News

IBSA USA Showcases Innovative Therapies at Pri-Med South 2024

Presenting Topical Pain Management and Thyroid Solutions for Primary Care

This February, all eyes in the primary care community are on the Pri-Med South Primary Care CME/CE Conference & Expo in Florida. Designed specifically for clinicians in primary care, family medicine, and internal medicine, this year’s conference took place February 8-10, 2024, in Fort Lauderdale. 

Over the years, IBSA USA has had a notable presence at Pri-Med conferences across the country. Pri-Med South is an ideal platform for IBSA USA to provide attendees with information about its innovative therapies for topical pain management and thyroid disease. 

During the conference, IBSA USA provided healthcare practitioners with an in-depth look at Licart® (diclofenac epolamine) topical system 1.3% the only once-a-day topical nonsteroidal anti-inflammatory drug (NSAID) for acute pain due to minor strains, sprains, and contusions¹ and Tirosint®-SOL (levothryoxine sodium), a unique liquid formulation of levothyroxine (LT4) for the treatment of hypothyroidism. 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.2

"Our presence at this conference underscores our commitment to the primary care community,” said Walter Sandulli, VP of Marketing for IBSA USA. “It was a great opportunity to engage with healthcare professionals and share the latest information about IBSA’s innovative products including our two recent FDA-approved label updates for Tirosint-SOL.” 

For more information on Licart® (diclofenac epolamine) topical system 1.3% including Full Prescribing Information, boxed warning visit https://licart.com/wp-content/uploads/2023/03/Licart-Package-Insert-6-2023.pdf. 

For more information on Tirosint-SOL including Full Prescribing Information, boxed warning visit: https://tirosintsol.com/wp-content/uploads/2023/11/Tirosint-SOL-USPI.pdf.

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IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
•    Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
•    LICART is contraindicated in the setting of coronary artery bypass graft (CABG) surgery
Gastrointestinal Bleeding, Ulceration, and Perforation
•    NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CONTRAINDICATIONS

LICART is contraindicated in the following patients:
•    Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product.
•    History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
•    In the setting of coronary artery bypass graft (CABG) surgery.
•    On non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds.

WARNINGS AND PRECAUTIONS

•    Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop
•    Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure
•    Heart Failure and Edema: Avoid use of LICART in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure
•    Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of LICART in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function
•    Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs
•    Exacerbation of Asthma Related to Aspirin Sensitivity: LICART is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity)
•    Serious Skin Reactions: Discontinue LICART at first appearance of skin rash or other signs of hypersensitivity
•    Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation
•    Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia
•    Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically
•    Fetal Toxicity: Limit use of NSAIDs, including LICART, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus  

ADVERSE REACTIONS

Most common adverse reactions for LICART are application site pruritus and other application site reactions (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Full Prescribing Information, including Boxed Warning, go to https://licart.com/wp-content/uploads/2023/03/Licart-Package-Insert-6-2023.pdf

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 https://tirosintsol.com/wp-content/uploads/2023/11/Tirosint-SOL-USPI.pdf

 

References:

1.    Licart (diclofenac epolamine) topical system 1.3% [package insert]. Parsippany, NJ: IBSA Pharma; 2020. 

2.    Tirosint-SOL Package Insert, IBSA Pharma Inc. 2023. 

 

PM-07-24-0011