LUMIGAN® 0.01% and 0.

03%
(bimatoprost ophthalmic solution)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LUMIGAN® 0.01% and
0.03% (bimatoprost ophthalmic solution) safely and effectively. See full prescribing
information for LUMIGAN®.
®
LUMIGAN 0.01% and 0.03% (bimatoprost ophthalmic solution) Initial U.S. Approval:
2001
_________INDICATIONS AND USAGE _________
LUMIGAN® is a prostaglandin analog indicated for the reduction of elevated intraocular
pressure in patients with open angle glaucoma or ocular hypertension. (1)
_______DOSAGE AND ADMINISTRATION_______
One drop in the affected eye(s) once daily in the evening. (2)
_____DOSAGE FORMS AND STRENGTHS _____
Solution containing 0.1 mg/mL bimatoprost (LUMIGAN® 0.01%) or containing 0.3 mg/mL
bimatoprost (LUMIGAN® 0.03%). (3)

_______WARNINGS AND PRECAUTIONS _______

• Pigmentation.
Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur
(5.1). Iris pigmentation likely to be permanent.
• Eyelash Changes.
Gradual change to eyelashes including increased length, thickness and number
of lashes. Usually reversible. (5.2)
___________ADVERSE REACTIONS ___________
Most common adverse reaction (range 25% - 45%) is conjunctival hyperemia. (6.1)
_______USE IN SPECIFIC POPULATIONS _______
Use in pediatric patients below the age of 16 years is not recommended because of
potential safety concerns related to increased pigmentation following long-term chronic
use. (7.3)

See 14 for Patient Counseling Information Revised: December 2013

FULL PRESCRIBING INFORMATION:
CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
5WARNINGS AND PRECAUTIONS
5.1 Pigmentation
5.2 Eyelash Changes
5.3 Intraocular Inflammation
5.4 Macular Edema
5.5 Angle-closure, Inflammatory, or Neovascular Glaucoma
5.6 Bacterial Keratitis
5.7 Use with Contact Lenses
6ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Events
7 USE IN SPECIFIC POPULATIONS
7.1 Pregnancy
7.2 Nursing Mothers
7.3 Pediatric Use
7.4 Geriatric Use
7.5 Hepatic Impairment
8 OVERDOSAGE
9 DESCRIPTION
10 CLINICAL PHARMACOLOGY
10.1 Mechanism of Action
10.2 Pharmacokinetics
11 NONCLINICAL TOXICOLOGY
11.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
12 CLINICAL STUDIES
13 HOW SUPPLIED/STORAGE AND HANDLING
14 PATIENT COUNSELING INFORMATION
14.1 Potential for Pigmentation
14.2 Potential for Eyelash Changes
14.3 Handling the Container
14.4 When to Seek Physician Advice
14.5 Use with Contact Lenses
14.6 Use with Other Ophthalmic Drugs
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
®
LUMIGAN 0.01% and 0.03% (bimatoprost ophthalmic solution) is indicated for the reduction
of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
(who are intolerant of other intraocular pressure lowering medications or insufficiently
responsive (failed to achieve target IOP determinded after multiple measurements over time)
to another intraocular pressure lowering medication.)

2 DOSAGE AND ADMINISTRATION

The recommended dosage is one drop in the affected eye(s) once daily in the evening.
LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) should not be administered
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.
LUMIGAN® 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.
3 DOSAGE FORMS AND STRENGTHS
®
Ophthalmic solution containing bimatoprost 0.1 mg/mL (LUMIGAN 0.01%) or containing
®
bimatoprost 0.3 mg/mL (LUMIGAN 0.03%).

4 CONTRAINDICATIONS
®
LUMINGAN is contraindicated in patients with hypersensitivity to bimatoprost or any other
ingredient in this product.
5 WARNINGS AND PRECAUTIONS
5.1 Pigmentation
Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues.
The most frequently reported changes have been increased pigmentation of the iris,
periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as
bimatoprost is administered. The pigmentation change is due to increased melanin content
in the melanocytes rather than to an increase in the number of melanocytes. 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. Patients who receive treatment should be informed 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 spread concentrically toward 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. While treatment with LUMIGAN 0.01% and 0.03%
(bimatoprost ophthalmic solution) can be continued in patients who develop noticeably
increased iris pigmentation, these patients should be examined regularly. (see PATIENT
COUNSELING INFORMATION, 14.1).
5.2 Eyelash Changes
®
LUMIGAN 0.01% and 0.03% 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.
5.3 Intraocular Inflammation
®
LUMIGAN 0.01% and 0.03% should be used with caution in patients with active intraocular
inflammation (e.g., uveitis) because the inflammation may be exacerbated.
5.4 Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment
with bimatoprost ophthalmic solution.
LUMIGAN® 0.01% and 0.03% should be used with caution in aphakic patients, in
pseudophakic patients with a torn posterior lens capsule, or in patients with known risk
factors for macular edema.
5.5 Angle-closure, Inflammatory or Neovascular Glaucoma
LUMIGAN® 0.01% and 0.03% has not been evaluated for the treatment of angle-closure,
inflammatory or neovascular glaucoma.
5.6 Bacterial Keratitis
There have been reports of bacterial keratitis associated with the use of multiple-dose
containers of topical ophthalmic products. These containers had been inadvertently
contaaminated by patients
p who, in
i most cases, had a concurrent corneal disease or a
disru
uption of the ocular epithelia
al surface (see
e PATIENT CO
OUNSELING INFORMATIO ON,
14.3).
5.7 Use
U with Con ntact Lenses
Patie
ent wearing sooft (hydrophilicc) contact lensses should be instructed to remove conta
act
®
lense
es prior to adm
ministration off LUMIGAN (0.01%( or 0.03
3%) and wait at
a least 15
minuutes following administrationn before reinse erting soft con
ntact lenses.
6 ADDVERSE REA ACTIONS
6.1 Clinical
C Studiies Experiencce
Beca ause clinical studies
s are conducted undder widely varying conditioons, adverse reaction
r
ratess observed in the clinical studies
s of a drrug cannot be mpared to rates in the
e directly com
cliniccal studies of another
a drug and
a may not reflect
r the rate
es observed in
n practice.
In cliinical studies with
w bimatopro ost ophthalmicc solutions (0.01% or 0.03%
%) the most co
ommon
adveerse event wass conjunctival hyperemia (ra ange 25% – 45%).
4 Approxim
mately 0.5% too 3% of
patie
ents discontinu ued therapy due to conjuncttival hyperemiia with 0.01% or 0.03%
bimaatoprost ophth halmic solutionns. Other comm mon events (> >10%) include
ed growth of
eyela ashes, and oc cular pruritus.
Additional ocular adverse
a eventts (reported in 1 to 10% of patients)
p with bimatoprost
b
ophthalmic solutio ons included ocular dryness, visual disturb bance, ocular burning, foreign body
senssation, eye paiin, pigmentatioon of the perioocular skin, ble
epharitis, cata
aract, superficiial
puncctate keratitis, eyelid erythem
ma, ocular irrittation, eyelash
h darkening, eye
e discharge, tearing,
photophobia, allerrgic conjunctivvitis, asthenopia, increases ini iris pigmenttation, conjuncctival
edemma, conjunctiv val hemorrhage, and abnorm mal hair growth. Intraocular inflammation,,
repoorted as iritis was
w reported in n less than 1%% of patients. Systemic
S adveerse events reeported
in ap
pproximately 10% of patientts with bimatop prost ophthalmmic solutions were
w infections
(prim
marily colds an nd upper respiratory tract inffections). Othe
er systemic ad dverse
evennts(reported in n 1 to 5% of pa
atients) included headachess, abnormal livver function te ests, and
astheenia.

6.2 Postmarketin
P ng Events
®
The following adve erse reactionss have been id dentified during g postmarketing use of LUM MIGAN
0.01% and 0.03% multidose. Be ecause postmarketing reporrting is volunta ary and from a
popuulation of unce
ertain size, it iss not possible to reliably esttimate the freq
quency of thesse
reacctions:
®
LUMMIGAN 0.01% %
Eye disorders
Eye pain, Vision blurred
b
vous system disorders
Nerv
Headdache
Resppiratory, thorracic and meddiastinal diso
orders
Asthma, Exacerba ation of Asthm
ma, Dyspnea
®
LUMMIGAN 0.03% %
Eye disorders
Deeppened lid sulccus (enophthallmos), Erythem
ma (periorbital), Eyelid edem
ma, Macular edema
e
Skin
n and subcuta aneous tissuee disorders
Hair growth abnorrmal
Gasttrointestinal disorders
Naussea
Nervvous system disorders
Dizziness, Headacche
Resppiratory, thorracic and med diastinal diso
orders
Asthma, Exacerba ation of Asthm
ma, Dyspnea
Vasccular disorde ers
Hypeertension
7 USSE IN SPECIF FIC POPULAT TIONS
7.1 P
Pregnancy
Preggnancy Catego ory C
Tera
atogenic effectts: In embryo/ffetal developm
mental studiess in pregnant mice
m and rats,
aborrtion was obseerved at oral doses of bimattoprost which achieved
a at le
east 33 or 97 times,
t
respectively, the maximum
m intennded human exposure
e baseed on blood AUC levels.
oses at least 41
At do 4 times the maximum
m inten
nded human exposure
e baseed on blood AUUC
levells, the gestatio
on length was reduced in th
he dams, the in
ncidence of de
ead fetuses, la
ate
resorptions, peri- and
a postnatal pup mortality was increase ed, and pup boody weights weere
reduced.
quate and well-controlled studies of LUMIGAN® 0.01%
Therre are no adeq % and 0.03%
(bimatoprost ophthhalmic solution) administrattion in pregnan
nt women. Because animal
oductive studies are not alw
repro ways predictivee of human response LUMIGAN® should be
administered durin
ng pregnancy only if the pottential benefit justifies the po
otential risk to
o the
fetuss.
7.2 Nursing Moth hers
®
It is n
not known whether LUMIGA AN 0.01% an nd 0.03% is exxcreted in humman milk, altho
ough
in annimal studies, bimatoprost has
h been show wn to be excreeted in breast milk. Becausee
®
many drugs are exxcreted in hum man milk, cauttion should be
e exercised whhen LUMIGAN N is
administered to a nursing woma an.
7.3 Pediatric Use e
Use in pediatric pa
atients below the
t age of 16 years is not re
ecommended because of
potential safety co
oncerns related
d to increased
d pigmentation ng-term chronic
n following lon
use.
7.4 Geriatric Use e
No o
overall clinical differences in ectiveness havve been obserrved between elderly
n safety or effe
and other adult paatients.
7.5 Hepatic Impa airment
atients with a history
In pa h of liverr disease or ab
bnormal ALT, AST and/or bilirubin
b at baseline,
bimaatoprost 0.03%% had no adve erse effect on liver function over
o 48 month
hs.
8 O OVERDOSAGE
®
No innformation is available
a on overdosage
o in humans. If ovverdose with LUMIGAN
L 0.0
01%
and 0.03% (bimato oprost ophtha
almic solution) occurs, treatm
ment should be
b symptomatic.
In orral (by gavagee) mouse and rat studies, dooses up to 1000 mg/kg/day did not producee any
toxiccity. This dose expressed ass mg/m2 is at least 70 timess higher than the
t accidental dose
of on UMIGAN®
ne bottle of LU
0.03% for a 10 kg child.

9 D DESCRIPTION N
®
LUMMIGAN 0.01% % and 0.03% ((bimatoprost ophthalmic
o solution) is a syn
nthetic prostam
mide
analoog with ocularr hypotensive activity. Its ch
hemical name is (Z)-7-[(1R,22R,3R,5S)-3,5 5-
Dihyydroxy-2-[(1E,33S)-3-hydroxyy-5-phenyl-1-p pentenyl]cyclopentyl]-5-N-etthylheptenamide,
and its molecular weight
w is 415.58. Its molecu ular formula iss C25H37NO4 4. Its chemical
struccture is:

Bimaatoprost is a powder,
p ohol and methyl alcohol and
which is very soluble in ethyl alco d
®
sligh
htly soluble in water.
w LUMIGGAN 0.01% and a 0.03% is a clear, isotoniic, colorless, sterile
s
ophtthalmic solutioon with an osm
molality of approximately 290 0 mOsmol/kg..
®
LUMMIGAN 0.01% % contains Ac ctive: bimatopprost 0.1 mg/m
mL; Preservattive: benzalko onium
chlorride 0.2 mg/m
mL; Inactives s: sodium chlooride; sodium phosphate, dibasic;
d citric acid;
and purified waterr. Sodium hydroxide and/or hydrochloric acid
a may be added
a to adjus st pH.
The pH during its shelf life range
es from 6.8-7..8.
®
LUMMIGAN 0.03% % contains Ac ctive: bimatopprost 0.3 mg/m
mL; Preservattive: benzalko onium
chlorride 0.05 mg//mL; Inactives s: sodium chloride; sodiumm phosphate, dibasic; citricc acid;
and purified waterr. Sodium hydroxide and/or hydrochloric acid may be added
a to adjusst pH.
The pH during its shelf life range
es from 6.8-7..8.
10 C CLINICAL PH HARMACOLO OGY
10.1 Mechanism of Action
Bimaatoprost, a proostaglandin an nalog, is a syn
nthetic structurral analog of prostaglandin
p w
with
oculaar hypotensivee activity. It se
electively mimics the effectss of naturally occurring
o
subsstances, prostaamides. Bimatoprost is belie eved to lower intraocular prressure (IOP) in
humans by increasing outflow of o aqueous humor through both b the trabec
cular meshwork and
uveooscleral routess. Elevated IOP presents a major
m risk facttor for glaucom
matous field lo
oss.
The higher the levvel of IOP, the greater the lik kelihood of opptic nerve dam mage and visua al field
loss..
10.2 Pharmacokinetics
Absorptio
on: After one drop
d of bimatooprost ophthalmic solution 0.03%
0 was
administered oncee daily to both eyes of 15 he
ealthy subjectss for two weekks, blood
concentrations peaked within 10 minutes after dosing and were below the lower limit of
detection (0.025 ng/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. Approxi-mately 12% of bimatoprost remains unbound in human plasma.

Metabolism: Bimatoprost is the major circulating species in the blood once it

reaches the systemic circulation following ocular dosing. Bimatoprost then undergoes
oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.
Elimination: Following an intravenous dose of radiolabeled bimatoprost (3.12 µg/kg)
to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL
and decreased rapidly with an elimination half-life of approximately 45 minutes. The total
blood clearance of bimatoprost was 1.5 L/hr/kg. Up to 67% of the administered dose was
excreted in the urine while 25% of the dose was recovered in the feces.
11 NONCLINICAL TOXICOLOGY
11.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage at
doses of up to
2 mg/kg/day and 1 mg/kg/day respectively (at least 192 and 291 times the recommended
human exposure based on blood AUC levels respectively) for 104 weeks.
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 based on blood AUC levels).
12 CLINICAL STUDIES
In clinical studies of patients with open angle glaucoma or ocular hypertension with a mean
®
baseline IOP of 26 mmHg, the IOP-lowering effect of LUMIGAN 0.03% (bimatoprost
ophthalmic solution) once daily (in the evening) was 7-8 mmHg.
In a 3 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 and was approximately 0.5 mmHg less effective
® ®
than LUMIGAN 0.03%. In this same study, LUMIGAN 0.01% also had a similar overall
®
safety profile compared with LUMIGAN 0.03%. After 12 months of treatment,
® ®
discontinuations were 8.1% for LUMIGAN 0.01% and 13.4% for LUMIGAN
0.03%.
Results of dosing for up to five years with products in this drug class showed that the onset
of noticeable increased iris pigmentation occurred within the first year of treatment for the
majority of the patients who developed noticeable increased iris pigmentation. Patients
continued to show signs of increasing iris pigmentation throughout the five years.
Observation of increased iris pigmentation did not affect the incidence, nature or severity of
adverse events (other than increased iris pigmentation). IOP reduction is similar regardless
of the development of increased iris pigmentation.
13 HOW SUPPLIED/STORAGE AND HANDLING
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:
1 mL fill in a 5 mL container
2.5 mL fill in a 5 mL container
3 mL fill in a 5 mL container
5 mL fill in a 10 mL container
7.5 mL fill in a 10 mL container
LUMIGAN® (bimatoprost ophthalmic solution) 0.03% is supplied sterile in opaque white low
density polyethylene ophthalmic dispenser bottles and tips with turquoise polystyrene caps
in the following sizes:
3 mL fill in 5 mL container
5 mL fill in 10 mL container
7.5 mL fill in 10 mL container
Storage: LUMIGAN® 0.01% and 0.03% should be stored at 2° to 25°C (36° to
77°F). Discard unused contents 4 weeks after opening.
14 PATIENT COUNSELING INFORMATION
14.1 Potential for Pigmentation
Patients should be advised about the potential for increased brown pigmentation of the iris,
which may be permanent. Patients should also be informed about the possibility of eyelid
skin darkening, which may be reversible after discontinuation of LUMIGAN®0.01% and
0.03% (bimatoprost ophthalmic solution).
14.2 Potential for Eyelash Changes
Patients should also be informed of the possibility of eyelash and vellus hair changes in the
treated eye during treatment with LUMIGAN® 0.01% and 0.03%. These changes 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.
14.3 Handling the Container
Patients should be instructed to avoid allowing the tip of the dispensing container to contact
the eye, surrounding structures, fingers, or any other surface in order to avoid eye injury
and contamination of the solution Serious damage to the eye and subsequent loss of vision
may result from using contaminated solutions.
14.4 When to Seek Physician Advice
Patients should also be advised 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% and 0.03%.
14.5 Use with Contact Lenses
LUMIGAN® (0.01% and 0.03%) contains the preservative benzalkonium chloride, which may
be absorbed by and cause dis-coloration of soft contact lenses. Patients wearing soft
(hydrophilic) contact lenses should be instructed to remove contact lenses prior to
administration of LUMIGAN® (0.01% and 0.03%) and wait at least 15 minutes following
administration before reinserting soft contact lenses.

14.6 Use with Other Ophthalmic Drugs

If more than one topical ophthalmic drug is being used, the drugs should be administered at
least five (5) minutes between applications.
Manufactured by:
®
LUMIGAN 0.01% Opthalmic solution
Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, County Mayo, Ireland

LUMIGAN® 0.03% Opthalmic solution

Allergan Sales, LLC, 8301 Mars Drive, Waco, Texas 76712, U.S.A.
© 2014 Allergan, Inc. ® marks owned by Allergan, Inc.