CONTRAINDICATIONS
Fexofenadine HCl is contraindicated in patients with known hypersensitivity to any of its
ingredients.
PRECAUTIONS
Carcinogenesis, Mutagenesis, and Impairment of Fertility
The carcinogenic potential and reproductive toxicity of fexofenadine HCl were assessed using
terfenadine studies with adequate fexofenadine HCl exposure (based on plasma
area-under-the-concentration vs. time [AUC] values). No evidence of carcinogenicity was
observed in an 18-month study in mice and a 24-month study in rats at daily oral doses of 150 mg/kg
of terfenadine (which led to fexofenadine exposures that were respectively approximately 3 and 5
times the exposure from the maximum recommended daily oral dose of fexofenadine HCl in adults
and children).
In in vitro tests (Bacterial Reverse Mutation, CHO/HGPRT Forward Mutation, and Rat
Lymphocyte Chromosomal Aberration assays) and in vivo tests (Mouse Bone Marrow
Micronucleus assay), fexofenadine HCl revealed no evidence of mutagenicity.
In rat fertility studies, dose-related reductions in implants and increases in postimplantation losses
were observed at an oral dose of 150 mg/kg of terfenadine (which led to fexofenadine HCl
exposures that were approximately 3 times the exposure of the maximum recommended daily oral
dose of fexofenadine HCl in adults). These doses also produced plasma AUC values or
fexofenadine that were ³3 times the human therapeutic value (based on a 60 mg twice-daily
fexofenadine HCl dose).
Pregnancy Category C
Teratogenic Effects: There was no evidence of teratogenicity in rats or rabbits at oral terfenadine
doses of up to 300 mg/kg (which led to fexofenadine exposures that were approximately 4 and 31
times, respectively, the exposure from the maximum recommended daily oral dose of fexofenadine
in adults). These doses produced fexofenadine plasma AUC values that were up to 4 and 37 times
the human therapeutic value (based on a 60 mg twice-daily fexofenadine HCl dose), respectively.
There are no adequate and well-controlled studies in pregnant women. Fexofenadine HCl should be
used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: Dose-related decreases in pup weight gain and survival were observed in
rats exposed to oral doses ³150 mg/kg of terfenadine. At these doses, the plasma AUC values of
fexofenadine were ³3 times the human therapeutic values (based on a 60 mg twice-daily
fexofenadine HCl dose).
Nursing Mothers
There are no adequate and well-controlled studies in women during lactation. Because many drugs
are excreted in human milk, caution should be exercised when fexofenadine HCl is administered to
a nursing woman.
Pediatric Use
The recommended dose in patients 6-11 years of age is based on cross-study comparison of the
pharmacokinetics of fexofenadine HCl in adults and pediatric patients and on the safety profile of
fexofenadine HCl in both adults and pediatric patients at doses equal to or higher than the
recommended doses.
The safety of fexofenadine HCl tablets at a dose of 30 mg twice daily has been demonstrated in
438 pediatric patients 6-11 years of age in 2 placebo-controlled, 2-week, seasonal allergic rhinitis
trials. The safety of fexofenadine HCl for the treatment of chronic idiopathic urticaria in patients
6-11 years of age is based on cross-study comparison of the pharmacokinetics of fexofenadine HCl
in adult and pediatric patients and on the safety profile of fexofenadine in both adult and pediatric
patients at doses equal to or higher than the recommended dose.
The effectiveness of fexofenadine HCl for the treatment of seasonal allergic rhinitis in patients 6-11
years of age was demonstrated in one trial (n=411) in which fexofenadine HCl tablets, 30 mg twice
daily significantly reduced total symptoms scores compared to placebo, along with extrapolation of
demonstrated efficacy in patients 12 years and above, and the pharmacokinetic comparisons in
adults and children. The effectiveness of fexofenadine HCl for the treatment of chronic idiopathic
urticaria in patients 6-11 years of age is based on an extrapolation of the demonstrated efficacy of
fexofenadine HCl in adults with this condition and the likelihood that the disease course,
pathophysiology, and the drug's effect are substantially similar in children to that of adult patients.
The safety and effectiveness of fexofenadine in pediatric patients under 6 years of age have not
been established.
Geriatric Use
Clinical studies of fexofenadine HCl tablets and capsules did not include sufficient numbers of
subjects aged 65 and over to determine whether this population responds differently from younger
patients. Other reported clinical experience has not identified differences in responses between the
geriatric and younger patients. This drug is known to be substantially excreted by the kidney, and
the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in
dose selection, and it may be useful to monitor renal function (see CLINICAL
PHARMACOLOGY).