Discusses Battle with Hashimoto's Disease and Success with Tirosint®-SOL(levothyroxine sodium) oral solution


PARSIPPANY, N.J., May 4, 2023 - Professional golfer Azahara Muñoz and endocrinologist Dr. Kenilia Ventura will be featured on The Balancing Act® , a morning show produced by BrandStar® and airing on Lifetime TV®. The segment, hosted by Montel Williams and Olga Villaverde, will be broadcast nationally two times in May (May 8th and May 15th at7.30 am EST; 7.30 am PST) and two additional times in June. The segment highlights Muñoz's experience living with Hashimoto's thyroiditis, an autoimmune disorder that causes hypothyroidism. It informs viewers of the importance of proper thyroid function, including its critical role during pregnancy, factors that can interfere with the absorption of thyroid medication, and innovative treatment options for managing the symptoms of hypothyroidism including Tirosint®-SOL (levothyroxine sodium) oral solution.

Villaverde interviewed Muñoz and Dr. Ventura for the segment as they outlined the challenges Muñoz faced early in her disease journey such as fatigue, dizziness, and hair loss. They described her initial experiences with thyroid replacement therapies and her eventual discovery of Tirosint-SOL, a treatment that works to control her hypothyroid symptoms. Dr. Ventura described how the thyroid gland plays a critical role in virtually every single organ in the human body, especially during pregnancy. She explained how a mother's thyroid function affects the development of their baby's brain and central nervous system.

"During the first three months of pregnancy, babies depend on their mother's thyroid hormones to develop properly," said Dr. Ventura. "So, when I met Aza – who was pregnant at the time – we talked about her persisting hypothyroid symptoms, her clinical history, and what medications could be used safely while pregnant and beyond."

Dr. Ventura talks about why she prescribed Tirosint®-SOL for Aza and why she prescribes it to both pregnant and non-pregnant patients who have hypothyroidism, including those with hypothyroidism caused by Hashimoto's thyroiditis. "Studies have shown Tirosint-SOL to be very consistent," she said. "Because it is a liquid, it can be absorbed faster than conventional levothyroxine tablet formulations. It is not affected by medications that can change the acidity of the stomach and only contains three ingredients, so it's less likely to have issues with allergies or intolerances."

For Muñoz, the choice of a simple regimen to control her hypothyroidism was appealing. "I really care what I put into my body. I'm quite healthy; I eat healthy, I exercise, and this is a medication that I'm going to have to take for the rest of my life," added Muñoz. "It's nice to know that with Tirosint-SOL that I'm taking the purest option available. I've been feeling great since I've been taking it."

Tirosint-SOL has 15 dosing strengths including unique 13, 37.5, 44, and 62.5 microgram dosing options, the widest range of any therapy for hypothyroidism available in the U.S. Unlike traditional thyroid hormone tablet therapies, it is made with only three ingredients – levothyroxine, glycerol, and water.

Tirosint-SOL is widely available in retail pharmacies. IBSA offers a generous Copay Savings Coupon for Tirosint-SOL, which allows eligible patients with commercial insurance to pay as little as $4 for a one-month supply or $0 for a three-month supply. 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 possible out-of-pocket price available, regardless of a patient's insurance status. Additional information about these money-saving options can be found at TirosintSOL.com.

For more information about The Balancing Act segment with Aza Muñoz and Dr. Kenilia Ventura, visit thebalancingact.com. For Full Prescribing Information for Tirosint-SOL, including Boxed Warning, visit www.tirosintsol.com.

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 17 subsidiaries located in Europe, China, and the United States. The company has a consolidated turnover of 800 million CHF, and employs over 2,000 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.

About Hypothyroidism

Hypothyroidism is an endocrine disorder with numerous causes resulting in a deficiency in thyroid hormone. More than 27 million adults have been diagnosed with hypothyroidism.1 Large observational studies and meta-analyses have shown that about 4–7% of community-derived populations in the USA and Europe have undiagnosed hypothyroidism.2 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.3 The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin and hair loss.4 TSH laboratory tests are recommended as first-line screening tests for thyroid dysfunction.5 Levothyroxine sodium is a synthetic version of a hormone that is normally produced by the thyroid gland. It is used to treat patients who suffer from hypothyroidism or require suppression of thyroid stimulating hormone (TSH).

About The Balancing Act

The Balancing Act® is a morning show created and produced by BrandStar that offers sensible solutions and essential information in a fun, entertaining format; providing resources to help people do life better. The Balancing Act features everything from delicious recipes, style makeovers and dream getaways to parenting tips and the latest news in health and wealth. Tune in to The Balancing Act weekdays at 7:30 a.m. (ET/PT) on Lifetime® and find all previously aired episodes on TheBalancingAct.com.

About BrandStar

We're matchmakers; connecting People to Brands to Do Life Better. BrandStar has unparalleled experience in creating customized educational content for brands with laser targeted extensive distribution through their multi-channel network ecosystem and methodology. From Original television programming on Lifetime, BrandStar.tv, social media, digital marketing, to media management and PR; BrandStar helps brands connect with the right consumer, at the right time, with the right message, through all the right channels.

References

IMS Institute for Healthcare Informatics Report, "Medicine Use and the Shifting Costs of Healthcare"; 2014; pg. 46
Gottwald-Hostalek U. et al, 2022, Current Medical Research and Opinion, Vol 38, No 1, pp. 59-64
Canaris GJ, Manowitz NR, Mayor G, Ridgeway EC, "The Colorado Thyroid Disease Prevalence Study", Arch of Internal Medicine; 2000;160: 526-534
McDermott MT. "In the clinic: hypothyroidism". Annals of Internal Medicine; 2009;151 (11): ITC-6-1
Soh SB. Laboratory testing in thyroid conditions: pitfalls and clinical utility. Ann Lab Med. 2019;39(1):3.
For more information about IBSA, visit www.ibsagroup.com/media.

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

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SOURCE IBSA Pharma, Inc.