EUTHYROX® provides sealed levothyroxine safeguards hypothyroid treatment potency2,3
EUTHYROX offers a brand levothyroxine with precise and protected potency2,3 at a generic price.4
AB-rated to Synthroid® (levothyroxine sodium)—bioequivalent.5
Levothyroxine is highly sensitive to light, oxygen, and moisture/humidity3,6
- Light, oxygen, and moisture/humidity impact levothyroxine potency.3,6
- Repeated exposure to light, oxygen, and moisture/humidity during prescription fulfillment and home storage of levothyroxine can negatively impact potency over the course of the treatment.3,6
- Many patients store their medicines in well-lit and humid areas of their homes, including the kitchen or bathroom.6
Levothyroxine has a narrow therapeutic index7
- Levothyroxine is prescribed in micrograms.2
- Dosing precision and consistency are important for proper treatment.7
- Patients with inconsistent treatment run the risk of negative effects associated with under- and overtreatment.8
- Undertreated hypothyroid patients may experience symptoms similar to untreated hypothyroidism.8
- Undertreatment can be the result of an incorrect levothyroxine dosage or from tablets with incorrect potency due to exposure to environmental conditions.3,6
EUTHYROX blister packaging safeguards levothyroxine potency better than bottles3
- Blister-packaged tablets safeguard EUTHYROX from potency-robbing light and moisture.2,3,6
- Bottled levothyroxine tablets fail to provide the more effective protection that blister packaging offers.3
- Bottled levothyroxine may be repeatedly exposed to light, moisture, and oxygen. This can include before and after prescriptions are filled, and again when stored in light and in moist/humid areas of the home.3,6
A brand product at a generic price4
- Most health plans cover EUTHYROX on a generic or preferred brand tier.4
- Wholesale acquisition cost (WAC) and suggested wholesale price (SWP) are in line with generics.9
- Patients typically have low out-of-pocket costs.4,10
Additional EUTHYROX benefits
EUTHYROX is the world's most dispensed levothyroxine brand1
- More than 53 million patients are treated annually around the globe with EUTHYROX.1
Contains no dyes, lactose, or gluten2,13; braille-imprinted packaging
- All EUTHYROX tablets are dye-free, lactose-free, and gluten-free,2,13 which minimizes the possibility of adverse effects related to associated sensitivities.
- EUTHYROX packaging incorporates braille encoding for visually impaired patients.
- No history of EUTHYROX recalls in the United States.11
- Tablets are scored, with the dosage strength embossed.2
Fill prescriptions with EUTHYROX in blister packaging.
Safeguard your patients and their levothyroxine treatments3,6
INDICATIONS2
Hypothyroidism
EUTHYROX is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid Stimulating Hormone, TSH) Suppression
EUTHYROX is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
- EUTHYROX is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with EUTHYROX may induce hyperthyroidism.
- EUTHYROX is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
IMPORTANT SAFETY INFORMATION2
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including EUTHYROX, 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.
CONTRAINDICATIONS
EUTHYROX is contraindicated in patients with uncorrected adrenal insufficiency.
WARNINGS AND PRECAUTIONS
- EUTHYROX has a narrow therapeutic index. Overtreatment or undertreatment with EUTHYROX 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 in adult or pediatric patients. Titrate the dose of EUTHYROX carefully and monitor response to titration to avoid these effects. Monitor for the presence of drug or food interactions when using EUTHYROX and adjust the dose as necessary.
- In the elderly and in patients with cardiovascular disease, initiate EUTHYROX at lower doses than those recommended in younger individuals or in patients without cardiac disease.
- Patients with coronary artery disease who are receiving EUTHYROX should be monitored closely during surgical procedures for cardiac arrythmias. Monitor patients during concomitant administration of EUTHYROX and sympathomimetic agents for signs and symptoms of coronary insufficiency. If cardiovascular symptoms develop or worsen, reduce or withhold the EUTHYROX dose for one week and restart at a lower dose.
- Use of oral thyroid hormone is not recommended to treat myxedema coma. Use products formulated for IV administration to treat myxedema coma.
- Treat patients with adrenal insufficiency with replacement glucocorticoids prior to initiating treatment with EUTHYROX. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated.
- 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 EUTHYROX.
- Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in postmenopausal women. To mitigate this risk, administer the minimum dose of EUTHYROX that achieves the desired response.
ADVERSE REACTIONS
- Adverse reactions associated with EUTHYROX 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.
- In pediatric patients receiving levothyroxine therapy, pseudotumor cerebri and slipped capital femoral epiphysis have been reported. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in pediatric patients with resultant compromised adult height.
- Seizures have been reported rarely with levothyroxine therapy.
DRUG INTERACTIONS
- Many drugs and some foods affect thyroid hormone pharmacokinetics and metabolism and may alter the therapeutic response to EUTHYROX. 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 adjustment when regularly administering within one hour of certain foods that may affect absorption. Prescribers should consult appropriate reference sources for additional information on drug or food interactions with EUTHYROX.
USE IN SPECIFIC POPULATIONS
- EUTHYROX should not be discontinued during pregnancy, and hypothyroidism diagnosed during pregnancy should be promptly treated. TSH levels may increase during pregnancy, so TSH should be monitored and EUTHYROX dose adjusted as needed.
PLEASE REFER TO THE FULL PRESCRIBING INFORMATION THAT CAN BE FOUND HERE.
You are encouraged to report negative side effects of prescription drugs to the FDA. You can do this by contacting FDA at 1-800-FDA-1088 or you can visit www.fda.gov/medwatch.
To contact us regarding a product quality issue or submit a medical inquiry, click here.
Tell your healthcare provider if you experience any of the following: fast or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual period, hives or skin rash, or any other unusual medical event.
These are not all the possible side effects of EUTHYROX. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
An AB-rated pharmaceutical is one that is therapeutically equivalent to another product, expected to have "the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling."12 It is generally substitutable without requiring authorization from the prescriber.
EUTHYROX® is a registered trademark of Merck KGaA Darmstadt, Germany.
Synthroid® is a registered trademark of AbbVie, Inc.
USP: The US Pharmacopeia is a reference of uniform preparations for the most commonly used drugs—with tests to ensure their quality, potency and purity.
References: 1. Data on file. Merck KGaA, Darmstadt, Germany. 2. EUTHYROX package insert. Provell Pharmaceuticals LLC; 2022. 3. Chun J. Stability of levothyroxine tablets in blister packaging versus bottles and vials under simulated in-use conditions. AAPS Open. 2022;8:15. Accessed January 14, 2023. https://doi.org/10.1186/s41120-022-00062-5 4. Data on file. Managed Markets Insight & Technology LLC database; August 25, 2022. 5. FDA. Approved drug products with therapeutic equivalence evaluations. 43rd ed. 2023. Accessed February 27, 2023. https://www.fda.gov/media/71474/download 6. Benvenga S, Papi G, Antonelli A. Refractory hypothyroidism due to improper storage of levothyroxine tablets. Front Endocrinol (Lausanne). 2017;8:155. 7. FDA.gov. Real-world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug products. Accessed January 6, 2023. https://www.fda.gov/drugs/news-events-human-drugs/real-world-evidence-narrow-therapeutic-index-product-levothyroxine-reflects-therapeutic-equivalence 8. British Thyroid Foundation. Accessed March 15, 2023. https://www.btf-thyroid.org/hypothyroidism-leaflet 9. AnalySource®. Reprinted with permission by First Databank, Inc. All rights reserved. ©2023. 10. Feldman R. The devil in the tiers. J Law Biosci. 2021;8(1):lsaa081. https://doi.org/10.1093/jlb/lsaa081 11. FDA.gov. Recalls, Market Withdrawals, & Safety Alerts. Accessed March 27, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts 12. FDA. Accessed March 16, 2023. https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface 13. Data on file. Provell Pharmaceuticals LLC.
