Last update May 8, 2024

B02BX04

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Fc-peptide fusion protein that acts as an agonist at the thrombopoietin receptor stimulating platelet production. Indicated in chronic immune thrombocytopenic purpura (ITP) refractory to other treatments (corticosteroids, immunoglobulins). Subcutaneous administration of a weekly dose. 

Amino acid sequences of romiplostim have been found in both breast milk and infant plasma, without being able to estimate the amount or concentration of romiplstim excreted in breast milk. (Labrecque 2023).

Its very high molecular weight makes the passage into milk of significant amounts very unlikely. 

Of two infants born to mothers treated with romiplostim, one had moderate thrombocytosis that persisted despite discontinuation of breastfeeding (Labrecque 2023), indicating that it was not due to romiplostim; the other had no problem. (Patras 2020)

Due to its protein nature, it is inactivated in the gastrointestinal tract and is not absorbed, so its oral bioavailability is practically nil, except in premature infants and the immediate neonatal period in which there may be greater intestinal permeability.

It may be advisable to monitor hematological parameters in infants breastfed by mothers receiving romiplostim.

Translated with DeepL.com (free version)

Alternatives

We do not have alternatives for B02BX04.

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

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José María Paricio, founder of e-lactancia.

Tradenames

Main tradenames from several countries containing B02BX04 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. Baja - Poor %
Molecular weight 59.000 daltons
VD 0.05 - 0.1 l/Kg
Tmax 14 (7 - 50) hours
84 (24 - 840) hours

References

  1. Labrecque AA, Roy S, Young D, Chen SA, Brechenmacher L, Le D, Cooper S, Gibson P, Clarke AE, Dufour A, Skeith L. Romiplostim drug presence in pregnancy and lactation. Blood. 2023 May 18;141(20):2537-2540. Abstract
  2. Patras A, Figueroa R, Singh AP, Madan I. Romiplostim for management of refractory immune thrombocytopenic purpura in the immediate postpartum period. BMJ Case Rep. 2020 May 18;13(5). pii: e234335. Abstract Full text (link to original source)
  3. EMA. Romiplostim (Nplate) Ficha técnica. 2017 Full text (in our servers)
  4. EMA. Romiplostim (Nplate). Drug Summary. 2017 Full text (in our servers)

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