Tirosint®-SOL Now Available to Treat Hypothyroidism in the U.S.

PARSIPPANY, N.J., /PRNewswire/ -- IBSA Pharma Inc. announced that its Tirosint-SOL (levothyroxine sodium) oral solution is now available in the US market for the treatment of hypothyroidism and pituitary thyrotropin suppression.

Tirosint-SOL is the first and only liquid levothyroxine formulation approved by the FDA and is indicated for patients of all ages. Levothyroxine is a hormone that is normally produced by the thyroid gland. It is used to treat patients who suffer from hypothyroidism or inadequate levels of thyroid stimulating hormone (TSH).

Tirosint-SOL is the latest product to be launched in the US by the IBSA Pharma Inc., a fully-owned subsidiary of IBSA Institute Biochemique SA. Tirosint-SOL’s unique liquid formulation is made without excipients such as dyes, wheat starch (gluten), lactose, alcohol, sugar and others that may contribute to tolerability and absorption issues. It is packaged in monodose ampules in 12 different dosage strengths, including a 13 mcg/mL dose. Tirosint-SOL may be administered either directly into the mouth or diluted in a glass of water.

“Tirosint-SOL is the only FDA approved oral liquid levothyroxine therapy. It will be available through participating mail order and retail pharmacies starting March 1^st, " stated Aldo Donati, CEO of IBSA Pharma. Tirosint-SOL has been studied extensively in Europe and the value of its unique formulation demonstrated by several clinical studies that have been published in scientific journals.

“Tirosint-SOL represents an evolution in hypothyroidism treatment. While levothyroxine therapy has been available for decades, this is the first FDA-approved liquid levothyroxine formulation,” said Dr. Murray Ducharme, Professeur Associé, Faculté de Pharmacie at the University of Montreal. “This easy-to-swallow option will provide a useful new option for many patients who may benefit from a liquid rather than an oral solid version of this proven therapy.”

IBSA offers several programs to provide patients who need Tirosint-SOL, with cost-effective access to Tirosint-SOL. For eligible patients with commercial insurance, the Tirosint-SOL Copay Savings Card may reduce the cost of Tirosint-SOL to as little as $15 per month of therapy. For patients without insurance or with high copays or deductibles, the Tirosint Direct Program is available through participating mail order pharmacies and offers the lowest cash price available. Additional information can be found at www.tirosintsol.com. IBSA also offers a Patient assistance Program (PAP) for qualifying indigent patients. Additional information can be found at http://www.ibsapap.com/.

IBSA Pharma is part of IBSA Group, which is headquartered in Lugano, Switzerland. The company is a world leader in the treatment of thyroid disease and has a diversified product portfolio of prescription drugs. With products on five continents and in over 80 countries, IBSA manufactures 14 million vials of hormones, 300 million soft gel capsules and 60 million packages of finished products every year. IBSA has a commitment to scientific research and improving the health of patients.

Important Safety Information

WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS

• Thyroid hormones, including TIROSINT-SOL, 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

• 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
Adverse reactions associated 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 more information, visit www.ibsagroup.com/media.

*For Full Prescribing Information, visit www.TirosintSOL.com

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SOURCE IBSA Pharma Inc.