New Dosing Options are Available for Tirosint-SOL

The liquid therapy to treat hypothyroidism now comes in 15 different dosage strengths in single-use packaging.

IBSA Pharma is introducing three new dosage strengths of Tirosint-SOL (levothyroxine sodium) oral solution to treat hypothyroidism. The new dosing options – 37.5, 44 and 62.5 micrograms – are a first in the U.S. market. The three new doses add to Tirosint-SOL’s existing 12 options.

Tirosint-SOL is the only FDA-approved levothyroxine liquid that comes in monodose packaging. With only three ingredients – levothyroxine, glycerol, and water – Tirosint-SOL does not contain inactive ingredients or preservatives that are commonly found in traditional levothyroxine tablet therapies that can interfere with medication tolerability or absorption.

Tirosint-SOL is indicated to treat hypothyroid patients regardless of age. Patients can administer it by pouring the contents of the monodose ampule directly into the mouth, using a spoon or mixing it in water. A data matrix was recently added to the monodose ampule to facilitate its use in hospitals, where more complex cases of hypothyroidism are often initially treated.

“Up to this time, clinicians have often instructed parents, caregivers, and patients to split levothyroxine tablets to create these doses, which can result in significant dosing errors and inconvenience,” Charles Carter, Pharm.D., interim chair and associate professor of clinical research, Campbell University College of Pharmacy and Health Sciences, said in a statement. “Levothyroxine is a narrow therapeutic index drug with potentially deleterious clinical outcomes if administered in sub- or supratherapeutic doses.”

IBSA also recently enhanced its Tirosint-SOL copay coupon program. With the new program, eligible patients with commercial insurance can pay as little as $4 per one-month supply or $0 per three-month supply.

More than 12% of the U.S. population will develop a thyroid condition during their lifetime, and an estimated 20 million Americans have some form of thyroid disease, according to the American Thyroid Association.