Last update March 19, 2024

Cinacalcet Hydrochloride

High Risk

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

alcimimetic that reduces plasma levels of parathyroid hormone (PTH) and secondarily calcium levels. Indicated in the treatment of secondary hyperparathyroidism in patients with chronic renal failure on dialysis, hypercalcemia due to parathyroid carcinoma or primary hyperparathyroidism not amenable to parathyroidectomy (Dillon 2011, Muñoz 2009). Oral administration once or twice daily for weeks to months.

At the time of last update, we found no published data on its excretion in breast milk.

Its pharmacokinetic data (EMA 2017), -large volume of distribution and high percentage of binding to plasma proteins-, make passage into milk of significant amounts unlikely, but its prolonged half-life, its basic character (high pKa) and the prolonged duration of treatment could facilitate this.

Although its bioavailability is very low on an empty stomach (20-25%), it increases considerably (50-80%) with meals (EMA 2017), then cinacalcet that would have been excreted in breast milk could be well absorbed by the infant.

Possible adverse reactions are frequent and serious: hypocalcemia, seizures, arrhythmias, angioedema.... (EMA 2017)

Pending further published data on this drug in relation to breastfeeding, safer known alternatives may be preferable, especially during the neonatal period and in case of prematurity. Consider paraidectomy whenever possible. (Keutgen 2012)

If administered during breastfeeding, the infant's clinical status and plasma levels of calcium and PTH should be monitored periodically.

Alternatives

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

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.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

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.

Other names

Cinacalcet Hydrochloride in other languages or writings:

Group

Cinacalcet Hydrochloride belongs to this group or family:

Tradenames

Main tradenames from several countries containing Cinacalcet Hydrochloride 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
30 - 40 hours

References

  1. EMA. Cinacalcet (Mimpara). Drug Summary. 2017 Full text (in our servers)
  2. EMA. Cinacalcet (Mimpara). Ficha técnica. 2017 Full text (in our servers)
  3. 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
  4. Dillon ML, Frazee LA. Cinacalcet for the treatment of primary hyperparathyroidism. Am J Ther. 2011 Abstract
  5. 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

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