EUTHYROX

2 DOSAGE AND ADMINISTRATION Administer once daily, on an empty stomach, one-half to one hour before breakfast. ( 2.1 ) Administer at least 4 hours before or after drugs that are known to interfere with absorption. ( 2.1 ) Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. ( 2.1 ) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4 to 6 weeks. ( 2.2 ) See full prescribing information for dosing in specific patient populations. ( 2.3 ) Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status. ( 2.4 ) 2.1 General Administration Information Administer EUTHYROX tablets orally as a single daily dose, on an empty stomach, one-half to one hour before breakfast. Administer EUTHYROX at least 4 hours before or after drugs known to interfere with EUTHYROX absorption [see Drug Interactions (7.1) ]. Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect EUTHYROX absorption [see Drug Interactions (7.9) , Clinical Pharmacology (12.3) ]. Administer EUTHYROX to infants and children who cannot swallow intact tablets by crushing the tablet, suspending the freshly crushed tablet in a small amount (5 mL to 10 mL or 1 teaspoon to 2 teaspoons) of water and immediately administering the suspension by spoon or dropper. Do not store the suspension. Do not administer in foods that decrease absorption of EUTHYROX, such as soybean-based infant formula [see Drug Interactions (7.9) ]. 2.2 General Principles of Dosing The dose of EUTHYROX for hypothyroidism or pituitary TSH suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated [see Dosage and Administration (2.3) , Warnings and Precautions (5) , Drug Interactions (7) ]. Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4) ]. The peak therapeutic effect of a given dose of EUTHYROX may not be attained for 4 to 6 weeks. 2.3 Dosing in Specific Populations Primary Hypothyroidism in Adults and in Adolescents in Whom Growth and Puberty Are Complete Start EUTHYROX at the full replacement dose in otherwise healthy, non-elderly individuals who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of EUTHYROX is approximately 1.6 mcg per kg per day (for example: 100 mcg per day to 125 mcg per day for a 70 kg adult). Adjust the dose by 12.5 mcg to 25 mcg increments every 4 to 6 weeks until the patient is clinically euthyroid and the serum TSH returns to normal. Doses greater than 200 mcg per day are seldom required. An inadequate response to daily doses of greater than 300 mcg per day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors. For elderly patients or patients with underlying cardiac disease, start with a dose of 12.5 mcg per day to 25 mcg per day. Increase the dose every 6 to 8 weeks, as needed until the patient is clinically euthyroid and the serum TSH returns to normal. The full replacement dose of EUTHYROX may be less than 1 mcg per kg per day in elderly patients. In patients with severe longstanding hypothyroidism, start with a dose of 12.5 mcg per day to 25 mcg per day. Adjust the dose in 12.5 mcg to 25 mcg increments every 2 to 4 weeks until the patient is clinically euthyroid and the serum TSH level is normalized. Secondary or Tertiary Hypothyroidism Start EUTHYROX at the full replacement dose in otherwise healthy, non-elderly individuals. Start with a lower dose in elderly patients, patients with underlying cardiovascular disease or patients with severe longstanding hypothyroidism as described above. Serum TSH is not a reliable measure of EUTHYROX dose adequacy in patients with secondary or tertiary hypothyroidism and should not be used to monitor therapy. Use the serum free-T4 (L-thyroxine) level to monitor adequacy of therapy in this patient population. Titrate EUTHYROX dosing per above instructions until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range. Pediatric Dosage - Congenital or Acquired Hypothyroidism The recommended daily dose of EUTHYROX in pediatric patients with hypothyroidism is based on body weight and changes with age as described in Table 1. Start EUTHYROX at the full daily dose in most pediatric patients. Start at a lower starting dose in newborns (0 to 3 months) at risk for cardiac failure and in children at risk for hyperactivity (see below). Monitor for clinical and laboratory response [see Dosage and Administration (2.4) ]. Table 1. EUTHROX Dosing Guidelines for Pediatric Hypothyroidism AGE Daily Dose Per Kg Body Weight The dose should be adjusted based on clinical response and laboratory parameters [see Dosage and Administration (2.4) , Use in Specific Populations (8.4) ] 0 to 3 months 10 mcg/kg daily to 15 mcg/kg daily 3 to 6 months 8 mcg/kg daily to 10 mcg/kg daily 6 to 12 months 6 mcg/kg daily to 8 mcg/kg daily 1 to 5 years 5 mcg/kg daily to 6 mcg/kg daily 6 to 12 years 4 mcg/kg daily to 5 mcg/kg daily Greater than 12 years but growth and puberty incomplete 2 mcg/kg daily to 3 mcg/kg daily Growth and puberty complete 1.6 mcg/kg daily Newborns (0 to 3 months) at Risk for Cardiac Failure : Consider a lower starting dose in newborns at risk for cardiac failure. Increase the dose every 4 to 6 weeks as needed based on clinical and laboratory response. Pediatric Patients at Risk for Hyperactivity: To minimize the risk of hyperactivity in pediatric patients, start at one-fourth the recommended full replacement dose, and increase on a weekly basis by one-fourth the full recommended replacement dose until the full recommended replacement dose is reached. Pregnancy Pre-existing Hypothyroidism: EUTHYROX dose requirements may increase during pregnancy. Measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at a minimum, during each trimester of pregnancy. In patients with primary hypothyroidism, maintain serum TSH in the trimester-specific reference range. For patients with serum TSH above the normal trimester-specific range, increase the dose of EUTHYROX by 12.5 mcg daily to 25 mcg daily and measure TSH every 4 weeks until a stable EUTHYROX dose is reached and serum TSH is within the normal trimester-specific range. Reduce EUTHYROX dosage to pre-pregnancy levels immediately after delivery and measure serum TSH levels 4 to 8 weeks postpartum to ensure EUTHYROX dose is appropriate. New Onset Hypothyroidism: Normalize thyroid function as rapidly as possible. In patients with moderate to severe signs and symptoms of hypothyroidism, start EUTHYROX at the full replacement dose (1.6 mcg per kg body weight per day). In patients with mild hypothyroidism (TSH less than 10 mIU per liter) start EUTHYROX at 1 mcg per kg body weight per day. Evaluate serum TSH every 4 weeks and adjust EUTHYROX dosage until a serum TSH is within the normal trimester-specific range [see Use in Specific Populations (8.1) ]. TSH Suppression in Well-Differentiated Thyroid Cancer The dose of EUTHYROX should target TSH levels within the desired therapeutic range. This may require a EUTHYROX dose of greater than 2 mcg per kg per day, depending on the target level for TSH suppression. 2.4 Monitoring TSH and/or Thyroxine (T 4 ) Levels Assess the adequacy of therapy by periodic assessment of laboratory tests and clinical evaluation. Persistent clinical and laboratory evidence of hypothyroidism despite an apparent adequate replacement dose of EUTHYROX may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors. Adults In adult patients with primary hypothyroidism, monitor serum TSH levels after an interval of 6 to 8 weeks after any change in dose. In patients on a stable and appropriate replacement dose, evaluate clinical and biochemical response every 6 to 12 months and whenever there is a change in the patient's clinical status. Pediatrics In patients with congenital hypothyroidism, assess the adequacy of replacement therapy by measuring both serum TSH and total or free-T4. Monitor TSH and total or free-T4 in children as follows: 2 and 4 weeks after the initiation of treatment, 2 weeks after any change in dosage, and then every 3 to 12 months thereafter following dose stabilization until growth is completed. Poor compliance or abnormal values may necessitate more frequent monitoring. Perform routine clinical examination, including assessment of development, mental and physical growth, and bone maturation, at regular intervals. While the general aim of therapy is to normalize the serum TSH level, TSH may not normalize in some patients due to in utero hypothyroidism causing a resetting of pituitary-thyroid feedback. Failure of the serum T4 to increase into the upper half of the normal range within 2 weeks of initiation of EUTHYROX therapy and/or of the serum TSH to decrease below 20 mIU per liter within 4 weeks may indicate the child is not receiving adequate therapy. Assess compliance, dose of medication administered, and method of administration prior to increasing the dose of EUTHYROX [see Warnings and Precautions (5.4) and Use in Specific Populations (8.4) ]) ]. Secondary and Tertiary Hypothyroidism Monitor serum free-T4 levels and maintain in the upper half of the normal range in these patients.

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1 INDICATIONS AND USAGE EUTHYROX is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.