Reach for the product that eliminates head lice with non-neurotoxic asphyxiation
Ulesfia® Lotion— Leave Lice Breathless ®
Indication • Ulesfia® (benzyl alcohol) Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia® Lotion does not have ovicidal activity. Important Safety Information • Ulesfia® Lotion should only be used on children (6 months of age and older) under the direct supervision of an adult. Keep out of reach of children. Please see full Important Safety Information on back cover and full Prescribing Information enclosed.
Treating Head Lice With Pesticides May Lead to Resistance • Resistance of head lice to neurotoxic pesticides is
a growing problem1,2
— An increase in the development of pesticidal resistance has been documented in the United States1,2 • Since the introduction of insecticides, head lice have adapted by genetic alterations, which may lead to resistance3
Closed breathing spiracle of a louse after treatment with mayonnaise.4
• Household remedies, such as petroleum jelly and mayonnaise, have been used to treat head lice. However, these treatments are not FDA approved and have not been proven safe and effective5
Ulesfia® Lotion—A Different Physical Mechanism of Action Ulesfia® Lotion is a non-neurotoxic head lice therapy, unlike prescription pediculicides that contain chemical pesticides4 Ulesfia® Lotion asphyxiates head lice in 2 stages4,6*
1
2
The breathing apparatus of head lice are “stunned” open by benzyl alcohol
Inactive ingredients infiltrate the respiratory apparatus and kill the head lice
The normal “honeycomb” breathing apparatus of the louse.4
The breathing apparatus “stunned” open by Ulesfia® Lotion.4
*As demonstrated by in vitro studies.6 Important Safety Information • Intravenous administration of products containing benzyl alcohol has been associated with neonatal gasping syndrome
consisting of severe metabolic acidosis, gasping respirations, progressive hypotension, seizures, central nervous system depression, intraventricular hemorrhage, and death in preterm, low birth weight infants. Neonates (i.e. patients less than 1 month of age or preterm infants with a corrected age of less than 44 weeks) could be at risk for gasping syndrome if treated with Ulesfia®. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, bradycardia, and cardiovascular collapse.
Please see full Important Safety Information on back cover and full Prescribing Information enclosed.
Prescribe Ulesfia® Lotion to Eliminate Live Head Lice
®
Patients with no live head lice — intent-to-treat (ITT) population6 100
100
90
90
80
80
76.2% (n=63)
percent of patients
70
60
60
50
50
40
40
30
30
20
20
10
10
4.8% (n=62)
0
study 1
P<0.001
Ulesfia® Lotion
76%
75% (n=64)
70
of patients had no live lice 14 days after second application6*
26.2% (n=61)
0
P<0.001
study 2
Vehicle
Two randomized, multicenter, double-blind, vehicle-controlled, phase III trials were conducted in 628 subjects aged 6 months and older with active head lice infestation. The primary efficacy measurement was treatment success (%), defined as no live lice 14 days post second treatment. 125 patients in Study 1 were randomized to either Ulesfia® Lotion (n=63) or vehicle (n=62). 125 patients in Study 2 were randomized to either Ulesfia® Lotion (n=64) or vehicle (n=61). Treatment was administered in 2 applications, 1 week apart, 10 minutes each. The percentage of patients with treatment success for Ulesfia® Lotion vs vehicle in Study 1 was 76.2% vs 4.8% and in Study 2 was 75% vs 26.2%. • The ITT population enrolled the youngest members from each household with active head lice infestation * Ulesfia® Lotion should be used as part of an overall lice management program. Please see application instructions for more information.
Please see full Important Safety Information on back cover and full Prescribing Information enclosed.
4
Full Saturation Maximizes Efficacy
LONG
MEDIUM
SHORT
Achieve optimal results by applying according to hair length6
Hair length
Application (8-oz bottles)
Ear length or shorter (Up to 2 inches)
Up to ¾ bottle
2
Ear length (2 to 4 inches)
Up to 1 bottle
2
Up to 1½ bottles
3
Shoulder length (8 to 16 inches)
Up to 3 bottles
6
Past shoulders (16 to 22 inches)
Up to 4 bottles
8
Very long (over 22 inches)
Up to 6 bottles
Chin length (4 to 8 inches)
Number of bottles to prescribe
12
2
APPLICATIONS
10 1
MINUTES
WEEK APART
•M aximum efficacy resulting from complete saturation was also confirmed in phase II controlled clinical trials of benzyl alcohol 5%, measuring concentration, application, and duration • Clinical trials confirmed that a 10-minute application was equally as effective as a 30-minute application
Ulesfia® Lotion should be used as part of an overall head lice management program: • A fine-tooth comb or special nit comb may be used to remove dead lice and nits • All recently worn clothing, hats, used bedding, towels, and personal care items such as combs, brushes, and hair clips should be washed in hot water or dry-cleaned Individual results may vary.
Please see complete application instructions in the full Prescribing Information enclosed.
Prescribe Ulesfia® Lotion— Leave Lice Breathless 1 Rx =
both applications
• Asphyxiates lice in 2 stages4,6 • Non-neurotoxic formulation6 • 76% of patients had no live lice after 14 days6 • Full saturation maximizes efficacy
Ulesfia® Lotion should be used as part of an overall head lice management program: • A fine-tooth comb or special nit comb may be used to remove dead lice and nits • A ll recently worn clothing, hats, used bedding, towels, and personal care items such as combs, brushes, and hair clips should be washed in hot water or dry-cleaned Individual results may vary.
Indication • Ulesfia® (benzyl alcohol) Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia® Lotion does not have ovicidal activity. Important Safety Information • Intravenous administration of products containing benzyl alcohol has been associated with neonatal gasping syndrome consisting of severe metabolic acidosis, gasping respirations, progressive hypotension, seizures, central nervous system depression, intraventricular hemorrhage, and death in preterm, low birth weight infants. Neonates (i.e. patients less than 1 month of age or preterm infants with a corrected age of less than 44 weeks) could be at risk for gasping syndrome if treated with Ulesfia®. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, bradycardia, and cardiovascular collapse. • Avoid eye exposure. Ulesfia® may cause eye irritation. If Ulesfia® comes in contact with the eyes, flush them immediately with water. • Ulesfia® Lotion may cause allergic or irritant dermatitis. • Ulesfia® Lotion should only be used on children (6 months of age and older) under the direct supervision of an adult. Keep out of reach of children. • Most common application site adverse reactions were: site irritation (2%), and site anesthesia and hypoesthesia (2%), and pain (1%). • The most common adverse reactions are: pruritus, erythema, pyoderma and ocular irritation. Please see full Prescribing Information enclosed. References: 1. Frankowski BL, Bocchini JA Jr; Council on School Health and Committee on Infectious Diseases. Head lice. Pediatrics. 2010;126:392-403. 2. Meinking TL, Serrano L, Hard B, et al. Comparative in vitro pediculicidal efficacy of treatments in a resistant head lice population in the United States. Arch Dermatol. 2002;138:220-224. 3. Yoon KS, Gao J-R, Lee SH, et al. Permethrin-resistant human head lice, Pediculus capitis, and their treatment. Arch Dermatol. 2003;139:994-1000. 4. Meinking TL, Villar ME, Vicaria M, et al. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia™): a safe and effective topical treatment for head lice (pediculosis humanus capitis). Pediatr Dermatol. 2010;27(1):19-24. 5. Data on file, Shionogi Inc. 6. Ulesfia® (5% benzyl alcohol) Lotion [package insert]. Florham Park, NJ: Shionogi Inc; 2010. Ulesfia® Lotion is a registered trademark of Shionogi Inc. ©2012 Shionogi Inc. Florham Park, NJ All rights reserved. ULE12-PSA-001-00 04/12
Please see full Important Safety Information on back cover and full Prescribing Information enclosed.
6
• Avoid eye exposure. Ulesfia® may cause eye irritation. If Ulesfia® comes in contact with the eyes, flush them immediately with water. • The most common adverse reactions are: pruritus, erythema, pyoderma and ocular irritation. • Most common application site adverse reactions were: site irritation (2%), and site anesthesia and hypoesthesia (2%), and pain (1%).
Important Safety Information Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: application site dryness, application site excoriation, paraesthesia, application site dermatitis, excoriation, thermal burn, dandruff, erythema, rash, and skin exfoliation. Ulesfia® Lotion
Vehicle
Pruritus
12% (14/116)
4% (3/67)
Erythema
10% (32/309)
9% (19/217)
Pyoderma
7% (22/308)
4% (10/230)
Ocular irritation
6% (26/428)
1% (3/313)
Signs/Symptoms
Monitored Adverse Reactions With Onset After Treatment • Ulesfia® Lotion is indicated to treat children as young as 6 months of age Ulesfia® Lotion (n=478)
Vehicle (n=336)
Irritation
2% (11)
1% (2)
Anesthesia & hypoesthesia
2% (10)
0% (0)
Pain
1% (5)
0% (0)
Application Site Events
Application Site Symptoms
Adverse Events Profiles6
®
Prescribe Ulesfia® Lotion— Leave Lice Breathless 1 Rx =
both applications
• Asphyxiates lice in 2 stages4,6 • Non-neurotoxic formulation6 • 76% of patients had no live lice after 14 days6 • Full saturation maximizes efficacy
Ulesfia® Lotion should be used as part of an overall head lice management program: • A fine-tooth comb or special nit comb may be used to remove dead lice and nits • A ll recently worn clothing, hats, used bedding, towels, and personal care items such as combs, brushes, and hair clips should be washed in hot water or dry-cleaned Individual results may vary.
Indication • Ulesfia® (benzyl alcohol) Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia® Lotion does not have ovicidal activity. Important Safety Information • Intravenous administration of products containing benzyl alcohol has been associated with neonatal gasping syndrome consisting of severe metabolic acidosis, gasping respirations, progressive hypotension, seizures, central nervous system depression, intraventricular hemorrhage, and death in preterm, low birth weight infants. Neonates (i.e. patients less than 1 month of age or preterm infants with a corrected age of less than 44 weeks) could be at risk for gasping syndrome if treated with Ulesfia®. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, bradycardia, and cardiovascular collapse. • Avoid eye exposure. Ulesfia® may cause eye irritation. If Ulesfia® comes in contact with the eyes, flush them immediately with water. • Ulesfia® Lotion may cause allergic or irritant dermatitis. • Ulesfia® Lotion should only be used on children (6 months of age and older) under the direct supervision of an adult. Keep out of reach of children. • Most common application site adverse reactions were: site irritation (2%), and site anesthesia and hypoesthesia (2%), and pain (1%). • The most common adverse reactions are: pruritus, erythema, pyoderma and ocular irritation. Please see full Prescribing Information enclosed. References: 1. Frankowski BL, Bocchini JA Jr; Council on School Health and Committee on Infectious Diseases. Head lice. Pediatrics. 2010;126:392-403. 2. Meinking TL, Serrano L, Hard B, et al. Comparative in vitro pediculicidal efficacy of treatments in a resistant head lice population in the United States. Arch Dermatol. 2002;138:220-224. 3. Yoon KS, Gao J-R, Lee SH, et al. Permethrin-resistant human head lice, Pediculus capitis, and their treatment. Arch Dermatol. 2003;139:994-1000. 4. Meinking TL, Villar ME, Vicaria M, et al. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia™): a safe and effective topical treatment for head lice (pediculosis humanus capitis). Pediatr Dermatol. 2010;27(1):19-24. 5. Data on file, Shionogi Inc. 6. Ulesfia® (5% benzyl alcohol) Lotion [package insert]. Florham Park, NJ: Shionogi Inc; 2010. Ulesfia® Lotion is a registered trademark of Shionogi Inc. ©2012 Shionogi Inc. Florham Park, NJ All rights reserved. ULE12-PSA-001-00 04/12
6
Please see full Important Safety Information on back cover and full Prescribing Information enclosed. • Avoid eye exposure. Ulesfia® may cause eye irritation. If Ulesfia® comes in contact with the eyes, flush them immediately with water. • The most common adverse reactions are: pruritus, erythema, pyoderma and ocular irritation. • Most common application site adverse reactions were: site irritation (2%), and site anesthesia and hypoesthesia (2%), and pain (1%).
Important Safety Information Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: application site dryness, application site excoriation, paraesthesia, application site dermatitis, excoriation, thermal burn, dandruff, erythema, rash, and skin exfoliation. 6% (26/428)
Ocular irritation
7% (22/308)
Pyoderma
10% (32/309)
Erythema
12% (14/116)
Pruritus Signs/Symptoms
1% (3/313) 4% (10/230) 9% (19/217) 4% (3/67)
Ulesfia® Lotion
Vehicle
Monitored Adverse Reactions With Onset After Treatment • Ulesfia® Lotion is indicated to treat children as young as 6 months of age 1% (5)
Pain
2% (10)
Anesthesia & hypoesthesia
2% (11)
Irritation Application Site Events
Ulesfia® Lotion (n=478)
0% (0) 0% (0) 1% (2) Vehicle (n=336)
Application Site Symptoms
Adverse Events Profiles6
®