Ermeza Oral Solution Dosage

Generic name: LEVOTHYROXINE SODIUM 30ug in 1mL
Dosage form: oral solution
Drug class: Thyroid drugs

Medically reviewed by Drugs.com. Last updated on Apr 5, 2024.

Important Administration Instructions

Administer ERMEZA as a single daily oral dose, on an empty stomach, one-half to one hour before breakfast.

Administer ERMEZA at least 4 hours before or after drugs known to interfere with levothyroxine absorption [see Drug Interactions (7.1)].

Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect levothyroxine absorption [see Dosage and Administration (2.2 and 2.3), Drug Interactions (7.9) and Clinical Pharmacology (12.3)].

Convert mcg dosage to mL using the following equation and round up or down to the nearest syringe graduation [see Dosage and Administration (2.4)]:

Administer ERMEZA directly to the mouth using the 5 mL or 10 mL oral syringe provided in the original carton. A household teaspoon or tablespoon is not an adequate measuring device. Instruct patients to read the “Instructions for Use” carefully for complete directions on how to properly dose and administer ERMEZA.

Important Considerations for Dosing

ERMEZA oral solution may have a different concentration from other levothyroxine oral solution products. Use caution and consider the total dosage in terms of mcg and not volume (mL) when converting between ERMEZA and other levothyroxine oral solution products.

The dosage of ERMEZA 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), and 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 (2.5)].

For adult patients with primary hypothyroidism, titrate until the patient is clinically euthyroid and the serum TSH returns to normal [see Dosage and Administration (2.3)].

For secondary or tertiary hypothyroidism, serum TSH is not a reliable measure of ERMEZA dosage adequacy and should not be used to monitor therapy. Use the serum free-T4 level to titrate ERMEZA dosing until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range [see Dosage and Administration (2.3)].

The peak therapeutic effect of a given dose of ERMEZA may not be attained for 4 to 6 weeks.

Recommended Dosage and Titration

Primary, Secondary, and Tertiary Hypothyroidism in Adults

The recommended starting daily dosage of ERMEZA in adults with primary, secondary, or tertiary hypothyroidism is based on age and comorbid cardiac conditions, as described in Table 1. For patients at risk of atrial fibrillation or patients with underlying cardiac disease, start with a lower dosage and titrate the dosage more slowly to avoid exacerbation of cardiac symptoms. Dosage titration is based on serum TSH or free-T4 [see Dosage and Administration (2.2)].

Table 1. ERMEZA Dosing Guidelines for Hypothyroidism in Adults*
* Dosages greater than 200 mcg/day are seldom required. An inadequate response to daily dosages greater than 300 mcg/day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors [see Dosage and Administration (2.1) and Drug Interactions (7)].
Patient Population	Starting Dosage	Dosage Titration Based on Serum TSH or Free-T4
Adults diagnosed with hypothyroidism	Full replacement dose is 1.6 mcg/kg/day. Some patients require a lower starting dose.	Titrate dosage by 12.5 to 25 mcg increments every 4 to 6 weeks, as needed until the patient is euthyroid.
Adults at risk for atrial fibrillation or with underlying cardiac disease	Lower starting dose, less than 1.6 mcg/kg/day.	Titrate dosage every 6 to 8 weeks, as needed until the patient is euthyroid.
Geriatric patients	Lower starting dose, less than 1.6 mcg/kg/day.

Primary, Secondary, and Tertiary Hypothyroidism in Pediatric Patients

The recommended starting daily dosage of ERMEZA in pediatric patients with primary, secondary, or tertiary hypothyroidism is based on body weight and changes with age as described in Table 2. Titrate the dosage (every 2 weeks) as needed based on serum TSH or free-T4 until the patient is euthyroid [see Dosage and Administration (2.2)].

Table 2. ERMEZA Dosing Guidelines for Hypothyroidism in Pediatric Patients
* Adjust dosage based on clinical response and laboratory parameters [see Dosage and Administration (2.4) and Use in Specific Populations (8.4)].
Age	Starting Daily Dosage Per Kg Body Weight*
0-3 months	10-15 mcg/kg/day
3-6 months	8-10 mcg/kg/day
6-12 months	6-8 mcg/kg/day
1-5 years	5-6 mcg/kg/day
6-12 years	4-5 mcg/kg/day
Greater than 12 years but growth and puberty incomplete	2-3 mcg/kg/day
Growth and puberty complete	1.6 mcg/kg/day

Pediatric Patients from Birth to 3 Months of Age at Risk for Cardiac Failure

Start at a lower starting dosage and increase the dosage 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, start at one-fourth the recommended full replacement dosage, and increase on a weekly basis by one-fourth the full recommended replacement dosage until the full recommended replacement dosage is reached.

Hypothyroidism in Pregnant Patients

For pregnant patients with pre-existing hypothyroidism, measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at minimum, during each trimester of pregnancy. In pregnant patients with primary hypothyroidism, maintain serum TSH in the trimester-specific reference range. The recommended daily dosage of ERMEZA in pregnant patients is described in Table 3.

Table 3. ERMEZA Dosing Guidelines for Hypothyroidism in Pregnant Patients
Patient Population	Starting Dosage	Dose Adjustment and Titration
Pre-existing primary hypothyroidism with serum TSH above normal trimester-specific range	Pre-pregnancy dosage may increase during pregnancy	Increase ERMEZA dosage by 12.5 to 25 mcg per day. Monitor TSH every 4 weeks until a stable dose is reached and serum TSH is within normal trimester-specific range. Reduce ERMEZA dosage to pre-pregnancy levels immediately after delivery. Monitor serum TSH 4 to 8 weeks postpartum.
New onset hypothyroidism (TSH ≥ 10 IU per liter)	1.6 mcg/kg/day	Monitor serum TSH every 4 weeks and adjust ERMEZA dosage until serum TSH is within normal trimester specific range.
New onset hypothyroidism (TSH < 10 IU per liter)	1.0 mcg/kg/day

TSH Suppression in Well-differentiated Thyroid Cancer in Adult and Pediatric Patients

The ERMEZA dosage is based on the target level for TSH suppression for the stage and clinical status of thyroid cancer.

Converting Recommended Microgram Dosage to Milliliters

After determination of the recommended ERMEZA dosage in mcg [see Dosage and Administration (2.3)], convert the required mcg dosage to mL using the following equation:

Once the mcg dose has been converted to mL, it should be rounded up or down to the nearest syringe graduation (0.1 mL for doses up to 5 mL or 0.2 mL for doses up to 10 mL).

Example of dosing volumes in mL for the equivalent mcg dosages is shown in Table 4.

Table 4: Example Dosing Volumes (mL) for Equivalent Dosages (mcg)
Dose (mcg)	Dose (mL) using 5 mL syringe	Dose (mL) using 10 mL syringe
12.5	0.4	Do not use
25	0.8
50	1.7
75	2.5
88	2.9
100	3.3
112	3.7
125	4.2
137	4.6
150	5.0
175	Do not use	5.8
200		6.6
300		10.0

The 5 mL syringe provided in the original carton should be used for doses up to 5 mL with each graduation mark representing 0.1 mL.

The 10 mL syringe provided in the original carton should be used for doses over 5 mL with each graduation mark representing 0.2 mL.

Monitoring TSH and/or Thyroxine (T4) 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 ERMEZA, may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors.

The risk of thyroid imbalance can be linked to the switch between levothyroxine-containing products. Assess the adequacy of therapy by assessment of laboratory tests, and clinical evaluation is recommended.

Adults

In adult patients with primary hypothyroidism, monitor serum TSH levels after an interval of 6 to 8 weeks after any change in dosage. 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.

Pediatric Patients

In patients with 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 pediatric patients 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 dosage 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.

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 ERMEZA therapy and/or of the serum TSH to decrease below 20 mIU per liter within 4 weeks may indicate the patient is not receiving adequate therapy. Assess compliance, dose of medication administered, and method of administration prior to increasing the dose of ERMEZA [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].