Tirosint® now available in 15 dosage strengths 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. 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.
IMPORTANT SAFETY INFORMATION
Warning: Not for the Treatment of Obesity or for Weight Loss See full prescribing information for complete boxed warning
Doses beyond the range of daily hormonal requirements may produce serious often life threatening manifestations of toxicity.
Uncorrected adrenal insufficiency
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 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 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.