Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board (2024)

Razvi, S., Nicodemus, N., Ratnasingam, J., Arundhati, D., Soh, W. E. A., Kunavisarut, T., Zufry, H., Chaudhari, H., & Markova, A. (Accepted/In press). Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board. Current Medical Research and Opinion. https://doi.org/10.1080/03007995.2024.2378984

Razvi, Salman ; Nicodemus, Nemencio ; Ratnasingam, Jeyakantha et al. / Importance of right communication with healthcare providers and patients about the new levothyroxine formulation : an expert opinion from Asia Pacific Thyroid Advisory Board. In: Current Medical Research and Opinion. 2024.

@article{7b8ccf62a2c6439d82f5b4c3fda29e5a,

title = "Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board",

abstract = "Levothyroxine (LT4), being “narrow therapeutic index” drug, may lead to significant fluctuations in thyroid stimulating hormone (TSH) levels. Such fluctuations can result in clinically noteworthy disruptions in thyroid function and give rise to adverse clinical consequences. Consequently, regulatory standards for LT4 potency have been tightened, with the most stringent specifications requiring maintenance of potency within the range of 95–105% of the labeled dose throughout the entire shelf-life of the product. The LT4 new formulation with tightened specification adheres to these rigorous standards, demonstrating established bioequivalence to its older formulation while upholding an equivalent standard of safety and efficacy. Furthermore, the novel formulation exhibits enhanced stability and an extended shelf-life. Of paramount significance is its capacity to provide patients with accurate and consistent dosing, thereby effectively catering to their medical requirements. The primary objective of the Asia-Pacific advisory board meeting (held in June 2022 with endocrinologists, experts from India, Indonesia, Philippines, Thailand, Malaysia and Singapore) was to establish the importance of appropriate communication to HCPs, patients and other stakeholders regarding the LT4 new formulation. The aim of this brief review is to highlight the importance of communication with healthcare professionals that should focus on providing accurate information on the LT4 new formulation, emphasizing efficacy, safety, and bioequivalence with clear guidance and ensure that patients and clinicians are fully informed about any changes to medications such as LT4 to reduce the risk of unrelated adverse events being incorrectly attributed to the newer formulation.",

keywords = "hypothyroidism, levothyroxine, Thyroid, thyroxine, TSH",

author = "Salman Razvi and Nemencio Nicodemus and Jeyakantha Ratnasingam and Dasgupta Arundhati and Soh, {Wah Ek Abel} and Tada Kunavisarut and Hendra Zufry and Harshal Chaudhari and Alina Markova",

note = "Publisher Copyright: {\textcopyright} 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.",

year = "2024",

doi = "10.1080/03007995.2024.2378984",

language = "English",

journal = "Current Medical Research and Opinion",

issn = "0300-7995",

publisher = "Taylor and Francis Ltd.",

}

Razvi, S, Nicodemus, N, Ratnasingam, J, Arundhati, D, Soh, WEA, Kunavisarut, T, Zufry, H, Chaudhari, H & Markova, A 2024, 'Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board', Current Medical Research and Opinion. https://doi.org/10.1080/03007995.2024.2378984

Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board. / Razvi, Salman; Nicodemus, Nemencio; Ratnasingam, Jeyakantha et al.
In: Current Medical Research and Opinion, 2024.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Importance of right communication with healthcare providers and patients about the new levothyroxine formulation

T2 - an expert opinion from Asia Pacific Thyroid Advisory Board

AU - Razvi, Salman

AU - Nicodemus, Nemencio

AU - Ratnasingam, Jeyakantha

AU - Arundhati, Dasgupta

AU - Soh, Wah Ek Abel

AU - Kunavisarut, Tada

AU - Zufry, Hendra

AU - Chaudhari, Harshal

AU - Markova, Alina

N1 - Publisher Copyright:© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

PY - 2024

Y1 - 2024

N2 - Levothyroxine (LT4), being “narrow therapeutic index” drug, may lead to significant fluctuations in thyroid stimulating hormone (TSH) levels. Such fluctuations can result in clinically noteworthy disruptions in thyroid function and give rise to adverse clinical consequences. Consequently, regulatory standards for LT4 potency have been tightened, with the most stringent specifications requiring maintenance of potency within the range of 95–105% of the labeled dose throughout the entire shelf-life of the product. The LT4 new formulation with tightened specification adheres to these rigorous standards, demonstrating established bioequivalence to its older formulation while upholding an equivalent standard of safety and efficacy. Furthermore, the novel formulation exhibits enhanced stability and an extended shelf-life. Of paramount significance is its capacity to provide patients with accurate and consistent dosing, thereby effectively catering to their medical requirements. The primary objective of the Asia-Pacific advisory board meeting (held in June 2022 with endocrinologists, experts from India, Indonesia, Philippines, Thailand, Malaysia and Singapore) was to establish the importance of appropriate communication to HCPs, patients and other stakeholders regarding the LT4 new formulation. The aim of this brief review is to highlight the importance of communication with healthcare professionals that should focus on providing accurate information on the LT4 new formulation, emphasizing efficacy, safety, and bioequivalence with clear guidance and ensure that patients and clinicians are fully informed about any changes to medications such as LT4 to reduce the risk of unrelated adverse events being incorrectly attributed to the newer formulation.

AB - Levothyroxine (LT4), being “narrow therapeutic index” drug, may lead to significant fluctuations in thyroid stimulating hormone (TSH) levels. Such fluctuations can result in clinically noteworthy disruptions in thyroid function and give rise to adverse clinical consequences. Consequently, regulatory standards for LT4 potency have been tightened, with the most stringent specifications requiring maintenance of potency within the range of 95–105% of the labeled dose throughout the entire shelf-life of the product. The LT4 new formulation with tightened specification adheres to these rigorous standards, demonstrating established bioequivalence to its older formulation while upholding an equivalent standard of safety and efficacy. Furthermore, the novel formulation exhibits enhanced stability and an extended shelf-life. Of paramount significance is its capacity to provide patients with accurate and consistent dosing, thereby effectively catering to their medical requirements. The primary objective of the Asia-Pacific advisory board meeting (held in June 2022 with endocrinologists, experts from India, Indonesia, Philippines, Thailand, Malaysia and Singapore) was to establish the importance of appropriate communication to HCPs, patients and other stakeholders regarding the LT4 new formulation. The aim of this brief review is to highlight the importance of communication with healthcare professionals that should focus on providing accurate information on the LT4 new formulation, emphasizing efficacy, safety, and bioequivalence with clear guidance and ensure that patients and clinicians are fully informed about any changes to medications such as LT4 to reduce the risk of unrelated adverse events being incorrectly attributed to the newer formulation.

KW - hypothyroidism

KW - levothyroxine

KW - Thyroid

KW - thyroxine

KW - TSH

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U2 - 10.1080/03007995.2024.2378984

DO - 10.1080/03007995.2024.2378984

M3 - Article

AN - SCOPUS:85200571376

SN - 0300-7995

JO - Current Medical Research and Opinion

JF - Current Medical Research and Opinion

ER -

Razvi S, Nicodemus N, Ratnasingam J, Arundhati D, Soh WEA, Kunavisarut T et al. Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board. Current Medical Research and Opinion. 2024. doi: 10.1080/03007995.2024.2378984