Americans diagnosed with hypothyroidism and their clinical providers now have access to greater dosage flexibility within levothyroxine therapy, with three new dosage strengths of levothyroxine sodium oral solution now available to treat hypothyroidism. IBSA Pharma markets the drug as Tirosint®-SOL.
The unique new dosing options – 37.5, 44 and 62.5 micrograms – are a first in the U.S. market and offer clinicians precision and flexibility when treating patients. The three new doses add to Tirosint-SOL’s existing 12 options and create a new industry standard of 15 strengths of levothyroxine therapy, the widest range of any therapy for hypothyroidism that is approved by the U.S. Food and Drug Administration (FDA).
Recently published research has demonstrated that dissatisfaction is common among adults treated for hypothyroidism. While the causes of patient dissatisfaction are complex, the common practice of frequent dose titration of thyroid hormone treatment (more than two dose changes per year) has been associated with significantly lower levels of patient satisfaction with hypothyroidism therapy.
Tirosint-SOL’s extensive dosing options provide clinicians with more choices, enabling them to adapt levothyroxine therapy to individual needs and better treat the full spectrum of hypothyroid patients. Increased dosage flexibility may also eliminate or reduce the need to change patients’ doses.
“The addition of 37.5, 44 and 62.5 microgram dosages represents a much-needed advance in levothyroxine therapy, which is the standard of care for treating hypothyroidism,” says Charles Carter, PharmD, interim chair and associate professor of clinical research, Campbell University College of Pharmacy and Health Sciences. “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. Levothyroxine is a narrow therapeutic index drug with potentially deleterious clinical outcomes if administered in sub- or supratherapeutic doses. The splitting of tablets by patients can result in inconsistent levels of levothyroxine therapy, which should be a concern to clinicians and the patients they care for.”
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.