New Guidelines Cite Oral Levothyroxine Solution as an Option for Treating Congenital Hypothyroidism (CH)

Guidance Supports Use of Tirosint®-SOL In Pediatric Population

PARSIPPANY, N.J., Jan. 12, 2023 /PRNewswire/ -- The American Academy of Pediatrics (AAP), the Pediatric Endocrine Society (PES) and the American Thyroid Association (ATA) have published new guidelines for the treatment of congenital hypothyroidism (CH). For the first time, these leading medical societies cite levothyroxine oral solution as an option for managing patients with CH. Congenital hypothyroidism is a condition affecting up to 1 in every 2,000-4,000 live births in the United States annually. It is a leading cause of intellectual deficiency among infants.¹ CH is typically treated with levothyroxine, a synthetic thyroid hormone that is administered daily to restore thyroid hormones to normal levels. Tirosint-SOL (levothyroxine sodium) oral solution is the leading FDA-approved levothyroxine oral solution currently available in the US.

The newly published treatment guidelines reinforce the use of Tirosint-SOL in the pediatric population. A randomized clinical study published in the journal Hormone Research in Pediatrics examined the efficacy and safety of treating infants newly diagnosed with CH with levothyroxine oral solution in lieu of traditional levothyroxine tablet formulations. In total, 78 infants with congenital hypothyroidism (CH) were studied.² The study's authors concluded that levothyroxine oral solution was able to successfully treat CH patients to their therapeutic goals. Equally important, no study subject experienced cranial stenosis, a serious adverse effect experienced by infants who are exposed to excessive doses of levothyroxine.

"The mention of levothyroxine oral solution in newly published guidelines is an acknowledgement of the utility of drugs like Tirosint-SOL for treating infants with congenital hypothyroidism" stated Susan Rose, Professor Emeritus of the University of Cincinnati College of Medicine, and Cincinnati Children's Hospital Medical Center. "However, liquid formulations like Tirosint-SOL are more easily absorbed than traditional tablet formulations, the current standard of care. Clinicians wishing to prescribe it should take this into consideration." Rose went on to add that "the availability of FDA-approved levothyroxine oral solutions makes it critical to avoid the use of extemporaneously compounded liquid levothyroxine preparations which have been demonstrated to be pharmacologically inconsistent. Clinicians wishing to prescribe liquid levothyroxine for children now have an FDA-approved oral solution."

The new treatment guidelines for congenital hypothyroidism were developed jointly by the American Academy of Pediatrics (AAP), the Pediatric Endocrine Society (PES) and the American Thyroid Association (ATA). The new guidelines were published in Pediatrics, the Journal of the American Academy of Pediatrics. The journal is available in print and online.  

Commenting on the publication of the new guidelines, IBSA Pharma Chief Business and Medical Officer Dr. Carolyn Kong stated that "congenital hypothyroidism is a serious condition with significant public health implications. Traditional levothyroxine tablet formulations have been used for years to treat this population. These formulations require caregivers to crush a child's medication into powder and then to mix it into water before administration. The availability of a levothyroxine oral solutions like Tirosint^®-SOL, which has been demonstrated to be effective and safe for infants with CH, now provides patients and healthcare practitioners with a simple, consistent, and convenient option for treating CH."

Tirosint^®-SOL is the only FDA-approved levothyroxine oral solution available in monodose packaging for convenience and dosing precision. It does not contain gluten, dyes, colorants, lactose, and other ingredients that can cause tolerability and absorption problems. Its unique formulation consists of only three ingredients – levothyroxine, glycerol, and water – which is packaged in patented monodose ampules for precision and convenience. 

Tirosint^®-SOL is indicated to treat the full spectrum of hypothyroid patients regardless of age. It can be administered by pouring the contents of the monodose ampule directly into the mouth or using a spoon or mixing it with water. It is currently available in 15 dosage strengths including unique 13, 37.5, 44 and 62.5 microgram dosing options, giving it the widest dosing range of any levothyroxine therapy available.

To help provide patients with cost-effective access to Tirosint®-SOL, IBSA recently enhanced the Tirosint^®-SOL Copay Savings Coupon Program. With the new program, eligible patients with commercial insurance can pay as little as $4 for a one-month supply of Tirosint^®-SOL or $0 for a 3-month supply. Additional information, including money-saving options for patients without commercial insurance or with high copays or deductibles, can be found at www.TirosintSOL.com. 

Congenital hypothyroidism (CH) is an endocrine disorder present in up to 1 in every 2,000 - 4,000 live births in the United States each year. It is the result of inadequate thyroid function which results in low or inexistent levels of thyroid hormones. Thyroid hormones are key to the development of human infants. Untreated, or sub-optimally treated, CH is a leading cause of intellectual disability.¹ Levothyroxine is the current standard for treating

CH. It is a synthetic thyroid hormone that is administered daily and is available in intravenous and oral formulations. Oral tablets are the most popular form of levothyroxine and must be crushed and added to water before administration to infants. Levothyroxine therapy for CH, once started, continues for three years to life depending on the severity of the disease. Levothyroxine is available by prescription only.

IBSA Pharma is part of IBSA Group which is headquartered in Lugano, Switzerland. IBSA Pharma currently markets Tirosint^® (levothyroxine sodium) capsules and Tirosint^®-SOL (levothyroxine sodium) oral solution for the treatment of hypothyroidism and Licart^® (diclofenac epolamine) topical system 1.3% and Flector^® (diclofenac epolamine) topical system 1.3% for the treatment of acute pain due to strains, sprains, and contusions.

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

¹ Rastogi V et al, "Congenital hypothyroidism", Orphanet Journal of Rare Diseases, 2010; 5:17
² Peroni et al, "Congenital hypothyroidism treatment in infants: a comparative study between liquid and tablet formulations of levothyroxine", Hormone Res Paediatrics, 2014: (81) 50 -54

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

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

PM 01-22-0102

SOURCE IBSA Pharma, Inc.