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Allegra

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Allegra

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Phenylketonurics

ALLEGRA (fexofenadine hcl) ODT contains phenylalanine, a component of aspartame. Each 30 mg ALLEGRA (fexofenadine hcl) ODT contains 5.3 mg phenylalanine. ALLEGRA (fexofenadine hcl) products other than ALLEGRA (fexofenadine hcl) ODT do not contain phenylalanine.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of fexofenadine was assessed using terfenadine studies with adequate fexofenadine 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 in a 24-month study in rats at oral doses up to 150 mg/kg of terfenadine (which led to fexofenadine exposures that were approximately 3 and 5 times the exposure at the maximum recommended daily oral dose of ALLEGRA (fexofenadine hydrochloride) in adults [180 mg] and children [60 mg] respectively).

In in vitro (Bacterial Reverse Mutation, CHO/HGPRT Forward Mutation, and Rat Lymphocyte Chromosomal Aberration assays) and in vivo (Mouse Bone Marrow Micronucleus assay) tests, ALLEGRA (fexofenadine hydrochloride) 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 exposures that were approximately 3 times the exposure at the maximum recommended human daily oral dose of 180 mg of ALLEGRA (fexofenadine hydrochloride) based on comparison of AUCs). In mice, ALLEGRA (fexofenadine hydrochloride) produced no effect on male or female fertility at average oral doses up to 4438 mg/kg (which led to fexofenadine exposures that were approximately 13 times the exposure at the maximum recommended human daily oral dose of 180 mg of ALLEGRA (fexofenadine hydrochloride) based on comparison of AUCs).

Use In Specific Populations

Pregnancy

Teratogenic Effects: Pregnancy Category C. There was no evidence of teratogenicity in rats or rabbits at oral doses of terfenadine up to 300 mg/kg (which led to fexofenadine exposures that were approximately 4 and 30 times, respectively, the exposure at the maximum recommended human daily oral dose of 180 mg of ALLEGRA (fexofenadine hydrochloride) based on comparison of AUCs).

In mice, no adverse effects and no teratogenic effects during gestation were observed with ALLEGRA (fexofenadine hydrochloride) at oral doses up to 3730 mg/kg (which led to fexofenadine exposures that were approximately 15 times the exposure at the maximum recommended human daily oral dose of 180 mg of ALLEGRA (fexofenadine hydrochloride) based on comparison of AUCs).

There are no adequate and well controlled studies in pregnant women. ALLEGRA (fexofenadine hydrochloride) 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 an oral dose of 150 mg/kg of terfenadine (which led to fexofenadine exposures that were approximately 3 times the exposure at the maximum recommended human daily oral dose of 180 mg of ALLEGRA (fexofenadine hydrochloride) based on comparison of AUCs).

Nursing Mothers

It is not known if fexofenadine is excreted in human milk. 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 ALLEGRA (fexofenadine hydrochloride) is administered to a nursing woman.

Pediatric Use

The recommended doses of ALLEGRA (fexofenadine hydrochloride) in pediatric patients 6 months to 11 years of age are based on cross-study comparison of the pharmacokinetics of fexofenadine in adults and pediatric subjects and on the safety profile of ALLEGRA (fexofenadine hydrochloride) in both adult and pediatric subjects at doses equal to or higher than the recommended doses. The safety and effectiveness of ALLEGRA (fexofenadine hydrochloride) in pediatric patients under 6 months of age have not been established.

The safety of ALLEGRA (fexofenadine hydrochloride) is based on the administration of ALLEGRA (fexofenadine hcl) tablets at a dose of 30 mg twice daily demonstrated in 438 pediatric subjects 6 years to 11 years of age in 2 placebo-controlled 2-week seasonal allergic rhinitis trials. The safety of ALLEGRA (fexofenadine hydrochloride) at doses of 15mg and 30 mg given once and twice a day has been demonstrated in 969 pediatric subjects (6 months to 5 years of age) with allergic rhinitis in 3 pharmacokinetic studies and 3 safety studies. The safety of ALLEGRA (fexofenadine hydrochloride) for the treatment of chronic idiopathic urticaria in subjects 6 months to 11 years of age is based on cross-study comparison of the pharmacokinetics of ALLEGRA (fexofenadine hcl) in adult and pediatric subjects and on the safety profile of fexofenadine in both adult and pediatric subjects at doses equal to or higher than the recommended dose.

The effectiveness of ALLEGRA (fexofenadine hydrochloride) for the treatment of seasonal allergic rhinitis in subjects 6 to 11 years of age was demonstrated in 1 trial (n=411) in which ALLEGRA (fexofenadine hcl) tablets 30 mg twice daily significantly reduced total symptom scores compared to placebo, along with extrapolation of demonstrated efficacy in subjects aged 12 years and above, and the pharmacokinetic comparisons in adults and children. The effectiveness of ALLEGRA (fexofenadine hydrochloride) 30 mg twice daily for the treatment of seasonal allergic rhinitis in patients 2 to 5 years of age is based on the pharmacokinetic comparisons in adult and pediatric subjects and an extrapolation of the demonstrated efficacy of ALLEGRA (fexofenadine hydrochloride) in adult subjects with this condition and the likelihood that the disease course, pathophysiology, and the drug's effect are substantially similar in pediatric patients to those in adult patients. The effectiveness of ALLEGRA (fexofenadine hydrochloride) for the treatment of chronic idiopathic urticaria in patients 6 months to 11 years of age is based on the pharmacokinetic comparisons in adults and children and an extrapolation of the demonstrated efficacy of ALLEGRA (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. Administration of a 15 mg dose of ALLEGRA (fexofenadine hydrochloride) to pediatric subjects 6 months to less than 2 years of age and a 30 mg dose to pediatric subjects 2 to 11 years of age produced exposures comparable to those seen with a dose of 60 mg administered to adults.

Geriatric Use

Clinical studies of ALLEGRA (fexofenadine hcl) tablets and capsules did not include sufficient numbers of subjects aged 65 years and over to determine whether this population responds differently from younger subjects. Other reported clinical experience has not identified differences in responses between the geriatric and younger subjects. 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].

Renal Impairment

Based on increases in bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in adult patients with decreased renal function (mild, moderate or severe renal impairment). For pediatric patients with decreased renal function (mild, moderate or severe renal impairment), the recommended starting dose of fexofenadine is 30 mg once daily for patients 2 to 11 years of age and 15 mg once daily for patients 6 months to less than 2 years of age. [See DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

Hepatic Impairment

The pharmacokinetics of ALLEGRA (fexofenadine hydrochloride) in subjects with hepatic impairment did not differ substantially from that observed in healthy subjects.

Last reviewed on RxList: 11/1/2010
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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