Partnership highlights Tirosint-SOL’s efficacy for hypothyroidism

PARSIPPANY, N.J., June 4, 2024 — IBSA USA has renewed its partnership with professional golfer Azahara (Aza) Muñoz to promote Tirosint®-SOL (levothyroxine sodium) oral solution, a unique liquid hypothyroidism treatment, through the 2025 golf season. As part of the multi-year renewal, Muñoz will continue to serve as a spokesperson at in-person events, in videos, and on social media to promote the brand while wearing the Tirosint-SOL logo on the sleeve of her golf attire.

Muñoz, who has Hashimoto’s thyroiditis that results in hypothyroidism, has found relief since she began taking Tirosint-SOL and regained control over her hypothyroid symptoms. She attributes her restored energy and improved symptom relief to this innovative treatment option.

“Using Tirosint-SOL has been transformative for me — it has helped me get back in full swing both on and off the golf course. I’ve experienced significant improvements in my energy levels and overall well-being,” said Muñoz. “I now have the energy to keep up with my child’s active lifestyle.”

Tirosint-SOL was the first oral liquid formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypothyroidism, a condition in which a person cannot produce enough thyroid hormone to meet their body’s needs. In November 2023, the FDA approved two new label updates for Tirosint-SOL, offering patients increased flexibility in administration. As a result, Tirosint-SOL is now the only FDA-approved levothyroxine therapy with no labeled interaction with proton pump inhibitors (PPIs) and is the only FDA-approved levothyroxine therapy that can be administered 15 minutes before eating breakfast.1

“We are delighted to renew our partnership with Aza Muñoz, whose personal journey with hypothyroidism underscores the efficacy of Tirosint-SOL,” said Michael Scully, Head of Commercial Operations, IBSA USA. “The recent label changes further solidify Tirosint-SOL’s position as a unique treatment option for individuals living with hypothyroidism.”

Tirosint-SOL has 15 dosing strengths, including unique 13, 37.5, 44, and 62.5 microgram dosing options, the widest range of doses of any levothyroxine therapy available in the U.S. It is made with only three ingredients — levothyroxine, glycerol, and water1 — and is widely available in retail pharmacies.

IBSA offers a Copay Savings Card 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 a low cash price. Additional information about these money-saving options can be found at TirosintSOL.com.

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.

About IBSA Institut Biochimique
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 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. 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.

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

Contact: info@ibsapharma.com
(800) 587-3513

References:

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

PM-01-24-0029