Select therapeutic use:

Pancreatic, thyroid, and other endocrine cancers:

Indications for TIROSINT-SOL:

Adjunct to surgery and radioiodine therapy, in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitations of Use:

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

Adults and Children:

Take on empty stomach ½–1hr before breakfast. May mix ampule contents in water or give directly as single dose. Target TSH levels within desired therapeutic range for TSH suppression. Individualize. Doses >2mcg/kg/day may be required.

Contraindications:

Glycerol hypersensitivity. Uncorrected adrenal insufficiency.

Boxed Warning:

Not for treatment of obesity or for weight loss.

Warnings/Precautions:

Underlying cardiovascular disease. Monitor for cardiac arrhythmias during surgery in those with coronary artery disease. Reduce or withhold dose for 1 week if cardiac symptoms develop or worsen; restart at lower dose. Myxedema coma: use IV levothyroxine. Adults: Monitor TSH 6–8 weeks after dose change then every 6–12 months when stable. Peds: Monitor TSH and total or free-T4 at 2 and 4 weeks after initiation, 2 weeks after dose change then every 3–12 months thereafter. Correct adrenal insufficiency before initiation. Diabetes; monitor glycemic control. Increased bone resorption and decreased BMD (esp. in post-menopausal women). Use lowest effective dose. Elderly. Pregnancy: monitor TSH/free-T4 at least every trimester; adjust dose and do not discontinue (see full labeling). Nursing mothers.

Pharmacologic Class:

T4 (synthetic).

Interactions:

See full labeling. Absorption reduced by some foods (eg, soy flour, cottonseed meal, walnuts, fiber, grapefruit juice), aluminum and magnesium hydroxide, simethicone, proton pump inhibitors, iron, sucralfate; monitor. Give at least 4hrs apart from calcium carbonate, ferrous sulfate, bile acid sequestrants (eg, colesevelam, cholestyramine, colestipol), ion exchange resins (eg, kayexalate, sevelamer). Thyroid levels may be affected by clofibrate, estrogens, heroin, methadone, 5-fluorouracil, mitotane, tamoxifen, androgens, anabolic steroids, asparaginase, glucocorticoids, nicotinic acid (slow-release), salicylates (>2g/day), β-blockers (eg, propranolol), glucocorticoids, amiodarone. Monitor thyroid parameters with concomitant carbamazepine, furosemide (>80mg IV), heparin, hydantoins, NSAIDs. Potentiates, and is potentiated by, tri- and tetracyclic antidepressants. Concomitant sympathomimetics; monitor for coronary insufficiency. Antagonized by phenobarbital, rifampin, sertraline. Antagonizes digitalis glycosides. Marked hypertension and tachycardia with ketamine. Hypothyroidism risk with concomitant tyrosine kinase inhibitors (eg, imatinib). Monitor with oral anticoagulants, antidiabetic agents, orlistat.

Adverse Reactions:

Arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, skin rash; seizures (rare); Children: pseudotumor cerebri, slipped capital femoral epiphysis.

Generic Availability:

NO

How Supplied:

Unit-dose ampules (1mL)—5, 30

Pricing for TIROSINT-SOL

30 ampules of 150mcg/ml package (Qty: 1)
Appx. price $136
GoodRx

Thyroid disease:

Indications for TIROSINT-SOL:

Hypothyroidism.

Limitations of Use:

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

Adult:

Take on empty stomach ½–1hr before breakfast. May mix ampule contents in water or give directly as single dose. Individualize. Adjust dose as needed until patient is euthyroid and serum TSH normalized. Primary hypothyroidism: 1.6mcg/kg/day; adjust in increments of 12.5–25mcg every 4–6 weeks. Usual max 200mcg/day. Elderly or underlying cardiac disease: initially 12.5–25mcg once daily; increase every 6–8 weeks, as needed. Severe hypothyroidism: initially 12.5–25mcg once daily; adjust in increments of 12.5–25mcg every 2–4 weeks. Secondary or tertiary hypothyroidism, pregnancy: see full labeling.

Children:

Take on empty stomach ½–1hr before breakfast. May mix ampule contents in water or give directly. Congenital or acquired hypothyroidism: 0–3mos: 10–15mcg/kg/day; 3–6mos: 8–10mcg/kg/day; 6–12mos: 6–8mcg/kg/day; 1–5yrs: 5–6mcg/kg/day; 6–12yrs: 4–5mcg/kg/day; >12yrs (but growth and puberty incomplete): 2–3mcg/kg/day; (growth and puberty complete): 1.6mcg/kg/day. Newborns at risk for cardiac failure: consider lower initial dose; increase every 4–6 weeks as needed. Risk for hyperactivity: initially ¼ full replacement dose; increase by ¼ dose weekly until full dose reached.

Contraindications:

Glycerol hypersensitivity. Uncorrected adrenal insufficiency.

Boxed Warning:

Not for treatment of obesity or for weight loss.

Warnings/Precautions:

Underlying cardiovascular disease. Monitor for cardiac arrhythmias during surgery in those with coronary artery disease. Reduce or withhold dose for 1 week if cardiac symptoms develop or worsen; restart at lower dose. Myxedema coma: use IV levothyroxine. Adults: Monitor TSH 6–8 weeks after dose change then every 6–12 months when stable. Peds: Monitor TSH and total or free-T4 at 2 and 4 weeks after initiation, 2 weeks after dose change then every 3–12 months thereafter. Correct adrenal insufficiency before initiation. Diabetes; monitor glycemic control. Increased bone resorption and decreased BMD (esp. in post-menopausal women). Use lowest effective dose. Elderly. Pregnancy: monitor TSH/free-T4 at least every trimester; adjust dose and do not discontinue (see full labeling). Nursing mothers.

Pharmacologic Class:

T4 (synthetic).

Interactions:

See full labeling. Absorption reduced by some foods (eg, soy flour, cottonseed meal, walnuts, fiber, grapefruit juice), aluminum and magnesium hydroxide, simethicone, proton pump inhibitors, iron, sucralfate; monitor. Give at least 4hrs apart from calcium carbonate, ferrous sulfate, bile acid sequestrants (eg, colesevelam, cholestyramine, colestipol), ion exchange resins (eg, kayexalate, sevelamer). Thyroid levels may be affected by clofibrate, estrogens, heroin, methadone, 5-fluorouracil, mitotane, tamoxifen, androgens, anabolic steroids, asparaginase, glucocorticoids, nicotinic acid (slow-release), salicylates (>2g/day), β-blockers (eg, propranolol), glucocorticoids, amiodarone. Monitor thyroid parameters with concomitant carbamazepine, furosemide (>80mg IV), heparin, hydantoins, NSAIDs. Potentiates, and is potentiated by, tri- and tetracyclic antidepressants. Concomitant sympathomimetics; monitor for coronary insufficiency. Antagonized by phenobarbital, rifampin, sertraline. Antagonizes digitalis glycosides. Marked hypertension and tachycardia with ketamine. Hypothyroidism risk with concomitant tyrosine kinase inhibitors (eg, imatinib). Monitor with oral anticoagulants, antidiabetic agents, orlistat.

Adverse Reactions:

Arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, skin rash; seizures (rare); Children: pseudotumor cerebri, slipped capital femoral epiphysis.

Generic Availability:

NO

How Supplied:

Unit-dose ampules (1mL)—5, 30

Pricing for TIROSINT-SOL

30 ampules of 150mcg/ml package (Qty: 1)
Appx. price $136
GoodRx