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.
thyquidity
levothyroxine oral solution
thyquidity
levothyroxine oral solution
liquid from the start for manageable, personalized thyroid care for pediatric patients and those who have trouble swallowing tablets1,2
liquid from the start for manageable, personalized thyroid care for pediatric patients and those who have trouble swallowing tablets1,2
liquid from the start for manageable, personalized thyroid care for pediatric patients and those who have trouble swallowing tablets1,2
Thyquidity is an FDA-approved oral solution of levothyroxine, thoughtfully designed for pediatric patients and those who may struggle with tablets1,2
Thyquidity is an FDA-approved oral solution of levothyroxine, thoughtfully designed for pediatric patients and those who may struggle with tablets1,2
Thyquidity is an FDA-approved oral solution of levothyroxine, thoughtfully designed for pediatric patients and those who may struggle with tablets1,2
when the usual thyroid
treatment options don’t fit
when the usual thyroid
treatment options don’t fit
tablets may not be the best fit for all patients3
tablets may not be the best fit for all patients3
tablets may not be the best fit for all patients3
Liquid formulations provide an alternative for:
Liquid formulations provide an alternative for:
Liquid formulations provide an alternative for:
Families who don’t want to improvise because their kids have an aversion to or difficulty with tablets
Families who don’t want to improvise because their kids have an aversion to or difficulty with tablets
Families who don’t want to improvise because their kids have an aversion to or difficulty with tablets
Pediatric patients and those with dysphagia2,4,5
Pediatric patients and those with dysphagia2,4,5
Pediatric patients and those with dysphagia2,4,5
Patients who are still symptomatic, potentially due to absorption issues6
Patients who are still symptomatic, potentially due to absorption issues6
thyquidity offers an effective, personalized, exact-dosage formulation
thyquidity offers an effective, personalized, exact-dosage formulation
thyquidity offers an effective, personalized, exact-dosage formulation
for patients that need an alternative to tablets
for patients that need an alternative to tablets
for patients that need an alternative to tablets
Thyquidity is an FDA-approved, ready-to-use oral solution of levothyroxine designed specifically for patients who may struggle to take tablets—especially children1,2
Thyquidity is an option for:
Thyquidity is an FDA-approved, ready-to-use oral solution of levothyroxine designed specifically for patients who may struggle to take tablets—especially children1,2
Thyquidity is an option for:
Thyquidity is an FDA-approved, ready-to-use oral solution of levothyroxine designed specifically for patients who may struggle to take tablets—especially children1,2
Thyquidity is an option for:
Patients with different gastrointestinal (GI) disorders who may experience decreased efficacy with tablets7*†
Patients with different gastrointestinal (GI) disorders who may experience decreased efficacy with tablets7*†
Patients needing treatment post-surgery after hospital discharge1,8
Patients needing treatment post-surgery after hospital discharge1,8
Patients needing treatment post-surgery after hospital discharge1,8
Parents who may be experiencing daily challenges with compounding tablets into suspensions, who want an easier treatment choice for their child
Parents who may be experiencing daily challenges with compounding tablets into suspensions, who want an easier treatment choice for their child
Parents who may be experiencing daily challenges with compounding tablets into suspensions, who want an easier treatment choice for their child
She wakes up ready to take her medicine again.9‡
She wakes up ready to take her medicine again.9‡
She wakes up ready to take her medicine again.9‡
— parent of a thyquidity patient
— parent of a thyquidity patient
— parent of a thyquidity patient
*
*
*
Patients from birth to 3 months of age may be particularly susceptible to serious fluid and electrolyte complications from vomiting and/or osmotic diarrhea due to glycerol-induced GI irritation. Closely monitor patients for signs and symptoms.
†
†
†
Disorders that impair gastric acidity, such as Helicobacter pylori infection and autoimmune atrophic gastritis, as well as medications that block secretion of gastric acid, such as proton-pump inhibitors, may influence the bioavailability of levothyroxine.
‡
‡
‡
Adapted from Data on File, Oliva Therapeutics.
medication access and support
medication access and support
Thyquidity is covered by many commercial insurance plans, with copay assistance and additional support options available for eligible patients.
Thyquidity is covered by many commercial insurance plans, with copay assistance and additional support options available for eligible patients.
Thyquidity is covered by many commercial insurance plans, with copay assistance and additional support options available for eligible patients.
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. Arvedson J. Assessment of pediatric dysphagia and feeding disorders: clinical and instrumental approaches. Dev Disabil Res Rev. 2008;14:118-127. doi:10.1002/ddrr.17 3. Liu H, Li W, Zhang W, et al. Levothyroxine: conventional and novel drug delivery formulations. Endocr Rev. 2023;44:393-416. doi:10.1210/endrev/bnac030 4. Adkins C, Takakura W, Spiegel B, et al. Prevalence and characteristics of dysphagia based on a population-based survey. Clin Gastroenterol Hepatol. 2020;18(9):1970-1979. doi:10.1016/j.cgh.2019.10.029 5. Zdanowicz K, Rycyl A, Marek D, et al. Dysphagia among children—a single-center experience. J Clin Med. 2025;14:2906. doi:10.3390/jcm14092906 6. Centanni M. Thyroxine treatment: absorption, malabsorption, and novel therapeutic approaches. Endocrine. 2013;43:8-9. doi:10.1007/s12020-012-9814-9 7. Fallahi P, Ferrari SM, Elia G, et al. L-T4 therapy in enteric malabsorptive disorders. Front Endocrinol (Lausanne). 2021;12:626371. doi:10.3389/fendo.2021.626371 8. Fallahi P, Ferrari SM, Materazzi G, et al. Oral L-thyroxine liquid versus tablet in patients submitted to total thyroidectomy for thyroid cancer (without malabsorption): a prospective study. Laryngoscope Investig Otolaryngol. 2018;3:405-408. doi:10.1002/lio2.186 9. Data on File, Oliva Therapeutics; 2025.
1. THYQUIDITY (levothyroxine sodium) oral solution [package insert]. Ridgewood, NJ: Oliva Therapeutics, LLC: 04/2025. 2. Arvedson J. Assessment of pediatric dysphagia and feeding disorders: clinical and instrumental approaches. Dev Disabil Res Rev. 2008;14:118-127. doi:10.1002/ddrr.17 3. Liu H, Li W, Zhang W, et al. Levothyroxine: conventional and novel drug delivery formulations. Endocr Rev. 2023;44:393-416. doi:10.1210/endrev/bnac030 4. Adkins C, Takakura W, Spiegel B, et al. Prevalence and characteristics of dysphagia based on a population-based survey. Clin Gastroenterol Hepatol. 2020;18(9):1970-1979. doi:10.1016/j.cgh.2019.10.029 5. Zdanowicz K, Rycyl A, Marek D, et al. Dysphagia among children—a single-center experience. J Clin Med. 2025;14:2906. doi:10.3390/jcm14092906 6. Centanni M. Thyroxine treatment: absorption, malabsorption, and novel therapeutic approaches. Endocrine. 2013;43:8-9. doi:10.1007/s12020-012-9814-9 7. Fallahi P, Ferrari SM, Elia G, et al. L-T4 therapy in enteric malabsorptive disorders. Front Endocrinol (Lausanne). 2021;12:626371. doi:10.3389/fendo.2021.626371 8. Fallahi P, Ferrari SM, Materazzi G, et al. Oral L-thyroxine liquid versus tablet in patients submitted to total thyroidectomy for thyroid cancer (without malabsorption): a prospective study. Laryngoscope Investig Otolaryngol. 2018;3:405-408. doi:10.1002/lio2.186 9. Data on File, Oliva Therapeutics; 2025.
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.
