英文药名: Simponi(Golimumab Injection) 中文药名: 戈利木单抗注射剂 生产厂家: Centocor Ortho Biotech 药品介绍 药品名：Simponi(golimumab) 适应症：牛皮癣关节炎 类风湿关节炎 强直性脊柱炎 溃疡性结肠炎 生产商：Centocor Ortho Biotech 批准日期：2009年4月24日 近日，美国食品药品管理局（The U.S. Food and Drug Administration，FDA）批准治疗成人中至重度活动型风湿性关节炎（RA）、银屑病关节炎（PsA）及强直性脊柱炎(AS)的长效药物Simponi(golimumab)上市。 这三类关节炎均属慢性自身免疫性疾病，造成患者关节强直、疼痛以及活动受限。 Simponi属生物制品，皮下注射每月用药一次。Simponi与免疫抑制剂甲氨蝶呤（MTX）联用治疗风湿性关节炎, 也可与MTX联用或单用治疗银屑病关节炎；单用于强直性脊柱炎治疗。 FDA药品评价及研究中心麻醉镇痛和风湿病产品办公室主任称，Simponi的上市为这三类患者提供了新的治疗选择，同时FDA采取的风险最小化措施也将给患者提供与其他同类治疗药物相同的安全保障。 Important Safety Information for SIMPONI® (golimumab) SERIOUS INFECTIONS Patients treated with SIMPONI®(golimumab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI® if a patient develops a serious infection. Reported infections with TNF blockers, of which SIMPONI® is a member, include: •Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before SIMPONI® use and during therapy. Treatment for latent infection should be initiated prior to SIMPONI® use. •Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. •Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with SIMPONI® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI® in patients with clinically important active infections, including localized infections. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SIMPONI®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection. Risk of infection may be higher in patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Other serious infections observed in patients treated with SIMPONI® included sepsis, pneumonia, cellulitis, abscess and hepatitis B infection. MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers of which SIMPONI® is a member. Approximately half the cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children or adolescents. Malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. In the controlled portions of clinical trials of all TNF-blocking agents including SIMPONI®, more cases of lymphoma have been observed among patients receiving TNF-blocking treatment compared with control patients. In the RA, PsA, and AS clinical trials, the incidence of lymphoma per 100 patient-years of follow-up was 0.21 (95% CI: 0.03, 0.77) in the combined SIMPONI® group compared with an incidence of 0 (95% CI: 0, 0.96) in the placebo group. In the clinical trials, the incidence of malignancies other than lymphoma was not increased with exposure to SIMPONI® and was similar to what would be expected in the general population. In controlled and uncontrolled portions of the Phase 2/3 studies in UC with a mean follow-up of approximately 1 year, there were no cases of lymphoma with SIMPONI®. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. The risks and benefits of TNF-blocker therapy should be considered prior to initiating therapy in patients with a known malignancy or who develop a malignancy. Melanoma has been reported in patients treated with TNF-blocking agents, including SIMPONI®. Merkel cell carcinoma has been reported in patients treated with TNF-blocking agents. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers. These cases have had a very aggressive disease course and have been fatal. Nearly all reported cases have occurred in patients with Crohn's disease and some with ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. A risk for the development for HSTCL in patients treated with TNF blockers cannot be excluded. HEPATITIS B REACTIVATION The use of TNF-blocking agents including SIMPONI® has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants. All patients should be tested for HBV infection before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating TNF-blocker therapy. Exercise caution when prescribing SIMPONI® for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI®. Discontinue SIMPONI® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI®, and monitor patients closely. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported. Exercise caution and monitor patients with heart failure. Discontinue SIMPONI® if new or worsening symptoms of heart failure appear. DEMYELINATING DISORDERS TNF-blocking agents, of which SIMPONI® is a member, have been associated with rare cases of new-onset or exacerbation of demyelinating disorders, including multiple sclerosis (MS) and Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported with SIMPONI®. Exercise caution in considering the use of SIMPONI® in patients with these disorders. Consider discontinuation if these disorders develop. HEMATOLOGIC CYTOPENIAS There have been reports of pancytopenia, leukopenia, neutropenia, and thrombocytopenia in patients receiving SIMPONI® in clinical trials. Additionally, aplastic anemia has been reported in patients receiving TNF-blocking agents, of which SIMPONI® is a member. Exercise caution when using SIMPONI® in patients who have or had significant cytopenias. USE WITH OTHER DRUGS The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections, therefore the use of SIMPONI® in combination with these products is not recommended. Care should be taken when switching from one biologic to another since overlapping biological activity may further increase the risk of infection. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. The concomitant use of SIMPONI® with biologics approved to treat RA, PsA, or AS is not recommended because of the possibility of an increased risk of infection. VACCINATIONS/THERAPEUTIC INFECTIOUS AGENTS People receiving SIMPONI® can receive vaccinations, except for live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections. Administration of live vaccines to infants exposed to SIMPONI® in utero is not recommended for 6 months following the mother's last SIMPONI® injection during pregnancy due to an increased risk of infection. It is recommended that therapeutic infectious agents not be given concurrently with SIMPONI® due to the possibility of clinical infections, including disseminated infections. HYPERSENSITIVITY REACTIONS Serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported with SIMPONI®, some occurring after the first dose. If an anaphylactic or other serious allergic reaction occurs, discontinue SIMPONI® immediately and institute appropriate therapy. ADVERSE REACTIONS The most serious adverse reactions were serious infections and malignancies. Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 trials through Week 16, occurring in 7% and 6% of patients treated with SIMPONI® as compared with 6% and 5% of patients in the control group, respectively. The rate of injection-site reactions was 6% with patients treated with SIMPONI® compared with 2% of patients in the control group. In the Phase 2/3 trials in UC evaluating SIMPONI®-treated patients, no new adverse drug reactions were identified and the frequency of adverse drug reactions was similar to the safety profile observed in patients with RA, PsA and AS. --------------------------------------------------------- SIMPONI Rx Generic Name for SIMPONI Golimumab 50mg/0.5mL; soln for SC inj; preservative-free. Legal Classification: Rx Pharmacological Class for SIMPONI TNF blocker. Manufacturer of SIMPONI Janssen Biotech, Inc. Indications for SIMPONI Moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX). Active psoriatic arthritis (PsA), alone or with MTX. Active ankylosing spondylitis (AS). Adult dose for SIMPONI 50mg SC once monthly. Rotate sites. Children's dosing for SIMPONI <18yrs: not recommended. Warnings/Precautions for SIMPONI Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal). Active infections: do not initiate therapy. Chronic or history of recurring or opportunistic infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test for and treat latent TB prior to initiating therapy. Monitor closely if new infection, reactivation of hepatitis B virus (HBV), or blood dyscrasias develop; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, new or worsening CHF, or hematological abnormality (eg, cytopenias) develops. CHF (monitor). Immunosuppression. CNS demyelinating disorders. Malignancies. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. Interactions for SIMPONI Concurrent abatacept, anakinra, live vaccines, or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. Monitor CYP450 substrates with narrow therapeutic index. Adverse Reactions for SIMPONI Inj site reactions, infections (may be serious), upper respiratory tract infection, nasopharyngitis, hypertension; rare: malignancies (eg, lymphoma, esp children), blood dyscrasias, new or worsening CHF, elevated liver enzymes, antibody formation, exacerbation or new onset of psoriasis. How is SIMPONI supplied? Single-dose SmartJect autoinjector—1; Single-dose prefilled syringe—1 Related Disease: Ankylosing spondylitis Arthritis Rheumatoid arthritis TNF阻断剂Simponi获准用于溃疡性结肠炎患者 2013年5月15日，杨森生物技术公司宣布，美国食品药品管理局(FDA)已批准Simponi(戈利木单抗)用于已证实对皮质类固醇依赖或对口服氨基水杨酸、口服类固醇皮质激素、咪唑硫嘌呤或6-巯基嘌呤无充分应答或不能耐受的中至重度活动性溃疡性结肠炎(UC)患者的治疗。Simponi属于抗-肿瘤坏死因子(TNF)-α药物，此前已被批准用于治疗类风湿性关节炎、银屑病性关节炎和强直性脊柱炎。 这次获批得到来自针对传统药物治疗无应答或不能耐受的中至重度活动性UC患者评价临床试验数据的支持。与安慰剂组相比， 200 mg/100 mg Simponi治疗组6周时达到临床应答、临床缓解和黏膜内镜表现改善的患者比例显著较高。54周时100 mg Simponi治疗组患者仍维持临床应答的患者比例也明显高于安慰剂组。在接受Simponi诱导治疗后，30周和54周时仍呈现临床缓解、54周内任何时间点未显示失去应答的临床应答患者比例，100 mg Simponi治疗组也显著高于安慰剂组。 在UC试验中观察到的Simponi安全性结果与其用于风湿性适应证的已知安全性一致。与应用TNF-阻断剂相关的不良事件包括感染和某些癌症风险增加。 ----------------------------------------------------------              产地国家: 美国 原产地英文商品名: Simponi 50MG/0.5ML 1 Pen Injector 原产地英文药品名: GOLIMUMAB 中文参考商品译名: Simponi 50毫克/0.5毫升 1支筆式注射器 中文参考药品译名: 戈利木单抗注射剂 生产厂家中文参考译名: 强生全资子公司 生产厂家英文名: CENTOCOR ORTHO BIOTECH INC ---------------------------------------------------------- 产地国家: 美国 原产地英文商品名: Simponi 50MG/0.5ML 1Vial 原产地英文药品名: GOLIMUMAB 中文参考商品译名: Simponi 50毫克/0.5毫升 1瓶 中文参考药品译名: 戈利木单抗注射剂 生产厂家中文参考译名: 强生全资子公司 生产厂家英文名: CENTOCOR ORTHO BIOTECH INC ---------------------------------------------------------- 产地国家: 美国 原产地英文商品名: Simponi 100MG/1.0ML 1Vial 原产地英文药品名: GOLIMUMAB 中文参考商品译名: Simponi 100毫克/1.0毫升 1瓶 中文参考药品译名: 戈利木单抗注射剂 生产厂家中文参考译名: 强生全资子公司 生产厂家英文名: CENTOCOR ORTHO BIOTECH INC