Lumigan Drug Description

LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentylj-5-N-ethylheptenamide, Femigra and its molecular weight is 415.58. Its molecular formula is C₂₅H₃₇NO₄. Its chemical structure is:

Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. LUMIGAN® (bimatoprost ophthalmic solution 0.03% for glaucoma) 0.01% and 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg.

LUMIGAN® 0.01% contains Active: bimatoprost 0.1 mg/mL; Preservative: benzalkonium chloride 0.2 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8-7.8.

LUMIGAN® 0.03% contains Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8-7.8.

SIDE EFFECTS:Burning/stinging/irritation/redness of the eye, feeling as if something is in your eye, dry eyes, watering eyes, and increased sensitivity to light may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may slowly (over months to years) cause brown discoloration of the colored portion of the eye (iris). If you are using bimatoprost in only one eye, only that iris may change color. An increase in eyelash number/length/thickness and darkening of the eyelashes/eyelids may also occur in the treated eye. These changes may be permanent, but the long-term effects are uncertain. Notify your doctor if this occurs, and schedule regular eye exams to monitor it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, eye pain/swelling, swelling/redness of the eyelids.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:Before using bimatoprost, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., latanoprost, travoprost); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., macular edema, iritis, uveitis, lens extraction/aphakia).

If you develop an eye infection or injury, or have eye surgery, check with your doctor about the continued use of your current bottle of bimatoprost. You may be advised to start using a new bottle.

This drug may cause temporary unstable vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Important Safety Information

LUMIGAN^® 0.01% and 0.03% (bimatoprost ophthalmic solution) has been reported to cause darkening (pigmentation) of eye color, eyelid skin, and eyelashes as well as increased growth of eyelashes. Pigmentation changes can increase as long as LUMIGAN^® 0.01% and 0.03% is used. After stopping LUMIGAN^® 0.01% and 0.03%, darkening of eye color is likely to be permanent, while darkening of the eyelid skin and eyelash changes may be reversible. The effects of increased darkening beyond 5 years are not known.

When only one eye is treated, there is a possibility of eyelash Welgra changes in the eye treated with LUMIGAN^® 0.01% and 0.03%. These changes may result in differences between the eyes in eyelash length, thickness, darkness, number of eyelashes, and/or direction of eyelash growth. These changes are usually reversible upon stopping LUMIGAN^® 0.01% and 0.03% therapy.

Avoid allowing the tip of the dispensing bottle to touch the eye, anything around the eye, fingers, or any other surface in order to avoid contamination by common bacteria known to cause eye infections. Serious damage to the eye and loss of vision may result from using contaminated solutions.

If you have eye surgery or develop any eye reactions (such as trauma or infection), immediately consult with your physician about continuing the use of LUMIGAN^® 0.01% and 0.03%.

If you wear contact lenses, remove them before using LUMIGAN^® 0.01% and 0.03%. Then wait 15 minutes after using LUMIGAN^® 0.01% and 0.03% before you put your contacts back into your eyes.

The most common side effects are eye redness, growth of eyelashes, and itchy eyes.

There are potential side effects with LUMIGAN^® ophthalmic solution.

You may experience:

• Increased eyelash growth
• Itchy eyes
• Temporary eye redness

Eye redness can occur immediately after use, but usually lasts 4 to 6 weeks. Your eyes may get red, but they typically won't hurt or itch. Call your doctor if they do. Eye redness alone does not mean that your eyes are being harmed. It's important to follow your eye doctor's instructions and continue taking LUMIGAN^® so that you may realize the long-term benefits of managing your IOP.
In clinical studies, approximately 3% of patients taking LUMIGAN^® stopped taking LUMIGAN^® due to eye redness.

What to expect if you experience eye redness with LUMIGAN^®