March 1, 2019 – IBSA Pharma, Inc., has announced the launch of its Tirosint®-SOL (levothyroxine sodium) oral solution. The product is U.S. FDA-approved as a replacement therapy for primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also approved as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent, well-differentiated thyroid cancer.
The active ingredient in Tirosint-SOL, levothyroxine sodium, has been FDA-approved since 2000. Tirosint-SOL is currently the only FDA-approved liquid formulation of levothyroxine. Recommended dosing is based on individual patient factors.
Like other thyroid hormone products, Tirosint-SOL carries a black box warning that advises it should not be used to treat obesity or promote weight loss. The black box warning cautions that doses beyond the range of daily hormonal requirements may lead to serious or life-threatening toxicity.
Tirosint-SOL is available in cartons containing 30 single-dose ampules, and comes in 12 different dosage strengths that range from 13mcg/mL to 200mcg/mL. The wholesale acquisition cost (WAC) is $128.08 per 30mL.