标签更改摘要
- Safety and effectiveness have been established in pediatric patients from birth to less than 18 years for the treatment of VTE and the reduction in risk of recurrent VTE.
- Use is supported in these age groups by evidence from adequate and well-controlled studies of Xarelto in adults with additional pharmacokinetic, safety and efficacy data from a multicenter, prospective, open-label, active-controlled randomized study in 500 pediatric patients from birth to less than 18 years of age.
- Xarelto was not studied and therefore dosing cannot be reliably determined or recommended in children less than 6 months who were less than 37 weeks of gestation at birth; had less than 10 days of oral feeding, or had a body weight of less than 2.6 kg.
- Safety and effectiveness have been established for use in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.
- Use is supported in these age groups by evidence from adequate and well-controlled studies of Xarelto in adults with additional data from a multicenter, prospective, open-label, active controlled study in 112 pediatric patients to evaluate the single- and multiple-dose
pharmacokinetic properties of XARELTO and the safety and efficacy of XARELTO when used for thromboprophylaxis for 12 months in children with single ventricle physiology who had the Fontan procedure.
- Clinical studies that evaluated safety, efficacy, pharmacokinetic and pharmacodynamic data support the use of Xarelto 10 mg, 15 mg, and 20 mg tablets in pediatric patients. For the Xarelto 2.5 mg tablets, there are no safety, efficacy, pharmacokinetic and pharmacodynamic data to support the use in pediatric patients. Therefore, Xarelto 2.5 mg tablets are not recommended for use in pediatric patients.
- Although not all adverse reactions identified in the adult population have been observed in clinical trials of children and adolescent patients, the same warnings and precautions for adults should be considered for children and adolescents.
Information on dosing, PK parameters, adverse reactions, and clinical trial.