首页 > 资讯 > 美国食品药品监督管理局批准Tirosint®Sol（左旋甲状腺素钠）口服溶液两项新标签变更

美国食品药品监督管理局批准Tirosint®Sol（左旋甲状腺素钠）口服溶液两项新标签变更

泰然健康网
2025-08-29 02:05

PARSIPPANY, N.J.--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL (levothyroxine sodium) oral solution, a unique formulation of levothyroxine (LT4) for the treatment of hypothyroidism. The first regards the use of Tirosint-SOL in the presence of proton pump inhibitor (PPI) therapy.

PARSIPPANY，N.J.-（BUSINESS WIRE）-美国食品和药物管理局（FDA）批准了Tirosint SOL（左旋甲状腺素钠）口服溶液标签的两项新变化，这是一种独特的左旋甲状腺素（LT4）制剂，用于治疗甲状腺功能减退症。首先涉及在质子泵抑制剂（PPI）治疗的情况下使用替罗司汀溶胶。

The second regards the timing of Tirosint-SOL administration. Both label changes help to differentiate Tirosint-SOL from other levothyroxine therapies..

第二个问题是替罗司汀溶胶给药的时间。两种标记物的变化都有助于区分替罗司汀和其他左旋甲状腺素疗法。。

The absorption and performance of levothyroxine tablets has been shown to be affected by the concomitant use of proton pump inhibitors (PPIs).¹ The updated label removes PPIs as a drug that may decrease the absorption and reduce the efficacy of Tirosint-SOL. Similarly, current labeling for all levothyroxine sodium therapies instructs patients to self-administer the drug once daily, on an empty stomach, one-half to one hour before breakfast.

已显示左旋甲状腺素片剂的吸收和性能受到伴随使用质子泵抑制剂（PPI）的影响。¹更新后的标签将PPI作为一种药物去除，可能会降低吸收并降低替罗司汀溶胶的功效。同样，目前所有左旋甲状腺素钠疗法的标签都指示患者每天一次，空腹，早餐前半到一小时自行给药。

Tirosint-SOL’s updated label indicates that it can be administered 15 minutes before eating breakfast.².

Tirosint SOL的更新标签表明它可以在吃早餐前15分钟给药。².

Tirosint-SOL is now the only FDA-approved LT4 therapy without a labeled interaction with PPIs and the only FDA-approved LT4 therapy that can be administered 15 minutes before eating breakfast.

Tirosint SOL现在是FDA批准的唯一一种没有与PPI标记相互作用的LT4疗法，也是唯一一种FDA批准的LT4疗法，可以在吃早餐前15分钟给药。

“The availability of this liquid oral levothyroxine formulation, which is not affected by proton pump inhibitors and can be taken just 15 minutes before breakfast, is a real plus for hypothyroid patients and healthcare practitioners,” said Michael Scully, Head of Commercial Operations, IBSA USA. “These new label changes reinforce Tirosint-SOL’s position as a simple, convenient, and clean LT4 therapy with only three ingredients.”.

商业运营负责人Michael Scully说：“这种液体口服左旋甲状腺素制剂不受质子泵抑制剂的影响，只能在早餐前15分钟服用，对甲状腺功能减退症患者和医护人员来说是一个真正的选择。”，IBSA USA。”这些新的标签变化加强了Tirosint-SOL作为一种简单，方便，清洁的LT4疗法的地位，只有三种成分“。

The label changes resulted from two clinical studies sponsored and conducted by the Department of R&D and Scientific Affairs - IBSA Institut Biochimique SA, Switzerland. The results of the first study demonstrated a lack of interaction between Tirosint-SOL and the PPI drug omeprazole regardless of the timing of administration of the PPI.³ The results of the second study demonstrated that administration of Tirosint-SOL produces similar levels (bioavailability) of LT4 drug exposure in healthy individuals when taken 15 minutes in advance of eating breakfast as it does when administered 30 minutes before eating breakfast.

标签变化是由研发和科学事务部赞助和进行的两项临床研究-瑞士IBSA生物嵌合体研究所。第一项研究的结果表明，无论PPI的给药时间如何，替罗司汀溶胶与PPI药物奥美拉唑之间缺乏相互作用。³第二项研究的结果表明，在吃早餐前15分钟服用Tirosint SOL可以在健康个体中产生类似水平（生物利用度）的LT4药物暴露，就像在吃早餐前30分钟服用一样。

It did not evaluate Tirosint-SOL’s overall bioavailability when administered simultaneously with eating breakfast.⁴.

它没有评估Tirosint-SOL在吃早餐的同时使用时的整体生物利用度。⁴.

“Appropriate administration of levothyroxine can be difficult for patients, given the multiple therapies that can interfere with its absorption and the requirement to administer it in a fasting state,”⁵ said Dr. Francesco Celi, University of Connecticut School of Medicine. “The opportunity to provide patients living with hypothyroidism with a medication that is easier to use because it is not affected by PPIs, which are commonly used acid-reducing agents, and can be taken 15 minutes before breakfast, should be of interest to clinicians as it may increase adherence and improve therapeutic outcomes.”.

“考虑到可能干扰其吸收的多种疗法以及禁食状态下给予左旋甲状腺素的要求，患者可能难以适当使用左旋甲状腺素。”⁵康涅狄格大学医学院Francesco Celi博士说。“为甲状腺功能减退症患者提供更易于使用的药物的机会，因为它不受PPI的影响，PPI是常用的减酸剂，可以在早餐前15分钟服用，临床医生应该感兴趣，因为它可能会增加依从性并改善治疗效果“。

Tirosint-SOL has 15 dosing strengths including unique 13, 37.5, 44, and 62.5 microgram dosing options, the widest range of doses for any levothyroxine therapy available in the U.S. It is made with only three ingredients – levothyroxine, glycerol, and water.² Tirosint-SOL is widely available in retail pharmacies..

Tirosint SOL具有15种剂量强度，包括独特的13,37.5,44和62.5微克剂量选项，这是美国任何左旋甲状腺素治疗的最大剂量范围。它仅由三种成分制成-左旋甲状腺素，甘油和水。²Tirosint SOL广泛应用于零售药店。。

IBSA offers a generous Copay Savings Coupon for Tirosint-SOL, which allows eligible patients with commercial insurance to significantly reduce their out-of-pocket cost for the medication. For patients with high deductibles/copays or without insurance, the company offers a convenient mail-order pharmacy program called Tirosint Direct that offers Tirosint-SOL at the lowest cash price available.

IBSA为Tirosint-SOL提供慷慨的共付储蓄优惠券，使符合条件的商业保险患者能够显着降低药物的自付费用。对于免赔额/共付额高或没有保险的患者，该公司提供了一种名为Tirosint Direct的便利邮件订购药房计划，以最低的现金价格提供Tirosint SOL。

Additional information about these money-saving options can be found at TirosintSOL.com..

有关这些省钱选项的更多信息，请访问TirosintSOL.com。。

IMPORTANT SAFETY INFORMATION

重要的安全信息

WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS.

警告：不用于治疗肥胖或减肥。

See full prescribing information for complete boxed warning

请参阅完整的处方信息以获取完整的盒装警告

Thyroid hormones, including TIROSINT-SOL, should not be used for the treatment of obesity or for weight loss

甲状腺激素，包括TIROSINT-SOL，不应用于治疗肥胖或减肥

Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity

超出每日荷尔蒙需求范围的剂量可能会产生严重甚至危及生命的毒性表现

CONTRAINDICATIONS

禁忌症

Hypersensitivity to glycerol

对甘油过敏

Uncorrected adrenal insufficiency

未矫正的肾上腺皮质功能不全

WARNINGS AND PRECAUTIONS

警告和注意事项

Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate TIROSINT-SOL at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation

老年人和潜在心血管疾病患者的心脏不良反应：由于心脏不良反应（包括心房颤动）的风险增加，以低于完全替代剂量启动TIROSINT-SOL

Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma

粘液性水肿昏迷：不要使用口服甲状腺激素药物治疗粘液性水肿昏迷

Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of TIROSINT-SOL treatment

伴随肾上腺功能不全的患者的急性肾上腺危象：在开始TIROSINT-SOL治疗之前用替代糖皮质激素治疗

Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism

预防甲状腺功能亢进或甲状腺功能减退症的不完全治疗：适当的剂量滴定和仔细监测对于预防甲状腺功能减退症的持续存在或甲状腺功能亢进症的发展至关重要

Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy

糖尿病控制恶化：糖尿病患者的治疗可能会恶化血糖控制并导致抗糖尿病药物或胰岛素需求增加。开始，改变或停止甲状腺激素治疗后，仔细监测血糖控制

Decreased bone mineral density associated with thyroid hormone over-replacement. Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose

与甲状腺激素过度替代相关的骨矿物质密度降低。过度替换可以增加骨重吸收并降低骨矿物质密度。给出最低有效剂量

Limitations of Use

使用限制

Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients

不适用于碘充足患者的良性甲状腺结节和无毒弥漫性甲状腺肿的抑制

Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis

亚急性甲状腺炎恢复期暂时性甲状腺功能减退症的治疗无效

Adverse Reactions

不良反应

Common adverse reactions with TIROSINT-SOL are primarily those of hyperthyroidism due to therapeutic overdosage including arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash..

TIROSINT-SOL的常见不良反应主要是由于治疗过量导致的甲状腺功能亢进，包括心律失常，心肌梗塞，呼吸困难，肌肉痉挛，头痛，紧张，烦躁，失眠，震颤，肌肉无力，食欲增加，体重减轻，腹泻，不耐受，月经不规律和皮疹。。

For Full Prescribing Information, including Boxed Warning, go to https://tirosintsol.com/wp-content/uploads/2023/11/Tirosint-SOL-USPI.pdf.

For Full Prescribing Information, including Boxed Warning, go tohttps://tirosintsol.com/wp-content/uploads/2023/11/tirosint-sol-uspi.pdf.

About IBSA Institut Biochimique⁶

关于IBSA生物化学研究所⁶

IBSA (Institut Biochimique SA) is a Swiss multinational pharmaceutical Company, founded in 1945 in Lugano. Today, its products are present in over 90 Countries on 5 continents, through the Company’s 18 subsidiaries located in Europe, China, and the United States. The company has a consolidated turnover of 900 million CHF, and employs over 2,200 people between headquarters, subsidiaries and production sites.

IBSA（Institut Biochimique SA）是一家瑞士跨国制药公司，成立于1945年在卢加诺。今天，通过公司位于欧洲，中国和美国的18家子公司，其产品遍布五大洲的90多个国家。该公司合并营业额为9亿瑞士法郎，总部，子公司和生产场所之间雇用2200多万人。

IBSA holds 90 families of approved patents, plus others under development, as well as a vast portfolio of products, covering 10 therapeutic areas: reproductive medicine, endocrinology, pain and inflammation, osteoarticular, aesthetic medicine, dermatology, uro-gynaecology, cardiometabolic, respiratory, consumer health.

IBSA拥有90个已批准专利家族，以及其他正在开发的家族，以及庞大的产品组合，涵盖10个治疗领域：生殖医学，内分泌学，疼痛和炎症，骨关节，美容医学，皮肤病学，泌尿妇科，心脏代谢，呼吸，消费者健康。

It is also one of the largest operators worldwide in the area of reproductive medicine, and one of the world’s leaders in hyaluronic acid-based products. IBSA has based its philosophy on four pillars: Person, Innovation, Quality and Responsibility..

它也是全球生殖医学领域最大的运营商之一，也是世界透明质酸产品的领导者之一。IBSA的理念基于四大支柱：人，创新，质量和责任。。

About Hypothyroidism

关于甲状腺功能减退症

Hypothyroidism is an endocrine disorder with numerous causes, resulting in a deficiency in thyroid hormone. In the U.S., more than 24.5 million people are estimated to have hypothyroidism.⁷ Large observational studies and meta-analyses have shown that about 4-7% of community-derived populations in the U.S.

甲状腺功能减退症是一种多种原因的内分泌紊乱，导致甲状腺激素缺乏。在美国，估计有超过2450万人患有甲状腺功能减退症。⁷大量的观察研究和荟萃分析表明，美国约有4-7%的社区人口。

and Europe have undiagnosed hypothyroidism.⁸.

和欧洲有未确诊的甲状腺功能减退症。⁸.

About 2% of the U.S. population has pronounced hypothyroidism, and as much as 10% has subclinical (mild) hypothyroidism. The condition is most common in women over 40 years of age and in the elderly of both sexes.⁹ The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin, and hair loss.¹⁰ Thyroid stimulating hormone (TSH) laboratory tests are recommended as first-line screening tests for thyroid dysfunction.¹¹ Levothyroxine sodium is a synthetic version of a hormone that is normally produced by the thyroid gland.

大约2%的美国人口患有明显的甲状腺功能减退症，多达10%的人患有亚临床（轻度）甲状腺功能减退症。这种情况在40岁以上的女性和男女老年人中最为常见。⁹甲状腺功能减退症的体征和症状是非特异性的，可能包括疲劳，健忘，抑郁，便秘，肌肉痉挛，体重增加，皮肤干燥和脱发。¹⁰建议将促甲状腺激素（TSH）实验室检查作为甲状腺功能障碍的一线筛查试验。¹¹左甲状腺素钠是通常由甲状腺产生的激素的合成形式。

It is used to treat patients who suffer from hypothyroidism or require suppression of TSH..

它用于治疗患有甲状腺功能减退症或需要抑制TSH的患者。。

References

工具书类

Irving SA. Drugs that interact with levothyroxine: an observational study from the Thyroid Epidemiology, Audit and Research Study (TEARS). Clin Endocrinol (Oxf). January 2015;82(1):136-41.

Irving SA。与左旋甲状腺素相互作用的药物：来自甲状腺流行病学，审计和研究（眼泪）的观察性研究。Clin Endocrinol（Oxf）。2015年1月；82(1):136-41.

Tirosint-SOL Package Insert, IBSA Pharma Inc. 2023.

替洛星-SOL包装说明书，IBSA Pharma股份有限公司2023。

Ducharme M, et al. The pharmacokinetics of a novel solution of levothyroxine is not influenced by proton-pump inhibitor. Poster presentation at 2021 ATA Conference.

Ducharme M等人。新型左旋甲状腺素溶液的药代动力学不受质子泵抑制剂的影响。2021 ATA会议上的海报展示。

Ducharme M, et al. A novel levothyroxine solution results in similar bioavailability whether taken 30 or just 15 minutes before a high-fat high-calorie meal. Thyroid. 2022;32(8).

Ducharme M等人，无论是在高脂肪高热量餐前30分钟还是仅15分钟，新型左旋甲状腺素溶液均可产生相似的生物利用度。甲状腺。2022;32(8).

McMillan M, et al. “Comorbidities, concomitant medications, and diet as factors affecting levothyroxine therapy: results of the CONTROL Surveillance Project. Drugs in R&D. 2015;16(1):53–68.

McMillan M等人，“合并症，伴随药物和饮食作为影响左旋甲状腺素治疗的因素：对照监测项目的结果，R＆D。2015；16（1）：53-68中的药物。

IBSA Group Website, October 2023.

IBSA集团网站，2023年10月。

Wynn K. Hypothyroidism prevalence in the United States: A retrospective study combining National Health and Nutrition Examination Survey and Claims Data. J Endocr Soc. 2023;7:1-11.

Wynn K.美国甲状腺功能减退症患病率：一项结合国家健康和营养检查调查和索赔数据的回顾性研究。J Endocr Soc.2023；7:1-11.

Gottwald-Hostalek U, et al. Low awareness and under-diagnosis of hypothyroidism. Curr Med Res Opinion. 38(1):59-64.

Gottwald-Hostalek U等人对甲状腺功能减退症的认识不足和诊断不足。Curr Med Res Opinion。38(1):59-64.

Canaris GJ, Manowitz NR, Mayor G, Ridgeway EC. The Colorado thyroid disease prevalence study. Arch Intern Med. 2000;160(4):526-534.

Canaris GJ，Manowitz NR，Mayor G，Ridgeway EC。科罗拉多州甲状腺疾病患病率研究。Arch Intern Med.2000；160(4):526-534.

McDermott MT. In the clinic: hypothyroidism. Ann Intern Med. 2009;151(11):ITC-6-1.

McDermott MT.在临床上：甲状腺功能减退症。Ann Intern Med.2009；151（11）：ITC-6-1。

Soh SB. Laboratory testing in thyroid conditions: pitfalls and clinical utility. Ann Lab Med. 2019;39(1):3.

Soh SB.甲状腺疾病的实验室检测：缺陷和临床应用。Ann Lab Med.2019；39(1):3.

For more information about IBSA, visit www.ibsagroup.com/media.

有关IBSA的更多信息，请访问www.ibsagroup.com/media。

For Full Prescribing Information, including Boxed Warning, go to https://tirosintsol.com/wp-content/uploads/2023/11/Tirosint-SOL-USPI.pdf