Why Desiccated Thyroid Extract (DTE)?

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L-T4 monotherapy may not address the needs of every patient living with hypothyroidism1-5
A retrospective, observational, single-center study (N=5,686) found that, despite normal serum TSH levels,
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of patients receiving L-T4 alone fail to achieve normal serum levels of free T3 (the biologically active thyroid hormone)*†1

Therapy brands were not specified in the study.1

*This study evaluated if L-T4 monotherapy can normalize serum FT4 and FT3 in L-T4-treated athyreotic patients (n=1,811, with normal TSH levels on L-T4 for at least 3 months) vs matched euthyroid controls (n=3,875). Patient records were obtained from an academic hospital thyroid clinic.1

Similar findings were observed in multiple studies.2

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Higher serum T4 levels in patients taking monotherapy may impair systemic T3 production via deiodinase pathway downregulation1-4

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Due to a polymorphism of the D2 deiodinase gene, some patients may have impaired T4 to T3 conversion and require higher levels of intracellular T3 than can be provided by L-T4 therapy alone1,5

*This study evaluated if L-T4 monotherapy can normalize serum FT4 and FT3 in L-T4-treated athyreotic patients (n=1,811, with normal TSH levels on L-T4 for at least 3 months) vs matched euthyroid controls (n=3,875). Patient records were obtained from an academic hospital thyroid clinic.1

Similar findings were observed in multiple studies.2

Contemporary perspectives

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FT4, free thyroxine; FT3, free triiodothyronine; L-T4, levothyroxine sodium; L-T3, liothyronine sodium; T4, thyroxine; T3, triiodothyronine; TSH, thyroid-stimulating hormone.

Note that DTE products, including NP Thyroid®, have not been reviewed by the FDA for safety or efficacy.

IMPORTANT RISK INFORMATION, INCLUDING BOXED WARNING & INDICATIONS
Important Risk Information

Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
  • NP Thyroid® is contraindicated in patients with uncorrected adrenal insufficiency, untreated thyrotoxicosis, and hypersensitivity to any component of the product.
  • In the elderly and in patients with cardiovascular disease, NP Thyroid® should be used with greater caution than younger patients or those without cardiovascular disease.
  • Use of NP Thyroid® in patients with diabetes mellitus or adrenal cortical insufficiency may worsen the intensity of their symptoms.
  • The therapy of myxedema coma requires simultaneous administration of glucocorticoids.
  • Concomitant use of NP Thyroid® with oral anticoagulants alters the sensitivity of oral anticoagulants. Prothrombin time should be closely monitored in thyroid-treated patients on oral anticoagulants.
  • In infants, excessive doses of NP Thyroid® may produce craniosynostosis.
  • Partial loss of hair may be experienced by children in the first few months of therapy but is usually transient.
  • Adverse reactions associated with NP Thyroid® therapy are primarily those of hyperthyroidism due to therapeutic overdosage.
  • Many drugs and some laboratory tests may alter the therapeutic response to NP Thyroid®. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. Administer at least 4 hours before or after drugs that are known to interfere with absorption. Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption.
  • NP Thyroid® should not be discontinued during pregnancy, and hypothyroidism diagnosed during pregnancy should be promptly treated.

Indications

NP Thyroid® (thyroid tablets, USP) is a prescription medicine that is used to treat a condition called hypothyroidism from any cause, except for cases of temporary hypothyroidism, which is usually associated with an inflammation of the thyroid (thyroiditis). It is meant to replace or supplement a hormone that is usually made by your thyroid gland.

NP Thyroid® is also used in the treatment and prevention of normal functioning thyroid goiters, such as thyroid nodules, Hashimoto’s thyroiditis, multinodular goiter, and in the management of thyroid cancer.
Revised 10/2023