INDICATION
THYQUIDITY™ levothyroxine sodium (T4) indicated for:
- Hypothyroidism: As a 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
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
IMPORTANT SAFETY INFORMATION
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
See full prescribing information for complete boxed warning
- Thyroid hormones, including THYQUIDITY, 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-threating manifestations of toxicity. (6, 10).
Contraindications
THYQUIDITY is contraindicated in patients with uncorrected adrenal insufficiency.
Warnings and Precautions
Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Over-treatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias, particularly in patients with cardiovascular disease and in elderly patients. Initiate THYQUIDITY therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease.
Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive THYQUIDITY therapy. Monitor patients receiving concomitant THYQUIDITY and sympathomimetic agents for signs and symptoms of coronary insufficiency.
If cardiac symptoms develop or worsen, reduce the THYQUIDITY dose or withhold for one week and restart at a lower dose.
Myxedema coma: Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Use of oral thyroid hormone drug products is not recommended to treat myxedema coma. Administer thyroid hormone products formulated for intravenous administration to treat myxedema coma.
Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency: Thyroid hormone increases metabolic clearance of glucocorticoids. Initiation of thyroid hormone therapy prior to initiating glucocorticoid therapy may precipitate an acute adrenal crisis in patients with adrenal insufficiency. Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with THYQUIDITY.
Prevention of Hyperthyroidism or Incomplete Treatment of Hypothyroidism: THYQUIDITY has a narrow therapeutic index. Over- or undertreatment with THYQUIDITY may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism. Titrate the dose of THYQUIDITY carefully and monitor response to titration to avoid these effects. Monitor for the presence of drug or food interactions when using THYQUIDITY and adjust the dose as necessary.
Worsening of Diabetic Control: Addition of levothyroxine 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 THYQUIDITY.
Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement: Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in post-menopausal women. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase, and suppressed serum parathyroid hormone levels. Administer the minimum dose of THYQUIDITY that achieves the desired clinical and biochemical response to mitigate this risk.
Adverse Reactions
Adverse reactions associated with THYQUIDITY therapy are primarily those of hyperthyroidism due to therapeutic overdosage: 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.
Drug Interactions
See full prescribing information for drugs that affect thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to THYQUIDITY.
Use in Specific Populations
Pregnancy: Since TSH levels may increase during pregnancy, TSH should be monitored and THYQUIDITY dosage adjusted during pregnancy. THYQUIDITY should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. Pregnancy may increase THYQUIDITY requirements. Serum TSH levels should be monitored and the THYQUIDITY dosage adjusted during pregnancy to maintain TSH within normal trimester specific ranges. Since postpartum TSH levels are similar to preconception values, the THYQUIDITY dosage should return to the pre-pregnancy dose immediately after delivery.
Lactation: Limited published studies report that levothyroxine is present in human milk. No adverse effects on the breastfed infant have been reported and there is no information on the effects of levothyroxine on milk production. Adequate levothyroxine treatment during lactation may normalize milk production in hypothyroid lactating mothers with low milk supply. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for THYQUIDITY and any potential adverse effects on the breastfed infant from THYQUIDITY or from the underlying maternal condition.
Pediatric Use: Safety and effectiveness of THYQUIDITY has been established for the treatment of congenital hypothyroidism and acquired hypothyroidism in pediatric patients down to birth. Glycerol has the potential to cause gastrointestinal irritation resulting in vomiting and/or osmotic diarrhea. Patients in the first 3 months of life may be particularly susceptible to serious fluid and electrolyte complications from glycerol-induced gastrointestinal irritation. Closely monitor patients from birth to 3 months of age receiving THYQUIDITY for signs and symptoms of gastrointestinal irritation.
Geriatric Use: Because of the increased prevalence of cardiovascular disease among the elderly, initiate THYQUIDITY at less than the full replacement dose. Atrial arrhythmias can occur in elderly patients. Atrial fibrillation is the most common of the arrhythmias observed with levothyroxine overtreatment in the elderly.
The Important Safety Information does not include all the information needed to use THYQUIDITY safely and effectively. Visit THYQUIDITY.com for Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461- 7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
PP-THY-US-0005
