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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].
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.
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.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies in animals to evaluate carcinogenic potential of ULESFIA® Lotion have not been conducted. 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 genetic testing. Benzyl alcohol was negative in the Ames test with and without metabolic activation, sex-linked recessive lethal assay, and a replicative DNA synthesis assay (conducted in male rats). Negative results were obtained in the mouse lymphoma assay with metabolic activation, but a positive response was noted in the mouse lymphoma assay 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 Category B
There are no adequate and well-controlled studies with topical benzyl alcohol in pregnant women. Reproduction studies conducted in rats and rabbits were negative. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
No comparisons of animal exposure with human exposure are provided in this labeling due to the low systemic exposure noted in the clinical pharmacokinetic study [see CLINICAL PHARMACOLOGY] which did not allow for the determination of human AUC values that could be used for this calculation.
Pregnant rats were dosed with benzyl alcohol via subcutaneous injection at 100, 250, and 500 mg/kg/day. No teratogenic effects were noted at any dose. Maternal toxicity and decreased fetal weight occurred at 500 mg/kg/day. When pregnant rabbits received subcutaneous injections of benzyl alcohol at 100, 250, and 400 mg/kg/day, there were no teratogenic effects in offspring at any dose. In rabbits, maternal toxicity occurred at the two higher doses and was associated with decreased fetal weight at the highest dose.
It is not known whether benzyl alcohol is excreted into human milk. Because some systemic absorption of topical benzyl alcohol may occur and because many drugs are excreted in human milk, caution should be exercised when ULESFIA® Lotion is administered to a nursing woman.
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.
The safety of ULESFIA® Lotion in patients over 60 years of age has not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/17/2016
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