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）-美國食品和藥物管理局（FDA）批準了Tirosint SOL（左旋甲狀腺素鈉）口服溶液標簽的兩項新變化，這是一種獨特的左旋甲狀腺素（LT4）制劑，用于治療甲狀腺功能減退癥。首先涉及在質(zhì)子泵抑制劑（PPI）治療的情況下使用替羅司汀溶膠。

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

第二個問題是替羅司汀溶膠給藥的時間。兩種標記物的變化都有助于區(qū)分替羅司汀和其他左旋甲狀腺素療法。。

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.

已顯示左旋甲狀腺素片劑的吸收和性能受到伴隨使用質(zhì)子泵抑制劑（PPI）的影響。1更新后的標簽將PPI作為一種藥物去除，可能會降低吸收并降低替羅司汀溶膠的功效。同樣，目前所有左旋甲狀腺素鈉療法的標簽都指示患者每天一次，空腹，早餐前半到一小時自行給藥。

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

Tirosint SOL的更新標簽表明它可以在吃早餐前15分鐘給藥。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現(xiàn)在是FDA批準的唯一一種沒有與PPI標記相互作用的LT4療法，也是唯一一種FDA批準的LT4療法，可以在吃早餐前15分鐘給藥。

“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.”.

商業(yè)運營負責(zé)人Michael Scully說：“這種液體口服左旋甲狀腺素制劑不受質(zhì)子泵抑制劑的影響，只能在早餐前15分鐘服用，對甲狀腺功能減退癥患者和醫(yī)護人員來說是一個真正的選擇。”，IBSA USA?！边@些新的標簽變化加強了Tirosint-SOL作為一種簡單，方便，清潔的LT4療法的地位，只有三種成分“。

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.

標簽變化是由研發(fā)和科學(xué)事務(wù)部贊助和進行的兩項臨床研究-瑞士IBSA生物嵌合體研究所。第一項研究的結(jié)果表明，無論PPI的給藥時間如何，替羅司汀溶膠與PPI藥物奧美拉唑之間缺乏相互作用。3第二項研究的結(jié)果表明，在吃早餐前15分鐘服用Tirosint SOL可以在健康個體中產(chǎn)生類似水平（生物利用度）的LT4藥物暴露，就像在吃早餐前30分鐘服用一樣。

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

它沒有評估Tirosint-SOL在吃早餐的同時使用時的整體生物利用度。?.

“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,”? 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.”.

“考慮到可能干擾其吸收的多種療法以及禁食狀態(tài)下給予左旋甲狀腺素的要求，患者可能難以適當(dāng)使用左旋甲狀腺素?！?康涅狄格大學(xué)醫(yī)學(xué)院Francesco Celi博士說?！盀榧谞钕俟δ軠p退癥患者提供更易于使用的藥物的機會，因為它不受PPI的影響，PPI是常用的減酸劑，可以在早餐前15分鐘服用，臨床醫(yī)生應(yīng)該感興趣，因為它可能會增加依從性并改善治療效果“。

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種劑量強度，包括獨特的13,37.5,44和62.5微克劑量選項，這是美國任何左旋甲狀腺素治療的最大劑量范圍。它僅由三種成分制成-左旋甲狀腺素，甘油和水。2Tirosint SOL廣泛應(yīng)用于零售藥店。。

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為Tirosint-SOL提供慷慨的共付儲蓄優(yōu)惠券，使符合條件的商業(yè)保險患者能夠顯著降低藥物的自付費用。對于免賠額/共付額高或沒有保險的患者，該公司提供了一種名為Tirosint Direct的便利郵件訂購藥房計劃，以最低的現(xiàn)金價格提供Tirosint SOL。

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

有關(guān)這些省錢選項的更多信息，請訪問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：不用于治療肥胖或減肥。

See full prescribing information for complete boxed warning

請參閱完整的處方信息以獲取完整的盒裝警告

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

甲狀腺激素，包括TIROSINT-SOL，不應(yīng)用于治療肥胖或減肥

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

超出每日荷爾蒙需求范圍的劑量可能會產(chǎn)生嚴重甚至危及生命的毒性表現(xiàn)

CONTRAINDICATIONS

禁忌癥

Hypersensitivity to glycerol

對甘油過敏

Uncorrected adrenal insufficiency

未矯正的腎上腺皮質(zhì)功能不全

WARNINGS AND PRECAUTIONS

警告和注意事項

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

老年人和潛在心血管疾病患者的心臟不良反應(yīng)：由于心臟不良反應(yīng)（包括心房顫動）的風(fēng)險增加，以低于完全替代劑量啟動TIROSINT-SOL

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

粘液性水腫昏迷：不要使用口服甲狀腺激素藥物治療粘液性水腫昏迷

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

伴隨腎上腺功能不全的患者的急性腎上腺危象：在開始TIROSINT-SOL治療之前用替代糖皮質(zhì)激素治療

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

預(yù)防甲狀腺功能亢進或甲狀腺功能減退癥的不完全治療：適當(dāng)?shù)膭┝康味ê妥屑毐O(jiān)測對于預(yù)防甲狀腺功能減退癥的持續(xù)存在或甲狀腺功能亢進癥的發(fā)展至關(guān)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

糖尿病控制惡化：糖尿病患者的治療可能會惡化血糖控制并導(dǎo)致抗糖尿病藥物或胰島素需求增加。開始，改變或停止甲狀腺激素治療后，仔細監(jiān)測血糖控制

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

與甲狀腺激素過度替代相關(guān)的骨礦物質(zhì)密度降低。過度替換可以增加骨重吸收并降低骨礦物質(zhì)密度。給出最低有效劑量

Limitations of Use

使用限制

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

不適用于碘充足患者的良性甲狀腺結(jié)節(jié)和無毒彌漫性甲狀腺腫的抑制

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

亞急性甲狀腺炎恢復(fù)期暫時性甲狀腺功能減退癥的治療無效

Adverse Reactions

不良反應(yīng)

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的常見不良反應(yīng)主要是由于治療過量導(dǎo)致的甲狀腺功能亢進，包括心律失常，心肌梗塞，呼吸困難，肌肉痙攣，頭痛，緊張，煩躁，失眠，震顫，肌肉無力，食欲增加，體重減輕，腹瀉，不耐受，月經(jīng)不規(guī)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 Biochimique?

關(guān)于IBSA生物化學(xué)研究所?

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）是一家瑞士跨國制藥公司，成立于1945年在盧加諾。今天，通過公司位于歐洲，中國和美國的18家子公司，其產(chǎn)品遍布五大洲的90多個國家。該公司合并營業(yè)額為9億瑞士法郎，總部，子公司和生產(chǎn)場所之間雇用2200多萬人。

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擁有90個已批準專利家族，以及其他正在開發(fā)的家族，以及龐大的產(chǎn)品組合，涵蓋10個治療領(lǐng)域：生殖醫(yī)學(xué)，內(nèi)分泌學(xué)，疼痛和炎癥，骨關(guān)節(jié)，美容醫(yī)學(xué)，皮膚病學(xué)，泌尿婦科，心臟代謝，呼吸，消費者健康。

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..

它也是全球生殖醫(yī)學(xué)領(lǐng)域最大的運營商之一，也是世界透明質(zhì)酸產(chǎn)品的領(lǐng)導(dǎo)者之一。IBSA的理念基于四大支柱：人，創(chuàng)新，質(zhì)量和責(zé)任。。

About Hypothyroidism

關(guān)于甲狀腺功能減退癥

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.? Large observational studies and meta-analyses have shown that about 4-7% of community-derived populations in the U.S.

甲狀腺功能減退癥是一種多種原因的內(nèi)分泌紊亂，導(dǎo)致甲狀腺激素缺乏。在美國，估計有超過2450萬人患有甲狀腺功能減退癥。?大量的觀察研究和薈萃分析表明，美國約有4-7%的社區(qū)人口。

and Europe have undiagnosed hypothyroidism.?.

和歐洲有未確診的甲狀腺功能減退癥。?.

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.? The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin, and hair loss.1? 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.

大約2%的美國人口患有明顯的甲狀腺功能減退癥，多達10%的人患有亞臨床（輕度）甲狀腺功能減退癥。這種情況在40歲以上的女性和男女老年人中最為常見。?甲狀腺功能減退癥的體征和癥狀是非特異性的，可能包括疲勞，健忘，抑郁，便秘，肌肉痙攣，體重增加，皮膚干燥和脫發(fā)。1?建議將促甲狀腺激素（TSH）實驗室檢查作為甲狀腺功能障礙的一線篩查試驗。11左甲狀腺素鈉是通常由甲狀腺產(chǎn)生的激素的合成形式。

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

它用于治療患有甲狀腺功能減退癥或需要抑制TSH的患者。。

References

工具書類

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。與左旋甲狀腺素相互作用的藥物：來自甲狀腺流行病學(xué)，審計和研究（眼淚）的觀察性研究。Clin Endocrinol（Oxf）。2015年1月；82(1):136-41.

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

替洛星-SOL包裝說明書，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。新型左旋甲狀腺素溶液的藥代動力學(xué)不受質(zhì)子泵抑制劑的影響。2021 ATA會議上的海報展示。

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，無論是在高脂肪高熱量餐前30分鐘還是僅15分鐘，新型左旋甲狀腺素溶液均可產(chǎn)生相似的生物利用度。甲狀腺。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，“合并癥，伴隨藥物和飲食作為影響左旋甲狀腺素治療的因素：對照監(jiān)測項目的結(jié)果，R＆D。2015；16（1）：53-68中的藥物。

IBSA Group Website, October 2023.

IBSA集團網(wǎng)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.美國甲狀腺功能減退癥患病率：一項結(jié)合國家健康和營養(yǎng)檢查調(diào)查和索賠數(shù)據(jù)的回顧性研究。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等人對甲狀腺功能減退癥的認識不足和診斷不足。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。科羅拉多州甲狀腺疾病患病率研究。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.在臨床上：甲狀腺功能減退癥。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.甲狀腺疾病的實驗室檢測：缺陷和臨床應(yīng)用。Ann Lab Med.2019；39(1):3.

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

有關(guān)IBSA的更多信息，請訪問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

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

PM-01-23-0082B

PM-01-23-0082B

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左旋甲狀腺素鈉

網(wǎng)址: 美國食品藥品監(jiān)督管理局批準Tirosint?Sol（左旋甲狀腺素鈉）口服溶液兩項新標簽變更 http://www.u1s5d6.cn/newsview1737879.html