ERMEZA^®
Individualized Dosing
to Treat Hypothyroidism

Contraindications

ERMEZA is contraindicated in patients with:

• Uncorrected adrenal insufficiency
• Hypersensitivity to glycerin and edetate disodium, inactive ingredients in ERMEZA.

Warnings and Precautions

• Serious Risks Related to Overtreatment or Undertreatment of ERMEZA: ERMEZA has a narrow therapeutic index. Overtreatment or undertreatment with ERMEZA may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, gastrointestinal function, and glucose and lipid metabolism in adult or pediatric patients. In pediatric patients with congenital and acquired hypothyroidism, undertreatment may adversely affect cognitive development and linear growth, and overtreatment is associated with craniosynostosis and acceleration of bone age. Titrate the dose of ERMEZA carefully and monitor response to titration to avoid these effects. Consider the potential for food or drug interactions and adjust the administration or dosage of ERMEZA as needed.
• Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease: Over-treatment with ERMEZA 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 elderly patients. Initiate ERMEZA 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 ERMEZA therapy. If cardiac symptoms develop or worsen, reduce the ERMEZA dose or withhold for one week and restart at a lower dose.
• Myxedema Coma: May result in unpredictable absorption of ERMEZA 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 of glucocorticoids prior to initiating treatment with ERMEZA.
• 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 ERMEZA.
• 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. Administer the minimum dose of ERMEZA that achieves the desired clinical and biochemical response to mitigate this risk.

Adverse Reactions

• Adverse reactions associated with ERMEZA therapy 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 and impaired fertility
• Seizures have been reported rarely with the institution of levothyroxine therapy.
• Adverse Reactions in Pediatric Patients: Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants who have not undergone complete closure of the fontanelles, and in premature closure of the epiphyses in pediatric patients still experiencing growth with resultant compromised adult height.
• Hypersensitivity Reactions: Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include urticaria, pruritus, skin rash, flushing, angioedema, various gastrointestinal symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness, and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.

Drug Interactions

Many drugs and some foods affect thyroid hormone pharmacokinetics and metabolism and may alter the therapeutic response to ERMEZA. 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. Prescribers should consult appropriate reference sources for additional information on drug or food interactions with ERMEZA.

Use in Specific Populations

• Pregnancy: Since thyroid-stimulating hormone (TSH) levels may increase during pregnancy, TSH should be monitored and ERMEZA dosage adjusted during pregnancy. ERMEZA should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated.
• Lactation: Published studies report that ERMEZA is present in human milk following the oral administration of ERMEZA. No adverse effects on the breastfed infant have been reported and there is no information on the effects of ERMEZA on milk production. Adequate ERMEZA 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 ERMEZA and any potential adverse effects on the breastfed infant from ERMEZA or from the underlying maternal condition.
• Pediatric Use: Glycerin has the potential to cause gastrointestinal irritation resulting in vomiting and/or osmotic diarrhea. Closely monitor patients from birth to 3 months of age receiving ERMEZA for signs and symptoms of gastrointestinal irritation. Closely monitor patients during the first 2 weeks of ERMEZA therapy for cardiac overload and arrhythmias.
• Geriatric Use: Because of the increased prevalence of cardiovascular disease among the elderly, initiate ERMEZA 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 ERMEZA overtreatment in the elderly.

Indications

• Hypothyroidism: ERMEZA (levothyroxine sodium) oral solution is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
• Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: ERMEZA is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitations of Use

• ERMEZA 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 ERMEZA may induce hyperthyroidism.
• ERMEZA is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

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