FDA pom zoo Xarelto (rivaroxaban) rau 2 qhov kev qhia rau menyuam yaus: kev kho mob&tiv thaiv cov ntshav txhaws!

) for two pediatric indications: (1) for pediatrics from birth to under 18 years of age Patients, after at least 5 days of initial parenteral anticoagulation therapy, use Xarelto to treat venous thromboembolism (VTE) and reduce the risk of recurrent VTE. (2) For pediatric patients with congenital heart disease who are ≥2 years old and have undergone Fontan surgery, use Xarelto for thromboprophylaxis (thromboprophylaxis).

Qhov kev pom zoo no yog ib qho kev nce qib loj hauv kev kho mob antithrombotic rau cov neeg mob uas muaj hnub nyoog qis dua 18 xyoo. Xarelto yog qhov ncauj qhov ncauj Xa inhibitor. Qhov kev pom zoo suav nrog cov qauv tsim nyog rau hnub nyoog tshiab ntawm qhov hnyav raws li qhov ncauj ncua. Rau ob qhov kev qhia txog menyuam yaus no, koob tshuaj Xarelto nyob ntawm lub cev qhov hnyav, thiab cov neeg mob tuaj yeem noj cov tshuaj ncua qhov ncauj lossis ntsiav tshuaj.

Nws yog tsim nyog hais tias Xarelto yog tib lub qhov ncauj ncaj qha anticoagulant (DOAC) pom zoo los ntawm US FDA rau thawj qhov kev tiv thaiv ntawm thrombosis nyob rau hauv cov neeg mob tom qab phais Fontan. Nws kuj tseem yog Asmeskas kev lag luam uas muab cov kev hloov pauv hloov pauv thiab qhov hnyav-hloov kho tshuaj rau cov neeg mob menyuam yaus. DOAC tsuas yog qhov ncauj qhov ncauj.

Although VTE is more common in adults, blood clots are still a serious problem in children. Approximately 58 of every 10,000 hospitalized pediatric patients in the United States are affected, and the incidence is increasing. Children suffering from other diseases (such as infectious diseases, active cancer) or undergoing surgery (such as Fontan surgery) may be more likely to develop blood clots. Fontan surgery is carried out in children with only one functional ventricle in order to remove blood from The lower body turns to the lungs.

Cov txheej txheem kev kho mob tam sim no raug txwv thiab pom zoo rau cov qauv kev kho mob anticoagulant, xws li warfarin lossis heparin, rau cov menyuam yaus uas muaj thrombosis lossis muaj kev pheej hmoo ntawm thrombosis rov tshwm sim. Feem ntau, cov kws kho mob yuav tsum kho cov neeg laus noj raws li cov ntaub ntawv txwv ntawm cov kev kho mob no rau cov neeg mob hluas. Tsis tas li ntawd, rau qee qhov kev xaiv kev kho mob, qhov no yuav txhais tau tias kev txhaj tshuaj mob, kev txwv kev noj zaub mov, thiab kev soj ntsuam hauv chav kuaj tsis tu ncua-tag nrho cov no yog qhov nyuaj tshwj xeeb rau cov neeg mob hluas thiab lawv cov neeg saib xyuas.

Hauv 2021, Johnson& Johnson tus khub Bayer (Bayer) tau txais kev pom zoo Xarelto pediatric indications hauv Canada, European Union, United Kingdom, Nyiv, Switzerland, thiab Latin America: siv rau cov neeg mob menyuam yaus txij thaum yug txog rau hnub nyoog qis dua 18 xyoo, tom qab tau txais tsawg kawg 5 hnub tom qab. Thawj txoj kev kho parenteral anticoagulation, Xarelto yog siv los kho VTE thiab tiv thaiv VTE rov tshwm sim.

Qhov kev pom zoo no yog ua raws li cov pov thawj ntawm cov kev tshawb fawb txaus thiab tswj tau zoo ntawm Xarelto hauv cov neeg mob laus, nrog rau cov ntaub ntawv los ntawm ob theem 3 kev sim tshuaj ntawm Xarelto hauv cov neeg mob: (1) EINSTEIN-Jr, uas yav dhau los kuaj mob hauv menyuam yaus nrog VTE (2) UNIVERSE, uas yog siv rau cov neeg mob menyuam yaus uas muaj kev pheej hmoo ntawm VTE tom qab kev phais Fontan tsis ntev los no. Nws yog ib qho tsim nyog hais tias EINSTEIN-Jr yog qhov kev sim tshuaj loj tshaj plaws ua tiav rau hnub no los ntsuas kev kho mob ntawm cov menyuam yaus nrog VTE, thiab UNIVERSE yog thawj qhov kev sim tshuaj ntsuam xyuas NOAC los tiv thaiv thromboembolism tom qab Fontan hauv cov menyuam yaus uas muaj kab mob hauv lub plawv.

VTE cuam tshuam rau tib neeg ntawm txhua lub hnub nyoog. Kev kho mob tam sim no ntawm VTE hauv cov menyuam yaus feem ntau yog tso siab rau cov tshuaj tiv thaiv kab mob hauv cov hlab ntsha thiab yuav tsum tau kuaj xyuas thiab hloov tshuaj. Tam sim no, cov menyuam yaus' cov kev kho mob anticoagulation feem ntau yog los ntawm kev nthuav tawm cov ntaub ntawv soj ntsuam thiab cov ntaub ntawv neeg laus.

rivaroxaban uayog cov feem ntau siv tsis-vitamin K antagonist tshiab qhov ncauj anticoagulant (NOAC) nyob rau hauv lub ntiaj teb no, thiab nws yog marketed nyob rau hauv lub lag luam lub npe Xarelto. Txog tam sim no, Xarelto tau txais kev pom zoo rau 11 qhov kev qhia kho mob, uas yog qhov qhia tau zoo tshaj plaws ntawm tag nrho cov DOACs thiab feem ntau kawm txog qhov ncauj qhov ncauj Xa inhibitor hauv nws chav kawm.