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Last update Feb. 21, 2018

Цинакальцета Гидрохлорид

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

Calcimimético que reduce los niveles plasmáticos de paratohormona (PTH) y secundariamente los de calcio.
Indicado en el tratamiento de hiperparatiroidismo secundario en pacientes con insuficiencia renal crónica en diálisis, en hipercalcemia por carcinoma paratiroideo o por hiperparatiroidismo primario no susceptible de paratiroidectomía (Dillon 2011, Muñoz 2009).
Administración oral una o dos veces al día durante semanas a meses.

A fecha de última actualización no encontramos datos publicados sobre su excreción en leche materna.

Sus datos farmacocinéticos (EMA 2017), -amplio volumen de distribución y alto porcentaje de fijación a proteínas plasmáticas-, hacen poco probable el paso a leche de cantidades significativas, pero su prolongada vida media, su carácter básico (alto pKa) y la prolongada duración del tratamiento podrían facilitarlo.

Aunque su biodisponibildad es muy baja en ayunas (20-25%), aumenta considerablemente (50-80%) con las comidas (EMA 2017), luego el lactante podría absorber bien el cinacalcet que se hubiese excretado en leche materna.

Las reacciones adversas posibles son frecuentes y graves: hipocalcemia, convulsiones, arrtimias, angioedema... (EMA 2017).

Hasta conocer más datos publicados sobre este fármaco en relación con la lactancia, pueden ser preferibles alternativas conocidas más seguras, especialmente durante el periodo neonatal y en caso de prematuridad. Plantear siempre que sea posible la paraidectomía (Keutgen 2012).

Si se administra durante la lactancia, conviene hacer controles periódicos al lactante del estado clínico y de los niveles plasmáticos de Calcio y PTH.

Alternatives

Alendronate Sodium (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
Pamidronate Disodium ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Very Low Risk

High Risk

Very High Risk

Very Low Risk

High Risk

Very High Risk

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Group

Цинакальцета Гидрохлорид belongs to this group or family:

ATC H05: Calcium Homeostasis Hormones

Tradenames

Main tradenames from several countries containing Цинакальцета Гидрохлорид in its composition:

Pharmacokinetics

Variable	Value	Unit
Oral Bioavail.	20 - 25 vs 50 - 80	%
Molecular weight	394	daltons
Protein Binding	93 - 97	%
VD	13.9	l/Kg
pKa	10.3	-
Tmax	2 - 6	hours
T½	30 - 40	hours

References

EMA. Cinacalcet (Mimpara). Drug Summary. 2017 Full text (in our servers)
EMA. Cinacalcet (Mimpara). Ficha técnica. 2017 Full text (in our servers)
Keutgen XM, Buitrago D, Filicori F, Kundel A, Elemento O, Fahey TJ 3rd, Zarnegar R. Calcimimetics versus parathyroidectomy for treatment of primary hyperparathyroidism: retrospective chart analysis of a prospective database. Ann Surg. 2012 Abstract
Dillon ML, Frazee LA. Cinacalcet for the treatment of primary hyperparathyroidism. Am J Ther. 2011 Abstract
Muñoz Torres M, García Martín A. Tratamiento médico del hiperparatiroidismo primario: papel de los calcimiméticos. [Medical treatment of primary hyperparathyroidism: role of calcimimetics]. Endocrinol Nutr. 2009 Abstract

Цинакальцета Гидрохлорид

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

Alternatives

Other names

Group

Tradenames

Pharmacokinetics

References

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