Download Sklice Lotion should be used in the context of an overall

An Introduction to
Sklice® (ivermectin)
Lotion, 0.5%
SANOFI PASTEUR. Discovery Drive. Swiftwater, Pennsylvania 18370. www.sanofipasteur.us
US.IVE.12.08.004
© 2012 Sanofi Pasteur Inc.
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Sklice Lotion Indication1
Approval
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Approved by the US Food and Drug Administration in February 2012
Indication
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Sklice Lotion is a pediculicide indicated for the topical treatment of head lice
infestations in patients 6 months of age and older
Adjunctive Measures
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Sklice Lotion should be used in the context of an overall lice management program:
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Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding, and towels
Wash personal care items such as combs, brushes, and hair clips in hot water
A fine tooth comb or special nit comb may be used to remove dead lice and nits
Important Safety Information
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The most common adverse reactions (incidence <1%) were conjunctivitis, ocular
hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation
Please See Accompanying Full Prescribing Information for Sklice Lotion.
Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.
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Highlights of Sklice Lotion’s Safety Profile
Include:
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No Contraindications
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Adverse Reactions for Sklice Lotion
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Warnings and Precautions for Sklice Lotion
● In pivotal trials less than 1% of patients experienced adverse events which
included conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin,
and skin burning sensation
● In order to prevent accidental ingestion, Sklice Lotion should only be
administered on pediatric patients under the direct supervision of an adult
Please See Accompanying Full Prescribing Information for Sklice Lotion.
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Proven Effective in Clinical Trials
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a
In 2 clinical trials, patients received a single 10-minute treatment and were
instructed not to nit comb1,a
14 days after a single treatment, no live lice were observed in 76.1%
(54/71) and 71.4% (50/70) of patients1
The most common adverse reactions (incidence <1%) were conjunctivitis,
ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning
sensation
Two randomized, double-blind, vehicle-controlled trials in patients 6 months of age and older with head
lice infestations. The primary efficacy was assessed as the proportion of patients who were free of live
lice at day 2 and through day 8 to the final evaluation 14 (+2) days following a single application.2
Please See Accompanying Full Prescribing Information for Sklice Lotion.
Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.
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Sklice Lotion Formulation
Formulation
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Each gram of Sklice Lotion contains 5mg of ivermectin
Inactive ingredients include water, olive oil, oleyl alcohol, Crodalan AWS,
lanolin alcohol, cyclomethicone, shea butter, sodium citrate, sorbitan
tristearate, methylparaben, propylparaben, and citric acid
Mechanism of Action
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Binds selectively, with high affinity primarily to glutamate-gated chloride
channels in invertebrate nerve, muscle cells1-3
Increased permeability of cell membrane to chloride ions leads to:
● Hyperpolarization of nerve or muscle cell, resulting in paralysis and death of
the parasite1
Please See Accompanying Full Prescribing Information for Sklice Lotion.
Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012. 2. Cully DF, et al.
J Biol Chem. 1996;271(33):20187-20191. 3. Kane NS, et al. Proc Natl Acad Sci. 2000;97(25):13949-13954.
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Product Application
Sklice Lotion should be used in the context of an overall lice management program.
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Topical use only, not for oral, ophthalmic, or intravaginal use1
Apply product directly to dry hair, enough to thoroughly
coat scalp and hair (up to 1 tube)1
Leave the product on for 10 minutes and then rinse
out with water1
A 4-ounce tube is intended for single use; discard
unused portion1
Avoid contact with eyes1
Please See Accompanying Full Prescribing Information for Sklice Lotion.
Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.
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Sklice Lotion: Instructions for Use1
Sklice Lotion should be used in the context of an overall lice management program.
1
Apply Sklice Lotion directly to dry hair and scalp.
Completely cover scalp and hair closest to the scalp first, then
apply outwards toward the ends of hair. Avoid contact with eyes.
2
Rub Sklice Lotion throughout the hair.
1
It is important to completely cover the entire head so that all lice
and eggs are exposed to the lotion.
3
Be sure that each hair is coated from the scalp to the tip;
use up to 1 entire tube (4 oz) to completely cover hair
and scalp.
2
Important Safety Information for Sklice Lotion
The most common adverse reactions (incidence <1%) were
conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin,
and skin burning sensation
3
Please See Accompanying Full Prescribing Information for Sklice Lotion.
Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.
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Sklice Lotion: Instructions for Use (cont)1
4 Allow Sklice Lotion to stay on the hair and scalp for 10 minutes
after it has been applied. Use a timer or clock. Start timing after
you have completely covered the hair and scalp.
5 After 10 minutes, rinse lotion from hair and scalp using only water.
6 You or anyone who helps you apply Sklice Lotion should wash
their hands after application.
4
7 Do not use Sklice Lotion again without talking to your
health-care provider first.
For single use only; do not re-treat. Discard tube after use.
5
Please See Accompanying Full Prescribing Information for Sklice Lotion.
Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.
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Summary
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Sklice Lotion is a pediculicide indicated for the topical treatment of head lice
infestations in patients 6 months of age and older
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Sklice Lotion should be used in the context of an overall lice management program
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Single 10-minute treatment (single 4oz tube)
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Efficacy results in clinical trials
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76% and 71% of patients were lice-free 14 days post-treatment in 2 pivotal phase 3 trials
No nit combing required
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A fine tooth comb or special nit comb may be used to remove dead lice and nits
Important Safety Information for Sklice Lotion
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The most common adverse reactions (incidence <1%) were conjunctivitis, ocular
hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation
Please See Accompanying Full Prescribing Information for Sklice Lotion.
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