Lumigan

— THERAPEUTIC CATEGORIES —
  • Glaucoma
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Lumigan Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Bimatoprost 0.01%; oph soln; contains benzalkonium chloride.

    Pharmacological Class

    Prostaglandin analogue.

    How Supplied

    Soln—2.5mL, 5mL, 7.5mL

    How Supplied

    Lumigan (bimatoprost ophthalmic solution) 0.01% is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with turquoise polystyrene caps in the following sizes:

    • 2.5mL fill in a 5mL container
    • 5mL fill in a 10mL container
    • 7.5mL fill in a 10mL container

    Storage

    Store at 2°C to 25°C (36°F to 77°F). After opening, Lumigan 0.01% can be used until the expiration date on the bottle.

    Manufacturer

    AbbVie

    Generic Availability

    NO

    Lumigan Indications

    Indications

    Reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension.

    Lumigan Dosage and Administration

    Adult

    ≥16yrs: 1 drop in affected eye once daily in the PM.

    Adult

    Apply one drop in the affected eye(s) once daily in the evening. Do not administer Lumigan (bimatoprost ophthalmic solution) 0.01% more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. 

    Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours. 

    May be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

    Children

    <16yrs: not recommended.

    Lumigan Contraindications

    Not Applicable

    Lumigan Boxed Warnings

    Not Applicable

    Lumigan Warnings/Precautions

    Warnings/Precautions

    Do not exceed recommended dose. Intraocular inflammation. Aphakia. Pseudophakia with torn posterior lens capsule. Risk of macular edema. Contact lenses (remove; may reinsert lenses 15mins after administration). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Pigmentation

    • May cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. 

    • After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. 

    • Inform patients who receive treatment of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known.

    • Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the 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. 

    • Examine patients regularly during treatment with Lumigan (bimatoprost ophthalmic solution) 0.01%.

    Eyelash Changes

    • May gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. 

    • Eyelash changes are usually reversible upon discontinuation of treatment.

    Intraocular Inflammation

    • May cause intraocular inflammation. Use caution in patients with active intraocular inflammation (eg, uveitis).

    Macular Edema 

    • Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. 

    • Use caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

    Bacterial Keratitis  

    • There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. 

    Contact Lens Use

    • Removed contact lenses prior to instillation of Lumigan 0.01% and may be reinserted 15 minutes following its administration.

    Pregnancy Considerations

    Risk Summary

    • There are no adequate and well-controlled studies of Lumigan (bimatoprost ophthalmic solution) 0.01% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience.

    • Because animal reproductive studies are not always predictive of human response, administer Lumigan 0.01% during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mother Considerations

    Risk Summary

    • It is not known whether topical ocular treatment with Lumigan 0.01% could result in sufficient systemic absorption to produce detectable quantities in human milk. 

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Lumigan 0.01% and any potential adverse effects on the breastfed child from Lumigan 0.01%.

    Pediatric Considerations

    Not recommended for use in pediatric patients below the age of 16 years because of potential safety concerns related to increased pigmentation following long-term chronic use.

    Geriatric Considerations

    No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

    Lumigan Pharmacokinetics

    Absorption

    After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily to both eyes of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025ng/mL) in most subjects within 1.5 hours after dosing. Mean Cmax and AUC0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng•hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing. There was no significant systemic drug accumulation over time.

    Distribution

    Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of 0.67 L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.

    Metabolism

    Oxidation, N-deethylation, glucuronidation.

    Elimination

    Renal (67%), fecal (25%). Half-life: ~45 minutes.

    Lumigan Interactions

    Interactions

    Allow at least 5mins between application of other topical ophthalmic agents.

    Lumigan Adverse Reactions

    Adverse Reactions

    Conjunctival hyperemia, ocular effects (eg, edema, hemorrhage, irritation, pain, pruritus), hypertrichosis, eyelash growth, visual disturbances, increased ocular pigmentation (iris, eyelid, eyelashes; may be permanent), other eyelash changes, keratitis, infection, abnormal liver function tests.

    Lumigan Clinical Trials

    Clinical Trials

    In a 12-month clinical study of patients with open angle glaucoma or ocular hypertension with an average baseline IOP of 23.5 mmHg, the IOP-lowering effect of Lumigan 0.01% once daily (in the evening) was up to 7.5 mmHg.

    Lumigan Note

    Not Applicable

    Lumigan Patient Counseling

    Patient Counseling

    Potential for Pigmentation 

    • Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Also inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of Lumigan (bimatoprost ophthalmic solution) 0.01%. 

    Potential for Eyelash Changes 

    • Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with Lumigan 0.01%. May result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. 

    Handling the Container 

    • Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

    When to Seek Physician 

    • Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of Lumigan 0.01%.  

    Contact Lens Use 

    • Remove contact lenses prior to instillation of Lumigan 0.01% and may be reinserted 15 minutes following its administration.

    Use with Other Ophthalmic Drugs 

    • Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. 

    Cost Savings Program

    Lumigan Patient Support & Education:

    https://www.savewithays.com/?guid=toaster_limitedtimecopay_lumigan_patient

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