米泊美生钠注液 KYNAMRO (mipomersen sodium) FDA药品说明书翻译.pdfVIP

5.2 KYNAMRO REMS Because of the risk of hepatotoxicity, KYNAMRO is available only through a limited program under the REMS. Under the KYNAMRO REMS, only certified healthcare providers and pharmacies may prescribe and distribute KYNAMRO. Further information is available at www.KynamroREMS.com or by telephone at 1-877-KYNAMRO (1-8775962676).- +a¾6ÍWNþL™È\9Ÿ7-FJE÷Û0 jKYNAMRO REMSAÑB,´NþL™Aô`¼ÿ~AÑB (REMS)L€f,´AÑB9çÄ ižKYNAMRO REMS È9#¼k8¼9Ÿ87-¯+X\9ŸÄ 5.3 Injection Site Reactions#4G}ýÄ Injection site reactions have been reported in 84% of patients receiving KYNAMRO therapy. These local reactions typically consist of one or more of the following: erythema, pain, tenderness, pruritus and local swelling. Injection site reactions do not occur with all injections but resulted in discontinuation of therapy in 5% of patients in pooled Phase 3 trials. [SeeAdverse Reactions (6.1)] To minimize the potential for injection site reactions, proper technique for subcutaneous administration should be followed. [seePatient Counseling Information (17)] +X9Ÿ984%Ó65*)à #4G}ýÄ,´ÕFƒÄ pG#4G}ýÄ5;0/ýFJ/ý ¨» +÷ (æÖ4ÒÁÃ#4G}+ì,û,Ã,I,ÃpG6ï6ð ÄXdºBP¼ 3OÈ9 5%Ó65#4G} ýÄŒ9ŸÄjÿE«#4G}ýÄ,´7-WÈÄF¥þ F2ƒ,´,Þ;#4 °Ä 5.4 Flu-Like Symptoms#qOg+÷(æ Flu-like symptoms have been reported in 30% of patients receiving KYNAMRO therapy and include one or more of the following: influenza-like illness, pyrexia, chills, myalgia, arthralgia, malaise or fatigue. Flu-like symptoms, which typically occur within 2 days after an injection, do not occur with all injections but resulted in discontinuation of therapy in 3% of patients in pooled Phase 3 trials. [See Adverse Reactions (6.1)] +X9Ÿ930%Ó65*)à#qOg+÷(æ,´ÕFƒÈ#qOg+÷(æ5;0/ýFJ /ý+÷(æÖ#qOg+î +õÃÃHÃ6¼,ã8²,Ã=F2F+â•ÄXdºBP¼3 OÈ#qOg+÷(æk?±X#4 2 µ*)àÈ 93%Ó6