The IBSA USA team recently returned from ENDO 2024, a premier event in the field of endocrinology. The meeting, held in Boston from June 1-4, served as a pivotal platform for IBSA USA to engage with thousands of leading experts, researchers, and clinicians in the global endocrinology community. “ENDO 2024 is a highly anticipated conference on our calendar each year,” said Michael Scully, Head of Commercial Operations for IBSA USA. “This meeting provides an invaluable opportunity to engage with healthcare providers and share the significant strides IBSA is making in advancing patient care through our innovative therapies for thyroid disease.”
During the conference, IBSA USA showcased Tirosint® (levothyroxine sodium) capsules and Tirosint®-SOL (levothyroxine sodium) oral solution, unique formulations of levothyroxine (LT4) for the treatment of hypothyroidism. Since exhibiting last year, Tirosint®-SOL became the only FDA-approved LT4 therapy with no labeled interaction with Proton Pump Inhibitors (PPIs) and the only FDA-approved LT4 therapy that can be administered 15 minutes before eating breakfast.1 These label updates support how IBSA’s focus is on solutions that are tailored to meet the needs of patients with hypothyroidism.
Medications used to treat hypothyroidism can contain a variety of inactive ingredients such as wheat starch (gluten), lactose, sugars, dyes and talc, which can cause irritation or potentially make it more challenging to absorb thyroid medicine. IBSA’s Tirosint and Tirosint-SOL have limited ingredients which couldto help with enhanced absorption. Tirosint-SOL features a pleasant-tasting liquid and contains only three ingredients—levothyroxine, glycerol, and water. And for those that prefer a capsule, Tirosint includes four simple ingredients -- levothyroxine, glycerol, gelatin, and water -- and may work well for patients with food allergies, ingredient sensitivities, and for those with gastrointestinal (GI) conditions such as gastroesophageal reflux disease (GERD), celiac disease, inflammatory bowel disease.2 Both are available in 15 different dosage strengths, the widest dosage strength range of any LT4 therapy.
The Tirosint family of products which are designed to enhance tolerability and ensure dosing consistency, are manufactured by IBSA in Switzerland according to high quality standards in a facility dedicated solely to their production.
For more information on Tirosint and Tirosint-SOL and Full Prescribing Information, including Important Safety Information visit: Tirosint.com/PrescribingInformation and TirosintSOL.com/PrescribingInformation.
IBSA USA Exhibits Innovative Thyroid Solutions at ENDO 2024
Unique Levothyroxine Formulation Advances Patient Care
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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