d glaucoma. Cataracts and glaucoma havebeen reported postmarketing with the use of topical corticosteroid products. Advise patients to report any visual symptoms andconsider referral to an ophthalmologist for eva luation.
5.6 Concomitant Skin Infections
Use an appropriate antimicrobial agent if a skin infection is present or develops.
If a favorable response does not occur promptly,discontinue use of DUOBRII Lotion until the infection has been adequately treated.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drugcannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In randomized, double-blind, multicenter, vehicle-controlled clinical trials, 410 adults with plaque psoriasis were treated withDUOBRII Lotion or vehicle lotion and had post-baseline safety data. Subjects applied DUOBRII Lotion or vehicle lotion once dailyfor up to eight weeks. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with DUOBRII Lotion andmore frequently than in vehicle-treated subjects.
Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with DUOBRII Lotion through Week 8
Adverse Reaction
DUOBRII Lotion
(N=270)
Vehicle Lotion
(N=140)
Contact Dermatitis 20 (7%) 0
Application Site Pain 7 (3%) 1 (1%)
Folliculitis 5 (2%) 0
Skin Atrophy 5 (2%) 0
Excoriation 5 (2%) 0
Rash 4 (1%) 0
Skin Abrasion 3 (1%) 0
Skin Exfoliation 2 (1%) 0
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, DUOBRII Lotionmay cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females hasnot been established. The potential risk to the fetus outweighs the potential benefit to the mother from DUOBRII Lotion duringpregnancy; therefore, DUOBRII Lotion should be discontinued as soon as pregnancy is recognized [see Contraindications (4),Warnings and Precautions (5.1), Clinical Pharmacology (12.3)].
Observational studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topicalcorticosteroids (see Data).
In animal reproduction studies with pregnant rats, reduced fetal body weights and reduced skeletal ossification were observed aftertopical administration of a tazarotene gel formulation during the period of organogenesis at a dose 11 times the maximumrecommended human dose (MRHD) (based on AUC comparison). In animal reproduction studies with pregnant rabbits, singleincidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies were observed after topicaladministration of a tazarotene gel formulation at 116 times the MRHD (based on AUC comparison) (see Data).
In animal reproduction studies with pregnant rats and rabbits, malformations, fetal toxicity, developmental delays, and/or behavioraldelays were observed after oral administration of tazarotene during the period of organogenesis at doses 9 and 228 times, respectively,the MRHD (based on AUC comparison). In pregnant rats, decreased litter size, decreased numbers of live fetuses, decreased fetalbody weights, and increas |
