Treatment Challenges
Actor
portrayal.
Treatment Challenges
Actor
portrayal.
Do you see patients like these in your practice?
Treatment Challenge:
Despite stable TSH levels, Catherine struggles with persistent symptoms
Age: 56 years
Occupation: Social worker
Treatment: Levothyroxine tablets; adjustment to treatment already made within the previous year
TSH levels: Within normal range
Symptomology: Common symptoms of hypothyroidism persist, including slowed thinking, weight gain, and fatigue1
It’s time to speak up about the symptoms I’m living with. I still don’t feel normal.”
Treatment Challenge:
Getting TSH levels to normal may leave some patients with unresolved persistent symptoms1
Age: 51 years
Occupation: Guidance counselor
Treatment: Levothyroxine tablets; adjustment to treatment already made within the previous year
TSH levels: Within normal range
Symptomology: Common symptoms of hypothyroidism persist, including brain fog, weight gain, and fatigue1
My TSH is within normal range, but I am still dealing with symptoms like brain fog, and I don’t feel normal.”
Actor portrayal.
Per ATA guidelines, the main goals of replacement therapy include resolution of patient symptoms and hypothyroid signs, normalization of TSH levels with improvement in thyroid hormone concentrations, and avoiding overtreatment (iatrogenic thyrotoxicosis), especially in the elderly.1
TIROSINT Capsules contain just 4 ingredients2
TIROSINT Capsules do not contain excipients that might interfere with absorption or tolerability2
Capsule shown not actual size.
This table provides information regarding formulation only and does not imply any product comparisons about safety or efficacy. For details, please see the Full Prescribing Information for each product. This is not a complete listing of all approved hypothyroidism medications.
*Ingredients may vary based on formulation.
TIROSINT offers a wide range of options for precise LT4 dosing2
INDICATION AND USAGE
TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with:
- Hypothyroidism – As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
- Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression – As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
- TIROSINT is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
- TIROSINT is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
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
- TIROSINT is contraindicated in patients with 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.
Adverse Reactions
Adverse reactions with levothyroxine therapy are primarily those of hyperthyroidism 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, muscle spasm
- 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, rash
- 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 hormone 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.
Drug Interactions
Many drugs and some foods can exert effects on thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT. Administer at least 4 hours before or after drugs that are known to interfere with absorption. See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism.
Please click here for Full Prescribing Information, including BOXED WARNING, for TIROSINT.
References: 1. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 2. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022.
References: 1. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022. 2. Data on file, Institut Biochimique SA (IBSA).
References: 1. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 2. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022.