Tirosint Sol

(Levothyroxine Sodium)

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Dosage & Administration

* Administer once daily, on an empty stomach, 15 minutes before breakfast (

2.1 General Administration Information

Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.

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

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption

[see Dosage and Administration (2.2 and 2.3)

Drug Interactions (7.9)and Clinical Pharmacology (12.3)]

TIROSINT-SOL may be administered in water or directly into the mouth:

* To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken. Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule and prepare the solution immediately before intake.
* To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.

)

* Administer at least 4 hours before or after drugs that are known to interfere with absorption (

2.1 General Administration Information

Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.

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

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption

[see Dosage and Administration (2.2 and 2.3)

Drug Interactions (7.9)and Clinical Pharmacology (12.3)]

TIROSINT-SOL may be administered in water or directly into the mouth:

)

* Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption (

2.1 General Administration Information

Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.

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

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption

[see Dosage and Administration (2.2 and 2.3)

Drug Interactions (7.9)and Clinical Pharmacology (12.3)]

TIROSINT-SOL may be administered in water or directly into the mouth:

)

* To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water (

2.1 General Administration Information

Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.

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

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption

[see Dosage and Administration (2.2 and 2.3)

Drug Interactions (7.9)and Clinical Pharmacology (12.3)]

TIROSINT-SOL may be administered in water or directly into the mouth:

)

* To administer TIROSINT-SOL directly, either squeeze it into the mouth OR onto a spoon and immediately consume (

2.1 General Administration Information

Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.

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

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption

[see Dosage and Administration (2.2 and 2.3)

Drug Interactions (7.9)and Clinical Pharmacology (12.3)]

TIROSINT-SOL may be administered in water or directly into the mouth:

)

* Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4-6 weeks (

2.2 Important Considerations for Dosing

The dosage of TIROSINT-SOL 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 dosage adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4)] .

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 TIROSINT-SOL dosage adequacy and should not be used to monitor therapy. Use the serum free-T4 level to titrate TIROSINT-SOL 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 TIROSINT-SOL may not be attained for 4 to 6 weeks.

)

* See full prescribing information for dosing in specific patient populations (

2.3 Recommended Dosage and Titration

Primary, Secondary, and Tertiary Hypothyroidism in Adults

The recommended starting daily dosage of TIROSINT-SOL 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. TIROSINT-SOL Dosing Guidelines for Hypothyroidism in Adults*

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)

*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)].

Primary, Secondary, and Tertiary Hypothyroidism in Pediatric Patients

The recommended starting daily dosage of TIROSINT-SOL 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. TIROSINT-SOL Dosing Guidelines for Hypothyroidism in Pediatric Patients

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

*Adjust dosage based on clinical response and laboratory parameters [see Dosage and Administration (2.4)and Use in Specific Populations (8.4)].

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 TIROSINT-SOL in pregnant patients is described in Table 3.

Table 3. TIROSINT-SOL 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 TIROSINT-SOL 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 TIROSINT-SOL dosage to pre-pregnancy levels immediately after delivery. Monitor serum TSH 4 to 8 weeks postpartum.

New onset hypothyroidism TSH

10 mIU per liter)

1.6 mcg/kg/day

Monitor serum TSH every 4 weeks and adjust TIROSINT-SOL dosage until serum TSH is within normal trimester-specific range.

New onset hypothyroidism (TSH < 10 mIU per liter)

1.0 mcg/kg/day

TSH Suppression in Well-differentiated Thyroid Cancer

in Adults and Pediatric Patients

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

)

* Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status (

2.4 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 TIROSINT-SOL, 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 dosage. In patients on a stable and appropriate replacement dosage, evaluate clinical and biochemical response every 6 to 12 months and whenever there is a change in the patient's clinical status.

Pediatrics 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 mental and physical growth and development, 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 TIROSINT-SOL 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 TIROSINT-SOL

[see Warning and Precautions (5.1)and Use in Specific Populations (8.4)]

Secondary (Pituitary) and Tertiary (Hypothalamic) Hypothyroidism

Monitor serum free-T4 levels and maintain in the upper half of the normal range in these patients.

)

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Tirosint SOL Prescribing Information

Thyroid hormones, including TIROSINT-SOL, 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
[see
6 ADVERSE REACTIONS
Adverse reactions associated with TIROSINT-SOL therapy are primarily those of hyperthyroidism due to therapeutic overdosage
[see Warnings and Precautions (5)and Overdosage (10)].
They include the following:
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 (GI):
diarrhea, vomiting, abdominal cramps, elevations in liver function tests
Dermatologic:
hair loss, flushing, rash
Endocrine:
decreased bone mineral density
Reproductive:
menstrual irregularities, impaired fertility
Seizures have been reported rarely with the institution of levothyroxine therapy.
Adverse reactions associated with TIROSINT-SOL are primarily those of hyperthyroidism due to therapeutic overdosage including: 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
To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
.
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 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 GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness, and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.
,
7.7 Sympathomimetics
Concurrent use of sympathomimetics and TIROSINT-SOL may increase the effects of sympathomimetics or thyroid hormone. Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease.
, and
10 OVERDOSAGE
The signs and symptoms of overdosage are those of hyperthyroidism
[see Warnings and Precautions (5)and Adverse Reactions (6)].
In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures occurred in a 3-year-old child ingesting 3.6 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium.
Reduce the TIROSINT-SOL dose or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status.
For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.
].

Indications and Usage (

1 INDICATION AND USAGE

TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:

Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer

Limitations of Use

Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis

Hypothyroidism

TIROSINT-SOL 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

TIROSINT-SOL 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

Tirosint-SOL 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 TIROSINT-SOL may induce hyperthyroidism
[see Warnings and Precautions (5.1)] .
Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.

)

11/2023

Dosage and Administration (

2.1 General Administration Information

Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.

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

Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption

[see Dosage and Administration (2.2 and 2.3)

Drug Interactions (7.9)and Clinical Pharmacology (12.3)]

TIROSINT-SOL may be administered in water or directly into the mouth:

To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken. Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule and prepare the solution immediately before intake.
To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.

)

11/2023

Dosage and Administration (

2.2 Important Considerations for Dosing

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)].

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

)

11/2023

Dosage and Administration (

2.3 Recommended Dosage and Titration

Primary, Secondary, and Tertiary Hypothyroidism in Adults

[see Dosage and Administration (2.2)].

Table 1. TIROSINT-SOL Dosing Guidelines for Hypothyroidism in Adults*

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)

[see Dosage and Administration (2.1)

and Drug Interactions (7)].

Primary, Secondary, and Tertiary Hypothyroidism in Pediatric Patients

[see Dosage and Administration (2.2)].

Table 2. TIROSINT-SOL Dosing Guidelines for Hypothyroidism in Pediatric Patients

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

*Adjust dosage based on clinical response and laboratory parameters [see Dosage and Administration (2.4)and Use in Specific Populations (8.4)].

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

Hypothyroidism in Pregnant Patients

The recommended daily dosage of TIROSINT-SOL in pregnant patients is described in Table 3.

Table 3. TIROSINT-SOL 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 TIROSINT-SOL 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 TIROSINT-SOL dosage to pre-pregnancy levels immediately after delivery. Monitor serum TSH 4 to 8 weeks postpartum.
New onset hypothyroidism TSH > 10 mIU per liter)	1.6 mcg/kg/day	Monitor serum TSH every 4 weeks and adjust TIROSINT-SOL dosage until serum TSH is within normal trimester-specific range.
New onset hypothyroidism (TSH < 10 mIU per liter)	1.0 mcg/kg/day

TSH Suppression in Well-differentiated Thyroid Cancer

in Adults and Pediatric Patients

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

)

11/2023

Warnings and Precautions (

5.2 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease

Overtreatment with levothyroxine 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 in elderly patients. Initiate TIROSINT-SOL therapy in this population at lower doses than those recommended in younger individuals or in patients without cardiac disease

[see Dosage and Administration (2.3)and Use in Specific Populations (8.5)].

Monitor for cardiac arrhythmias during surgical procedures in patients with coronary artery disease receiving suppressive TIROSINT-SOL therapy. Monitor patients receiving concomitant TIROSINT-SOL and sympathomimetic agents for signs and symptoms of coronary insufficiency

If cardiac symptoms develop or worsen, reduce the TIROSINT-SOL dose or withhold it for one week and restart at a lower dose.

)

11/2023

Warnings and Precautions (

5.1 Serious Risks Related to Overtreatment or Undertreatment with TIROSINT-SOL

TIROSINT-SOL has a narrow therapeutic index. Overtreatment or undertreatment with TIROSINT-SOL 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 [see Use in Specific Populations (8.4)].

Titrate the dose of TIROSINT-SOL carefully and monitor response to titration to avoid these effects [see Dosage and Administration (2.4)]. Consider the potential for food or drug interactions and adjust the administration or dosage of TIROSINT-SOL as needed [see Dosage and Administration (2.4), Drug Interactions (7.1), and Clinical Pharmacology (12.3)].

)

11/2023

TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:

Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism (
1 INDICATION AND USAGE
TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:
Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer
Limitations of Use
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis
Hypothyroidism
TIROSINT-SOL 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
TIROSINT-SOL 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
Tirosint-SOL 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 TIROSINT-SOL may induce hyperthyroidism
[see Warnings and Precautions (5.1)] .
Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer (
1 INDICATION AND USAGE
TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:
Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer
Limitations of Use
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis
Hypothyroidism
TIROSINT-SOL 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
TIROSINT-SOL 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
Tirosint-SOL 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 TIROSINT-SOL may induce hyperthyroidism
[see Warnings and Precautions (5.1)] .
Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
)

Limitations of Use

Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients (
1 INDICATION AND USAGE
TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:
Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer
Limitations of Use
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis
Hypothyroidism
TIROSINT-SOL 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
TIROSINT-SOL 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
Tirosint-SOL 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 TIROSINT-SOL may induce hyperthyroidism
[see Warnings and Precautions (5.1)] .
Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
)
Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis (
1 INDICATION AND USAGE
TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:
Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer
Limitations of Use
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis
Hypothyroidism
TIROSINT-SOL 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
TIROSINT-SOL 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
Tirosint-SOL 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 TIROSINT-SOL may induce hyperthyroidism
[see Warnings and Precautions (5.1)] .
Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
)

Administer once daily, on an empty stomach, 15 minutes before breakfast (
2.1 General Administration Information
Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.
Administer TIROSINT-SOL at least 4 hours before or after drugs known to interfere with TIROSINT-SOL absorption [see Drug Interactions (7.1)] .
Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption
[see Dosage and Administration (2.2 and 2.3)
,
Drug Interactions (7.9)and Clinical Pharmacology (12.3)]
.
TIROSINT-SOL may be administered in water or directly into the mouth:
- To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken. Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule and prepare the solution immediately before intake.
- To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.
)
Administer at least 4 hours before or after drugs that are known to interfere with absorption (
2.1 General Administration Information
Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.
Administer TIROSINT-SOL at least 4 hours before or after drugs known to interfere with TIROSINT-SOL absorption [see Drug Interactions (7.1)] .
Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption
[see Dosage and Administration (2.2 and 2.3)
,
Drug Interactions (7.9)and Clinical Pharmacology (12.3)]
.
TIROSINT-SOL may be administered in water or directly into the mouth:
- To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken. Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule and prepare the solution immediately before intake.
- To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.
)
Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption (
2.1 General Administration Information
Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.
Administer TIROSINT-SOL at least 4 hours before or after drugs known to interfere with TIROSINT-SOL absorption [see Drug Interactions (7.1)] .
Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption
[see Dosage and Administration (2.2 and 2.3)
,
Drug Interactions (7.9)and Clinical Pharmacology (12.3)]
.
TIROSINT-SOL may be administered in water or directly into the mouth:
- To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken. Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule and prepare the solution immediately before intake.
- To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.
)
To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water (
2.1 General Administration Information
Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.
Administer TIROSINT-SOL at least 4 hours before or after drugs known to interfere with TIROSINT-SOL absorption [see Drug Interactions (7.1)] .
Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption
[see Dosage and Administration (2.2 and 2.3)
,
Drug Interactions (7.9)and Clinical Pharmacology (12.3)]
.
TIROSINT-SOL may be administered in water or directly into the mouth:
- To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken. Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule and prepare the solution immediately before intake.
- To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.
)
To administer TIROSINT-SOL directly, either squeeze it into the mouth OR onto a spoon and immediately consume (
2.1 General Administration Information
Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes before breakfast.
Administer TIROSINT-SOL at least 4 hours before or after drugs known to interfere with TIROSINT-SOL absorption [see Drug Interactions (7.1)] .
Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption
[see Dosage and Administration (2.2 and 2.3)
,
Drug Interactions (7.9)and Clinical Pharmacology (12.3)]
.
TIROSINT-SOL may be administered in water or directly into the mouth:
- To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water. Stir the diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup with additional water and drink the contents to ensure that the total dose is taken. Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule and prepare the solution immediately before intake.
- To administer TIROSINT-SOL directly (without water), either squeeze it into the mouth OR onto a spoon and immediately consume.
)
Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4-6 weeks (
2.2 Important Considerations for Dosing
The dosage of TIROSINT-SOL 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 dosage adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4)] .
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 TIROSINT-SOL dosage adequacy and should not be used to monitor therapy. Use the serum free-T4 level to titrate TIROSINT-SOL 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 TIROSINT-SOL may not be attained for 4 to 6 weeks.
)

See full prescribing information for dosing in specific patient populations (

2.3 Recommended Dosage and Titration

Primary, Secondary, and Tertiary Hypothyroidism in Adults

[see Dosage and Administration (2.2)].

Table 1. TIROSINT-SOL Dosing Guidelines for Hypothyroidism in Adults*

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)

[see Dosage and Administration (2.1)

and Drug Interactions (7)].

Primary, Secondary, and Tertiary Hypothyroidism in Pediatric Patients

[see Dosage and Administration (2.2)].

Table 2. TIROSINT-SOL Dosing Guidelines for Hypothyroidism in Pediatric Patients

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

*Adjust dosage based on clinical response and laboratory parameters [see Dosage and Administration (2.4)and Use in Specific Populations (8.4)].

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

Hypothyroidism in Pregnant Patients

The recommended daily dosage of TIROSINT-SOL in pregnant patients is described in Table 3.

Table 3. TIROSINT-SOL 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 TIROSINT-SOL 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 TIROSINT-SOL dosage to pre-pregnancy levels immediately after delivery. Monitor serum TSH 4 to 8 weeks postpartum.
New onset hypothyroidism TSH > 10 mIU per liter)	1.6 mcg/kg/day	Monitor serum TSH every 4 weeks and adjust TIROSINT-SOL dosage until serum TSH is within normal trimester-specific range.
New onset hypothyroidism (TSH < 10 mIU per liter)	1.0 mcg/kg/day

TSH Suppression in Well-differentiated Thyroid Cancer

in Adults and Pediatric Patients

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

)

Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status (
2.4 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 TIROSINT-SOL, 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 dosage. In patients on a stable and appropriate replacement dosage, evaluate clinical and biochemical response every 6 to 12 months and whenever there is a change in the patient's clinical status.
Pediatrics 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 mental and physical growth and development, 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 TIROSINT-SOL 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 TIROSINT-SOL
[see Warning and Precautions (5.1)and Use in Specific Populations (8.4)]
.
Secondary (Pituitary) and Tertiary (Hypothalamic) Hypothyroidism
Monitor serum free-T4 levels and maintain in the upper half of the normal range in these patients.
)

TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule. Each ampule bears a colored label with the dosage strength and the product name (TIROSINT-SOL) (Table 4).

Table 4. TIROSINT-SOL Solution Strengths and Identifying Features

Strength (mcg/mL)	Color
13	Green
25	Orange
37.5	Dark Blue
44	Red
50	White
75	Purple
62.5	Grey
88	Olive
100	Yellow
112	Rose
125	Brown
137	Turquoise
150	Blue
175	Lilac
200	Pink

Pregnancy may require the use of higher doses of TIROSINT-SOL (

2.3 Recommended Dosage and Titration

Primary, Secondary, and Tertiary Hypothyroidism in Adults

[see Dosage and Administration (2.2)].

Table 1. TIROSINT-SOL Dosing Guidelines for Hypothyroidism in Adults*

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)

[see Dosage and Administration (2.1)

and Drug Interactions (7)].

Primary, Secondary, and Tertiary Hypothyroidism in Pediatric Patients

[see Dosage and Administration (2.2)].

Table 2. TIROSINT-SOL Dosing Guidelines for Hypothyroidism in Pediatric Patients

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

*Adjust dosage based on clinical response and laboratory parameters [see Dosage and Administration (2.4)and Use in Specific Populations (8.4)].

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

Hypothyroidism in Pregnant Patients

The recommended daily dosage of TIROSINT-SOL in pregnant patients is described in Table 3.

Table 3. TIROSINT-SOL 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 TIROSINT-SOL 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 TIROSINT-SOL dosage to pre-pregnancy levels immediately after delivery. Monitor serum TSH 4 to 8 weeks postpartum.
New onset hypothyroidism TSH > 10 mIU per liter)	1.6 mcg/kg/day	Monitor serum TSH every 4 weeks and adjust TIROSINT-SOL dosage until serum TSH is within normal trimester-specific range.
New onset hypothyroidism (TSH < 10 mIU per liter)	1.0 mcg/kg/day

TSH Suppression in Well-differentiated Thyroid Cancer

in Adults and Pediatric Patients

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

8.1 Pregnancy

Risk Summary

The clinical experience, including data from published postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and TIROSINT‑SOL dosage adjusted during pregnancy

[see Clinical Considerations]

. Animal reproductive studies have not been conducted with levothyroxine sodium. TIROSINT-SOL should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery. Untreated maternal hypothyroidism may have an adverse effect on fetal neurocognitive development.

Dose Adjustments During Pregnancy and the Postpartum Period

Pregnancy may increase TIROSINT-SOL requirements. Serum TSH levels should be monitored and the TIROSINT-SOL dosage adjusted during pregnancy. Since postpartum TSH levels are similar to preconception values, the TIROSINT-SOL dosage should return to the pre-pregnancy dose immediately after delivery

[see Dosage and Administration (2.3)].

)

See 17 for PATIENT COUNSELING INFORMATION and FDA‑approved patient labeling.

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