Celltrion USA Partners With Express Scripts and Cigna Healthcare to Expand Access to ZYMFENTRA (Infliximab-dyyb), the First and Only FDA-approved Subcutaneous Infliximab on Their Medical Benefit Formulary
Celltrion USA Partners With Express Scripts and Cigna Healthcare to Expand Access to ZYMFENTRA (Infliximab-dyyb), the First and Only FDA-approved Subcutaneous Infliximab on Their Medical Benefit Formulary
JERSEY CITY, N.J., Aug. 28, 2024 /PRNewswire/ -- Celltrion USA announced today that it has signed an agreement with Cigna Healthcare, the health benefits provider of the Cigna Group and Express Scripts, the pharmacy benefits services business of the Cigna Group's Evernorth and one of the nation's leading health insurers, that will help expand patient access to ZYMFENTRA (infliximab-dyyb), the first and only U.S. Food and Drug Administration (FDA)-approved subcutaneous infliximab. The agreement, effective August 1, 2024, lists ZYMFENTRA as the preferred medication on the Cigna's medical formulary serving 16.1 million insured lives.
Celltrion USA今天宣佈與Cigna Healthcare簽署了一份協議,Cigna Healthcare屬於Cigna Group,並與Cigna Group的Express Scripts達成合作,爲Cigna的健康保險提供商提供藥店福利服務業務。這將有助於擴大病患對ZYMFENTRA(infliximab-dyyb)的使用,這是首個也是唯一一個獲得美國食品藥品監督管理局(FDA)批准的皮下注射型infliximab。該協議自2024年8月1日生效,將ZYMFENTRA列爲Cigna醫學處方藥品單上的優選藥物,服務於1610萬名被保險人。
ZYMFENTRA was approved by the FDA in October 2023 for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) following treatment with an infliximab product administered intravenously.
ZYMFENTRA於2023年10月獲得FDA批准,用於治療疾病活動度適中或重度的潰瘍性結腸炎(UC)和克隆病(CD),並且是在靜脈注射infliximab治療後的維持治療藥物。
"Celltrion USA is dedicated to broadening access to innovative and effective treatment options and our partnership with Cigna and Express Scripts will enhance the choices available to physicians and patients," said Francine Galante, Vice President of Market Access at Celltrion USA. "We believe ZYMFENTRA will deliver substantial value to patients as an alternative administration option allowing patients to have greater flexibility in managing their disease."
Celltrion USA副總裁Francine Galante表示:「Celltrion USA致力於擴大患者獲得創新和有效的治療選擇,我們與Cigna和Express Scripts的合作將增加醫生和患者的選擇。我們相信,ZYMFENTRA作爲一種可替代的給藥選擇,將爲患者帶來巨大的價值,使患者在管理疾病時具有更大的靈活性。」
This follows Celltrion USA's announcement in April 2024 that Express Scripts provided ZYMFENTRA Preferred Brand Access on the Express Scripts National Preferred Formulary.
這是繼Celltrion USA於2024年4月宣佈Express Scripts在Express Scripts全國優選處方藥單上提供ZYMFENTRA首選品牌之後的進展。
About Celltrion USA
關於Celltrion USA
Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA (infliximab-dyyb), TRUXIMA (rituximab-abbs), HERZUMA (trastuzumab-pkrb), VEGZELMA (bevacizumab-adcd), and YUFLYMA(adalimumab-aaty) as well as a novel biologic ZYMFENTRA. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: .
Celltrion USA是Celltrion在2018年成立的美國子公司,總部位於新澤西。Celltrion USA致力於擴大美國患者獲得創新生物製品的機會。Celltrion目前擁有美國FDA批准的五種生物製品:INFLECTRA(infliximab-dyyb)、TRUXIMA(rituximab-abbs)、HERZUMA(trastuzumab-pkrb)、VEGZELMA(bevacizumab-adcd)和YUFLYMA(adalimumab-aaty),以及一種新穎的生物製品ZYMFENTRA。Celltrion USA將繼續利用Celltrion在生物技術、供應鏈卓越性和一流的銷售能力方面的獨特優勢,改善美國患者獲得優質生物製藥產品的機會。欲了解更多信息,請訪問:。
About ZYMFENTRA (infliximab-dyyb)[1]
關於ZYMFENTRA (infliximab-dyyb)[1]
ZYMFENTRA is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV),
ZYMFENTRA是一種處方藥,成人通過皮下注射使用(皮下注射),用於維持治療:中度至重度活動性潰瘍性結腸炎,經由靜脈輸注給予過一種infliximab產品治療後。
moderately to severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.
中度至重度活動性克羅恩病,經由靜脈輸注給予過一種infliximab產品治療後。ZYMFENTRA阻斷腫瘤壞死因子-alpha (TNF-alpha)的作用,該蛋白質在某些疾病的刺激下可能被過度產生,並導致免疫系統攻擊正常健康的身體部分。
ZYMFENTRA (infliximab-dyyb) was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040.
ZYMFENTRA (infliximab-dyyb)通過生物製品許可申請(BLA)的351(a)途徑在公共衛生服務法("單獨"BLA)下獲得FDA批准。ZYMFENTRA被視爲一種新生物製品,具有首個經過皮下給藥的劑型,因此其劑型在2037年之前將受到專利保護,其給藥途徑在2040年之前將受到專利保護。
Indication and Important Safety Information
適應症和重要安全信息
ZYMFENTRA is a prescription medicine indicated in adults for maintenance treatment of:
ZYMFENTRA是一種成人用藥物,用於維持治療:
- Moderately to severely active Crohn's disease following treatment with an infliximab product administered intravenously.
- Moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.
- 中度至重度活動性克羅恩病,經由靜脈輸注過一種infliximab產品治療後。
- 中度至重度活動性潰瘍性結腸炎,經由靜脈輸注過一種infliximab產品治療後。
It is not known if ZYMFENTRA is safe and effective in children under 18 years of age.
ZYMfentra (費曼特)在18歲以下兒童中的安全性和有效性尚未確定。
What is the most important information I should know about ZYMFENTRA?
關於ZYMfentra (費曼特),您應該知道的最重要信息是什麼?
SERIOUS INFECTIONS
嚴重感染
Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.
接受ZYMfentra (費曼特)治療的患者患有各種器官系統和部位的嚴重感染,可能導致住院或死亡。如果患者出現嚴重感染或敗血症,請中止使用ZYMfentra (費曼特)。
Reported infections include:
報告的感染包括:
- Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. 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.
- 患有活動性結核病(包括潛伏性結核重新激活)。患者常常出現瀰漫性或肺外疾病。在使用ZYMfentra (費曼特)治療前和治療期間,應對患者進行潛伏性結核病測試。在使用ZYMfentra (費曼特)治療之前,應先進行潛伏性感染的治療。
- 包括組織胞漿菌病、球孢子菌病、念珠菌病、麴黴病、隨泡球菌病和肺孢子菌病在內的侵襲性真菌感染。患者可能表現爲瀰漫性疾病而不是局部性疾病。對於有風險患者發生嚴重全身性疾病的侵襲性真菌感染,應考慮經驗性抗真菌治療。
- 由於機會性病原體引起的細菌、病毒和其他感染,包括萊格氏菌和李斯特菌。在開始治療慢性或反覆發作感染的患者之前,應仔細考慮治療adalimumab-aaty的風險和益處。
The risks and benefits of treatment with ZYMFENTRA 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 ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
在開始治療慢性或複發性感染的患者之前,應仔細考慮使用ZYMFENTRA的風險和益處。在使用ZYMFENTRA進行治療期間和治療後,密切監測患者是否出現感染的體徵和症狀,包括先前在開始治療前對潛伏性結核感染的檢測爲陰性的患者可能發展爲結核病的可能性。
Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection.
65歲以上的患者、伴發疾病和/或接受共同免疫抑制劑治療的患者可能感染風險更高。在臨床試驗中,用英夫利妥治療的患者中觀察到的其他嚴重感染包括細菌性關節炎、肺炎和尿路感染。
MALIGNANCIES
惡性腫瘤
Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products.
已報道有兒童、青少年和年輕成年人接受TNF阻斷劑治療,包括英夫利妥製劑的惡性腫瘤,其中一些是致命的。其中約一半是淋巴瘤,包括霍奇金淋巴瘤和非霍奇金淋巴瘤。其他病例涉及各種惡性腫瘤,包括通常與免疫抑制有關的罕見惡性腫瘤和兒童和青少年通常不會發現的惡性腫瘤。這些惡性腫瘤發生在第一次接受治療後中位數爲30個月。大多數患者正在接受共同免疫抑制劑。
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.
在接受TNF阻斷劑治療的患者中,已報道肝脾T細胞淋巴瘤的後期市場病例,這是一種罕見的T細胞淋巴瘤。這些病例病情非常嚴重並且致命。大多數報告的病例發生在克羅恩病或潰瘍性結腸炎患者中,其中大多數是青少年和年輕成年男性。幾乎所有這些患者在診斷之前或同時接受了硫唑嘌呤或6-巰基嘌呤與TNF阻斷劑的治療。特別是在這些患者類型中,仔細評估使用ZYMFENTRA的風險和益處。
Post-marketing 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 ZYMFENTRA, especially in these patient types.
使用TNF阻斷劑治療的患者中,已報道肝脾T細胞淋巴瘤的後市場病例,這是一種罕見的T細胞淋巴瘤。這些病例病情發展迅速且致命。大多數報告的病例發生在克羅恩病或潰瘍性結腸炎患者中,其中大多數是青少年和年輕成年男性。幾乎所有這些患者在診斷之前或同時接受了硫唑嘌呤或6-巰基嘌呤與TNF阻斷劑的治療。尤其在這些患者類型中,仔細評估使用ZYMFENTRA的風險和益處。
In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy 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.
在所有TNF阻斷劑的臨床試驗中,與對照組和一般人群中預期發生率相比,觀察到更多的惡性腫瘤病例。在一些TNF阻斷劑的臨床試驗中,包括英夫利昂產品,在與對照組相比觀察到更多的其他惡性腫瘤病例。由於TNF阻斷劑治療在惡性腫瘤發展中的潛在作用尚不清楚,在考慮治療當前或歷史上有惡性腫瘤病史的患者時應謹慎。
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.
有報道稱,經TNF阻斷劑治療,包括英夫利昂產品,在患者中發生了黑素瘤和默克爾細胞癌。建議對所有患者定期進行皮膚檢查,特別是那些有皮膚癌風險因素的患者。
CONTRAINDICATIONS
禁忌症
ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).
ZYMFENTRA對那些對英夫利昂-dyyb、其他英夫利昂產品、ZYMFENTRA的任何非活性成分或任何鼠蛋白髮生過嚴重過敏反應的患者禁忌(嚴重過敏反應包括過敏性休克、低血壓和血清病)。
HEPATITIS B VIRUS REACTIVATION
乙型肝炎病毒再活化
TNF blockers, 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 ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV, and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA, and monitor patients closely.
TNF阻斷劑,包括英夫利昂產品,與慢性攜帶者患者中乙肝病毒(HBV)的復活有關。一些病例是致命的。在開始使用ZYMFENTRA之前,應對患者進行HBV感染測試。對於HBV陽性的患者,請諮詢具有乙肝治療專業知識的醫生。在爲HBV攜帶者患者開具ZYMFENTRA處方時要謹慎,並在ZYMFENTRA治療期間及停藥後密切監測活動性HBV感染。對於發生HBV復活的患者,應停用ZYMFENTRA,並根據適當的支持性治療開始抗病毒治療。在考慮恢復ZYMFENTRA時要謹慎,並密切監測患者。
HEPATOTOXICITY
肝毒性。
Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia, and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. 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 evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued, and a thorough investigation of the abnormality should be undertaken.
在接受英夫利昂產品的患者中,肝膽疾病包括急性肝功能衰竭、黃疸異常肝功能、脂肪肝、肝炎、肝毒性、高膽紅素血癥和非酒精性脂肪肝在上市後報告。一些病例是致命的或需要肝移植。許多病例中,在發現肝損傷之前沒有觀察到氨基轉移酶升高。對於有肝功能異常症狀或體徵的患者,應進行肝損傷證據的評估。如果發生黃疸和/或明顯的肝酶升高(例如,超過正常上限的≥5倍),應停用ZYMFENTRA,並進行徹底的異常性調查。
CONGESTIVE HEART FAILURE
充血性心衰
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF.
有報道使用TNF阻斷劑導致充血性心衰惡化和新發充血性心衰的病例。其中的一些病例導致了致命結果。在其他幾個TNF阻斷劑治療充血性心衰的探索性試驗中,使用TNF阻斷劑的患者中,充血性心衰惡化導致住院或死亡的比例更高。ZYMFENTRA尚未針對有充血性心衰病史的患者進行研究,因此在充血性心衰患者中應謹慎使用ZYMFENTRA。
HEMATOLOGIC REACTION
血液系統反應
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product 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 ZYMFENTRA in patients who develop significant hematologic abnormalities.
有報道白細胞減少症、中性粒細胞減少症、血小板減少症和全血細胞減少症(其中一些是致命的)。與英夫利昔單抗治療的因果關係尚不清楚。對於有持續或有明顯血液學異常病史的患者,應謹慎使用。告知患者如果出現血液異常或感染的體徵和症狀,立即就診。對於發生明顯血液學異常的患者,考慮停用ZYMFENTRA。
HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS
過敏反應和其他給藥反應
In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension, and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.
根據上市後經驗,使用英夫利昔單抗產品後出現嚴重全身性過敏反應(包括過敏性休克、低血壓和血清病)。如果出現過敏性休克或其他臨床上顯著的過敏反應,應採用適當的治療並停用ZYMFENTRA。
INJECTION SITE REACTIONS
注射部位反應
In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.
在臨床研究中,使用ZYMFENTRA後報告了局部注射部位反應。如果出現臨床上顯著的注射部位反應,應採用適當的治療並停用ZYMFENTRA。
NEUROLOGIC REACTIONS
TNF阻滯劑, 包括adalimumab products,已經發現與中樞神經系統脫髓鞘和周圍神經系統脫髓鞘疾病的新發病例或惡化以及輻射學證據有關,包括多發性硬化症(MS)和視神經炎,以及包括格林-巴利綜合症在內的周圍脫髓鞘疾病。在考慮使用adalimumab-aaty治療已經存在或最近發生中樞或周圍神經系統的脫髓鞘性疾病的患者時,應格外謹慎,並應考慮停止adalimumab-aaty治療。
Agents that inhibit TNF have been associated with central nervous system (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 ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop.
抑制TNF的藥物與中樞神經系統(CNS)全身血管炎的表現、癲癇發作以及中樞神經系統脫髓鞘疾病的新發作或惡化,包括多發性硬化和視神經炎,以及周圍神經脫髓鞘疾病,包括格林-巴利綜合徵有關。在考慮使用ZYMFENTRA治療這些疾病的患者時,請謹慎行事,並在這些疾病發展時考慮停止使用。
RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS
在同時使用其他生物製品時感染的風險
Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended.
嚴重感染和中性粒細胞減少報告與ZYMFENTRA與其他免疫抑制的生物製品的同時使用有關。ZYMFENTRA與其他用於治療UC和CD的免疫抑制的生物製品的同時使用可能會增加感染的風險,不推薦同時使用。
RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS
來自先前生物製品的附加免疫抑制效應的風險
Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA.
考慮先前生物製品的半衰期和作用方式,以避免在啓動ZYMFENTRA時出現意外的附加免疫抑制效應。
AUTOIMMUNITY
自身免疫性
Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop.
TNF阻斷劑的治療可能導致自身抗體的形成,並出現類似紅斑狼瘡的綜合症。如果出現類似紅斑狼瘡的症狀,請停止ZYMFENTRA治療。
VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS
疫苗接種和使用活疫苗/治療性傳染源
Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA.
在開始使用ZYMFENTRA之前,請根據當前疫苗接種指南更新疫苗接種情況。由於可能導致臨床感染(包括瀰漫性感染),不應與ZYMFENTRA同時使用活疫苗或治療性傳染源。建議在嬰兒出生後至少等待6個月後才對在子宮內接觸到ZYMFENTRA的嬰兒進行任何活疫苗的接種。
ADVERSE REACTIONS
DEVOTE研究數據(高
In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA -treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD.
在ZYMFENTRA的臨床試驗中,≥3%接受ZYMFENTRA治療的患者最常見的不良反應包括局部反應、COVID-19、貧血、關節痛、感染部位反應、丙氨酸轉氨酶增高和腹痛(UC),以及COVID-19、頭痛、上呼吸道感染、注射部位反應、腹瀉、肌酸激酶增高、關節痛、丙氨酸轉氨酶增高、高血壓、尿路感染、中性粒細胞減少、頭暈和白細胞減少(CD)。
Please click for Full U.S. Prescribing Information.
請點擊查看完整的美國處方信息。
Globally, prescribing information varies; refer to the individual country product label for complete information.
在全球範圍內,處方信息有所不同; 有關完整信息,請參閱各個國家的產品標籤。
[1] Zymfentra Prescribing Information |
[1] Zymfentra處方信息 |
For further information please contact:
Samantha Cranko
[email protected]
+1 917-453-0346
要了解更多信息,請聯繫:
Samantha Cranko
[email protected]
+1 917-453-0346
SOURCE Celltrion USA
來源:Celltrion USA