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Data on Levothyroxine Presented at the 2024 American Thyroid Association Annual Meeting

At the recent American Thyroid Association (ATA) Annual Meeting in Chicago – the largest global event for thyroid specialists – IBSA USA had the opportunity to share clinical data with clinicians and researchers from around the world. 
During the meeting, held from October 30 – November 3, 2024, four poster presentations highlighted important findings on levothyroxine therapies.The studies accepted for presentation included:

  • Treatment with Soft Gel Capsule L-T4 in Hypothyroid Patients with Gastric Diseases Associated with L-T4 Malabsorption
  • Drug Administration as a Factor Affecting Levothyroxine Therapy – Results of the CONTROL Surveillance II Study
  • A Randomized Comparative Study Between Liquid (Tirosint®-SOL) and Tablet Formulations of Levothyroxine in Neonates and Infants with Congenital Hypothyroidism – Preliminary Results 
  • Liquid L-T4 Formulation in Hypothyroid Patients with Celiac Diseases or Non-Celiac Gluten Sensitivity

 

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“Findings from the studies presented at ATA underscore some of the challenges commonly associated with levothyroxine therapies and highlight the factors that make our Tirosint® and Tirosint®-SOL formulations unique,” said Michael Scully, Head of Commercial Operations for IBSA USA. “IBSA’s therapies are designed with patient tolerability and dosing consistency in mind, addressing the specific needs of those with absorption challenges or ingredient sensitivities. We were pleased to present this data and to connect with healthcare professionals in the exhibit hall to share more about our products.”

IBSA USA markets two products for the treatment of hypothyroidism including Tirosint® (levothyroxine sodium) capsules and Tirosint®-SOL (levothyroxine sodium) oral solution. Both are unique formulations of levothyroxine (LT4) and contain limited ingredients which may help with improved tolerability. Additionally, IBSA USA offers the widest range of dosage strengths of any LT4 therapy, providing 15 different dosage strengths to help ensure precise and consistent dosing.

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Endocrinologists and healthcare professionals treating hypothyroidism may find several differential factors important when managing their patients’ care. Tirosint-SOL is an oral solution that contains just three ingredients -- levothyroxine, glycerol, and water and is the only FDA-approved LT4 therapy that can be taken 15 minutes before breakfast and has no labeled interaction with Proton Pump Inhibitors (PPIs).1 In addition, Tirosint soft gel capsules may be a good option for patients with hypothyroidism who have food allergies, ingredient sensitivities, or gastrointestinal (GI) conditions such as gastroesophageal reflux disease (GERD), celiac disease, or inflammatory bowel disease.2 

The Tirosint family of products are manufactured by IBSA in Switzerland according to the high quality standards in a facility dedicated solely to their production.

For more information on Tirosint and Tirosint-SOL and Full Prescribing Information, including Boxed Warning and Important Safety Information visit: Tirosint.com/PrescribingInformation and TirosintSOL.com/PrescribingInformation. 

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

•    Thyroid hormones, including TIROSINT, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.
•    In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
•    Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

CONTRAINDICATIONS
•    Uncorrected adrenal insufficiency

WARNINGS AND PRECAUTIONS
•    Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease. Initiate TIROSINT at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including 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: Treat with replacement glucocorticoids prior to initiation of TIROSINT treatment
•    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
•    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
•    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
•    Use for the suppression of nontoxic diffuse goiter or nodular thyroid disease: Use is not recommended in iodine-insufficient patients

Limitations of Use
•    Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
•    Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis

Adverse Reactions 
Common adverse reactions with levothyroxine therapy are primarily those of hypothyroidism due to therapeutic overdosage. They include the following:
•    General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating
•    Central Nervous System: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia
•    Musculoskeletal: tremors, muscle weakness
•    Cardiovascular: palpitations, tachycardia, arrythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest
•    Respiratory: dyspnea
•    Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests
•    Dermatologic: hair loss, flushing
•    Endocrine: decreased bone mineral density
•    Reproductive: menstrual irregularities, impaired fertility

Adverse reactions in Children
Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height. Seizures have been reported rarely with the institution of levothyroxine therapy.

Hypersensitivity Reactions
Hypersensitivity reactions to inactive ingredients (in this product or other levothyroxine products) have occurred in patients treated with thyroid ho0rmone products. These include urticaria, pruritis, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.
 

For Full Prescribing Information, including Boxed Warning, go to Tirosint-PI.pdf

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

•  See full prescribing information for complete boxed warning

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

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

CONTRAINDICATIONS

•  Hypersensitivity to glycerol

•  Uncorrected adrenal insufficiency

WARNINGS AND PRECAUTIONS

•  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

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

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

•  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

•  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

•  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 of Use

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

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

Adverse Reactions

•  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.

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

 

References:

1.    Licart (diclofenac epolamine) topical system 1.3% [package insert]. Parsippany, NJ: IBSA Pharma; 2020. 

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

 

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References  1. Tirosint-SOL Package Insert, IBSA Pharma Inc. 2023.    2. Santaguida MG, Virili C, Del Duca, et al. Endocrine. 2015;49(1):51-57 Specific GI conditions included here were H. Pylori infection, lactose intolerance and celiac disease.