Asfotase-alfa

Asfotase-alfa Reactions 1680, p57 - 2 Dec 2017 Elevated alkaline phosphatase levels: case report A female neonate [age at the time of reaction onset not clearly stated] developed elevated alkaline phosphatase levels during treatment with asfotase alfa. The girl was clinically diagnosed with perinatal hypophosphatasia. On day 13 of life, she was started on enzyme replacement therapy with subcutaneous asfotase alfa 2 mg/kg/dose three times weekly. Owing to the absence of signs of clinical improvement, the dose of asfotase alfa was increased sequentially to a maximum dose of 9 mg/kg/dose by day 67 of life. On day 75 of life, she showed a very high level of alkaline phosphatase (> 12,000 U/L) consistent with the absorption of asfotase alfa. The baby’s asfotase alfa dose was reduced to 3 mg/kg/dose due to these elevated alkaline phosphatase levels. Following asfotase alfa dose reduction, the alkaline phosphatase levels decreased. Thereafter, due to lack of improvement of her perinatal hypophosphatasia, it was decided to discontinue asfotase alfa treatment. She was then extubated and was provided supportive care. On day 100 of life, she eventually died. Author comment: "Asfotase alfa was initiated at 2 mg/kg/dose SC three times a week on day 13. The dose was sequentially increased to a supraphysiologic level in the absence of signs of clinical improvement, to a maximum of 9 mg/kg/dose on day 67". "The ERT was decreased to 3 mg/kg/dose on day 75 because of very high ALP levels (> 12,000 U/L) consistent with drug absorption". Costain G, et al. Enzyme replacement therapy in perinatal hypophosphatasia: Case report of a negative outcome and lessons for clinical practice. Molecular Genetics and Metabolism Reports 14: 22-26, Mar 2018. Available from: URL: http:// doi.org/10.1016/j.ymgmr.2017.10.006 - Canada 803285434 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Asfotase-alfa

Reactions Weekly , Volume 1680 (1) – Dec 2, 2017
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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-38988-1
Publisher site
See Article on Publisher Site

Abstract

Reactions 1680, p57 - 2 Dec 2017 Elevated alkaline phosphatase levels: case report A female neonate [age at the time of reaction onset not clearly stated] developed elevated alkaline phosphatase levels during treatment with asfotase alfa. The girl was clinically diagnosed with perinatal hypophosphatasia. On day 13 of life, she was started on enzyme replacement therapy with subcutaneous asfotase alfa 2 mg/kg/dose three times weekly. Owing to the absence of signs of clinical improvement, the dose of asfotase alfa was increased sequentially to a maximum dose of 9 mg/kg/dose by day 67 of life. On day 75 of life, she showed a very high level of alkaline phosphatase (> 12,000 U/L) consistent with the absorption of asfotase alfa. The baby’s asfotase alfa dose was reduced to 3 mg/kg/dose due to these elevated alkaline phosphatase levels. Following asfotase alfa dose reduction, the alkaline phosphatase levels decreased. Thereafter, due to lack of improvement of her perinatal hypophosphatasia, it was decided to discontinue asfotase alfa treatment. She was then extubated and was provided supportive care. On day 100 of life, she eventually died. Author comment: "Asfotase alfa was initiated at 2 mg/kg/dose SC three times a week on day 13. The dose was sequentially increased to a supraphysiologic level in the absence of signs of clinical improvement, to a maximum of 9 mg/kg/dose on day 67". "The ERT was decreased to 3 mg/kg/dose on day 75 because of very high ALP levels (> 12,000 U/L) consistent with drug absorption". Costain G, et al. Enzyme replacement therapy in perinatal hypophosphatasia: Case report of a negative outcome and lessons for clinical practice. Molecular Genetics and Metabolism Reports 14: 22-26, Mar 2018. Available from: URL: http:// doi.org/10.1016/j.ymgmr.2017.10.006 - Canada 803285434 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680

Journal

Reactions WeeklySpringer Journals

Published: Dec 2, 2017

References

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