visual field loss

                    Absorption

                    Absorbed through cornea where prodrug omidenepag isopropyl is hydrolyzed to become biologically active metabolite, omidenepag

                    Peak plasma time: 10-15 min

                    Metabolism

                    Rapidly metabolized in the eye to omidenepag (active moiety) by carboxylesterase-1

                    Omidenepag (active form) is further metabolized by liver through oxidation, N-dealkylation, glucuronidation, sulfate conjugation, or taurine conjugation

                    Elimination

                    By 168 hr after ocular instillation, 89% of administered radioactive dose was excreted

                    Excretion: 83% (feces); 4% (urine)

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                    Administration

                    Ophthalmic Administration

                    Remove contact lenses before administering solution; lenses may be reinserted 15 minutes after administration

                    Advise patients that if more than one topical ophthalmic drug is being used, administer drugs at least 5 min apart

                    Advise patients to avoid touching tip of the bottle to eye or any surface, as this may contaminate solution

                    Advise patients to not touch tip to their eye to avoid the potential for injury to eye

                    Gently shake bottle before administering

                    Storage

                    Unopened bottle

                    • Refrigerate at 2-8ºC (36-46ºF)

                    Opened bottle

                    • Store for up to 31 days at up to 30ºC (86ºF)
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                    Images

                    No images available for this drug.
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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                    Formulary

                    FormularyPatient Discounts

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                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    Tier Description
                    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.