Quzyttir
(cetirizine hydrochloride)Dosage & Administration
For intravenous administration only
Recommended dosages:
Recommended dosage regimen is once every 24 hours as needed for acute urticaria
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Quzyttir Prescribing Information
QUZYTTIR™ is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
Limitations of use:
QUZYTTIR™ is not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function.
QUZYTTIR is a single use injectable product for intravenous administration only. The recommended dosage regimen is once every 24 hours as needed for treatment of acute urticaria. Administer QUZYTTIR as an intravenous push over a period of 1 to 2 minutes. QUZYTTIR is not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function [see Pediatric Use ].
Adults and adolescents 12 years of age and older
The recommended dosage is 10 mg administered by intravenous injection.
Children 6 to 11 years of age
The recommended dosage is 5 mg or 10 mg depending on symptom severity administered by intravenous injection.
Children 6 months to 5 years of age
The recommended dosage is 2.5 mg administered by intravenous injection.
QUZYTTIR is a sterile, clear, colorless, non-pyrogenic, isotonic aqueous solution of cetirizine hydrochloride for intravenous injection; supplied in 2 mL size amber glass vials for single use. Each 2 mL size amber glass vial contains 1 mL drug solution with 10 mg cetirizine hydrochloride (equivalent to 8.42 mg of cetirizine).
Pregnancy
Risk Summary
There are no adequate and well-controlled studies in pregnant women with cetirizine hydrochloride the active ingredient in QUZYTTIR. In animal reproduction studies, there was no evidence of fetal harm with administration of cetirizine hydrochloride by the oral route to pregnant mice, rats, and rabbits, during the period of organogenesis, at doses that were 45 times and higher than the maximum recommended human dose (MRHD) in adults. In rats treated during late gestation and the lactation period, cetirizine hydrochloride had no effects on pup development at oral doses up to approximately 30 times the MRHD in adults. In mice treated during late gestation and the lactation period, cetirizine hydrochloride administered by the oral route to the dams had no effects on pup development at a dose that was approximately 10 times the MRHD in adults; however, lower pup weight gain during lactation was observed at a dose that was 45 times the MRHD in adults (See Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively.
Data
Animal Data: In embryofetal development studies conducted in mice, rats, and rabbits, cetirizine hydrochloride, administered during the period of organogenesis, was not teratogenic at doses up to 45, 220, and 260 times the MRHD, respectively (on a mg/m2 basis with maternal oral doses up to 96, 225, and 135 mg/kg).
In a prenatal and postnatal development (PPND) study conducted in mice, cetirizine hydrochloride was administered at oral doses up to 96 mg/kg/day from gestation day 15 through lactation day 21. Cetirizine hydrochloride lowered pup body weight gain during lactation at an oral dose in dams that was approximately 45 times the MRHD (on a mg/m2 basis with a maternal oral dose of 96 mg/kg/day); however, there were no effects on pup weight gain at an oral dose in dams that was approximately 10 times the MRHD (on a mg/m2 basis with a maternal oral dose of 24 mg/kg/day). In a PPND study conducted in rats, cetirizine hydrochloride was administered at oral doses up to 180 mg/kg/day from gestation day 17 to lactation day 22. Cetirizine hydrochloride did not have any adverse effects on rat dams or offspring development at doses up to approximately 30 times the MRHD (on a mg/m2 basis with a maternal oral dose of 30 mg/kg/day). Cetirizine hydrochloride caused excessive maternal toxicity at an oral dose in dams that was approximately 180 times the MRHD (on a mg/m2 basis with a maternal oral dose of 180 mg/kg/day).
Lactation
Risk Summary
Cetirizine hydrochloride has been reported to be present in human breast milk. In mice and beagle dogs, studies indicated that cetirizine hydrochloride was excreted in milk (See Data). When a drug is present in animal milk, it is likely the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for QUZYTTIR and any potential adverse effects on the breastfed child from QUZYTTIR or from the underlying maternal condition.
Data
Animal Data: Cetirizine hydrochloride was detected in the milk of mice. No adverse developmental effects on pups were seen when cetirizine hydrochloride was administered orally to dams during lactation at a dose that was approximately 10 times the MRHD in adults [See Use in Specific Populations ]. Studies in beagle dogs indicated that approximately 3% of the dose of cetirizine hydrochloride was excreted in milk. The concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk.
Pediatric Use
The safety and efficacy of QUZYTTIR have been established in patients 6 months to 17 years of age. The efficacy of QUZYTTIR for the treatment of acute urticaria down to 6 months of age is based on extrapolation of the efficacy of QUZYTTIR in adults with acute urticaria [See Clinical Studies ] and supported by pharmacokinetic data with oral cetirizine hydrochloride (the active ingredient in QUZYTTIR) in patients 6 months to 17 years of age. Based upon the known PK profile of oral cetirizine hydrochloride, the exposure of IV cetirizine hydrochloride in pediatric patients (6 months to 17 years of age) is expected to be similar to the exposure of IV cetirizine hydrochloride in adults at the labeled doses. Extrapolation of efficacy is based on the likelihood that the disease course, pathophysiology and the drug's effect are similar between these two populations.
The safety of QUZYTTIR in children 6 months to 17 years of age is supported by safety information from placebo-controlled clinical trials with oral cetirizine hydrochloride in patients 6 months of age and older [see Adverse Reactions ]. QUZYTTIR demonstrates a higher Cmax compared to oral cetirizine hydrochloride in adults [See Clinical Pharmacology ]. As QUZYTTIR is indicated for an acute condition administered in a medically supervised setting, the safety for higher Cmax in children 6 months to less than 18 years of age is supported by the safety data from the clinical trial with IV cetirizine hydrochloride in adults [see Adverse Reactions ] and available safety information from pediatric overdose cases.
Because of the absence of pharmacokinetic and safety information for cetirizine hydrochloride in children below 6 years of age with impaired renal or hepatic function, the use of QUZYTTIR in this impaired patient population is not recommended [see Dosage And Administration ].
The safety and efficacy of QUZYTTIR in patients less than 6 months of age has not been established.
Geriatric Use
In clinical trials with QUZYTTIR, 18 patients were 65 years and older, and 6 patients were 75 years and older. No overall differences in safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In clinical trials with cetirizine hydrochloride oral tablets, 186 patients were 65 years and older, and 39 patients were 75 years and older. No overall differences in safety were observed between these patients and younger patients.
With regard to efficacy, the clinical trials with cetirizine hydrochloride oral tablets and QUZYTTIR did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.
Hepatic Impairment
No dosage adjustment is required in patients with hepatic impairment. Monitor for antihistaminic side effects in this patient population [See Clinical Pharmacology ].
Renal Impairment
No dosage adjustment is required in patients with moderate and severe renal impairment and in patients on dialysis. Monitor for antihistaminic side effects in this patient population [see Clinical Pharmacology ].
The use of QUZYTTIR is contraindicated in patients with a known hypersensitivity to cetirizine hydrochloride or any of its ingredients, levocetirizine, or hydroxyzine.
Somnolence/Sedation
In clinical trials with QUZYTTIR and cetirizine hydrochloride tablets, the occurrence of somnolence/sedation has been reported in some patients. Exercise due caution when driving a car or operating potentially dangerous machinery. Avoid concurrent use of QUZYTTIR with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur.