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New FDA-Approved Label Updates Give Patients More Flexible Delivery
PARSIPPANY, N. J. , Dec. 4, 2023–(BUSINESS WIRE)–The U. S. Food and Drug Administration (FDA) has announced that the U. S. Food and Drug Administration is not working to announce that the U. S. Food and Drug Administration is not working to prevent the U. S. Food and Drug Administration from entering the U. S. Food and Drug Administration (FDA). The U. S. Food and Drug Administration (FDA) has approved two new label adjustments for the oral solution of Tirosint-SOL (levothyroxine sodium), a pure levothyroxine (LT4) formulation for the remedy of hypothyroidism. The first consideration is the use of Tirosint-SOL in the presence of a proton pump inhibitor (PPI) drug. The timing considers the timing of the administration of Tirosint-SOL. Both of these label changes help differentiate Tyrosint-SOL from other levothyroxine therapies.
The absorption and functionality of levothyroxine tablets have been shown to be impaired by concomitant use of proton pump inhibitors (PPIs). ¹ The updated label removes PPIs as a drug that would possibly minimize absorption and decrease the efficacy of Tyrosint-SOL. Similarly, existing labels for all levothyroxine sodium remedies instruct patients to self-administer the drug once a day, on an empty stomach, between an hour and an hour before breakfast. The updated Tirosint-SOL label states that it can be given 15 minutes before breakfast. ²
Tirosint-SOL is now the FDA-approved LT4 treatment with no marked interactions with PPIs and the FDA-approved LT4 treatment that can be administered 15 minutes before breakfast.
“The availability of these liquid oral formulations of levothyroxine, which is unaffected by proton pump inhibitors and can be taken as little as 15 minutes before breakfast, is a real advantage for hypothyroidism patients and healthcare professionals,” said Michael Scully, chief commercial officer at IBSA. UNITED STATES. “This new label adjusts Tirosint-SOL’s position as a simple, convenient, blank LT4 treatment with only 3 ingredients. “
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. It did not evaluate Tirosint-SOL’s overall bioavailability when administered simultaneously with eating breakfast.⁴
“Proper management of levothyroxine can be challenging for patients, given the multiple treatments that can interfere with its absorption and the desire to administer it on an empty stomach⁵,” said Francesco Celi, M. D. , of the University of Connecticut School of Medicine. The option of offering patients with hypothyroidism a drug that is less difficult to use because it is not affected by PPIs, commonly used acid-reducing agents, and which can be taken 15 minutes before breakfast, is of interest to clinicians, as it can improve adherence and improve treatment outcomes.
Tirosint-SOL offers 15 doses, adding unique dosing features of 13, 37. 5, 44 and 62. 5 micrograms, the widest dosage diversity for any levothyroxine remedy available in the United States. It’s made with just 3 ingredients: levothyroxine, glycerol, and water. ² Tyrosint-SOL is widely found in retail pharmacies.
IBSA offers a generous co-pay savings coupon for Tirosint-SOL, which allows eligible patients with advertising insurance to pay in particular their out-of-pocket expenses for the drug. For patients with high deductibles/copays or no insurance, the company offers convenient email. apply for a pharmacy program called Tirosint Direct that offers Tirosint-SOL at the lowest price available. Additional information about those cost-effective features can be found at TirosintSOL. com.
IMPORTANT SAFETY INFORMATION
WARNING: NOT FOR THE TREATMENT OF OBESITY OR WEIGHT LOSS.
See the full prescription for the full boxed warning.
Thyroid hormones, adding TIROSINT-SOL, do not deserve to be used for obesity remedy or weight loss.
Doses in excess of hormonal requirements can produce serious and even life-threatening manifestations of toxicity.
CONTRAINDICATIONS
Hypersensitivity to glycerol.
Uncorrected adrenal insufficiency
WARNINGS & PRECAUTIONS
Cardiac Adverse Reactions in the Elderly and in Patients With Underlying Cardiovascular Disease: Initiate TIROSINT-SOL at a lower dose than the full replacement dose because cardiac adverse reactions are greater, adding atrial fibrillation.
Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma
Acute adrenal crisis in patients with concomitant adrenal insufficiency: with glucocorticoid replacement prior to initiation of TIROSINT-SOL therapy.
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
Deterioration of diabetes: Treatment in patients with diabetes mellitus would possibly worsen blood glucose and lead to an increased need for antidiabetic medications or insulin. Monitor blood glucose carefully after initiating, modifying, or preventing thyroid hormone therapy.
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
Limitations on Use
Not indicated for the suppression of benign thyroid nodules and diffuse non-toxic goiter in patients receiving sufficient iodine.
Not indicated for the remedy of brief hypothyroidism in the recovery phase of subacute thyroiditis.
Undesirable effects
Common adverse reactions related to TIROSINT-SOL are mainly hyperthyroidism due to curative overdoses, adding arrhythmias, myocardial infarction, dyspnea, muscle spasms, headache, nervousness, irritability, insomnia, tremor, muscle weakness, increased appetite, weight loss, diarrhea. , heat intolerance, menstrual irregularities and skin rashes.
For complete prescribing information and a boxed warning, visit https://tirosintsol. com/wp-content/uploads/2023/11/Tirosint-SOL-USPI. pdf.
About the IBSA Institute of Biochemistry⁶
IBSA (Institut Biochimique SA) is a Swiss multinational pharmaceutical company, founded in 1945 in Lugano. Today, its products are supplied in more than 90 countries on five continents, through the company’s 18 subsidiaries in Europe, China and the United States. It has a consolidated turnover of CHF 900 million and employs more than 2,200 people at its head office, subsidiaries and production sites. IBSA has 90 approved patent families, in addition to others under development, as well as a broad product portfolio covering 10 Healing Areas: Reproductive Medicine, Endocrinology, Pain & Inflammation, Osteoarticular, Aesthetic Medicine, Dermatology, Urogynecology, Cardiometabolic, Respiratory, Customer Health. It is also one of the world’s largest operators in the reproductive medicine sector and one of the world leaders in hyaluronic acid products. IBSA has based its philosophy on 4 pillars: People, Innovation, Quality and Responsibility.
About Hypothyroidism
Hypothyroidism is an endocrine disorder with causes that result in a deficiency of thyroid hormone. In the U. S. , it is estimated that more than 24. 5 million people suffer from hypothyroidism. ⁷ Large observational studies and meta-analyses have shown that approximately 4% to 7% of network populations in the U. S. have hypothyroidism. A number of people in the U. S. and Europe have undiagnosed hypothyroidism. ⁸
Approximately 2% of the U. S. population has pronounced hypothyroidism, and up to 10% have subclinical (mild) hypothyroidism. This condition is not unusual in women over the age of 40 and in older adults of both sexes. ⁹ Signs and symptoms of hypothyroidism are nonspecific and may possibly be accompanied by 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 screening. dysfunction. ¹¹ Levothyroxine sodium is an artificial edit of a hormone produced through the thyroid gland. It is used to treat patients with hypothyroidism or who require TSH suppression.
References
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.
Tirosint-SOL Prospectus, IBSA Pharma Inc. 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, 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).
McMillan M, et al. “Comorbidities, concomitant medications and nutrition affecting levothyroxine treatment: effects of the CONTROL surveillance project. Drugs in R
IBSA Group website, October 2023.
Wynn K. Prevalence of hypothyroidism in the United States: A retrospective combining a national fitness and nutrition survey and claims data. J Endocr Soc. 2023;7:1-11.
Gottwald-Hostalek U, et al. Underdiagnosis of hypothyroidism. Curr Med Opinion Res. 38(1):59-64.
Canaris GJ, Manowitz NR, Mayor G, Ridgeway EC. Colorado Thyroid Disease Prevalence Study. Arch Intern Med. 2000; 160(4):526-534.
McDermott MT. In the clinic: hypothyroidism. Ann Intern Med. 2009; 151(11):ITC-6-1.
So SB. Laboratory Tests in Thyroid Conditions: Difficulties and Clinical Utility. Ann Lab Med. 2019; 39(1):3.
For more facts about IBSA, www. ibsagroup. com/media.
For complete prescribing information and a boxed warning, visit https://tirosintsol. com/wp-content/uploads/2023/11/Tirosint-SOL-USPI. pdf
PM-01-23-0082B
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Contacts
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