7
GIVE THEM A DROP THAT LASTS Proven effective through 16 hours 1-3 FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE LASTACAFT ® (alcaftadine ophthalmic solution) 0.25% is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. 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. Patients should be advised not to wear a contact lens if their eye is red. LASTACAFT ® should not be used to treat contact lens-related irritation. Please see additional Important Safety Information inside.

FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS › Assets › Lastacaft › LASTACA… · FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE

  • Upload
    others

  • View
    3

  • Download
    0

Embed Size (px)

Citation preview

Page 1: FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS › Assets › Lastacaft › LASTACA… · FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE

GIVE THEM A DROP THAT LASTS

Proven effective through 16 hours1-3

FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS

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.

IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONSTo 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.

Patients should be advised not to wear a contact lens if their eye is red.

LASTACAFT® should not be used to treat contact lens-related irritation.

Please see additional Important Safety Information inside.

Page 2: FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS › Assets › Lastacaft › LASTACA… · FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE

Study Design and MethodologyThese 2 trials were phase 4, multicenter, double-masked, randomized, active- and placebo-controlled studies. In one study, 157 subjects were randomized to receive LASTACAFT® (alcaftadine ophthalmic solution) 0.25% bilaterally (n = 53), Pataday ® bilaterally (n = 52), or placebo bilaterally (n = 52). In a second study, 127 subjects were randomized to receive LASTACAFT® ophthalmic solution bilaterally (n = 43), Pataday ® bilaterally (n = 43), or placebo bilaterally (n = 41). Each trial included subjects ≥ 10 years of age in the intent-to-treat population. The Conjunctival Allergen Challenge (CAC) model was used to compare the duration of action for LASTACAFT®, Pataday ®, and placebo at 16 hours post dosing.

The trials were approximately 6 weeks and 5 weeks, respectively, and each subject received 1 dose of LASTACAFT® (alcaftadine ophthalmic solution) 0.25%, Pataday ®, or placebo at visit 3.4,5

The CAC was conducted 16 hours post dosing of study treatments, and the results shown were obtained 3 minutes post CAC. The main efficacy end point was ocular itching evaluated by the subject at 3 minutes post CAC at visit 3. Ratings were made on a scale of 0 to 4 (allowing half-unit increments), where 0 = “none” and 4 = “an incapacitating itch with an irresistible urge to rub.”4,5

IMPORTANT SAFETY INFORMATION (continued)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.

Patients should be advised not to wear a contact lens if their eye is red.

LASTACAFT® (alcaftadine ophthalmic solution) 0.25% should not be used to treat contact lens-related irritation.

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® (alcaftadine ophthalmic solution) 0.25% treated eyes, were eye irritation, burning and/or stinging upon instillation, eye redness, and eye pruritus.

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 see accompanying full Prescribing Information.

16 Hours Post Dosing (3 minutes post CAC)4

aMinimal itch defined as an ocular itch score from 0 to < 1.

Once-dailydosing1

For patients with itching due to allergic conjunctivitis

DURATION OF LASTACAFT® (alcaftadine ophthalmic solution) 0.25%

PROVEN VS PATADAY ® AND PLACEBO

bMinimal itch defined as an ocular itch score from 0 to < 1.

16 Hours Post Dosing (3 minutes post CAC)5

Statistically Significant Results Shown Across 2 Trials

Page 3: FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS › Assets › Lastacaft › LASTACA… · FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE

Once-dailydosing1

For patients with itching due to allergic conjunctivitis

PRESCRIBE A FULL DAY OF EFFICACY

Works Fast at 3 Minutes2,3

Study Design and MethodologyAll clinical efficacy trials were phase 3, double-masked, randomized, vehicle-controlled studies. These 3 trials included 274 patients ≥ 10 years of age in the intent-to-treat population. The Conjunctival Allergen Challenge (CAC) model was used in all 3 studies to test the effect of LASTACAFT® (alcaftadine ophthalmic solution) 0.25% at onset and duration of action. Each study included 4 visits over approximately 5 weeks, and each patient received a total of 2 doses of LASTACAFT® ophthalmic solution or vehicle.6

At visit 3, the CAC was conducted 16 hours post dosing of LASTACAFT® (alcaftadine ophthalmic solution) 0.25% or vehicle, and the results shown were obtained 3 minutes post CAC. At visit 4, the CAC was conducted 15 minutes post dosing of LASTACAFT® ophthalmic solution or vehicle, and the results shown were obtained 3 minutes post CAC. The main study end point was ocular itching evaluated by the patient at 3 minutes post CAC at visits 3 and 4. Ratings were made on a scale of 0 to 4 (allowing half-unit increments), where 0 = “none” and 4 = “an incapacitating itch with an irresistible urge to rub.”2,3,6

Lasts All Day Through 16 Hours2,3

IMPORTANT SAFETY INFORMATION (continued)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.

Patients should be advised not to wear a contact lens if their eye is red.

LASTACAFT® (alcaftadine ophthalmic solution) 0.25% should not be used to treat contact lens-related irritation.

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 REACTIONSThe most frequent ocular adverse reactions, occurring in < 4% of LASTACAFT® (alcaftadine ophthalmic solution) 0.25% treated eyes, were eye irritation, burning and/or stinging upon instillation, eye redness, and eye pruritus.

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 see accompanying full Prescribing Information.

aMinimal itch defined as an ocular itch score from 0 to < 1.

bMinimal itch defined as an ocular itch score from 0 to < 1.

Page 4: FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS › Assets › Lastacaft › LASTACA… · FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE

INDICATIONS AND USAGELASTACAFT® (alcaftadine ophthalmic solution) 0.25% is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

IMPORTANT SAFETY INFORMATIONWARNINGS 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.

Patients should be advised not to wear a contact lens if their eye is red.

LASTACAFT® should not be used to treat contact lens- related irritation.

Remove contact lenses prior to instillation of LASTACAFT® (alcaftadine ophthalmic solution) 0.25%. 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.

Please see accompanying full Prescribing Information.

USE IN SPECIFIC POPULATIONS• Classified as a Pregnancy Category B product1

• FDA approved for use in patients as young as 2 years of age1

Visit Lastacaft.com for the latest savings offers

for eligible patients

Page 5: FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS › Assets › Lastacaft › LASTACA… · FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE

DO YOU WANT ALL-DAY ITCHY-EYE ALLERGY RELIEF?

• LASTACAFT® ophthalmic solution is approved to prevent itching due to eye allergies1

• LASTACAFT® works fast at 3 minutes and prevents itchy eyes all day through 16 hours1

• LASTACAFT® ophthalmic solution was also evaluated for safety in a separate clinical study of 909 patients over 6 weeks1

o The most common eye-related side effects that were reported in less than 4% of LASTACAFT® treated eyes were: eye irritation, burning and/or stinging in the eyes after use, eye redness, and eye itching1

o The most common non–eye-related side effects that were reported in less than 3% of patients with LASTACAFT® treated eyes were: inflammation of the nose and the upper part of the throat, headache, and the flu1

INDICATIONS AND USAGELASTACAFT® (alcaftadine ophthalmic solution) 0.25% is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONSTo 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.

Patients should be advised not to wear a contact lens if their eye is red.

LASTACAFT® should not be used to treat contact lens-related irritation.

Please see additional Important Safety Information on next page.

Just one LASTACAFT® (alcaftadine ophthalmic solution) 0.25% drop, once a day, helps prevent eyes from itching due to eye allergies all day (through 16 hours).1

Page 6: FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS › Assets › Lastacaft › LASTACA… · FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE

Common allergens associated with eye allergies7

Pollen from trees and grasses

Pollen from ragweed

Seasonal allergens

Dust mites Cat dander

Year-round allergens

GET LASTING RELIEFVisit Lastacaft.com for the

latest savings offers

IMPORTANT SAFETY INFORMATION (continued)WARNINGS AND PRECAUTIONS (continued)Remove contact lenses prior to instillation of LASTACAFT® (alcaftadine ophthalmic solution) 0.25%. 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.

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 see accompanying full Prescribing Information.

Page 7: FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS › Assets › Lastacaft › LASTACA… · FOR PATIENTS WITH ITCHING DUE TO ALLERGIC CONJUNCTIVITIS INDICATIONS AND USAGE

1. LASTACAFT® Prescribing Information. 2. Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011;27(3):623-631. 3. Data on file, Allergan, Inc., 2005. 4. Data on file, Allergan, Inc., 2013. 5. Data on file, Allergan, Inc., 2011. 6. Data on file, Allergan, Inc., 2010. 7. Bielory L. Ocular allergy. Mt Sinai J Med. 2011;78(5):740-758. 8. IMS Health, Inc. Total Patient Tracker. Plymouth Meeting, PA: IMS Health, Inc.; October 25, 2013.

©2014 Allergan, Inc., Irvine, CA 92612 ® marks owned by Allergan, Inc. Pataday is a registered trademark owned by Novartis AG. www.Lastacaft.com APC62OV14 143032

*Based on IMS Health, Inc., Total Patient Tracker data from March 2011–January 2013. Projected patient count was calculated using estimated total prescription counts via national audits and total prescription and patient counts from source-collected data.

PRESCRIBED FOR OVER

PATIENTS8,*

Visit Lastacaft.com to learn about current savings offers for eligible patients

IMPORTANT SAFETY INFORMATION (continued)ADVERSE REACTIONSThe most frequent ocular adverse reactions, occurring in < 4% of LASTACAFT® (alcaftadine ophthalmic solution) 0.25% treated eyes, were eye irritation, burning and/or stinging upon instillation, eye redness, and eye pruritus.

The most frequent non-ocular adverse reactions, occurring in < 3% of subjects with LASTACAFT® (alcaftadine ophthalmic solution) 0.25% treated eyes, were nasopharyngitis, headache, and influenza. Some of these events were similar to the underlying disease being studied.

Please see accompanying full Prescribing Information.