Lumigan

Common Side Effects of Lumigan

Tell your doctor if any of the following symptoms become severe or don't go away:

• Increased tear production
• Mild burning, dryness, itching, or redness of the eye
• Headache
• Feeling like you have something in your eye
• Changes in eyelash growth

Serious Side Effects of Lumigan

Tell your doctor right away if you experience any of the following serious side effects:

• Darkening of the eyelid, eye color, or whites of the eyes
• Eye or eyelid discharge
• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)
• Vision changes
• Sensitivity to light
• Pinkeye (conjunctivitis)
• Severe pain, swelling, irritation, or inflammation of the eye
• Severe eye fatigue

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Eyelash-thickening treatments
• Other medicines you apply to the eye

Lumigan and Other Interactions

Lumigan may make your eyes more sensitive to light, so use caution when driving or performing other activities that require good eyesight.

Lumigan is part of the drug class:

• Prostaglandin analogues

Serious side effects have been reported with Lumigan. See the “Lumigan Precautions” section.

Common side effects of Lumigan include the following:

• itchy eyes
• dry eyes
• burning or stinging eyes
• eye redness
• headaches

This is not a complete list of Lumigan side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Ocular Hypertension and Glaucoma

Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP-lowering drugs or who have not responded adequately (i.e., failed to achieve target IOP as determined after multiple measurements over time) to another IOP-lowering drug.1

Safety and efficacy not established for the treatment of angle-closure, inflammatory, or neovascular glaucoma.1

At least as effective as latanoprost 0.005% in controlling diurnal IOP;2 7 may be more effective than timolol 0.5% in reducing IOP in patients with open-angle glaucoma or ocular hypertension.2 5

• Risk of changes in eyelashes and permanent darkening of iris, eyelashes, or skin around the eyes associated with therapy.1 Potential for disparity between eyes if only one eye is treated.1

• Importance of learning and adhering to proper administration techniques to avoid contamination of the solution with common bacteria that can cause ocular infections.1 Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic solutions.1

• Importance of informing clinicians if an intercurrent ocular condition (e.g., trauma, infection) develops or ocular surgery is planned.1 Importance of immediately reporting ocular reactions, particularly conjunctivitis and eyelid reactions.1

• Importance of delaying insertion of contact lenses for at least 15 minutes after bimatoprost instillation, since benzalkonium chloride preservative may be absorbed by soft lenses.1

• Importance of administering different topical ophthalmic preparations at least 5 minutes apart.1

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or intend to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information. (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Lumigan® (bimatoprost ophthalmic solution) 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

The following adverse reactions are described elsewhere in the labeling:

• Pigmentation including blepharal pigmentation and iris hyperpigmentation [see Warnings and Precautions (5.1)]
• Eyelash Changes [see Warnings and Precautions (5.2)]
• Intraocular Inflammation [see Warnings and Precautions (5.3)]
• Macular Edema [see Warnings and Precautions (5.4)]
• Hypersensitivity [see Contraindications (4)]

Clinical Trial 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.

In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia. Other adverse drug reactions (reported in 1 to 4% of patients) with Lumigan® 0.01% in this study included conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye pruritus, erythema of eyelid, eyelids pruritus, growth of eyelashes, hypertrichosis, instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred, and visual acuity reduced.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Lumigan® 0.01%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Lumigan®, or a combination of these factors include: asthma-like symptoms, dry eye, dyspnea, eye discharge, eye edema, foreign body sensation, headache, hypersensitivity including signs and symptoms of eye allergy and allergic dermatitis, lacrimation increased, and periorbital and lid changes including deepening of the eyelid sulcus.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses up to 2 mg/kg/day and 1 mg/kg/day, respectively (192 and 291 times the estimated human systemic exposure to bimatoprost 0.03% dosed bilaterally once daily, respectively, based on blood AUC levels)

Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.

Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day (at least 103 times the recommended human exposure to bimatoprost 0.03% dosed bilaterally once daily based on blood AUC levels).

You should not use Lumigan if you are allergic to bimatoprost.

To make sure this medicine is safe for you, tell your doctor if you have:

• an eye condition called uveitis; or

• swelling or infection of your eye.

It is not known whether Lumigan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether bimatoprost passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Lumigan is not approved for use by anyone younger than 16 years old.

Avoid using too much of this medicine, which can actually make it less effective.

Do not use other eye medications unless your doctor tells you to.

You should not use this medicine if you are allergic to bimatoprost.

To make sure bimatoprost ophthalmic is safe for you, tell your doctor if you have ever had:

• swelling or infection in your eye;

• retinal detachment; or

• eye surgery or injury affecting the lens of your eye.

Bimatoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, usually an increase in brown pigment. You may also notice increased growth or thickness of your eyelashes. These changes occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether bimatoprost ophthalmic passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Bimatoprost ophthalmic is not approved for use by anyone younger than 16 years old.

Skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

An overdose of bimatoprost ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• eye swelling, redness, severe discomfort, crusting or drainage (may be signs of infection);

• vision changes; or

• red, swollen, or itchy eyelids.

Common side effects may include:

• eye redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on bimatoprost used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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