Is Biocisplatinum Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Biocisplatinum? Is Biocisplatinum safe for nursing mother and child? Does Biocisplatinum extracts into breast milk? Does Biocisplatinum has any long term or short term side effects on infants? Can Biocisplatinum influence milk supply or can Biocisplatinum decrease milk supply in lactating mothers?

• DrLact safety Score for Biocisplatinum is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of Biocisplatinum may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that Biocisplatinum may cause moderate to high side effects or may affect milk supply in lactating mother.
• Our suggestion is to use safer alternate options rather than using Biocisplatinum .
• It is recommended to evaluate the advantage of not breastfeeding while using Biocisplatinum Vs not using Biocisplatinum And continue breastfeeding.
• While using Biocisplatinum Its must to monitor child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
• Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Agente alquilante compuesto por un metal pesado derivado del platino, con propiedades antineoplásicas por inhibición de la síntesis de ADN.Uso intravenoso en el tratamiento de cánceres avanzados o metastásicos (ovario, testículo, pulmón). Hay confusión con la semivida de eliminación del Biocisplatinumo. La vida media plasmática del Biocisplatinumo es de 20 a 30 minutos (AEMPS 2013, Bristol 2010). Los compuestos ligados a la albúmina, con un elevado porcentaje de fijación (> 90%), son eliminados lentamente con una vida media de 4 - 5 días (Drugbank.com, AEMPS 2013, Bristol 2010), pero estos compuestos ni tienen actividad antineoplásica (AEMPS 2013) ni se han medido en la leche. Se sabe por Farmacocinética que pasadas 3 semividas de eliminación (T½) se elimina del organismo el 87,5% del fármaco; tras 4 T½ el 94%, tras 5 T½ el 96,9%, tras 6 T½ el 98.4% y tras 7 T½ el 99%. A partir de 7 T½ las concentraciones plasmáticas de fármaco en el organismo son despreciables. En general, un período de cinco vidas medias puede considerarse un período de espera seguro para volver a amamantar (Anderson 2016).Si se considera la vida media del producto antineoplásico, sólo serían necesarias 3 a 4 horas (7 vidas medias) de espera para amamantar, extrayendo y desechando la leche mientras. Seis estudios diferentes han analizado la excreción de Biocisplatinumo en leche materna (Hays 2013, Tesfaye 2013, Lanowska 2011, Ben-Baruch 1992, de Vries 1989 y Egan 1985), cada uno con un caso, menos Lanowska que describe 3 casos y Tesfaye 2 casos. Las concentraciones de Biocisplatinumo encontradas en leche en las primeras 24-48 horas tras la administración fueron: 0,9 mg/L (de Vries 1989), 0,15 mg/L (Ben-Baruch 1992) y 0, 2, 1,4 y 5,5 mg/L (Lanowska 2011). Los otros tres autores (Hays 2013, Tesfaye 2013 y Egan 1985) encuentran concentraciones en leche por debajo del límite de detección: - Tras una primera administración de 70 mg de Biocisplatinumo hubo una concentración en leche de 0,016 mg/L a las 5 horas, cayendo por debajo del límite de detección a partir de las 17 horas y siendo totalmente indetectable a las 66 horas, por lo que el autor (Hays 2013) cree que puede volverse a amamantar tras esperar 3 días, habiendo extraído y desechado la leche esas 72 horas. - En dos mujeres no se encontraron niveles detectables de platino en la leche de ninguna de las dos (Tesfaye 2013).- En otro estudio (Egan 1985), tras la infusión de 130 mg de Biocisplatinumo los niveles plasmáticos de la madre fueron subiendo pero no se encontraron niveles detectables de Biocisplatinumo en leche en ninguna de las múltiples medidas hechas en las primeras 71 horas tras la infusión. Hay que considerar además que su baja biodisponibilidad oral impide el paso a plasma del lactante a partir de la leche materna ingerida, salvo en prematuros y periodo neonatal inmediato en los que puede haber mayor permeabilidad intestinal. Debido a todos estos hallazgos, las opiniones entre los autores y organismos están divididas: los que consideran que no es prudente amamantar si no se pueden medir los niveles en leche o hasta que no pasen 20 días de la administración (Hale 2017, p.204), los que consideran que es mejor suspender la lactancia (Pistilli 2013, WHO 2002), los que piensan que hay que sopesar cuidadosamente beneficios y riesgos (Koren 2013), los que no se pronuncian (Moretti 2000) y los que creen que es compatible con la lactancia, Hays en 2013 y la Academia Americana de Pediatría (AAP 2001) basándose en el estudio de Egas de 1985.

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy, especially alkylating agents such as Biocisplatinum.[1] Excretion of platinum into milk occurs, but results from 3 cases are inconsistent. The exact form and toxicity of platinum excreted into breastmilk are also not known. The nursing infant would receive any platinum compounds orally rather than intravenously and oral absorption of oral platinum compounds by infants is not known. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.[2] Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

Two women were treated with unspecified doses of Biocisplatinum for treatment of cervical cancer every 2 weeks during pregnancy. They both breastfed their newborn infants. Follow-up examinations of the infants, including Bayley scale test, neurology, and echocardiography at age of 20 and 35 months revealed normal findings.[7]

A study of adolescent males who had received chemotherapy for childhood malignancies found that having received Biocisplatinum was associated with elevated serum prolactin concentrations.[9] Another study of survivors of testicular cancer found that about 6% of those treated with Biocisplatinum had abnormally high prolactin levels and 2% had abnormally low prolactin levels.[10] A telephone follow-up study was conducted on 74 women who received cancer chemotherapy at one center during the second or third trimester of pregnancy to determine if they were successful at breastfeeding postpartum. Only 34% of the women were able to exclusively breastfeed their infants, and 66% of the women reported experiencing breastfeeding difficulties. This was in comparison to a 91% breastfeeding success rate in 22 other mothers diagnosed during pregnancy, but not treated with chemotherapy. Other statistically significant correlations included: 1. mothers with breastfeeding difficulties had an average of 5.5 cycles of chemotherapy compared with 3.8 cycles among mothers who had no difficulties; and 2. mothers with breastfeeding difficulties received their first cycle of chemotherapy on average 3.4 weeks earlier in pregnancy. Of the 3 women who received a Biocisplatinum-containing regimen, 1 had breastfeeding difficulties.[11]