CAMBRIDGE, England & BOSTON--(

英国剑桥和波士顿--(

BUSINESS WIRE

商业热线

)--Cycle Pharmaceuticals, Inc. (Cycle) announces today completion of the acquisition of Banner Life Sciences, LLC (Banner) which includes its BAFIERTAM

)--Cycle Pharmaceuticals，Inc.（Cycle）今天宣布完成对Banner Life Sciences，LLC（Banner）的收购，其中包括其BAFIERTAM

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®

(monomethyl fumarate) product for the treatment of relapsing forms of multiple sclerosis (MS), in adults, approved by the US Food and Drug Administration (FDA).

（富马酸单甲酯）产品，用于治疗成人复发性多发性硬化症（MS），经美国食品和药物管理局（FDA）批准。

MS affects an estimated 1 million people in the US with around 200 new cases being diagnosed each week.

据估计，美国约有100万人患有多发性硬化症，每周诊断出约200例新病例。

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Approximately 85% of diagnoses are the relapsing-remitting form of the condition and, without treatment, about 50% of those progress to the more serious secondary-progressive form within 10 years.

大约85%的诊断是该病的复发缓解形式，如果不进行治疗，大约50%的诊断在10年内发展为更严重的继发性进展形式。

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BAFIERTAM will become Cycle’s second branded product for the treatment of MS alongside TASCENSO ODT

BAFIERTAM将与TASCENSO ODT一起成为Cycle治疗MS的第二个品牌产品

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(fingolimod). As with TASCENSO, BAFIERTAM patients will benefit from Cycle’s industry leading hub program, Cycle Vita™*. BAFIERTAM patients will continue to be supported by Banner’s established network during a transition period.

（芬戈莫德）。与TASCENSO一样，BAFIERTAM患者将受益于Cycle行业领先的中心计划Cycle Vita™*。在过渡期间，巴菲坦患者将继续得到Banner建立的网络的支持。

The purchase of Banner was funded from cash on hand and demonstrates the capability of Cycle to reinvest in products where it can provide the highest quality medicines and support to patients who need it most. This acquisition comes at a time of increasing attention to the long-standing concern about the substandard quality of generic medicines in the neurology community.

Banner的购买资金来自库存现金，表明Cycle有能力对产品进行再投资，为最需要的患者提供最高质量的药物和支持。此次收购正值人们越来越关注神经病学界对仿制药质量不合格的长期担忧之际。

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, as most recently documented in MS by Professor Darin Okuda (UT Southwestern Medical Center, Dallas, TX).

，正如达林·奥田教授（德克萨斯州达拉斯UT西南医学中心）最近在MS中记录的那样。

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We are delighted to strengthen Cycle’s offer to the MS community by adding BAFIERTAM to our MS product portfolio. We will be able to support more patients via our best-in-class patient support hub Cycle Vita*, as well as giving patients full confidence in the medicines they are using to manage their MS,.

我们很高兴通过将巴菲坦添加到我们的MS产品组合中来加强Cycle对MS社区的报价。我们将能够通过我们一流的患者支持中心周期Vita*支持更多患者，并让患者对他们用于管理MS的药物充满信心，。

” says James Harrison – CEO of Cycle.

Cycle首席执行官詹姆斯·哈里森（JamesHarrison）表示。

Ondra LLP served as exclusive financial advisor to Cycle, Goodwin Procter LLP acted as legal advisor.

Ondra LLP担任Cycle的独家财务顾问，Goodwin Procter LLP担任法律顾问。

Leerink Partners served as exclusive financial advisor to Banner and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor.

Leerink Partners担任Banner的独家财务顾问，Skadden、Arps、Slate、Meagher&Flom LLP担任法律顾问。

To find out more about BAFIERTAM, please visit

欲了解更多有关巴菲坦的信息，请访问

www.bafiertam.com

www.bafiertam.com

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.

To find out more about TASCENSO ODT, please visit

要了解更多有关塔塞诺ODT的信息，请访问

www.tascenso.com

任务普查.com

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To find out more about Cycle Vita, please visit

欲了解有关Cycle Vita的更多信息，请访问

www.cyclevita.life

www.cyclevita.life

or call 888-360-8482.

或致电888-360-8482。

About BAFIERTAM

关于BAFIERTAM

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(monomethyl fumarate)

（富马酸单甲基酯）

BAFIERTAM is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if BAFIERTAM is safe and effective in children.

巴非坦是一种处方药，用于治疗成人复发性多发性硬化症（MS），包括临床孤立综合征，复发缓解性疾病和活动性继发性进行性疾病。目前尚不清楚巴非坦对儿童是否安全有效。

SELECTED SAFETY INFORMATION

所选安全信息

CONTRAINDICATIONS

禁忌症

BAFIERTAM is contraindicated in patients with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. BAFIERTAM should not be taken with dimethyl fumarate or diroximel fumarate.

巴非坦禁用于已知对富马酸单甲基酯，富马酸二甲酯，富马酸地洛西美尔或巴非坦的任何赋形剂过敏的患者。巴非坦不应与富马酸二甲酯或富马酸地罗昔米一起服用。

WARNINGS AND PRECAUTIONS

警告和注意事项

Anaphylaxis and Angioedema -

过敏反应和血管性水肿-

BAFIERTAM can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (the prodrug of BAFIERTAM) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue BAFIERTAM and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema..

巴非坦在第一次给药后或治疗期间的任何时间均可引起过敏反应和血管性水肿。服用富马酸二甲酯（巴非坦的前药）的患者的体征和症状包括呼吸困难，荨麻疹以及喉咙和舌头肿胀。如果患者出现过敏反应或血管性水肿的体征和症状，应指示患者停用巴非坦并立即寻求医疗护理。。

Progressive Multifocal Leukoencephalopathy -

进行性多灶性白质脑病-

Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (the prodrug of BAFIERTAM). PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability.

。PML是由JC病毒（JCV）引起的大脑机会性病毒感染，通常仅发生在免疫功能低下的患者中，通常会导致死亡或严重残疾。

A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial. During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5x10.

。在临床试验期间，患者经历了长时间的淋巴细胞减少（淋巴细胞计数主要<0.5x10）。

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/L for 3.5 years) while taking dimethyl fumarate. The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly..

/服用富马酸二甲酯3.5年）。该患者没有其他确定的全身性疾病导致免疫系统功能受损，并且之前没有接受过那他珠单抗治疗，这与PML有关。患者也没有同时服用任何免疫抑制或免疫调节药物。。

PML has also occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (<0.9x10

PML也发生在上市后服用富马酸二甲酯的患者中，这些患者存在淋巴细胞减少症（<0.9x10

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/L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8x10

/五十） 。

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/L persisting for more than 6 months.

/我坚持了6个多月。

At the first sign or symptom suggestive of PML, withhold BAFIERTAM and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes..

在第一个提示PML的体征或症状时，停止服用巴非坦并进行适当的诊断评估。与PML相关的典型症状多种多样，持续数天至数周，包括身体一侧进行性无力或四肢笨拙，视力障碍以及思维，记忆和方向的改变，导致困惑和性格改变。。

Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Cases of PML, diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with other MS medications associated with PML.

磁共振成像（MRI）的发现可能在临床体征或症状之前就很明显。据报道，在接受其他与PML相关的MS药物治疗的患者中，根据MRI检查结果和脑脊液中JCV DNA的检测诊断出PML病例，而没有PML特有的临床体征或症状。

Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis.

这些患者中的许多随后出现PML症状。因此，用MRI监测可能与PML一致的体征可能是有用的，任何可疑的发现都应该导致进一步的调查，以便早期诊断PML（如果存在）。据报道，与诊断时具有特征性临床体征和症状的PML患者相比，最初无症状的PML患者停用另一种与PML相关的MS药物后，PML相关的死亡率和发病率较低。

It is not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in disease in these patients..

目前尚不清楚这些差异是由于MS治疗的早期发现和停止，还是由于这些患者的疾病差异。。

Herpes Zoster and Other Serious Opportunistic Infections -

带状疱疹和其他严重机会性感染-

Serious cases of herpes zoster have occurred with dimethyl fumarate (the prodrug of BAFIERTAM), including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on BAFIERTAM for signs and symptoms of herpes zoster.

富马酸二甲酯（巴非坦的前药）已发生严重的带状疱疹病例，包括播散性带状疱疹，带状疱疹眼，带状疱疹脑膜脑炎和带状疱疹脑膜脊髓炎。这些事件可能在治疗期间的任何时间发生。监测服用巴非坦的患者带状疱疹的体征和症状。

If herpes zoster occurs, appropriate treatment for herpes zoster should be administered..

如果发生带状疱疹，应进行适当的带状疱疹治疗。。

Other serious opportunistic infections have occurred with dimethyl fumarate, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC.

富马酸二甲酯还发生了其他严重的机会性感染，包括严重的病毒（单纯疱疹病毒，西尼罗河病毒，巨细胞病毒），真菌（念珠菌和曲霉）和细菌（诺卡氏菌，单核细胞增生李斯特菌，结核分枝杆菌）感染。据报道，这些感染发生在绝对淋巴细胞计数（ALC）减少的患者以及ALC正常的患者中。

These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment..

这些感染影响了大脑、脑膜、脊髓、胃肠道、肺、皮肤、眼睛和耳朵。症状和体征与任何这些感染相一致的患者应立即进行诊断评估并接受适当治疗。。

Consider withholding BAFIERTAM treatment in patients with herpes zoster or other serious infections until the infection has resolved.

考虑停止对带状疱疹或其他严重感染患者进行巴非坦治疗，直到感染消退。

Lymphopenia -

淋巴细胞减少-

BAFIERTAM may decrease lymphocyte counts. In the MS placebo-controlled trials with dimethyl fumarate (the prodrug of BAFIERTAM), mean lymphocyte counts decreased by approximately 30% during the first year of treatment with dimethyl fumarate and then remained stable. Four weeks after stopping dimethyl fumarate, mean lymphocyte counts increased, but did not return to baseline.

巴非坦可能会降低淋巴细胞计数。在富马酸二甲酯（巴非坦的前药）的MS安慰剂对照试验中，富马酸二甲酯治疗的第一年平均淋巴细胞计数下降了约30%，然后保持稳定。停用富马酸二甲酯四周后，平均淋巴细胞计数增加，但没有恢复到基线水平。

Six percent (6%) of dimethyl fumarate patients and <1% of placebo patients experienced lymphocyte counts <0.5x10.

富马酸二甲酯患者中有6%（6%）和安慰剂患者中有1%的淋巴细胞计数小于0.5x10。

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/L (lower limit of normal 0.91x10

/L（正常下限0.91x10

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/L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with dimethyl fumarate or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x10

/五十） 。富马酸二甲酯或安慰剂治疗的患者感染率（60%比58%）和严重感染率（2%比2%）相似。淋巴细胞计数<0.8x10的患者严重感染的发生率没有增加

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/L or <0.5x10

/L或<0.5x10

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/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x10

/在对照试验中，尽管在一项扩展研究中，一名患者在长期淋巴细胞减少的情况下发展为PML（淋巴细胞计数主要<0.5x10

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/L for 3.5 years).

/L为3.5年）。

In controlled and uncontrolled clinical trials with dimethyl fumarate, 2% of patients experienced lymphocyte counts <0.5 x 10

在富马酸二甲酯的对照和非对照临床试验中，2%的患者淋巴细胞计数<0.5 x 10

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/L for at least six months, and in this group, the majority of lymphocyte counts remained <0.5x10

/L至少六个月，在这组中，大多数淋巴细胞计数保持在0.5x10以下

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/L with continued therapy. In these patients with prolonged, severe lymphopenia, the median time for lymphocyte counts to return to normal after discontinuing dimethyl fumarate was 96.0 weeks.

/L继续治疗。在这些长期严重淋巴细胞减少的患者中，停用富马酸二甲酯后淋巴细胞计数恢复正常的中位时间为96.0周。

In these controlled and uncontrolled clinical studies, among patients who did not experience prolonged, severe lymphopenia during treatment, the median times for lymphocyte counts to return to normal after discontinuing dimethyl fumarate were as follows:

在这些受控和不受控制的临床研究中，在治疗期间未经历长期严重淋巴细胞减少的患者中，停用富马酸二甲酯后淋巴细胞计数恢复正常的中位时间如下：

4.3 weeks in patients with mild lymphopenia (lymphocyte count ≥0.8x10

轻度淋巴细胞减少症患者（淋巴细胞计数≥0.8x10）4.3周

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/L) at discontinuation,

/五十） 停药时，

10.0 weeks in patients with moderate lymphopenia (lymphocyte count 0.5 to <0.8x10

中度淋巴细胞减少症患者10.0周（淋巴细胞计数0.5至<0.8x10

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/L) at discontinuation, and

/五十） 停药时，以及

16.7 weeks in patients with severe lymphopenia (lymphocyte count <0.5x10

严重淋巴细胞减少症患者16.7周（淋巴细胞计数<0.5x10

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/L) at discontinuation.

/五十） 停药时。

Neither BAFIERTAM nor dimethyl fumarate have been studied in patients with preexisting low lymphocyte counts.

巴非坦和富马酸二甲酯均未在先前存在低淋巴细胞计数的患者中进行研究。

Obtain a CBC, including lymphocyte count, before initiating treatment with BAFIERTAM, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of BAFIERTAM in patients with lymphocyte counts less than 0.5 x 10

在开始用巴非坦治疗之前，开始治疗后6个月，然后每6至12个月，并根据临床指示，获得CBC，包括淋巴细胞计数。考虑在淋巴细胞计数小于0.5 x 10的患者中中断巴非坦

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/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if BAFIERTAM is discontinued or interrupted because of lymphopenia. Consider withholding treatment from patients with serious infections until resolution.

/我坚持了六个多月。鉴于淋巴细胞计数可能延迟恢复，如果巴非坦因淋巴细胞减少而停用或中断，则继续获得淋巴细胞计数直至其恢复。。

Decisions about whether or not to restart BAFIERTAM should be individualized based on clinical circumstances..

关于是否重新启动巴非坦的决定应根据临床情况进行个体化。。

Liver Injury -

肝损伤-

Clinically significant cases of liver injury have been reported in patients treated with dimethyl fumarate (the prodrug of BAFIERTAM) in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with dimethyl fumarate. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed.

据报道，在上市后使用富马酸二甲酯（巴非坦的前药）治疗的患者出现了具有临床意义的肝损伤病例。开始用富马酸二甲酯治疗后，发病时间从几天到几个月不等。已经观察到肝损伤的体征和症状，包括血清氨基转移酶升高至正常上限的5倍以上，总胆红素升高至正常上限的2倍以上。

These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients..

这些异常在停止治疗后得到解决。有些病例需要住院治疗。报告的病例均未导致肝衰竭，肝移植或死亡。然而，新的血清转氨酶升高与药物性肝细胞损伤引起的胆红素水平升高相结合，是严重肝损伤的重要预测指标，可能导致某些患者的急性肝衰竭，肝移植或死亡。。

Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials with dimethyl fumarate.

在富马酸二甲酯的对照试验中，观察到肝转氨酶升高（大多数不超过正常上限的3倍）。

Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with BAFIERTAM and during treatment, as clinically indicated. Discontinue BAFIERTAM if clinically significant liver injury induced by BAFIERTAM is suspected.

如临床所示，在用巴非坦治疗之前和治疗期间获得血清转氨酶，碱性磷酸酶（ALP）和总胆红素水平。如果怀疑巴非坦引起临床上显着的肝损伤，则停止使用巴非坦。

Flushing -

冲洗-

BAFIERTAM may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials of dimethyl fumarate (the prodrug of BAFIERTAM), 40% of dimethyl fumarate-treated patients experienced flushing. Flushing symptoms generally began soon after initiating dimethyl fumarate and usually improved or resolved over time.

巴非坦可能会引起潮红（例如，温暖，发红，瘙痒和/或烧灼感）。在富马酸二甲酯（巴非坦的前药）的临床试验中，40%的富马酸二甲酯治疗患者出现潮红。潮红症状通常在开始富马酸二甲酯后不久开始，并且通常随着时间的推移而改善或消退。

In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued dimethyl fumarate for flushing, and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization. Studies with dimethyl fumarate show that administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dosing may reduce the incidence or severity of flushing.

在大多数经历过潮红的患者中，其严重程度为轻度或中度。3%（3%）的患者停用富马酸二甲酯进行冲洗，1%的患者出现严重的冲洗症状，不危及生命，但导致住院治疗。富马酸二甲酯的研究表明，在给药前30分钟服用非肠溶阿司匹林（剂量高达325 mg）可能会降低潮红的发生率或严重程度。

In the BAFIERTAM studies, the presence of food did not impact the incidence of flushing..

。。

Serious Gastrointestinal Reactions -

严重的胃肠道反应-

Serious gastrointestinal reactions, including perforation, ulceration, hemorrhage, and obstruction, some with fatal outcomes, have been reported in the postmarketing setting with the use of fumaric acid esters, including dimethyl fumarate, with or without concomitant aspirin use. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation.

据报道，在上市后使用富马酸酯（包括富马酸二甲酯），无论是否同时使用阿司匹林，都会出现严重的胃肠道反应，包括穿孔，溃疡，出血和梗阻，其中一些会导致致命的后果。这些事件大多数发生在富马酸酯治疗开始后6个月内。

In controlled clinical trials, the incidence of serious gastrointestinal adverse events was 1% in patients treated with dimethyl fumarate; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%). Monitor patients, promptly evaluate, and discontinue BAFIERTAM for new or worsening severe gastrointestinal signs and symptoms..

在对照临床试验中，富马酸二甲酯治疗的患者严重胃肠道不良事件的发生率为1%；这些事件均不致命，包括呕吐（0.3%）和腹痛（0.3%）。监测患者，及时评估并停用巴非坦治疗新的或恶化的严重胃肠道体征和症状。。

DRUG INTERACTIONS

药物相互作用

Concomitant Dimethyl Fumarate or Diroximel Fumarate -

富马酸二甲酯或富马酸二肟

Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate. Therefore, BAFIERTAM is contraindicated in patients currently taking dimethyl fumarate or diroximel fumarate. BAFIERTAM may be initiated the day following discontinuation of either of these drugs.

富马酸二甲酯和富马酸地肟酯均被代谢为富马酸单甲基酯。因此，巴非坦在目前服用富马酸二甲酯或富马酸地罗昔米的患者中是禁忌的。巴非坦可能在停药后的第二天开始服用。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Pregnancy -

怀孕-

There are no adequate data on the developmental risk associated with the use of BAFIERTAM in pregnant women.

关于孕妇使用巴非坦的发育风险，尚无足够的数据。

Available data from a pregnancy registry for dimethyl fumarate (the prodrug of BAFIERTAM), observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see Data)..

。大多数报告的富马酸二甲酯暴露发生在怀孕的头三个月（见数据）。。

In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses (see Data).

在动物中，当富马酸二甲酯（DMF）在怀孕和哺乳期间以临床相关剂量给药时，观察到对子代存活，生长，性成熟和神经行为功能的不利影响（参见数据）。

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively..

指定人群的主要出生缺陷和流产的背景风险尚不清楚。所有怀孕都有出生缺陷，丢失或其他不良后果的背景风险。在美国普通人群中，临床公认的妊娠中主要出生缺陷和流产的估计背景风险分别为2-4%和15-20%。。

Lactation -

哺乳期-

There are no data on the presence of DMF or MMF in human milk. The effects on the breastfed infant and on milk production are unknown. Patients should call their healthcare provider if they are breastfeeding or plan to breastfeed because it is not known if BAFIERTAM passes into breast milk.

没有关于母乳中存在DMF或MMF的数据。对母乳喂养婴儿和产奶量的影响尚不清楚。如果患者正在母乳喂养或计划母乳喂养，应致电医疗保健提供者，因为不知道巴非坦是否会进入母乳。

Pediatric Use -

儿科使用-

Safety and effectiveness in pediatric patients have not been established.

儿科患者的安全性和有效性尚未确定。

Geriatric Use -

老年使用-

Clinical studies of dimethyl fumarate (the prodrug of BAFIERTAM) and of BAFIERTAM did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

。

Please click here for

请单击此处

Important Safety Information

重要安全信息

and full

和完整

Prescribing Information

处方信息

,

,

including

包括

Patient Information

患者信息

for BAFIERTAM.

BAFIERTAM。

About TASCENSO ODT

关于TASCENSO ODT

®

®

INDICATIONS

适应症

TASCENSO ODT is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

TASCENSO ODT是一种处方药，用于治疗多发性硬化症（MS）的复发形式，包括成人和10岁及以上儿童的临床孤立综合征，复发缓解疾病和活动性继发性进行性疾病。

CONTRAINDICATIONS

禁忌症

Do not take TASCENSO ODT if:

如果出现以下情况，请勿服用TASCENSO ODT：

In the last 6 months you experienced heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure.

在过去的6个月中，您经历了心脏病发作，不稳定型心绞痛，中风或小中风（短暂性脑缺血发作或TIA）或某些类型的心力衰竭。

You have an irregular or abnormal heartbeat (arrhythmia), including a heart finding called prolonged QT as seen on an ECG, or if you take medicines that change your heart rhythm.

你的心跳不规则或异常（心律不齐），包括心电图上显示的称为QT延长的心脏发现，或者如果你服用改变心律的药物。

You are allergic to fingolimod or any of the other ingredients.

你对芬戈莫德或任何其他成分过敏。

IMPORTANT SAFETY INFORMATION

重要安全信息

Warnings and Precautions

警告和注意事项

TASCENSO ODT may cause serious side effects. TASCENSO ODT can slow your heart rate, therefore you will be monitored after the first dose. There is an increased risk of serious infections, some of which can be life threatening; contact your doctor if you develop any symptoms of infections. You may experience shortness of breath and increased blood pressure.

TASCENSO ODT可能会引起严重的副作用。。严重感染的风险增加，其中一些可能危及生命；如果您出现任何感染症状，请联系您的医生。您可能会出现呼吸急促和血压升高。

Progressive Multifocal Leukoencephalopathy (PML), a rare brain infection, has occurred in patients taking fingolimod; call your doctor immediately if you experience symptoms including weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

服用芬戈莫德的患者发生了进行性多灶性白质脑病（PML），这是一种罕见的脑部感染；如果你出现症状，包括身体一侧无力或四肢笨拙，视力障碍，思维，记忆和方向改变，导致困惑和性格改变，请立即致电医生。

If PML is confirmed, treatment should be stopped. Your doctor will monitor you for the development of Immune Reconstitution Inflammatory Syndrome (PML-IRIS), which has been reported in patients who stopped treatment after developing PML. Macular edema, a vision problem that can cause some of the same vision symptoms as an MS attack may occur; call your doctor immediately if you have any vision changes.

如果确诊PML，应停止治疗。您的医生将监测您的免疫重建炎症综合征（PML-IRIS）的发展情况，据报道，PML患者在发展为PML后停止治疗。黄斑水肿是一种视力问题，可能会导致一些与MS发作相同的视力症状；如果视力有任何变化，请立即致电医生。

TASCENSO ODT may cause liver damage; call your doctor immediately if you experience unexplained nausea, abdominal pain, fatigue, anorexia, jaundice and/or dark urine. Rare cases of Posterior Reversible Encephalopathy Syndrome in adults have been reported with fingolimod; call your doctor immediately if you experience sudden onset of severe headaches, altered mental status, visual disturbances or seizures.

TASCENSO ODT可能导致肝损伤；如果出现无法解释的恶心、腹痛、疲劳、厌食、黄疸和/或尿黑，请立即致电医生。芬戈莫德报道了罕见的成人后部可逆性脑病综合征病例；如果你突然出现严重头痛、精神状态改变、视力障碍或癫痫发作，请立即致电医生。

TASCENSO ODT may cause harm to your unborn baby; speak to your doctor before becoming pregnant. Stopping TASCENSO ODT may cause worsening of your MS symptoms, consult a doctor before stopping treatment. Malignancies have been associated with fingolimod treatment; lim.

TASCENSO ODT可能会对您的未出生婴儿造成伤害；怀孕前请咨询医生。停止TASCENSO ODT可能会导致MS症状恶化，停止治疗前请咨询医生。恶性肿瘤与芬戈莫德治疗有关；林。

Adverse Reactions

不良反应

The most common side effects with fingolimod are headache, abnormal liver tests, diarrhea, cough, flu, inflammation of the sinuses, back pain, stomach pain, and pain in arms and legs.

芬戈莫德最常见的副作用是头痛、肝脏检查异常、腹泻、咳嗽、流感、鼻窦炎、背痛、胃痛以及四肢疼痛。

If you have any new or worsening negative side effects whilst taking TASCENSO ODT you should immediately call you doctor.

如果服用TASCENSO ODT时出现任何新的或恶化的负面副作用，应立即致电医生。

Tell your doctor about all your medical conditions and all medicines you take, before starting treatment.

在开始治疗之前，告诉你的医生你的所有病情和服用的所有药物。

If you take too much TASCENSO ODT immediately call your doctor or go to the nearest hospital emergency room.

如果你服用太多TASCENSO ODT，请立即致电医生或前往最近的医院急诊室。

For more detailed information, please refer to the full Prescribing Information at

有关更多详细信息，请参阅完整的处方信息

www.tascenso.com/PI

www.tascensus.com/PI

.

.

For more detailed information, please refer to the Medication Guide -

有关更多详细信息，请参阅药物指南-

www.tascenso.com/MG

tascunsa.com/mg

.

.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-888-533-1625 or the FDA at: 1-800-FDA-1088 or

要报告疑似不良反应，请联系Cycle Pharmaceuticals Ltd（电话：1-888-533-1625）或FDA（电话：1-800-FDA-1088）或

www.fda.gov/medwatch

政府/医疗观察

.

.

References

参考文献

Healthline. (2022). Multiple Sclerosis: Facts, Statistics, and You. [online] Available via:

健康热线。（2022年）。多发性硬化症：事实、统计和你。[在线]可通过以下方式获得：

https://www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic#risk-factors

https://www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic#risk-因素

[Accessed Jan 13 2025].

[于2025年1月13日访问]。

American Academy of Neurology. (2001). Substitution of Generic Drugs May Cause Problems for Epilepsy Patients. [online] Available via:

美国神经病学学会。（2001年）。仿制药的替代可能会给癫痫患者带来问题。[在线]可通过以下方式获得：

https://www.aan.com/PressRoom/home/PressRelease/115

https://www.aan.com/PressRoom/home/PressRelease/115

[Accessed Jan 13 2025].

[于2025年1月13日访问]。

Okuda DT, et al. (2024). Clinical and radiological implications of subpotent generic fingolimod in multiple sclerosis: a case series. Therapeutic Advances in Neurological Disorders. 2024;17, 17562864241300047. Available at:

Okuda DT等人（2024年）。亚功能通用芬戈莫德在多发性硬化症中的临床和放射学意义：病例系列。神经系统疾病的治疗进展。2024年；1717562864241300047。网址：

https://doi/10.1177/17562864241300047

https://doi/10.1177/17562864241300047

[Accessed: Jan 13 2025].

[访问日期：2025年1月13日]。

*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482 or visit .

*并非所有患者都可以获得某些支持领域。资格标准可能适用于确保符合所有适用的联邦和州要求，福利可能仅限于商业保险患者。有关资格、条款和条件的更多详细信息，请致电888-360-8482联系Cycle Vita团队或访问。

www.cyclevita.life

www.cyclevita.life

.

.

BAFIERTAM

巴菲坦

®

®

is a registered trademark of Banner Life Sciences, LLC. TASCENSO ODT

是Banner Life Sciences，LLC.TASCENSO ODT的注册商标

®

®

is a registered trademark of Handa Neuroscience, LLC. Cycle Vita™ is a trademark of Cycle Pharmaceuticals Limited.

是Handa Neuroscience，LLC的注册商标。Cycle Vita™是Cycle Pharmaceuticals Limited的商标。

©2025 Cycle Pharmaceuticals Limited. All rights reserved.

©2025 Cycle Pharmaceuticals Limited。。

About Cycle Pharmaceuticals

关于Cycle Pharmaceuticals

Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease patient community. Cycle focuses on rare metabolic, immunological, and neurological genetic conditions. Within neurological conditions, we focus on multiple sclerosis.

Cycle Pharmaceuticals成立于2012年，其唯一目标是为服务不足的罕见病患者社区提供药物治疗和产品支持。。在神经系统疾病中，我们专注于多发性硬化症。

Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit .

Cycle总部位于英国剑桥，在马萨诸塞州波士顿设有办事处。有关更多信息，请访问。

www.cyclepharma.com

www.cyclepharma.com

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