近日，生物仿制药Renflexis获美国食品和药物管理局（FDA）批准。该药是强生（JNJ）重磅品牌药Remicade的生物仿制药。用于治疗成人及儿科克罗恩病（CD），成人溃疡性结肠炎（UC）、类风湿性关节炎（RA）、强直性脊柱炎（AS）、银屑病关节炎（PsA）以及成人斑块型银屑病的治疗.
批准日期：2017年4月27日   公司：默克公司
RENFLEXIS（英夫利昔单抗仿制药[infliximab-abda]）用于注射，用于静脉注射
美国最初批准：2017年
RENFLEXIS（infliximab-abda）与REMICADE（英夫利昔单抗）生物相似*。
警告：严重的感染和恶意，查看完整的盒装警告的完整处方信息。
导致住院或死亡的严重感染风险增加，包括结核病（TB），细菌性败血症，侵袭性真菌感染（如组织胞浆菌病）和其他机会病原体引起的感染。
如果患者出现严重感染，请停用RENFLEXIS。
对潜伏性结核病进行检测;如果阳性，在开始使用RENFLEXIS之前开始治疗结核病。在治疗期间监测所有患者的活动性结核病，即使最初的潜伏性结核病检测结果为阴性。
已经报道了用肿瘤坏死因子（TNF）阻滞剂（包括英夫利昔单抗产品）治疗的儿童和青少年患者的淋巴瘤和其他一些致命的恶性肿瘤。
已经报道了用包括英夫利昔单抗产品的TNF阻断剂治疗的患者的致命肝脾T细胞淋巴瘤（HSTCL）的上市后病例。几乎所有人都接受了硫唑嘌呤或6-巯基嘌呤伴随TNF-blocker诊断或诊断。大多数病例报告患者克罗恩病或溃疡性结肠炎，其中大多数是青少年或年轻成年男性。
最近的重大变化
警告和注意事项：恶性肿瘤：3/2019
警告和注意事项：输注期间和输注后的心血管和脑血管反应：3/2019
作用机制
英夫利昔单抗产品通过高亲和力结合TNFα的可溶性和跨膜形式来中和TNFα的生物活性，并抑制TNFα与其受体的结合。英夫利昔单抗产品不能中和TNFβ（淋巴毒素-α），这是一种利用与TNFα相同的受体的相关细胞系。归因于TNFα的生物活性包括：
诱导促炎性细胞因子如白细胞介素（IL）1和6，通过增加内皮细胞层渗透性和内皮细胞和白细胞粘附分子的表达，中性粒细胞和嗜酸性粒细胞功能活性的激活，诱导急性期反应物和其他肝脏蛋白来增强白细胞迁移以及由滑膜细胞和/或软骨细胞产生的组织降解酶。表达由英夫利昔单抗产物结合的跨膜TNFα的细胞可以在体外或体内裂解。
英夫利昔单抗产品在利用人成纤维细胞，内皮细胞，嗜中性粒细胞，B和T淋巴细胞和上皮细胞的多种用于维生素测定的多种维生素测定中抑制TNFα的功能活性。这些生物反应标志物与英夫利昔单抗产品发挥其临床作用的机制之间的关系是未知的。抗TNFα抗体降低棉花顶体t猴结肠炎模型中的疾病活动，并减少胶原诱导的关节炎小鼠模型中的滑膜炎和关节糜烂。
英夫利昔单抗产品可预防由于人TNFα的组成型表达而发生多关节炎的转基因小鼠的疾病，并且在疾病发作后给药时，允许侵蚀的关节愈合。
适应症和用法
RENFLEXIS是一种肿瘤坏死因子（TNF）阻断剂，适用于：
克罗恩病 ：
减轻体征和症状，诱导和维持对常规治疗反应不足的中度至重度活动性疾病的成年患者的临床缓解。
减少瘘管病患者的肠外和直肠阴道瘘排出次数，保持瘘管闭合。
小儿克罗恩病：
减轻体征和症状，诱导和维持对常规治疗反应不足的中度至重度活动性疾病的儿科患者的临床缓解。
溃疡性结肠炎：
减少症状和体征，诱导和维持临床缓解和粘膜愈合，并消除对中度至重度活动性疾病患者使用皮质类固醇，这些患者对常规治疗的反应不足。
类风湿性关节炎联合甲氨蝶呤：
减轻体征和症状，抑制结构损伤的进展，改善中度活动性疾病患者的身体机能。
强直性脊柱炎：
减少活动性疾病患者的体征和症状。
银屑病关节炎：
减少活动性关节炎的体征和症状，抑制结构损伤的进展，改善身体机能。
斑块型牛皮癣：
治疗患有慢性严重（即广泛和/或致残）斑块状银屑病的成年患者，这些患者是全身治疗的候选者，并且当其他全身治疗在医学上不太合适时。
剂量和给药
RENFLEXIS通过静脉内输注给药，持续时间不少于2小时。
克罗恩病
在0,2和6周时为5mg/kg，然后每8周一次。一些最初对治疗有反应的成年患者如果后来失去了反应，可能会增加剂量10mg/kg。
小儿克罗恩病
在0,2和6周时为5mg/kg，然后每8周一次。
溃疡性结肠炎
在0,2和6周时为5mg/kg，然后每8周一次。
类风湿关节炎
与甲氨蝶呤联合使用时，0周，2周和6周均为3mg/kg，共8周。一些患者可以从增加剂量高达10mg/kg或每4周一次治疗中受益。
强直性脊柱炎
在0,2和6周时为5mg/kg，然后每6周一次。
银屑病关节炎和斑块银屑病
在0,2和6周时为5mg/kg，然后每8周一次。
剂量形式和强度
用于注射：在20mL小瓶中的100mg冻干的英夫利昔单抗-abda用于静脉输注。
禁忌症
RENFLEXIS剂量>5mg/kg，适用于中度至重度心力衰竭。
以前对英夫利昔单抗产品的严重超敏反应或已知对RENFLEXIS或toany鼠蛋白的无活性成分的超敏反应。
警告和注意事项
•严重感染-在活动性感染期间不要给予RENFLEXIS。
如果感染发生，请仔细监测并在感染严重时停止RENFLEXIS。
•侵袭性真菌感染-对于在RENFLEXIS患有全身性疾病的患者，考虑对那些患有真菌病的地区或前往真菌病地区的人进行经验性抗真菌治疗。
•恶性肿瘤-包括侵袭性癌症和淋巴瘤在内的恶性肿瘤的发生率在TNF阻滞剂治疗的患者中比在对照组中更高。由于HSTCL仔细评估风险/益处的风险，特别是如果患者患有克罗恩病或溃疡性结肠炎，则是男性，并且正在接受硫唑嘌呤或6-巯基治疗。
•启动RENFLEXIS前乙型肝炎病毒再激活 - 检测HBV感染。在治疗期间和数月后监测HBV携带者。如果发生再激活，请停止RENFLEXIS并开始抗病毒治疗。
•肝毒性-严重的肝脏反应，一些致命或需要移植的肝脏。在黄疸和/或标记的肝酶升高的情况下停止RENFLEXIS。
•心力衰竭-可能会出现新的症状或症状加重。
•血细胞减少症-建议患者在出现症状和症状时立即就医，并考虑停用RENFLEXIS。
•过敏反应-严重的输液反应，包括过敏反应，可能会发生类似疾病的反应。
•心血管和脑血管反应 - 在RENFLEXISinfusion开始的24小时内和24小时内报告了脑血管事件，心肌梗塞（一些致命）和心律失常。在RENFLEXIS输注期间监测患者，如果发生严重反应，则停止输注。
•脱髓鞘疾病-可能发生恶化或新发病。
•狼疮样综合征-如果综合征发展，停止RENFLEXIS。
•活疫苗或治疗性感染因子-不应与RENFLEXIS一起使用。在开始使用RENFLEXIS之前，让儿科患者了解最新的疫苗接种情况。在对子宫内暴露于infliximab的婴儿进行活疫苗接种之前，建议在出生后至少六个等待期。
产品。
不良反应
最常见的不良反应（>10％）-感染（如上呼吸道，鼻窦炎和咽炎），输液相关反应，头痛和腹痛。
要报告疑似不良反应，请联系Merck＆Co.，Inc。的子公司Merck Sharp＆Dohme Corp.，电话号码是1-877-888-4231，或联系FDA，电话号码是1-800-FDA1088或www.fda.gov/medwatch。
药物相互作用
•与阿那白滞素或abatacept一起使用 - 增加严重感染的风险。
用于特定人群
•儿科用途 - 英夫利昔单抗产品尚未在患有克罗恩病或溃疡性结肠炎<6岁的儿童中进行过研究。
有关患者咨询信息和药物指南，请参阅。
*生物仿制药意味着生物产品基于数据证明它与FDA批准的生物产品高度相似，称为参考产品，并且生物仿制药产品和参考产品之间没有临床意义上的差异.RENFLEXIS的相似性已经证明了其完整处方信息中描述的使用条件（例如，适应症，给药方案），强度，剂型和给药途径。
包装提供/存储和处理
用于注射100mg小瓶的每个RENFLEXIS（infliximab-abda）单独包装在acarton中。
NDC 0006-4305-02 100毫克小瓶
每个单剂量小瓶含有100mg英夫利昔单抗-abda，为白色冻干粉末，最终重建体积为10mL。
储存和稳定性
将未开封的RENFLEXIS样品瓶存放在2ºC至8ºC（36ºF至46ºF）的冰箱中。 不要在纸箱和样品瓶上的失效日期之后使用RENFLEXIS。 该产品不含防腐剂。
[有关重组产品的储存条件，请参阅剂量和用法]。
完整说明书资料附件：
https://www.merck.com/product/usa/pi_circulars/r/renflexis/renflexis_pi.pdf
RENFLEXIS (infliximab-abda) for injection, for intravenous use
Initial U.S. Approval: 2017
RENFLEXIS (infliximab-abda) is biosimilar* to REMICADE (infliximab).
Important Safety Information
Important Safety Information
Only your doctor can recommend a course of treatment after checking your health condition. RENFLEXIS can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with RENFLEXIS.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including RENFLEXIS, the chances of getting lymphoma or other cancers may increase.
You should discuss any concerns about your health and medical care with your doctor.
What should I tell my doctor before I take RENFLEXIS?
You should let your doctor know if you have or ever had any of the following:
Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start RENFLEXIS. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with, and during treatment with, RENFLEXIS. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking RENFLEXIS. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
Lived in a region where certain fungal infections like histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections may develop or become more severe if you take RENFLEXIS. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
Infections that keep coming back, diabetes, or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take RENFLEXIS.
Hepatitis B virus (HBV) infection or think you maybe a carrier of HBV. Your doctor will test you for HBV.
Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).
Also tell your doctor if you:
Use the medicines Kineret® (anakinra), Orencia® (abatacept), or Actemra® (tocilizumab) or other medicines called biologics used to treat the same problems as RENFLEXIS.
Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using RENFLEXIS during your pregnancy. Tell your baby's doctor about your RENFLEXIS use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
Recently received or are scheduled to receive a vaccine. Adults and children taking RENFLEXIS should not receive live vaccines or treatment with a weakened bacteria (such as Bacille Calmette-Guérin [BCG] for bladder cancer) while taking RENFLEXIS.
What should I watch for and talk to my doctor about before or while taking RENFLEXIS?
The following serious (sometimes fatal) side effects have been reported in people taking RENFLEXIS.
You should tell your doctor right away if you have any of the signs listed below:
Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. RENFLEXIS can make you more likely to get an infection or make any infection that you have worse.
Lymphoma, or any other cancers in adults and children.
Skin Cancer—any changes in or growths on your skin.
Heart Failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash, and/or joint pain.
Liver Injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood Problems—in some patients taking infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you have a fever that does not go away, bruising, bleeding, or severe paleness.
Nervous System Disorders—numbness, weakness, tingling, changes in your vision, or seizures.
Allergic Reactions (some severe) during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like Syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
The more common side effects with infliximab products are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
What conditions is RENFLEXIS used to treat?
RENFLEXIS is a prescription medication used to treat:
Crohn's Disease
Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Pediatric Crohn's Disease
Can reduce signs and symptoms and induce and maintain remission in children (ages 6–17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Ulcerative Colitis
Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Rheumatoid Arthritis
Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
Psoriatic Arthritis
Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
Ankylosing Spondylitis
Can reduce signs and symptoms in patients with active ankylosing spondylitis
Plaque Psoriasis
Approved for the treatment of adult patients with chronic (doesn’t go away) severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if RENFLEXIS is appropriate considering other available therapies

Indications
RHEUMATOID ARTHRITIS
RENFLEXIS is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)
CROHN'S DISEASE
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy
RENFLEXIS is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease
PEDIATRIC CROHN'S DISEASE
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy
ULCERATIVE COLITIS
RENFLEXIS is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy
PSORIATIC ARTHRITIS
RENFLEXIS is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis (PsA)
ANKYLOSING SPONDYLITIS
RENFLEXIS is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS)
PLAQUE PSORIASIS
RENFLEXIS is indicated for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. RENFLEXIS should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician
Selected Safety Information
SERIOUS INFECTIONS
Patients treated with infliximab products 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 RENFLEXIS if a patient develops a serious infection or sepsis.
Reported infections 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 RENFLEXIS use and during therapy.a,b Treatment for latent infection should be initiated prior to RENFLEXIS use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered 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 RENFLEXIS should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RENFLEXIS, 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, pediatric patients, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab products included pneumonia, cellulitis, abscess, and skin ulceration.
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most 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. Carefully assess the risks and benefits of treatment with RENFLEXIS, especially in these patient types.
In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including infliximab products, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with infliximab products was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
CONTRAINDICATIONS
RENFLEXIS is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. RENFLEXIS should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue RENFLEXIS if new or worsening CHF symptoms appear. RENFLEXIS should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.
HEPATITIS B REACTIVATION
TNF inhibitors, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating RENFLEXIS. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing RENFLEXIS for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with RENFLEXIS. Discontinue RENFLEXIS in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of RENFLEXIS and monitor patients closely.
HEPATOTOXICITY
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving infliximab products postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be eva luated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, RENFLEXIS should be discontinued, and a thorough investigation of the abnormality should be undertaken.
HEMATOLOGIC EVENTS
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported in patients using infliximab products. The causal relationship to infliximab therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of RENFLEXIS in patients who develop significant hematologic abnormalities.
HYPERSENSITIVITY
Infliximab products have been associated with hypersensitivity reactions that differ in their time of onset and required hospitalization in some cases. Most hypersensitivity reactions, which include urticaria, dyspnea, and hypotension, have occurred during or within 2 hours of infusion. Serious infusion reactions including anaphylaxis were infrequent. RENFLEXIS should be discontinued for severe hypersensitivity reactions. Medications for the treatment of hypersensitivity reactions should be available.
NEUROLOGIC EVENTS
TNF inhibitors, including infliximab products, have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering RENFLEXIS in patients with these disorders and consider discontinuation if these disorders develop.
AUTOIMMUNITY
Treatment with infliximab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
USE WITH OTHER DRUGS
Concomitant use of RENFLEXIS with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as RENFLEXIS is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.
LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS
Live vaccines or therapeutic infectious agents should not be given with RENFLEXIS due to the possibility of clinical infections, including disseminated infections.
Bring pediatric patients up to date with all vaccinations prior to initiating RENFLEXIS. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab products.
ADVERSE REACTIONS
In clinical trials with infliximab products, the most common adverse reactions occurring in >10% of patients treated with infliximab products included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.