Risk Management



Latisse™ Treatment Consent Form

Click here for the AAO prescribing recommendations for Latisse.

SAVE THIS FORM TO YOUR COMPUTER BY USING THE DOWNLOAD BUTTON. A PREVIEW IS DISPLAYED BELOW.

PLACE LETTERHEAD HERE AND REMOVE NOTE.   Version 07/01/2009
CHANGE FONT FOR LARGE PRINT
NOTE:  THIS FORM IS INTENDED AS A SAMPLE ONLY OF THE INFORMATION YOU AS THE PHYSICIAN SHOULD PERSONALLY DISCUSS WITH THE PATIENT.  PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE.  GIVE THE PATIENT A COPY.

(Courtesy of John W. Shore, M.D., a practicing ophthalmologist in Austin, Texas.)

INFORMED CONSENT FOR LATISSE™ TREATMENT

(Treatment for hypotrichosis)

WHAT ARE THE INDICATIONS FOR LATISSE™ TREATMENT?
Latisse™ is the brand name for bimatoprost, a sister medication already FDA approved for the treatment of glaucoma known as Lumigan®. LatisseTM is FDA approved for the treatment of hypotrichosis of the eyelashes by making them grow longer, thicker and darker.  Hypotrichosis is a medical term for short or missing lashes. It is frequently seen in men and women as they approach middle age. Latisse™ is believed to affect the growth (anagen) phase of the eyelash hair cycle by increasing the length of the growth phase and increasing the number of hairs along the eyelid margin.  The onset of action is gradual with most users seeing a significant improvement in the length and number of lashes by 2 months.  If Latisse™ is discontinued the eyelashes and eyelids will return to their previous appearance over several weeks to months.

Alternatives: There are no FDA approved alternatives. You may decide that you do not want to use Latisse™ now and are willing to live with short or missing eyelashes.

WHAT ARE THE RISKS and POSSIBLE SIDE EFFECTS OF USING LATISSE™?
1.    The following side effects are the most frequently reported, but occur in less than 4% of users (i.e. 4 out of 100 users):
a.    Eye irritation and itching
b.    Conjunctival hyperemia or red eye (redness of the white, moist covering of the eyeball)
c.    Dry eye symptoms
d.    Eyelid redness
2.    Although rare, Latisse™ has the potential to permanently increase the brown pigmentation of the iris (colored part of the eyeball, inside the eye).
3.    Latisse™ may cause hyperpigmentation or darkening of the eyelid skin which may or may not be reversible upon discontinuation of the treatment.
4.    Latisse™ may lower intraocular pressure (IOP) or pressure inside the eye; however, the magnitude of this reduction is usually not a cause for concern.
a.    If you have a history of abnormal eye pressures or glaucoma you should only use Latisse™ under the close supervision of your ophthalmologist.
b.    Inform anyone conducting an eye pressure examination that you are using Latisse™.
5.    You should inform your ophthalmologist that you are using Latisse™ if eye surgery is planned.
6.    Do not use Latisse™ if you are allergic or hypersensitive to bimatoprost (LumiganR) or any other ingredient in this product.
7.    Latisse™ is intended for use on the skin at the base of the eyelashes of the UPPER eyelids only.
8.    DO NOT APPLY to the lower eyelids as this will increase the chance of side effects such as hyperpigmentation or darkening of the eyelid skin.
9.    You should discontinue use of Latisse™ and call your physician immediately if you develop an eye infection, sudden decrease in vision, suffer eye trauma, or develop eye or eyelid reactions.

WHAT ARE THE CONTRAINDICATIONS OF USING LATISSE™?
You should NOT use Latisse™ if: you are allergic or hypersensitive to bimatoprost (LumiganR) or any other ingredient in this product; are about  to undergo cataract or other eye procedures, have an intraocular inflammation (uveitis), have risk factors for macular edema, have an eye infection, or are being treated for glaucoma with eye drops, unless cleared by your treating ophthalmologist. LATISSE™ is not approved for people under the age of 18. It is not recommended for pregnant or lactating women.

PATIENT’S ACCEPTANCE OF RISKS
I have read the above information and have discussed it with my physician. I understand that it is impossible for the physician to inform me of every possible complication that may occur. My physician has told me that results cannot be guaranteed. By signing below, I agree that my physician has answered all of my questions and I give informed consent to proceed with Latisse™ treatment.

Patient Signature        Date

Witness

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