REFERENCES

Data on file. IQVIA Top Branded Oral Rx Medication. AbbVie Inc. January 2018.
SYNTHROID [package insert]. North Chicago, IL: AbbVie Inc.
Lomenick JP, Wang L, Ampah SB, et al. Generic levothyroxine compared with Synthroid in young children with congenital hypothyroidism. J Clin Endocrinol Metab. 2013;98(2):653-658.
Data on file. Branded Drugs & Thyroid Market and Naturals. AbbVie Inc. 2015.
US Food and Drug Administration. Q&A on CGMPs. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm124740.htm. Accessed January 22, 2021.
US Food and Drug Administration. Current Good Manufacturing Practice Regulations. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm. Accessed January 22, 2021.
Data on file. 37% Data. AbbVie Inc.
Delta Marketing Dynamics. DMD Synthroid Rx Audit Summary, August 2017.
US Department of Health and Human Services. Approved drug products with therapeutic equivalence evaluations. 41st ed.
https://www.fda.gov/media/71474/download. Published 2021. Accessed January 22, 2021.
Data on file. Synthroid Consumer AAU report. AbbVie Inc. 2017
Baskin HJ, Cobin RH, Duick DS, et al; for American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. [published correction appears in Endocr Pract. 2008;14(6):802-803]. Endocr Pract. 2002;8(6):457-469.
Garber JR, Cobin RH, Gharib H, et al. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr Pract. 2012;18(6):988-1028.
Demers LM, Spencer CA, eds; National Academy of Clinical Biochemistry. Laboratory medicine practice guidelines: laboratory support for the diagnosis of thyroid disease.
https://www.aacc.org/-/media/Files/Science-and-Practice/Practice-Guidelines/Thyroid-Disease/ThyroidArchived2010.pdf?la=en&hash=0556298535B60C441FBB6AC742E3A4652E0332F8. Published 2002. Accessed January 22, 2021.
Managed Markets Insights & Technology (MMIT). Accessed January 2021. As of December 2020.
Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado thyroid disease prevalence study. Arch Intern Med. 2000;160:526-534.
Carr D, McLeod DT, Parry G, Thornes HM. Fine adjustment of thyroxine replacement dosage: comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment.Clin Endocrinol (Oxf). 1988;28(3):325-333.
Hypothyroidism. American Thyroid Association website.
https://www.thyroid.org/wp-content/uploads/patients/brochures/Hypothyroidism_web_booklet.pdf?pdf=Hypothyroidism%20Booklet. Updated 2019. Accessed January 21, 2021.
Alexander EK, Pearce EN, Brent GA, et al. 2017 Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and the postpartum. Thyroid. 2017;27(3):315-389.
Hollowell JG, Staehling NW, Flanders WD, et al. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002;87(2):489-499.

INDICATION²

Hypothyroidism
SYNTHROID^® (levothyroxine sodium) tablets, for oral use is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid Stimulating Hormone, TSH) Suppression
SYNTHROID is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitation of Use²

SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients, as there are no clinical benefits and over-treatment with SYNTHROID may induce hyperthyroidism.

SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

INDICATION²

Limitation of Use²

SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

INDICATION²

Limitation of Use²

SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

INDICATION²

Hypothyroidism: SYNTHROID^® (levothyroxine sodium) tablets, for oral use is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

IMPORTANT SAFETY INFORMATION²

WARNING:

Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

IMPORTANT SAFETY INFORMATION²

WARNING:

IMPORTANT SAFETY INFORMATION²

WARNING: Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of

IMPORTANT SAFETY INFORMATION²

WARNING: Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of

US-SYNT-210030

REFERENCES

INDICATION2

Limitation of Use2

INDICATION2

Limitation of Use2

INDICATION2

INDICATION2

Limitation of Use2

INDICATION2

IMPORTANT SAFETY INFORMATION2

WARNING:

IMPORTANT SAFETY INFORMATION2

WARNING:

IMPORTANT SAFETY INFORMATION2

WARNING: Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of

IMPORTANT SAFETY INFORMATION2

WARNING: Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of

INDICATION²

Limitation of Use²

INDICATION²

Limitation of Use²

INDICATION²

INDICATION²

Limitation of Use²

INDICATION²

IMPORTANT SAFETY INFORMATION²

IMPORTANT SAFETY INFORMATION²

IMPORTANT SAFETY INFORMATION²

IMPORTANT SAFETY INFORMATION²