XEGLYZE SIDE EFFECTS
- Generic Name: abametapir lotion
- Brand Name: Xeglyze
- Drug Class: Topical Pediculicide
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)
|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)
|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.|
In vitro studies suggest there is a potential for inhibition of cytochrome P450 (CYP) 3A4, 2B6 and 1A2 enzymes following a single application of XEGLYZE. Use of XEGLYZE with drugs that are substrates of these enzymes may lead to increased systemic concentrations of the interacting drugs. Avoid administration of drugs that are substrates of CYP3A4, CYP2B6, or CYP1A2 within 2 weeks after application of XEGLYZE. If this is not feasible, avoid use of XEGLYZE.
SRC: NLM .