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warnings and cautions
5 WARNINGS AND PRECAUTIONS Risk of Neonatal Benzyl Alcohol Toxicity: Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Safety and effectiveness in pediatric patients below the age of 6 months have not been established. Use is not recommended in pediatric patients under 6 months of age because of the potential for increased systemic absorption. (5.1) Risk of Benzyl Alcohol Toxicity from Accidental Ingestion: Administer only under direct supervision of an adult. (5.2) 5.1 Risk of Neonatal Benzyl Alcohol Toxicity XEGLYZE contains benzyl alcohol. Systemic exposure to benzyl alcohol has been associated with serious and fatal adverse reactions including “gasping syndrome” in neonates and low birth weight infants. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth weight infants may be more likely to develop toxicity [ see Use in Specific Populations (8.4) ]. The safety and effectiveness of XEGLYZE have not been established in pediatric patients below the age of 6 months. Use is not recommended in pediatric patients under 6 months of age because of the potential for increased systemic absorption. 5.2 Risk of Benzyl Alcohol Toxicity from Accidental Ingestion In order to prevent accidental ingestion in pediatric patients, XEGLYZE should only be administered under direct supervision of an adult. Ingestion of benzyl alcohol in large quantities may result in gastrointestinal (nausea, vomiting, diarrhea) and central nervous system (headache, ataxia, convulsions, coma) adverse reactions. Serious adverse reactions may include respiratory depression and death. If accidentally swallowed, advise the patient or the caregiver to call their Poison Control Center at 1-800-222-1222.
6 ADVERSE REACTIONS Most common adverse reactions (incidence of ≥ 1%) were erythema, rash, skin burning sensation, contact dermatitis, vomiting, eye irritation, pruritus, and hair color changes. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories. Inc., at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 the rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The data described below reflect exposure to a single 10-minute treatment of XEGLYZE in 349 subjects (6 months of age and older) with head lice infestation in randomized, double-blind, vehicle-controlled trials (Trials 1 and 2). Of these subjects, 21 were 6 months to 4 years of age, 166 subjects were 4 to 12 years of age, 57 subjects were 12 to 18 years of age, and 105 subjects were 18 years of age or older. Table 1 provides adverse reactions that occurred in at least 1% of subjects in the XEGLYZE group and at a greater frequency than in the vehicle group. Table 1: Adverse Reactions Occurring in ≥ 1% of the XEGLYZE Group and at a Greater Frequency than in the Vehicle Group (Trials 1 and 2) Adverse Reactions XEGLYZE N=349 Subjects (%) Vehicle N=350 Subjects (%) Erythema 14 (4.0) 6 (2) Rash 11 (3.2) 8 (2.3) Skin burning sensation 9 (2.6) 0 (0.0) Contact dermatitis 6 (1.7) 4 (1.1) Vomiting 6 (1.7) 2 (0.6) Eye irritation 4 (1.2) 2 (0.6) Hair color changes 3 (1) 0 (0.0) During the trials, subjects were monitored for new onset of scalp erythema/edema, scalp pruritus, and eye irritation. The number and percentage of subjects who developed these local adverse reactions after treatment are presented in Table 2. Table 2: Monitored Local Adverse Reactions with New Onset on Day 1 Post-Treatment (Trials 1 and 2) Adverse Reactions XEGLYZE Subjects (%)* Vehicle Subjects (%)* Scalp Erythema/Edema 11 (3.2) 5 (1.4) Scalp Pruritus 2 (1.4) 1 (0.7) Eye Irritation 6 (1.7) 5 (1.4) * For the calculation of the percentages, the denominators are the number of subjects who did not have the monitored local adverse reaction at baseline.