Ulesfia

Patient Information

ULESFIA^®
(Yoo-Les-fee-ah)
(benzyl alcohol 5%) Lotion

Read the Patient Information that comes with ULESFIA Lotion before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Note: For use on scalp hair and scalp only

What is ULESFIA Lotion?

ULESFIA Lotion is a prescription medicine used to get rid of lice in scalp hair of children and adults.

It is not known if ULESFIA Lotion is safe for children under 6 months of age or in people over age 60.

Once ULESFIA Lotion is washed off, a fine-tooth comb may be used to remove treated lice and nits from the hair and scalp. All personal items exposed to the hair or lice should be washed in hot water or dry-cleaned. See “How do I stop the spread of lice?” at the end of this leaflet.

What should I tell my healthcare provider before I use ULESFIA Lotion?

Tell your healthcare provider if your baby was born early so your healthcare provider can decide if your infant is old enough for ULESFIA Lotion.

Before you use ULESFIA Lotion, tell your healthcare provider if you:

• have any skin conditions or sensitivities
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if ULESFIA Lotion can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding. It is not known if ULESFIA Lotion passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby while using ULESFIA Lotion.

How should I use ULESFIA Lotion?

• Use ULESFIA Lotion exactly as prescribed. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider.
• Use ULESFIA Lotion in two applications that are one week apart. ULESFIA Lotion gets rid of lice but does not get rid of lice eggs so a second application is needed one week (7 days) after the first application.
• ULESFIA Lotion coats the lice on your scalp and scalp hair. It is important to use enough ULESFIA Lotion to coat completely every single louse and to leave it on your scalp for the full 10 minutes. See the detailed Instructions for Use at the end of this leaflet.
• Because you need to completely cover all of the lice with ULESFIA Lotion, you may need help in applying ULESFIA Lotion to your scalp and hair. Make sure that you and anyone who helps you apply ULESFIA Lotion reads and understands this leaflet and the Instructions for Use.
• Children need adult help in applying ULESFIA Lotion.
• Do not get into eyes. If ULESFIA Lotion gets in the eye, flush with water right away.
• Do not swallow ULESFIA Lotion. If swallowed, call your healthcare provider right away.
• Wash your hands after you apply ULESFIA Lotion.

What are the possible side effects of ULESFIA Lotion?

People using ULESFIA Lotion may have skin or eye:

• itching,
• redness,
• irritation. If skin or eye irritation happens, rinse with water right away, then call your healthcare provider or go to the emergency department.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of ULESFIA Lotion. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ULESFIA Lotion?

• Store ULESFIA Lotion in a dry place at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze ULESFIA Lotion.

Keep ULESFIA Lotion and all medicines out of the reach of children.

What are the ingredients in ULESFIA Lotion?

Active ingredient: benzyl alcohol, 5%

Inactive ingredients: purified water, mineral oil, sorbitan monooleate, polysorbate 80,

carbomer 934P and trolamine

General Information about ULESFIA Lotion

Medicines are sometimes prescribed for conditions other than those described in the Patient Information leaflet. Do not use ULESFIA Lotion for any condition for which it was not prescribed by your healthcare provider. Do not give ULESFIA Lotion to other people, even if they have the same symptoms as you. It may harm them.

This leaflet summarizes the most important information about ULESFIA Lotion. If you would like more information, talk to your healthcare provider. You can also ask your healthcare provider for information about ULESFIA Lotion that is written for healthcare professionals.

Instructions for Use

Apply the full amount of ULESFIA Lotion prescribed by your healthcare provider for each of your 2 applications one week apart. ULESFIA Lotion gets rid of lice but does not get rid of lice eggs so a second application is needed one week (7 days) after the first application.

ULESFIA Lotion comes in a single 8 oz. bottle, and in a 2 pack containing two 8 oz. bottles with a lice comb. For different hair lengths, use the following as a guide for the amount of ULESFIA Lotion you may need to cover the hair and scalp completely:

 

Hair Length	Amount of ULESFIA Lotion to apply each time
	8 oz. bottle
Short-up to 2 inches	up to ¾ of the bottle
Short-2-4 inches	up to 1 bottle
Medium-4-8 inches	up to 1½ bottles
Medium-8-16 inches	up to 3 bottles
Long-16-22 inches	up to 4 bottles
Long-22 inches or more	up to 6 bottles

 

Step 1

 

 

• Cover your face and eyes with a towel and keep your eyes closed tightly.
• Apply ULESFIA Lotion directly to dry scalp and dry hair.
• ULESFIA Lotion must cover your entire scalp and all scalp hair. Have an adult help you apply ULESFIA Lotion.

Step 2

 

 

• Massage ULESFIA Lotion into your hair and scalp.
• When your head is completely covered with enough ULESFIA Lotion, dripping will happen. Protect your eyes and skin from these drips with your towel.

 

 

• Be sure to apply ULESFIA Lotion to the area behind your ears.

 

 

• Be sure to apply ULESFIA Lotion to the back of your neck.

If not enough ULESFIA Lotion is used, some lice may escape treatment. It is important to use the full amount of ULESFIA Lotion prescribed by your healthcare provider.

 

 

Correct application of ULESFIA Lotion.

Step 3

 

 

• Allow ULESFIA Lotion to stay on your hair for 10 minutes. Use a timer or clock.
• Start timing after you have completely covered your hair and scalp with ULESFIALotion.

Step 4

 

 

• After 10 minutes, completely rinse ULESFIA Lotion from your hair and scalp with water.
• You or anyone who helps you apply ULESFIA Lotion should wash hands after application.
• You can shampoo your hair right after the application.
• A lice comb may be used to remove the dead lice after both applications.

Step 5

One week (7 days) after your first application, repeat the steps above to help get rid of lice that hatched from eggs.

How do I stop the spread of lice?

To help prevent the spread of lice from one person to another, here are some steps you can take.

• Avoid head-to-head contact at school, on the playground, in physical education classes, during sports activities, and while playing with other children.
• Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not.
• Avoid sleepovers and slumber parties during lice outbreaks. Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice.
• After finishing treatment with lice medicine, check everyone in your family for lice after one week. Be sure to talk to your healthcare provider about treatments for those who have lice.
• Machine-wash any bedding and clothing used by anyone having lice or thought to have been exposed to lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.

Description

ULESFIA® (benzyl alcohol) Lotion is supplied as a white topical lotion containing benzyl alcohol, 5%. Inactive ingredients in this formulation are water, mineral oil, sorbitan monooleate, polysorbate 80, carbomer 934P and trolamine.

The active ingredient, benzyl alcohol, is a clear, colorless liquid with a mild aromatic odor. Benzyl alcohol has a molecular mass of 108.14 g/mol. The molecular formula is C₇H₈O.

The chemical structure of benzyl alcohol is:

Benzyl Alcohol

 

Indications

Indication

ULESFIA^® Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.

Limitation Of Use

ULESFIA^® Lotion does not have ovocidal activity.

Adjunctive Measures

ULESFIA^® Lotion should be used in the context of an overall lice management program:

• 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.

Dosage And Administration

ULESFIA Lotion is not for oral, ophthalmic, or intravaginal use.

Using the guidelines in Table 1, apply sufficient ULESFIA Lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat application after 7 days. Avoid contact with eyes.

Table 1: ULESFIA Lotion Usage Guideline

Hair Length		Amount of ULESFIA Lotion per Application
		Ounces	8 oz bottle Size
Short	0-2 inches	4-6 oz	½-¾ bottle
	2-4 inches	6-8 oz	¾-1 bottle
Medium	4-8 inches	8-12 oz	1-1½ bottles
	8-16 inches	12-24 oz	1½-3 bottles
Long	16-22 inches	24-32 oz	3-4 bottles
	Over 22 inches	32-48 oz	4-6 bottles

 

How Supplied

Dosage Forms And Strengths

ULESFIA Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion).

Storage And Handling

ULESFIA Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion)

• NDC 69202-780-08 as an 8 fl oz (227 g) in a polypropylene bottle
• NDC 69202-780-88 as a package containing two individual 8 fl oz (NDC 69202-780-08) polypropylene bottles with a nit comb

Store at 20° C -25° C (68° F -77° F); excursions permitted to 15° C -30° C (59° F -86° F) [See USP controlled room temperature].

Do not freeze.

Manufactured by: Contract Pharmaceuticals Limited Mississauga, Ontario L5N 6L6 Canada. Revised Apr 2020

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The rates of adverse reactions below were derived from two randomized, multi-center, vehicle-controlled clinical trials and one open-label study in subjects with head lice infestation.

Skin, scalp, and ocular irritation were monitored in the clinical trials. All subjects were queried about the presence of skin and scalp symptoms; the results are presented in Table 2.

Table 2: Monitored Adverse Reactions -Application Site Symptoms

Event	ULESFIA Lotion	Vehicle
Application site Irritation	2% (11/478)	1% (2/336)
Application site anesthesia & hypoesthesia	2% (10/478)	0% (0/336)
Pain	1% (5/478)	0% (1/336)

 

The subset of subjects who did not have pruritus, erythema, edema or pyoderma of skin and scalp, or ocular irritation prior to treatment were assessed for these signs and symptoms after treatment; the results are presented in Table 3.

Table 3: Monitored Adverse Reactions -Pruritus, Erythema, Pyoderma and Ocular Irritation with Onset After Treatment

Signs/Symptoms	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)

 

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.

Drug Interactions

No Information Provided

WarningS

Included as part of the “PRECAUTIONS” Section

Precautions

Neonatal Toxicity

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 Lotion [see Use In Specific Populations].

Eye Irritation

Avoid eye exposure. ULESFIA Lotion may cause eye irritation. If ULESFIA Lotion comes in contact with the eyes, flush them immediately with water. If irritation persists, consult a physician.

Contact Dermatitis

ULESFIA Lotion may cause allergic or irritant dermatitis.

Use In Children

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.

Patient Counseling Information

“See FDA-approved patient labeling (PATIENT INFORMATION)”

Inform the patient and caregiver of the following instructions:

• Apply ULESFIA Lotion for 10 minutes as directed in the ULESFIA Lotion Usage Guideline Table.
• Apply a second treatment 1 week (7 days) after the initial application.
• Use only on dry scalp and dry scalp hair.
• Avoid contact with eyes.
• ULESFIA Lotion may cause eye irritation, skin irritation, and contact sensitization.
• Wash hands after application.
• Report any signs of irritation at the application site and any signs of adverse reactions.
• Keep out of reach of children.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ULESFIA Lotion. However, no evidence of carcinogenic activity was noted for benzyl alcohol in 2 year oral carcinogenicity studies in rats (doses up to 400 mg/kg benzyl alcohol) or mice (doses up to 200 mg/kg benzyl alcohol) conducted by the National Toxicology Program.

Benzyl alcohol has produced mixed results in genotoxicity tests. Benzyl alcohol was not mutagenic in the Ames test with and without metabolic activation, sex-linked recessive lethal assay, and a replicative DNA synthesis assay (conducted in male rats). Benzyl alcohol was negative in the mouse lymphoma assay with metabolic activation, but positive without metabolic activation at a concentration producing a high level of cellular toxicity. Benzyl alcohol was positive in the Chinese hamster ovary chromosomal aberration assay with metabolic activation.

No fertility studies have been conducted with benzyl alcohol.

Use In Specific Populations

Pregnancy

Risk Summary

Rare pregnancy outcomes reported in the published literature with benzyl alcohol use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug.

In animal reproduction studies, subcutaneous administration of benzyl alcohol to pregnant rats and rabbits during organogenesis did not cause any malformations (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of benzyl alcohol observed in animal studies to the systemic exposure that would be expected in humans after topical use of ULESFIA Lotion.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively

Data

Animal Data

In embryo-fetal development studies, pregnant rats and rabbits received subcutaneous doses of benzyl alcohol during organogenesis at doses up to 500 mg/kg/day and 400 mg/kg/day, respectively. There were no malformations noted in either species. In rats, maternal toxicity and decreased fetus weight occurred at 500 mg/kg/day. In rabbits, maternal toxicity occurred at 250 and 400 mg/kg/day and was associated with decreased fetal weight at 400 mg/kg/day.

Lactation

Risk Summary

There is no information available on the presence of benzyl alcohol in human or animal milk, the effects of the drug on breastfed infant, or the effects of the drug on milk production. When used as prescribed, topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, breastfeeding is not expected to result in exposure of the infant to ULESFIA Lotion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ULESFIA Lotion and any potential adverse effects on the breastfed infant from ULESFIA Lotion or from the underlying maternal condition.

Pediatric Use

The safety and effectiveness of ULESFIA Lotion was evaluated in two multicenter, randomized, double-blind, vehicle-controlled studies which were conducted in 628 subjects 6 months of age and older with active head lice infestation [see Clinical Studies].

Rates of adverse events in younger children (6 months to 12 years) were similar to those of older children and adults.

Safety in pediatric patients below the age of 6 months has not been established. ULESFIA Lotion is not recommended in pediatric patients under six months of age because of the potential for increased systemic absorption due to a high ratio of skin surface area to body mass and the potential for an immature skin barrier.

Neonates could be at risk for gasping syndrome if treated with ULESFIA Lotion [see WARNINGS AND PRECAUTIONS].

Intravenous administration of products containing benzyl alcohol has been associated with neonatal gasping syndrome. The gasping syndrome (characterized by central nervous depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages > 99 mg/kg/day in preterm neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hemotologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although expected systemic exposure of benzyl alcohol from proper use of ULESFIA Lotion is substantially lower than those reported in association with the gasping syndrome, the minimum amount of benzyl alcohol at which toxicity may occur is not known.

Geriatric Use

The safety of ULESFIA Lotion in patients over 60 years of age has not been established.

Overdose

If oral ingestion occurs, seek medical advice immediately.

Contraindications

None.

Clinical Pharmacology

Mechanism Of Action

In vitro studies of the effect of ULESFIA Lotion on native, captured lice suggest that benzyl alcohol inhibits lice from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate.

Pharmacokinetics

The absorption of benzyl alcohol from ULESFIA Lotion was evaluated in 19 subjects with head lice infestation. Subjects were divided into two age groups: 6 months to 3 years and 4 to 11 years. ULESFIA Lotion was applied for an exaggerated exposure period (3 times the normal exposure period). Benzyl alcohol was quantified in a single plasma sample in 4 out of 19 subjects (21%): three subjects in the 6 months to 3 years age group at 0.5 hour post-treatment (ranging from 1.97 to 2.99 mcg/mL) and one subject in the 4 to 11 year age group (1.63 mcg/mL) at 1 hour post- treatment out of a total of 102 samples analyzed.

Drug Interaction Studies

Drug interaction studies were not conducted with ULESFIA Lotion.

Clinical Studies

Two multicenter, randomized, double-blind, vehicle-controlled trials were conducted in 628 subjects 6 months of age and older with active head lice infestation. For the evaluation of efficacy, the youngest subject from each household was enrolled in the Primary Treatment Cohort with ULESFIA Lotion or vehicle. Other infested household members were enrolled in a Secondary Treatment Cohort and received the same treatment as the youngest subjects. The Secondary Treatment Cohort was not included in the efficacy analysis, but was evaluated for all safety parameters.

In Study One, 125 Primary Treatment Cohort Subjects were randomized to ULESFIALotion (N=63) and vehicle (N=62). Study Two enrolled 125 Primary Treatment Cohort Subjects: 64 randomized to ULESFIA Lotion and 61 to vehicle. Treatment was applied two times separated by one week.

Efficacy was assessed as the proportion of subjects who were free of live lice 14 days after the final treatment. Subjects with live lice present at any time after first treatment were considered to be treatment failures. Table 4 contains the proportion of subjects who were free of live lice in each of the two trials.

Table 4: Proportion of Subjects Free of Live Lice 14 Days After Last Treatment

	ULESFIA LOTION	Vehicle
Study 1	(N=63) 48 (76.2%)	(N=62) 3 (4.8%)
Study 2	(N=64) 48 (75.0%)	(N=61) 16 (26.2%)