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`Page 1 of 4
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`Allergan Product Information
`
`Below are downloadable materials with information about Allergan eye care products. Print the materials as handouts to educate your
`patients about their treatment and proper administration of the products.
`Click any of the product names below to review downloadable product information.
`
`To view PDF files, Adobe® Reader® must be installed on your computer. Do not have this program? Download here.
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`RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%
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`REFRESH® Brand (OTC)
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`LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
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`ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1%
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`COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
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`LATISSE® (bimatoprost ophthalmic solution) 0.03%
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`INDICATION(S) AND IMPORTANT SAFETY INFORMATION
`Click the links to go to each product's Indication(s) and Important Safety Information.
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`ACUVAIL® 0.45%
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`ALPHAGAN® P 0.1%
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`COMBIGAN® 0.2%/0.5%
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`LASTACAFT® 0.1%
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`LATISSE® 0.03%
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`LUMIGAN® 0.01%
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`RESTASIS® 0.05%
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`ZYMAXID® 0.5%
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`ACUVAIL® (ketorolac tromethamine ophthalmic solution) 0.45% Important Information
`INDICATION
`ACUVAIL® ophthalmic solution is a nonsteroidal anti-inflammatory indicated for the treatment of pain and inflammation following cataract surgery.
`Important Safety Information
`CONTRAINDICATIONS
`ACUVAIL® solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
`WARNINGS AND PRECAUTIONS
`Delayed Healing
`Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs
`and topical steroids may increase the potential for healing problems.
`Potential for Cross-Sensitivity
`There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
`Increased Bleeding Time
`With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal
`anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
`Corneal Effects
`Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion,
`corneal ulceration, or corneal perforation. These events may be sight threatening.
`
`Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular
`surface diseases (eg, dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may
`become sight threatening.
`
`Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days postsurgery may increase patient risk for the
`occurrence and severity of corneal adverse events.
`
`ACUVAIL® should not be administered while wearing contact lenses.
`ADVERSE REACTIONS
`The most common adverse events were reported in 1% to 6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema,
`ocular pain, headache, tearing, and vision blurred. Some of these events may be the consequence of the cataract surgical procedure.
`Please click here for the full Prescribing Information for ACUVAIL®.
`ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% Important Information
`
`https://www.allerganoptometry.com/Product-Information/
`
`MYLAN - EXHIBIT 1099
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
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`Page 2 of 4
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`INDICATIONS AND USAGE
`ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in
`patients with open-angle glaucoma or ocular hypertension.
`IMPORTANT SAFETY INFORMATION
`CONTRAINDICATIONS
`Neonates and Infants (under the age of 2 years): ALPHAGAN® P is contraindicated in neonates and infants (under the age of 2 years).
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`Hypersensitivity Reactions: ALPHAGAN® P is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.
`WARNINGS AND PRECAUTIONS
`Potentiation of Vascular Insufficiency: ALPHAGAN® P may potentiate syndromes associated with vascular insufficiency. ALPHAGAN® P should be used with caution in patients
`with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
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`Severe Cardiovascular Disease: Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be
`exercised in treating patients with severe cardiovascular disease.
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`Contamination of Topical Ophthalmic Products After Use: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic
`products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
`DRUG INTERACTIONS
`Antihypertensives/Cardiac Glycosides: Because ALPHAGAN® P may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with
`ALPHAGAN® P is advised.
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`CNS Depressants: Although specific drug interaction studies have not been conducted with ALPHAGAN® P, the possibility of an additive or potentiating effect with CNS depressants
`(alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.
`
`Tricyclic Antidepressants: Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these
`agents with ALPHAGAN® P in humans can lead to resulting interference with the IOP-lowering effect. Caution is advised in patients taking tricyclic antidepressants, which can affect
`the metabolism and uptake of circulating amines.
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`Monoamine Oxidase Inhibitors: Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic
`side effect such as hypotension. Caution is advised in patients taking MAO inhibitors, which can affect the metabolism and uptake of circulating amines.
`ADVERSE REACTIONS
`Adverse reactions occurring in approximately 10% to 20% of the subjects receiving brimonidine ophthalmic solution (0.1% to 0.2%) included: allergic conjunctivitis, conjunctival
`hyperemia, and eye pruritus. Adverse reactions occurring in approximately 5% to 9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral
`dryness, and visual disturbance.
`Please click here for the full Prescribing Information for ALPHAGAN® P.
`COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% Important Information
`INDICATIONS AND USAGE: COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic
`receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due
`to inadequately controlled IOP; the IOP-lowering of COMBIGAN® dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate
`ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.
`IMPORTANT SAFETY INFORMATION
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`CONTRAINDICATIONS: COMBIGAN® is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease; in patients
`with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; in neonates and infants (under the age of 2 years); in patients with a hypersensitivity reaction
`to any component of COMBIGAN® in the past.
`WARNINGS AND PRECAUTIONS: COMBIGAN® contains timolol maleate. COMBIGAN® is administered topically, but can be absorbed systemically. The adverse reactions with
`systemic administration of beta-adrenergic blocking agents may occur with topical use (eg, severe respiratory reactions including death due to bronchospasm in patients with asthma
`have been reported with systemic or ophthalmic administration of timolol maleate).
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`Sympathetic stimulation may be essential to support the circulation in patients with diminished myocardial contractility and its inhibition by beta-adrenergic receptor blockade may
`precipitate more severe failure. In patients with no history of cardiac failure, continued depression of the myocardium with beta-blocking agents over time can lead to cardiac failure.
`Discontinue COMBIGAN® at the first sign or symptom of cardiac failure.
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`Patients with chronic obstructive pulmonary disease (eg, chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease
`should not receive beta-blocking agents, including COMBIGAN®.
`
`COMBIGAN® may potentiate syndromes associated with vascular insufficiency. Use caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon,
`orthostatic hypotension, or thromboangiitis obliterans.
`
`Patients taking beta-blockers with a history of atopy or severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic
`challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
`
`Beta-adrenergic blockade can potentiate muscle weakness with myasthenic symptoms (eg, diplopia, ptosis, and generalized weakness). Although rare, timolol can increase muscle
`weakness in some patients with myasthenia gravis or myasthenic symptoms.
`
`Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia and clinical signs (eg, tachycardia) of hyperthyroidism. Use caution in patients
`subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Carefully manage patients
`that may develop thyrotoxicosis to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.
`
`Ocular hypersensitivity has occurred with brimonidine tartrate ophthalmic solutions 0.2% (eg, increase in IOP).
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`Some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents due to impairment of beta-adrenergically mediated reflexes during surgery. If necessary
`during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.
`ADVERSE REACTIONS: The most frequent reactions with COMBIGAN® in about 5% to 15% of patients included: allergic conjunctivitis, conjunctival folliculosis, conjunctival
`hyperemia, eye pruritus, ocular burning, and stinging.
`DRUG INTERACTIONS: COMBIGAN® may reduce blood pressure. Use caution in patients on antihypertensives and/or cardiac glycosides.
`
`Observe patients receiving a beta-adrenergic blocking agent orally and COMBIGAN® for additive effects of beta-blockade, both systemic and on intraocular pressure. Concomitant use
`of two topical beta-adrenergic blocking agents is not recommended.
`
`Use caution in the co-administration of beta-adrenergic blocking agents (eg, COMBIGAN®) and oral or intravenous calcium antagonists due to possible atrioventricular conduction
`disturbances, left ventricular failure, and hypotension. Avoid co-administration in patients with impaired cardiac function.
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`Observe patients closely when a beta-blocker is administered to patients receiving catecholamine-depleting drugs (eg, reserpine) due to possible additive effects and the production of
`hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension.
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`Specific drug interaction studies have not been conducted with COMBIGAN®, but consider the possibility of an additive or potentiating effect with CNS depressants (alcohol,
`barbiturates, opiates, sedatives, or anesthetics).
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`Concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
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`Potentiated systemic beta-blockade (eg, decreased heart rate, depression) has been reported with combined use of CYP2D6 inhibitors (eg, quinidine, SSRIs) and timolol.
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`https://www.allerganoptometry.com/Product-Information/
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`Page 3 of 4
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`Tricyclic antidepressants (TCAs) can blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of TCAs with COMBIGAN® in humans can interfere
`with the IOP-lowering effect. Caution is advised in patients taking TCAs, which can affect the metabolism and uptake of circulating amines.
`
`Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially increase systemic side effect such as hypotension. Use caution in
`patients taking MAO inhibitors, which can affect the metabolism and uptake of circulating amines.
`Please click here for the full Prescribing Information for COMBIGAN®.
`LASTACAFT® (alcaftadine ophthalmic solution) 0.25% Important Information
`INDICATIONS AND USAGE
`LASTACAFT® (alcaftadine ophthalmic solution) 0.25% is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
`MECHANISM OF ACTION
`Alcaftadine is an H1 histamine receptor antagonist and inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation have also
`been demonstrated.
`IMPORTANT SAFETY INFORMATION
`WARNINGS AND PRECAUTIONS
`To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed
`when not in use.
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`Patients should be advised not to wear a contact lens if their eye is red.
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`LASTACAFT® should not be used to treat contact lens-related irritation.
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`Remove contact lenses prior to instillation of LASTACAFT®. The preservative in LASTACAFT®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be
`reinserted after 10 minutes following administration of LASTACAFT®.
`
`LASTACAFT® is for topical ophthalmic use only.
`ADVERSE REACTIONS
`The most frequent ocular adverse reactions, occurring in < 4% of LASTACAFT® treated eyes, were eye irritation, burning and/or stinging upon instillation, eye redness, and eye
`pruritus.
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`The most frequent non-ocular adverse reactions, occurring in < 3% of subjects with LASTACAFT® treated eyes, were nasopharyngitis, headache, and influenza. Some of these events
`were similar to the underlying disease being studied.
`Please click here for the full Prescribing Information for LASTACAFT®.
`LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
`Indication
`LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.
`Important Safety Information
`Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP),
`the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use
`LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.
`
`Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation, which is
`likely to be permanent.
`
`Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as
`bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.
`There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with skin surfaces. Apply LATISSE® only to the skin of the upper eyelid
`margin at the base of the eyelashes.
`LATISSE® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated.
`Adverse Reactions: The most frequently reported adverse events were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and
`erythema of the eyelid. These events occurred in less than 4% of patients.
`Postmarketing Experience: The following reactions have been identified during postmarketing use of LATISSE® in clinical practice: burning sensation (eyelid), erythema periorbital,
`eye swelling, eyelid irritation, eyelid edema, eyelid pruritus, iris hyperpigmentation, lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of
`sections of eyelashes, and temporary eyelash breakage, respectively), rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region), skin
`discoloration (periorbital), and vision blurred.
`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.
`Please click here for the full Prescribing Information for LATISSE®.
`LUMIGAN® (bimatoprost ophthalmic solution) 0.01% Important Information
`Indication
`LUMIGAN® (bimatoprost ophthalmic solution) 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
`Important Safety Information
`Warnings and Precautions
`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. 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.
`Intraocular Inflammation: LUMIGAN® 0.01% should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated.
`Macular Edema: Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. LUMIGAN® 0.01% 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.
`Angle-Closure, Inflammatory, or Neovascular Glaucoma: LUMIGAN® 0.01% has not been evaluated for the treatment of angle-closure, inflammatory, or neovascular glaucoma.
`Use With Contact Lenses: Contact lenses should be removed prior to instillation of LUMIGAN® 0.01% and may be reinserted 15 minutes following its administration.
`Adverse Reactions
`In clinical studies with bimatoprost ophthalmic solution (0.01%), the most common adverse event was conjunctival hyperemia (range 25%-45%). Approximately 0.5% to 3% of patients
`discontinued therapy due to conjunctival hyperemia with 0.01% bimatoprost ophthalmic solution. Other common events (> 10%) included growth of eyelashes and ocular pruritus.
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`https://www.allerganoptometry.com/Product-Information/
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`Page 4 of 4
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`Use in Specific Populations
`Pediatric Use: 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.
`Please click here for the full Prescribing Information for LUMIGAN®.
`RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% Important Information
`
`Indication and Usage
`RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular
`inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
`Important Safety Information
`Contraindications
`RESTASIS® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
`Warnings and Precautions
`Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, individuals prescribed RESTASIS® should not touch the vial tip to their eye or
`other surfaces.
`Use With Contact Lenses: RESTASIS® should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the
`emulsion.
`Adverse Reactions
`In clinical trials, the most common adverse reaction following the use of RESTASIS® was ocular burning (upon instillation)—17%. Other reactions reported in 1% to 5% of patients
`included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
`Please click here for the full Prescribing Information for RESTASIS®.
`ZYMAXID® (gatifloxacin ophthalmic solution) 0.5% Important Information
`INDICATION
`ZYMAXID® (gatifloxacin ophthalmic solution) 0.5% is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the
`following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group,* Streptococcus oralis,* and
`Streptococcus pneumoniae.
`
`*Efficacy for this organism was studied in fewer than 10 infections.
`IMPORTANT SAFETY INFORMATION
`WARNINGS AND PRECAUTIONS
`ZYMAXID® solution should not be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use of ZYMAXID® may result in overgrowth of
`nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have
`signs and symptoms of bacterial conjunctivitis or during the course of therapy with ZYMAXID®.
`ADVERSE REACTIONS
`The most frequently reported adverse reactions occurring in ≥ 1% of patients in the gatifloxacin study population (N = 717) were: worsening of the conjunctivitis, eye irritation,
`dysgeusia, and eye pain. Additional adverse events reported with other formulations of gatifloxacin ophthalmic solution include chemosis, conjunctival hemorrhage, dry eye,
`eye discharge, eyelid edema, headache, increased lacrimation, keratitis, papillary conjunctivitis, and reduced visual acuity.
`Please click here for the full Prescribing Information for ZYMAXID®.
`
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