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  • CLASSES

    Hypotrichosis Agent
    Other Miotics-Antiglaucoma Preparations, Plain

    DEA CLASS

    Rx

    DESCRIPTION

    Topical ophthalmic agent; synthetic prostamide used to lower IOP in patients with open-angle glaucoma or ocular hypertension; also approved for hypotrichosis.

    COMMON BRAND NAMES

    Latissee, Lumigan

    HOW SUPPLIED

    Bimatoprost/Latissee/Lumigan Ophthalmic Sol: 0.01%, 0.03%

    DOSAGE & INDICATIONS

    For the reduction of elevated or increased intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
    Ophthalmic dosage (Lumigan ophthalmic solution)
    Adults

    Instill 1 drop to the affected eye(s) once daily in the evening. More frequent administration may decrease the IOP-lowering effect.

    Adolescents 16 years and older

    Instill 1 drop to the affected eye(s) once daily in the evening. More frequent administration may decrease the IOP-lowering effect.

    For treatment of hypotrichosis of the eyelashes.
    Ophthalmic dosage (Latisse 0.03% ophthalmic solution)
    Adults

    Apply 1 drop to each eye at night using the supplied applicator; apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. Do not apply to lower lashes. Additional applications will not further increase the growth of eyelashes. Upon discontinuation, eyelash growth is expected to return to its pre-treatment level.

    Children >= 5 years and Adolescents

    Apply 1 drop to each eye at night using the supplied applicator; apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. Do not apply to lower lashes. Bimatoprost has been studied in children and adolescents 5—17 years who were post-chemotherapy or had alopecia areata and in adolescents 15—17 years with hypotrichosis not associated with a medical condition. Upon discontinuation, eyelash growth is expected to return to its pre-treatment level.

    MAXIMUM DOSAGE

    Adults

    1 drop/day instilled in each affected eye or applied to each upper eyelid.

    Geriatric

    1 drop/day instilled in each affected eye or applied to each upper eyelid.

    Adolescents

    1 drop/day applied to each upper eyelid.

    Children

    Children >= 5 years: 1 drop/day applied to each upper eyelid.
    Children < 5 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustment in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustment in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Ophthalmic Administration

    Instruct patient on proper use of bimatoprost (see Patient Information).
    Wash hands before and after use.
    Contact lenses should be removed prior to ocular application and may be reinserted 15 minutes following drug administration. Lumigan contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses.
    Lumigan administration:
    Lumigan (bimatoprost ophthalmic solution) is for ophthalmic use only.
    Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch and gently close the eyes for 1—2 minutes. Do not blink.
    To avoid contamination, do not touch the tip of the dropper to the eye, fingertips, or other surface.
    The solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
    Latisse administration:
    Prior to using, ensure the patient's face is clean and makeup removed.
    The disposable sterile applicator is the only applicator that should be used. Each applicator should be used for 1 eye only; dispose of the applicator after each use.
    After applying 1 drop of solution to the applicator, apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. The upper lid margin in the area of eyelash growth should feel lightly moist without runoff. Blot excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth.
    Do not apply to the lower eyelash line.
     

    STORAGE

    Latissee:
    - Store between 36 to 77 degrees F
    Lumigan:
    - Store between 36 to 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Bimatoprost is contraindicated in patients with hypersensitivity to bimatoprost.

    Closed-angle glaucoma

    Bimatoprost should not be used in patients with closed-angle glaucoma, or inflammatory or neovascular glaucoma.

    Aphakia, corneal abrasion, iritis, keratitis, ocular infection, ocular surgery, ocular trauma, uveitis

    Bimatoprost should be used with caution in patients with active intraocular inflammation (e.g., iritis, uveitis). Prostaglandin analogs have been reported to cause intraocular inflammation and use in patients with active intraocular inflammation may exacerbate the condition. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. Inadvertent contamination of the bimatoprost containers may increase the risk of infection in ocular surgery patients, or in patients who develop an ocular infection or ocular trauma, including corneal abrasion. If there is any damage to the ocular epithelial surface, bimatoprost should be used with caution. Bimatoprost should be used with caution in patients with aphakia, pseudophakic patients with a torn posterior lens capsule, and patients with known risk factors for macular edema. Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost.

    Contact lenses

    Contact lenses should be removed prior to administration of bimatoprost and may be reinserted after 15 minutes. Bimatoprost ophthalmic solution contains the preservative benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses.

    Sunlight (UV) exposure

    Bimatoprost may gradually change eye color, increasing the amount of brown pigment in the iris. This change may be permanent. Patients should be informed of the possibility of iridal discoloration. Some patients may also develop photophobia and may be more sensitive to sunlight (UV) exposure.

    Children, infants, neonates

    The use of bimatoprost for the reduction of intraocular pressure in neonates, infants, children, and adolescents < 16 years is not recommended because of potential safety concerns related to increased pigmentation after long-term chronic use. Safety and efficacy of bimatoprost for hypotrichosis has not been established for neonates, infants, and children < 5 years of age. The use of bimatoprost for hypotrichosis has been studied in children and adolescents 5—17 years who were post-chemotherapy or had alopecia areata and in adolescents 15—17 years with hypotrichosis not associated with a medical condition.

    Pregnancy

    There are no adequate and well-controlled studies of bimatoprost ophthalmic solution in pregnant women; however, there is no increase in the risk of major birth defects or miscarriages based on postmarketing data. After repeated ophthalmic administration of bimatoprost, the drug does not significantly accumulate systemically. According to the manufacturer, bimatoprost should not be administered during pregnancy unless the potential benefit justifies the potential risk to the fetus.

    Breast-feeding

    It is not known whether bimatoprost is excreted in breast milk. Because the drug's half-life is short, systemic concentrations after ophthalmic administration are very low, and protein binding is > 80%, clinically significant amounts of the drug are not expected to be bioavailable to a nursing infant via breast-milk. To further minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. According to the manufacturer, caution should be exercised when it is administered to a breast-feeding woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    keratitis / Delayed / 0-10.0
    visual impairment / Early / 0-10.0
    ocular hemorrhage / Delayed / Incidence not known
    macular edema / Delayed / Incidence not known

    Moderate

    blepharitis / Early / 0-10.0
    cataracts / Delayed / 0-10.0
    blurred vision / Early / 0-10.0
    erythema / Early / 1.0-4.0
    photophobia / Early / 1.0-3.0
    conjunctivitis / Delayed / 1.0-3.0
    iritis / Delayed / 0-1.0
    conjunctival hyperemia / Early / 15.0
    ocular inflammation / Early / Incidence not known
    hypertension / Early / Incidence not known
    dyspnea / Early / Incidence not known

    Mild

    ocular irritation / Rapid / 0-10.0
    foreign body sensation / Rapid / 0-10.0
    xerophthalmia / Early / 0-10.0
    ocular pain / Early / 0-10.0
    skin hyperpigmentation / Delayed / 1.0-10.0
    hirsutism / Delayed / 1.0-5.0
    asthenia / Delayed / 1.0-5.0
    headache / Early / 1.0-5.0
    ocular discharge / Delayed / 1.0-3.0
    iridal discoloration / Delayed / 1.0-3.0
    hypertrichosis / Delayed / 1.0
    ocular pruritus / Rapid / 15.0
    lacrimation / Early / Incidence not known
    nausea / Early / Incidence not known
    dizziness / Early / Incidence not known
    infection / Delayed / Incidence not known
    maculopapular rash / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Bimatoprost products.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no adequate and well-controlled studies of bimatoprost ophthalmic solution in pregnant women; however, there is no increase in the risk of major birth defects or miscarriages based on postmarketing data. After repeated ophthalmic administration of bimatoprost, the drug does not significantly accumulate systemically. According to the manufacturer, bimatoprost should not be administered during pregnancy unless the potential benefit justifies the potential risk to the fetus.

    It is not known whether bimatoprost is excreted in breast milk. Because the drug's half-life is short, systemic concentrations after ophthalmic administration are very low, and protein binding is > 80%, clinically significant amounts of the drug are not expected to be bioavailable to a nursing infant via breast-milk. To further minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. According to the manufacturer, caution should be exercised when it is administered to a breast-feeding woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    •reduction of intraocular pressure (IOP): Bimatoprost selectively mimics endogenous prostamides to produce ocular hypotension. IOP is thought to be reduced by increased aqueous humor outflow through both trabecular network and uveoscleral routes. In vitro biological assays suggest that bimatoprost and related prostamides may also activate novel receptors, which have not yet been identified.
    •promotion of eyelash growth: The mechanism for promotion of eyelash growth is not known; however, an increase in the percent of hairs and an increase in the duration of the hair growth (anagen) phase is postulated.

    PHARMACOKINETICS

    Bimatoprost ophthalmic solution is administered topically to the eye. There is no significant systemic drug accumulation with repeated dosing. Bimatoprost is metabolized via oxidation, n-deethylation, and glucuronidation.

    Intravenous Route

    The elimination half-life following an intravenous dose is approximately 45 minutes with 67% of the administered dose excreted in the urine and 25% recovered in the feces.

    Other Route(s)

    Ophthalmic Route
    Following ocular administration, bimatoprost is absorbed primarily through the sclera. Peak blood concentrations are achieved within 10 minutes and are undetectable within 90 minutes. Reduction of IOP begins approximately 4 hours after the first dose, with the maximum effect occurring in about 8—12 hours.