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New FDA-approved label updates offer patients more flexible administration PARSIPPANY, N.J.--(BUSINESS WIRE)-- The U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL (levothyroxine sodium) oral solution, a unique formulation of levothyroxine (LT4) for the treatment of hypothyroidism. The first regards the use of Tirosint-SOL in the presence of proton pump inhibitor (PPI) therapy. The second regards the timing of Tirosint-SOL administration. Both label changes help to differentiate Tirosint-SOL from other levothyroxine therapies. The absorption and performance of levothyroxine tablets has been shown to be affected by the concomitant use of proton pump inhibitors (PPIs).¹ The updated label removes PPIs as a drug that may decrease the absorption and reduce the efficacy of Tirosint-SOL. Similarly, current labeling for all levothyroxine sodium therapies instructs patients to self-administer the drug once daily, on an empty stomach, one-half to one hour before breakfast. Tirosint-SOL’s updated label indicates that it can be administered 15 minutes before eating breakfast.² Tirosint-SOL is now the only FDA-approved LT4 therapy without a labeled interaction with PPIs and the only FDA-approved LT4 therapy that can be administered 15 minutes before eating breakfast. “The availability of this liquid oral levothyroxine formulation, which is not affected by proton pump inhibitors and can be taken just 15 minutes before breakfast, is a real plus for hypothyroid patients and healthcare practitioners,” said Michael Scully, Head of Commercial Operations, IBSA USA. “These new label changes reinforce Tirosint-SOL’s position as a simple, convenient, and clean LT4 therapy with only three ingredients.” The label changes resulted from two clinical studies sponsored and conducted by the Department of R&D and Scientific Affairs - IBSA Institut Biochimique SA, Switzerland. The results of the first study demonstrated a lack of interaction between Tirosint-SOL and the PPI drug omeprazole regardless of the timing of administration of the PPI.³ The results of the second study demonstrated that administration of Tirosint-SOL produces similar levels (bioavailability) of LT4 drug exposure in healthy individuals when taken 15 minutes in advance of eating breakfast as it does when administered 30 minutes before eating breakfast. It did not evaluate Tirosint-SOL’s overall bioavailability when administered simultaneously with eating breakfast.⁴ “Appropriate administration of levothyroxine can be difficult for patients, given the multiple therapies that can interfere with its absorption and the requirement to administer it in a fasting state,”⁵ said Dr. Francesco Celi, University of Connecticut School of Medicine. “The opportunity to provide patients living with hypothyroidism with a medication that is easier to use because it is not affected by PPIs, which are commonly used acid-reducing agents, and can be taken 15 minutes before breakfast, should be of interest to clinicians as it may increase adherence and improve therapeutic outcomes.” Tirosint-SOL has 15 dosing strengths including unique 13, 37.5, 44, and 62.5 microgram dosing options, the widest range of doses for any levothyroxine therapy available in the U.S. It is made with only three ingredients – levothyroxine, glycerol, and water.² Tirosint-SOL is widely available in retail pharmacies. IBSA offers a generous Copay Savings Coupon for Tirosint-SOL, which allows eligible patients with commercial insurance to significantly reduce their out-of-pocket cost for the medication. For patients with high deductibles/copays or without insurance, the company offers a convenient mail-order pharmacy program called Tirosint Direct that offers Tirosint-SOL at the lowest cash price available. Additional information about these money-saving options can be found at 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. For Full Prescribing Information, including Boxed Warning, go to . About IBSA Institut Biochimique⁶ 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 18 subsidiaries located in Europe, China, and the United States. The company has a consolidated turnover of 900 million CHF, and employs over 2,200 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. About Hypothyroidism Hypothyroidism is an endocrine disorder with numerous causes, resulting in a deficiency in thyroid hormone. In the U.S., more than 24.5 million people are estimated to have hypothyroidism.⁷ Large observational studies and meta-analyses have shown that about 4-7% of community-derived populations in the U.S. and Europe have undiagnosed hypothyroidism.⁸ 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.⁹ The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin, and hair loss.¹⁰ Thyroid stimulating hormone (TSH) laboratory tests are recommended as first-line screening tests for thyroid dysfunction.¹¹ 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 suppression of TSH. References Irving SA. Drugs that interact with levothyroxine: an observational study from the Thyroid Epidemiology, Audit and Research Study (TEARS). Clin Endocrinol (Oxf). January 2015;82(1):136-41. Tirosint-SOL Package Insert, IBSA Pharma Inc. 2023. Ducharme M, et al. The pharmacokinetics of a novel solution of levothyroxine is not influenced by proton-pump inhibitor. Poster presentation at 2021 ATA Conference. Ducharme M, et al. A novel levothyroxine solution results in similar bioavailability whether taken 30 or just 15 minutes before a high-fat high-calorie meal. Thyroid. 2022;32(8). McMillan M, et al. “Comorbidities, concomitant medications, and diet as factors affecting levothyroxine therapy: results of the CONTROL Surveillance Project. Drugs in R&D. 2015;16(1):53–68. IBSA Group Website, October 2023. Wynn K. Hypothyroidism prevalence in the United States: A retrospective study combining National Health and Nutrition Examination Survey and Claims Data. J Endocr Soc. 2023;7:1-11. Gottwald-Hostalek U, et al. Low awareness and under-diagnosis of hypothyroidism. Curr Med Res Opinion. 38(1):59-64. Canaris GJ, Manowitz NR, Mayor G, Ridgeway EC. The Colorado thyroid disease prevalence study. Arch Intern Med. 2000;160(4):526-534. McDermott MT. In the clinic: hypothyroidism. Ann Intern Med. 2009;151(11):ITC-6-1. Soh SB. Laboratory testing in thyroid conditions: pitfalls and clinical utility. Ann Lab Med. 2019;39(1):3. For more information about IBSA, visit . For Full Prescribing Information, including Boxed Warning, go to PM-01-23-0082B

Online Pharmacy to Offer Hypothyroidism Treatments at Low Cost PARSIPPANY, N.J., March 7, 2023 /PRNewswire/ -- IBSA Pharma announced today that it has entered into an agreement with Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs) to offer Tirosint® (levothyroxine sodium) oral capsules at a low cash price via the Cost Plus Drugs online pharmacy. The agreement is the first of its kind for a branded levothyroxine drug. Levothyroxine is a synthetic hormone used to treat hypothyroidism. It is one of the most widely dispensed prescription medications in the United States with an estimated 116 million prescriptions filled in 2016.¹ Tirosint capsules is the leading branded gel capsule formulation of levothyroxine in the US. It is formulated without excipients that can cause tolerability and drug absorption problems commonly observed with traditional levothyroxine tablet therapies. Tirosint has money savings options available for patients, their availability in the Cost Plus Drugs program is a first for both companies. Cost Plus Drugs launched its online pharmacy in 2021 and was co-founded by investor-entrepreneur Mark Cuban to reduce the cost of prescription medications. It offers the most commonly prescribed drugs at low transparent prices by negotiating prices directly with manufacturers and passing along the savings to consumers. "Everyone should have access to safe, affordable prescription drugs at transparent prices" commented Cuban at the company's founding. Currently, most of Cost Plus Drugs' offerings are generic drugs. The agreement with IBSA marks one of the company's first forays into the branded segment of the US pharmaceutical market. Cuban is currently a Tirosint patient. Commenting on the agreement, IBSA Pharma CEO Nicholas Hart stated that "hypothyroidism is a prevalent condition with significant public health implications. We are delighted to offer Tirosint capsules to patients via Cost Plus Drugs. Tirosint has been clinically proven to provide the benefits of levothyroxine, the standard of care for treating hypothyroidism, in a formulation that is free of gluten, dyes, lactose, sugars and other excipients commonly found in tablet formulations. These can be problematic for many patients. Studies have shown that up to 31% of levothyroxine-treated patients have gastrointestinal and other problems that can lead to underperformance of levothyroxine therapy and suboptimal control of hypothyroidism.²" Tirosint capsules is a prescription medication that IBSA Pharma markets to physicians and patients. Tirosint capsules are indicated to treat hypothyroidism in patients six years and older and available in 13,25,50,75,88, 100,112,125,137, 150, 175 and 200 mcg doses. Additional information, including money saving options, can be found at . 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. ² Up to 13 million Americans have undiagnosed hypothyroidism. ³ 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.⁴ The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin and hair loss.⁵ TSH laboratory tests are recommended as first-line screening tests for thyroid dysfunction.⁶ 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 inadequate levels 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: Tirosint capsules and Tirosint-SOL (levothyroxine sodium) oral solution for the treatment of hypothyroidism; Licart (diclofenac epolamine) topical system 1.3% and Flector (diclofenac epolamine) topical system 1.3% 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 . For full prescribing information, visit . References Verble, M. Inappropriate use and overdose of PPIs: a strategy for discontinuation. Pharmacy Times, August 2018:35. IMS Institute for Healthcare Informatics Report, "Medicine Use and the Shifting Costs of Healthcare"; 2014; pg. 46 Booth, M, 2019. Published online at: Canaris GJ, Manowitz NR, Mayor G, Ridgeway EC, "The Colorado Thyroid Disease Prevalence Study", Arch of Internal Medicine; 2000;160: 526-534 McDermott MT. "In the clinic: hypothyroidism". Annals of Internal Medicine; 2009;151 (11): ITC-6-1 Soh SB. Laboratory testing in thyroid conditions: pitfalls and clinical utility. Ann Lab Med. 2019;39(1):3. IMPORTANT SAFETY INFORMATION Warning: Not for the Treatment of Obesity or for Weight Loss Thyroid hormones, including TIROSINT, 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 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 Use for the suppression of nontoxic diffuse goiter or nodular thyroid disease: Use is not recommended in iodine-insufficient patients 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 levothyroxine therapy are primarily those of hypothyroidism due to therapeutic overdosage. They include the following: General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central Nervous System: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal: tremors, muscle weakness Cardiovascular: palpitations, tachycardia, arrythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory: dyspnea Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic: hair loss, flushing Endocrine: decreased bone mineral density Reproductive: menstrual irregularities, impaired fertility Adverse reactions in Children Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height. Seizures have been reported rarely with the institution of levothyroxine therapy. Hypersensitivity Reactions Hypersensitivity reactions to inactive ingredients (in this product or other levothyroxine products) have occurred in patients treated with thyroid ho0rmone products. These include urticaria, pruritis, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur. PM-04-23-0001 View original content to download multimedia: SOURCE IBSA Pharma Inc.

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. New Treatment Guidelines for Congenital Hypothyroidism Published Mention Levothyroxine Oral Solution 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 . About Congenital Hypothyroidism (CH) 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. About IBSA Pharma Inc. 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 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 . For full prescribing information, visit . 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