甲苯磺酸索拉非尼片 (多吉美_Nexavar)的产品信息（EMA）.pdf

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1

1.NAMEOFTHEMEDICINALPRODUCT

Nexavar200mgfilm-coatedtablets

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains200mgofsorafenib(astosylate).

Forthefulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Film-coatedtablet(tablet).

Red,round,facetedbiconvexfilm-coatedtablet,withBayercrossononesideand200ontheother

side.

4.CLINICALPARTICULARS

4.1Therapeuticindications

Hepatocellularcarcinoma

Nexavarisindicatedforthetreatmentofhepatocellularcarcinoma(seesection5.1).

Renalcellcarcinoma

Nexavarisindicatedforthetreatmentofpatientswithadvancedrenalcellcarcinomawhohavefailed

priorinterferon-alphaorinterleukin-2basedtherapyorareconsideredunsuitableforsuchtherapy.

Differentiatedthyroidcarcinoma

Nexavarisindicatedforthetreatmentofpatientswithprogressive,locallyadvancedormetastatic,

differentiated(papillary/follicular/Hürthlecell)thyroidcarcinoma,refractorytoradioactiveiodine.

4.2Posologyandmethodofadministration

Nexavartreatmentshouldbesupervisedbyaphysicianexperiencedintheuseofanticancertherapies.

Posology

TherecommendeddoseofNexavarinadultsis400mgsorafenib(twotabletsof200mg)twicedaily

(equivalenttoatotaldailydoseof800mg).

Treatmentshouldcontinueaslongasclinicalbenefitisobservedoruntilunacceptabletoxicityoccurs.

Posologyadjustments

Managementofsuspectedadversedrugreactionsmayrequiretemporaryinterruptionordose

reductionofsorafenibtherapy.

Whendosereductionisnecessaryduringthetreatmentofhepatocellularcarcinoma(HCC)and

advancedrenalcellcarcinoma(RCC),theNexavardoseshouldbereducedtotwotabletsof200mg

sorafeniboncedaily(seesection4.4).