FDA Approves New Label Changes for Tirosint-SOL, Expanding Administration Options

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Announced on December 04, 2023, the approved label changes allow for administration regardless of timing of proton pump administration and for administration 15 minutes before breakfast.

US FDA logo in black over a white background. | Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration has approved a pair of label changes to levothyroxine sodium oral solution (Tirosint-SOL) aimed at offering patients with hypothyroidism with more flexible administration options, according to an announcement from IBSA Pharma.

Announce don December 04, 2023, the approved label changes pertain to use in the presence of proton pump inhibitor therapy and the timing of levothyroxine sodium oral solution administration, which IBSA Group suggests helps to differentiate the unique formulation levothyroxine from other levothyroxine therapies. With the approvals, becomes the first FDA-approved LT4 therapy without a labeled interaction with proton pump inhibitors and the first FDA-approved LT4 therapy that can be administered 15 minutes before eating breakfast.1

“Appropriate administration of levothyroxine can be difficult for patients, given the multiple therapies that can interfere with its absorption and the requirement to administer it in a fasting state,” said Francesco Celi, University of Connecticut School of Medicine. “The opportunity to provide patients living with hypothyroidism with a medication that is easier to use because it is not affected by PPIs, which are commonly used acid-reducing agents, and can be taken 15 minutes before breakfast, should be of interest to clinicians as it may increase adherence and improve therapeutic outcomes.”

With its initial approval dating back to 2000, levothyroxine sodium oral solution (Tirosint-SOL) is available in 15 dosing strengths, including unique 13, 37.5, 44, and 62.5 microgram dosing options. The approved label changes for the agent are based on the results of 2 clinical trials sponsored and conducted by the Department of R&D and Scientific Affairs - IBSA Institut Biochimique SA, Switzerland.1

In the first trial, results provided evidence of an apparent lack of inebriation between the agent and omeprazole, a proton pump inhibitor, regardless of the timing of administration of the proton pump inhibitor. In the second trial, results suggested administration of levothyroxine sodium oral solution produced bioavailability in healthy individuals when taken 15 minutes in advance of eating breakfast as it did when administered 30 minutes before eating breakfast. In their announcement IBSA Group pointed out these trials did not examine bioavailability when administered simultaneously with breakfast.1

Full prescribing information for levothyroxine sodium oral solution includes a Black Boxed Warning against use for weight loss to treat obesity. In their announcement IBSA Pharma noted the company offers a Copay Savings Coupon and mail-order pharmacy program to ensure increased access to patients.1

“The availability of this liquid oral levothyroxine formulation, which is not affected by proton pump inhibitors and can be taken just 15 minutes before breakfast, is a real plus for hypothyroid patients and healthcare practitioners,” said Michael Scully, Head of Commercial Operations, IBSA USA.1 “These new label changes reinforce Tirosint-SOL’s position as a simple, convenient, and clean LT4 therapy with only three ingredients.”

References:

  1. IBSA Pharma. Food and Drug Administration grants two new label changes to Tirosint®-sol (Levothyroxine Sodium) oral solution. Business Wire. December 4, 2023. Accessed December 4, 2023. https://www.businesswire.com/news/home/20231204748430/en/.

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