IBSA Increases Dosage Flexibility of Tirosint® Capsules

Tirosint® now available in 15 dosage strengths

PARSIPPANY, N.J., April 4, 2023 /PRNewswire/ -- Americans diagnosed with hypothyroidism now have access to greater dosage flexibility for levothyroxine therapy. IBSA Pharma Inc. is introducing three new dosage strengths of Tirosint® (levothyroxine sodium) capsules to treat hypothyroidism.[1] The three new dosing options – 37.5, 44 and 62.5 micrograms – add to Tirosint's existing 12 options and, along with similar doses of Tirosint®-SOL (levothyroxine sodium) oral solution, provide the widest range of doses for any levothyroxine drug approved by the U.S. Food and Drug Administration (FDA).

Recently published research has demonstrated that dissatisfaction is common among adults treated for hypothyroidism.[2] While the causes of patient dissatisfaction are complex, the common practice of frequent dose titration of thyroid hormone treatment (more than two dose changes per year) has been associated with significantly lower levels of patient satisfaction with hypothyroidism therapy.[3]

Tirosint's extensive dosing options provide clinicians with more choices, enabling them to adapt levothyroxine therapy to individual needs to better treat the full spectrum of hypothyroid patients. Increased dosage flexibility may also eliminate or reduce the need to change patients' doses.

"The addition of 37.5, 44 and 62.5 microgram dosages, along with the brand's unique 13 mcg dose, provides physicians and patients with much-needed flexibility in levothyroxine therapy, the standard of care for treating hypothyroidism," said Carolyn Kong, PharmD, Chief Medical and Business Officer of IBSA Pharma Inc. "Up to this time, clinicians who wanted to prescribe oral solid formulations of levothyroxine in these doses needed to instruct caregivers and patients to split levothyroxine tablets or combine different dosage strengths. This can result in both inconvenience and significant dosing errors. Levothyroxine is a narrow therapeutic index drug with potentially deleterious clinical outcomes if administered in sub- or supratherapeutic doses. These new doses of Tirosint will now match those of Tirosint-SOL, providing a convenient and safe way to provide these doses of levothyroxine to patients who need them."

Tirosint is the leading FDA-approved levothyroxine gel capsule available in the US. It has been clinically proven to effectively treat the full spectrum of hypothyroid patients from those with general hypothyroidism to those who have concomitant conditions that can complicate therapy. With only four ingredients – levothyroxine, glycerin, gelatin, and water – Tirosint does not contain inactive ingredients or preservatives that are commonly found in traditional levothyroxine tablet therapies that can interfere with medication tolerability or absorption. Tirosint is indicated to treat hypothyroidism in patients 6 years of age and older and for pituitary thyrotropin (Thyroid Stimulating Hormone – TSH) suppression as an adjunct to surgery and radioactive iodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Tirosint is widely available in retail pharmacies. To help provide patients with cost-effective access to Tirosint, IBSA provides copay coupons and other cost saving programs. With the Tirosint Copay Savings Coupon, eligible patients with commercial insurance may pay as little as $25 per one-month supply of Tirosint or $50 per three-month supply. Patients with high deductibles/copays, without commercial insurance or paying cash can access the Tirosint Direct Program to get the lowest cash price for Tirosint. Additional information can be found at Tirosint.com. 

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.[4] Large observational studies and meta-analyses have shown that about 4–7% of community-derived populations in the USA and Europe have undiagnosed hypothyroidism.[5] 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.[6] The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin and hair loss.[7] TSH laboratory tests are recommended as first-line screening tests for thyroid dysfunction.[8] 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 supression of thyroid stimulating hormone (TSH).

About IBSA Pharma Inc.
IBSA Pharma is part of IBSA Group, which is headquartered in Lugano, Switzerland. It currently markets 4 prescription medications in the United States including Tirosint capsules. These include Tirosint-SOL (levothyroxine sodium) oral solution which is indicated as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism and for pituitary thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer; Licart (diclofenac epolamine) topical system 1.3% and Flector (diclofenac epolamine) topical system 1.3% which are indicated for the treatment of acute pain from minor strains, sprains, and contusions.

IBSA Institut Biochimique SA
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.

To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800- FDA-1088

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

References

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, should not be used for the treatment of obesity or for weight loss.
• Doses beyond the range of daily hormonal requirements may produce serious often life threatening manifestations of toxicity.

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 no 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

Adverse Reactions  
Adverse reactions associated with Tirosint 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.

PM-00-23-0031

SOURCE IBSA Pharma, Inc.