Dosing Options for Levothyroxine Gel Capsule Tirosint Expanded

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Tirosint is now available in 15 dosage strengths.

IBSA Pharma announced the launch of Tirosint® (levothyroxine sodium) gel capsules in 3 new dosage strengths: 37.5mcg, 44mcg, and 62.5mcg.

Tirosint is indicated as a replacement therapy in primary (thyroid), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also approved for use as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

In addition to the 3 new dosing options, Tirosint gel capsules are available in 12 other strengths: 13mcg, 25mcg, 50mcg, 75mcg, 88mcg, 100mcg, 112mcg, 125mcg, 137mcg, 150mcg, 175mcg, and 200mcg.

“The addition of 37.5, 44 and 62.5 microgram dosages, along with the brand’s unique 13mcg dose, provides physicians and patients with much-needed flexibility in levothyroxine therapy, the standard of care for treating hypothyroidism,” said Carolyn Kong, PharmD, Chief Medical and Business Officer of IBSA Pharma Inc. “Up to this time, clinicians who wanted to prescribe oral solid formulations of levothyroxine in these doses needed to instruct caregivers and patients to split levothyroxine tablets or combine different dosage strengths. This can result in both inconvenience and significant dosing errors. Levothyroxine is a narrow therapeutic index drug with potentially deleterious clinical outcomes if administered in sub- or supratherapeutic doses.” 

Tirosint-Sol, an oral solution formulation of levothyroxine sodium, is also available in similar dosage strengths.

The Company is offering the Tirosint Copay Savings Card to assist eligible patients.

References:

  1. IBSA increases dosage flexibility of Tirosint® News release. IBSA Pharma, Inc. Accessed April 4, 2023. https://www.prnewswire.com/news-releases/ibsa-increases-dosage-flexibility-of-tirosint-capsules-301778917.html.
  2. Package insert. IBSA Pharma Inc.; 2022. Accessed April 4, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021924Orig1s021lbl.pdf.