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New Data Highlight Use of Tirosint® (levothyroxine sodium) Capsules in Patients with T4 Malabsorption Due to Gastric Disorders

June 20, 2013

Study suggests Tirosint may be favorable treatment option for millions of patients with celiac disease, lactose intolerance or H. pylori infection

CRANFORD, N.J., June 20, 2013 /PRNewswire/ – Akrimax Pharmaceuticals, LLC, a privately-held, innovative specialty pharmaceutical company, today announced data that show a lower dose of Tirosint(®) (levothyroxine sodium) capsules is required as compared with standard T4 tablets for hypothyroidism patients with impaired gastric acid secretion to reach their target thyroid-stimulating hormone (TSH) levels.

The American Association of Clinical Endocrinologist (AACE) Guidelines for Clinical Practice for Evaluation and Treatment of Hypothyroidism call for physicians to treat hypothyroidism with oral levothyroxine replacement therapy. Careful dose titration and monitoring is necessary in order to maintain a euthyroid state, while avoiding adverse events due to overtreatment.(1) TSH levels in patients receiving levothyroxine should be no more than 4.0 mU/L.(2)

Azeez Farooki, MD, Assistant Attending Physician, Endocrinology Service, Memorial Sloan-Kettering Cancer Center, said, “Dose titration can be cumbersome for patients with hypothyroidism who suffer from gastrointestinal disorders like H.pylori infection, lactose intolerance or celiac disease. These patients often require higher doses of T4 due to malabsorption issues. Such patients may endure frequent dose changing and lab tests, which is less than ideal. These data are encouraging because they suggest that, in many patients with malabsorptive disorders, Tirosint improves upon the absorption of traditional levothyroxine (T4) tablets.”

The pilot study examined patients who had T4 malabsorption and were in T4 treatment for more than 5 years with the same brand of tablets. A total of 36 patients met the study criteria, and 30 (28 females / 2 males; median age=51 years; median T4 dose=2.05 mg/kg/day) completed the study. T4 treatment was switched from the usual tablets to a lower dose of the softgel T4 capsules (median T4 dose=1.77 mg/kg/day; p=0.0082). Thyroid function and TSH were measured before and after 3, 6, 12 and 18 months from the treatment switch.

A slight serum TSH increase was observed in some patients after 3 months of treatment, with no change in Free T4 (FT4) levels. After 6 months, however, despite the reduced dose of T4, mean TSH values were similar (1.82 vs. 1.86 mU/l) in about two out of three patients (responders n=21) and so remained until the end of the study. In all of the remaining patients (non-responders n=9), TSH levels were significantly higher than baseline values throughout the study. In 4 of them, additional intestinal disorders were detected. Mean levels of FT4 and FT3 were in the normal range and not significantly modified throughout the study.

These findings were recently presented during an oral session at ENDO 2013, the Endocrine Society’s 95th Annual Meeting, in San Francisco, CA. The abstract is available on the ENDO web site: https://endo.confex.com/endo/2013endo/webprogram/Paper6139.html.

About Hypothyroidism

Hypothyroidism is an endocrine disorder with numerous causes resulting in a deficiency in thyroid hormone. About 2% of the U.S. population has pronounced hypothyroidism, and as much as 10% has subclinical (mild) hypothyroidism.(3) Up to 13 million Americans have undiagnosed hypothyroidism.(4) The condition is most common in women over 40 years of age and in the elderly of both sexes.(3) The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, cold intolerance, coarse hair, dry skin, weight gain, delayed return phase of reflexes, and constipation.(1, 5) Laboratory tests (TSH, FT3 and FT4) are the most common way hypothyroidism is detected. Treatment with levothyroxine sodium oral tablets is the standard of care in hypothyroidism.

Studies in women taking levothyroxine sodium during pregnancy have not shown an increased risk of congenital abnormalities. Therefore, the possibility of fetal harm appears remote. Tirosint should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated.(6)

About Tirosint(®) (levothyroxine sodium) capsules

Tirosint (levothyroxine sodium) is the first and only levothyroxine therapy in a liquid gel cap. Tirosint gel caps are pure. Tirosint gel caps contain only T4, water, glycerin, and gelatin.

Tirosint is available in 10 dosage strengths, including an exclusive 13 microgram dose. Tirosint is administered as a single daily dose, preferably one-half to one-hour before breakfast. Tirosint should be taken at least 4 hours apart from drugs that are known to interfere with its absorption. Tirosint capsules cannot be cut or crushed. Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.

Tirosint capsules are housed in blister packs to protect it from light and moisture. Blister packs are clearly marked for daily dosing. Tirosint should be protected from light and moisture and stored at 25 degrees C (77 degrees F); excursions permitted to 15 degrees-30 degrees C (59 degrees-86 degrees F).

IMPORTANT SAFETY INFORMATION

WARNINGS

Thyroid hormones, including TIROSINT, 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.

In patients with nontoxic diffuse goiter or nodular thyroid disease, particularly the elderly or those with underlying cardiovascular disease, levothyroxine sodium therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis. If the serum TSH level is not suppressed, TIROSINT should be used with caution in conjunction with careful monitoring of thyroid function for evidence of hyperthyroidism and clinical monitoring for potential associated adverse cardiovascular signs and symptoms of hyperthyroidism.

CONTRAINDICATIONS

Levothyroxine is contraindicated in patients with untreated subclinical (suppressed serum TSH level with normal T3 and T4 levels) or overt thyrotoxicosis of any etiology and in patients with acute myocardial infarction. Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency since thyroid hormones may precipitate an acute adrenal crisis by increasing the metabolic clearance of glucocorticoids. TIROSINT is contraindicated in patients with hypersensitivity to any of the inactive ingredients in TIROSINT capsules. TIROSINT is also contraindicated for anyone who may be unable to swallow a capsule (e.g., infants, small children).

PRECAUTIONS

Effects on bone mineral density – In women, long-term levothyroxine sodium therapy has been associated with increased bone resorption, thereby decreasing bone mineral density, especially in postmenopausal women on greater than replacement doses or in women who are receiving suppressive doses of levothyroxine sodium. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase and suppressed serum parathyroid hormone levels. Therefore, it is recommended that patients receiving levothyroxine sodium be given the minimum dose necessary to achieve the desired clinical and biochemical response.

Patients with underlying cardiovascular disease – Exercise caution when administering levothyroxine to patients with cardiovascular disorders and to the elderly in whom there is an increased risk of occult cardiac disease. In these patients, levothyroxine therapy should be initiated at lower doses than those recommended in younger individuals or in patients without cardiac disease and it should be noted that unlike levothyroxine sodium tablets, TIROSINT capsules cannot be cut in half. If cardiac symptoms develop or worsen, the levothyroxine dose should be reduced or withheld for one week and then cautiously restarted at a lower dose. Overtreatment with levothyroxine sodium may have adverse cardiovascular effects such as an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias. Patients with coronary artery disease who are receiving levothyroxine therapy should be monitored closely during surgical procedures, since the possibility of precipitating cardiac arrhythmias may be greater in those treated with levothyroxine. Concomitant administration of levothyroxine and sympathomimetic agents to patients with coronary artery disease may precipitate coronary insufficiency.

ADVERSE REACTIONS

Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage such as fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating, and other adverse reactions. This is not an exhaustive list. Please refer to TIROSINT’s full Prescribing Information for a more comprehensive list of adverse reactions associated with hyperthyroidism.

About Akrimax Pharmaceuticals

Akrimax Pharmaceuticals, LLC is a privately-held, innovative specialty pharmaceutical company that acquires, develops and markets advanced ethical prescription medications. Akrimax’s marketed products include: Suprenza(TM), Primlev(TM), Tirosint(®), NitroMist(®), Inderal LA(®), and InnoPran XL(®). In order to bring the best treatments to patients, Akrimax is continuously evaluating opportunities to partner with other organizations that strive to improve patient care. For more information, visit www.akrimax.com.

References

(1 )American Association of Clinical Endocrinologists. Medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocrine Practice. 2002;8(6):457-467.

(2) Garber, JR, Cobin RH, Gharib H, et al.; Association Task Force of Hypothyroidism in Adults. Clinical Practice Guidelines for Hypothyroidism in Adults; co-sponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association [published online ahead of print, 2012] Endocrine Practice 2012; Vol. 10; 4158/EP12280.GI

(3 )McDermott MT. In the clinic: hypothyroidism. Ann Intern Med. 2009;151(11): ITC-6-ITC-1.

(4) Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado Thyroid Disease Prevalence Study. Arch Intern Med. 2000;160:526-534.

(5) Shapiro LS, Surks MI. Hypothyroidism. In: Becker KL, ed. Principles and Practice of Endocrinology and Metabolism. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2001:445-454.

(6 )Tirosint Prescribing Information: http://tirosint.com/images/patient-side-pdfs/Tirosint%20Promo%20PI.pdf

SOURCE Akrimax Pharmaceuticals, LLC


Source: PR Newswire