IBSA USA Showcases Various Therapies at AANP 2024

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 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 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.
 

For Full Prescribing Information, including Boxed Warning, go to Tirosint-PI.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

                                                  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