NATROBA (spinosad)

Head Lice Infestations An open-label, single-center trial was conducted over a period of seven days to determine the pharmacokinetic profile of spinosad 1.8% in pediatric subjects with head lice infestation. Fourteen (14) subjects, 4 – 15 years of age, with head lice were enrolled into the trial. All subjects applied a single topical (scalp) treatment of spinosad 1.8% for 10 minutes, after which the test article was washed off, and subjects underwent plasma sampling. Results demonstrated that sp...

14.1 Head Lice Infestations Two multicenter, randomized, investigator-blind, active-controlled trials were conducted in 1038 subjects 6 months of age and older with head lice infestation. A total of 552 subjects were treated with NATROBA. For the evaluation of efficacy, the youngest subject from each household was considered to be the primary subject of the household, and other members in the household were enrolled in the study as secondary subjects and evaluated for all safety parameters. In Study 1, 91 primary subjects were randomized to NATROBA, and 89 primary subjects were randomized to p...

Most common adverse events for lice treatment (>1%) were application site erythema and ocular erythema. ( 6.1 ) Most common adverse reactions for scabies treatment (>1%) were application site irritation (pain and burning) and dry skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipher Pharmaceuticals US LLC at 1-855-628-7622 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse...

None. None. ( 4 )

Benzyl Alcohol Toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. ( 5.1 ) 5.1 Benzyl Alcohol Toxicity NATROBA contains benzyl alcohol and is not approved for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants when administered intravenously [see Use in Specific Populations (8.4) ] .