IBSA Increases Dosage Flexibility of Liquid Hypothyroidism Treatment for Patients and Clinicians; Introduces Unique New Dosing Options

PARSIPPANY, N.J., Aug. 25, 2021 /PRNewswire/ -- Americans diagnosed with hypothyroidism and their clinical providers now have access to greater dosage flexibility within levothyroxine therapy. IBSA Pharma Inc. is introducing three new dosage strengths of its Tirosint®-SOL (levothyroxine sodium) oral solution to treat hypothyroidism. ¹ The unique new dosing options – 37.5, 44 and 62.5 micrograms – are a first in the U.S. market and offer clinicians unprecedented precision and flexibility when treating patients. The three new doses add to Tirosint-SOL’s existing 12 options and create a new industry standard of 15 strengths of levothyroxine therapy, the widest range of any therapy for hypothyroidism that is 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-SOL’s extensive dosing options provide clinicians with more choices, enabling them to adapt levothyroxine therapy to individual needs and 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 represents a much-needed advance in levothyroxine therapy, which is the standard of care for treating hypothyroidism,” said Charles Carter, PharmD, interim chair and associate professor of clinical research, Campbell University College of Pharmacy and Health Sciences. “Up to this time, clinicians have often instructed parents, caregivers and patients to split levothyroxine tablets to create these doses, which can result in significant dosing errors and inconvenience. Levothyroxine is a narrow therapeutic index drug with potentially deleterious clinical outcomes if administered in sub- or supratherapeutic doses. The splitting of tablets by patients can result in inconsistent levels of levothyroxine therapy, which should be a concern to clinicians and the patients they care for.”

Tirosint-SOL is the only FDA-approved levothyroxine liquid that comes in monodose packaging for precision and convenience. It has been clinically proven to effectively treat the full spectrum of hypothyroid patients from patients with general hypothyroidism to those who have concomitant conditions that can complicate therapy. With only three ingredients – levothyroxine, glycerol, and water – Tirosint-SOL does not contain inactive ingredients or preservatives that are commonly found in traditional levothyroxine tablet therapies that can interfere with medication tolerability or absorption.⁴

Tirosint-SOL is indicated to treat hypothyroid patients regardless of age. Patients can administer it by pouring the contents of the monodose ampule directly into the mouth, using a spoon or mixing it in water. A data matrix was recently added to the monodose ampule to facilitate its use in hospitals, where more complex cases of hypothyroidism are often initially treated.

Tirosint-SOL is widely available in retail pharmacies. To help provide patients with cost-effective access to Tirosint-SOL, IBSA recently enhanced the Tirosint-SOL Copay Coupon Program. With the new program, eligible patients with commercial insurance may pay as little as $4 per one-month supply of Tirosint-SOL or $0 per three-month supply. Additional information, including money-saving options for patients without commercial insurance or with high copays or deductibles, can be found at TirosintSOL.com.

About IBSA Pharma Inc.
IBSA Pharma Inc. 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 over 80 countries, IBSA has a commitment to scientific research and improving the health of patients.

References

1. Tirosint-SOL Prescribing Information, 2021, IBSA Pharma Inc., Parsippany, NJ
2. Mitchell, A.L., Hegedüs, L., Žarković, M., Hickey, J.L. and Perros, P. (2021), Patient satisfaction and quality of life in hypothyroidism: An online survey by the British Thyroid Foundation. Clin Endocrinol, 94: 513-520. https://doi.org/10.1111/cen.14340
3. McMillan M et al. Levothyroxine Dose Changes and Hypothyroid Patient Satisfaction: Results of the CONTROL TS Study. Annals of Thyroid Research. 2017;3(2):0110-0114
4. McMillan M et al. Comorbidities, concommitant medications and diet as factors affecting levothyroxine therapy: results of The CONTROL Surveillance Project. Drugs in R&D. 2015: 16 (1): 53-68

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

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SOURCE IBSA Pharma, Inc.