INDICATIONS
THYQUIDITY is levothyroxine sodium (T4) indicated for:
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:
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-threatening manifestations of toxicity.
IMPORTANT SAFETY INFORMATION (cont'd)
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
Many drugs can affect thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to THYQUIDITY (see full Prescribing Information for additional details).
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.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Please see the full Prescribing Information including BOXED WARNING.
All patient and physician images are representative only.
INDICATIONS
THYQUIDITY is levothyroxine sodium (T4) indicated for:
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
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-threatening manifestations of toxicity.
IMPORTANT SAFETY INFORMATION (cont'd)
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
Many drugs can affect thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to THYQUIDITY (see full Prescribing Information for additional details).
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.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Please see the full Prescribing Information including BOXED WARNING.
All patient and physician images are representative only.
INDICATIONS
THYQUIDITY is levothyroxine sodium (T4) indicated for:
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
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-threatening manifestations of toxicity.
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
Many drugs can affect thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to THYQUIDITY (see full Prescribing Information for additional details).
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.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Please see the full Prescribing Information including BOXED WARNING.
All patient and physician images are representative only.
precision in every dose1
precision in every dose1
precision in every dose1
a single-strength oral solution designed for consistency and dosing confidence1,2
a single-strength oral solution designed for consistency and dosing confidence1,2
a single-strength oral solution designed for consistency and dosing confidence1,2
Adjustments by weight in pediatric care1
Adjustments by weight in pediatric care1
Adjustments by weight in pediatric care1
Titrate therapy with precise, flexible dosing1
Titrate therapy with precise, flexible dosing1
Titrate therapy with precise, flexible dosing1
Measured by volume using a calibrated syringe1
Measured by volume using a calibrated syringe1
Measured by volume using a calibrated syringe1
Patients can benefit from a therapy that fits their real-life needs.
Patients can benefit from a therapy that fits their real-life needs.
Patients can benefit from a therapy that fits their real-life needs.
designed to deliver an individualized dose to patients1
designed to deliver an individualized dose to patients1
designed to deliver an individualized dose to patients1
Administration and dosing information.
Administer THYQUIDITY as a single daily oral dose, on an empty stomach, one-half to one hour before breakfast.
Administer THYQUIDITY at least 4 hours before or after drugs known to interfere with THYQUIDITY absorption (see full Prescribing Information for details).
Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect THYQUIDITY absorption (see full Prescribing Information for details).
Administer THYQUIDITY directly to the mouth using a calibrated oral syringe provided by the pharmacy. A household teaspoon or tablespoon is not an adequate measuring device.
The dose of THYQUIDITY for hypothyroidism or pituitary TSH suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated. Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters.
The peak therapeutic effect of a given dose of THYQUIDITY may not be attained for 4 to 6 weeks.
Patient Type
Starting dose
Dose adjustment and TSH measurement*
Primary Hypothyroidism in Adults
Otherwise healthy, nonelderly individuals who have been hypothyroid for only a short time (a few months)
~1.6 mcg/kg/day
Adjust by 12.5 to 25 mcg increments every 4 to 6 weeks until clinically euthyroid and TSH normalized
Elderly patients or patients with underlying cardiac disease
12.5 to 25 mcg/day
Increase dose every 6 to 8 weeks, as needed, until clinically euthyroid and TSH normalized
Patients with severe, long-standing hypothyroidism
12.5 to 25 mcg/day
Adjust by 12.5 to 25 mcg increments every 2 to 4 weeks until clinically euthyroid and TSH normalized
Pediatric patients
See Prescribing Information for age-specific dosing guidelines from age 0 to completion of puberty as well as for newborns (0-3 months) at risk for cardiac failure and children at risk for hyperactivity
Pregnant patients with pre-existing hypothyroidism
Thyquidity dose requirements may increase during pregnancy. Measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at a minimum, during each trimester of pregnancy. Maintain serum TSH in the trimester-specific reference range
For patients with serum TSH above the normal trimester- specific range, increase the dose of THYQUIDITY by 12.5 to 25 mcg/day and measure TSH every 4 weeks until a stable THYQUIDITY dose is reached and serum TSH is within the normal trimester-specific range.
Reduce THYQUIDITY dosage to pre-pregnancy levels immediately after delivery and measure serum TSH levels 4 to 8 weeks postpartum to ensure THYQUIDITY dose is appropriate
Pregnant patients with new-onset hypothyroidism
Normalize thyroid function as rapidly as possible
Evaluate serum TSH every 4 weeks and adjust Thyquidity dosage until serum TSH is within the normal trimester-specific range
Patients with TSH suppression in well-differentiated thyroid cancer
Generally, TSH is suppressed to below 0.1 mIU per liter, and this usually requires a Thyquidity dose of >2 mcg/kg/day
However, in patients with high-risk tumors, the target level for TSH suppression may be lower
Microgram to milliliter conversion: mcg x 0.05 = mL (or total mcg divided by 20)
Example: 60 mcg = 3.0 mL; 95 mcg = 4.75 mL; 120 mcg = 6.0 mL
*
Serum TSH is not a reliable measure of THYQUIDITY dose adequacy in patients with secondary or tertiary hypothyroidism and should not be used to monitor therapy. Use the serum free-T4 level to monitor adequacy of therapy in this patient population. Titrate THYQUIDITY dosing per above instructions until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.
TSH: thyroid-stimulating hormone.
thyquidity offers an established safety profile1
thyquidity offers an established safety profile1
thyquidity offers an established safety profile1
Adverse reactions associated with Thyquidity are primarily those of hyperthyroidism due to therapeutic overdosage:
Adverse reactions associated with Thyquidity are primarily those of hyperthyroidism due to therapeutic overdosage:
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, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest
Respiratory
Dyspnea
Gastrointestinal
Diarrhea, vomiting, abdominal cramps, elevations in liver function tests
Dermatologic
Hair loss, flushing, rash
Endocrine
Decreased bone mineral density
Reproductive
Menstrual irregularities, impaired fertility
Seizures have been reported rarely with the institution of levothyroxine therapy.
thyroid treatment that fits.
Oliva Therapeutics is proud to offer Thyquidity for patients who need something different—supporting providers in personalizing care with confidence.
thyroid treatment that fits.
Oliva Therapeutics is proud to offer Thyquidity for patients who need something different—supporting providers in personalizing care with confidence.
thyroid treatment that fits.
Oliva Therapeutics is proud to offer Thyquidity for patients who need something different—supporting providers in personalizing care with confidence.
References
1. THYQUIDITY (levothyroxine sodium) oral solution [package insert]. Ridgewood, NJ: Oliva Therapeutics, LLC: 04/2025. 2. Duntas LH, Jonklaas J. Levothyroxine dose adjustment to optimise therapy throughout a patient’s lifetime. Adv Ther. 2019;36(suppl 2):S30-S46. doi:10.1007/s12325-019-01078-2
INDICATIONS
THYQUIDITY is levothyroxine sodium (T4) indicated for:
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:
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-threatening manifestations of toxicity.
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
Many drugs can affect thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to THYQUIDITY (see full Prescribing Information for additional details).
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.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Please see the full Prescribing Information including BOXED WARNING.
All patient and physician images are representative only.
INDICATIONS
THYQUIDITY is levothyroxine sodium (T4) indicated for:
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:
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-threatening manifestations of toxicity.
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
Many drugs can affect thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to THYQUIDITY (see full Prescribing Information for additional details).
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.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Please see the full Prescribing Information including BOXED WARNING.
All patient and physician images are representative only.
INDICATIONS
THYQUIDITY is levothyroxine sodium (T4) indicated for:
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:
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-threatening manifestations of toxicity.
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
Many drugs can affect thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, metabolism, protein binding, and target tissue response) and may alter the therapeutic response to THYQUIDITY (see full Prescribing Information for additional details).
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.
To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics, LLC at 1-877-200-6088, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Please see the full Prescribing Information including BOXED WARNING.
All patient and physician images are representative only.
Thyquidity is a registered trademark of Jerome Stevens Pharmaceuticals, Inc.
© 2026 Oliva Therepeutics. All rights reserved. US-THY-25002-05/26
This site is intended for U.S. healthcare professionals only.
Thyquidity is a registered trademark of Jerome Stevens Pharmaceuticals, Inc.
© 2026 Oliva Therepeutics. All rights reserved. US-THY-25004-05/26
This site is intended for U.S. healthcare professionals only.
Thyquidity is a registered trademark of Jerome Stevens Pharmaceuticals, Inc.
© 2026 Oliva Therepeutics. All rights reserved.
US-THY-25002-05/26
This site is intended for U.S. healthcare professionals only.
