Recormon

Recormon Use In Pregnancy & Lactation

epoetin beta

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Nonclinical Safety under Actions).
For epoetin beta, all safety information with regard to exposure to Recormon during pregnancies has been gained from post marketing experience. A review of the available post marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/foetal development or postnatal development and treatment with Recormon. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.
Labor and Delivery: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Nonclinical Safety under Actions).
For epoetin beta, all safety information with regard to exposure during labor and delivery has been gained from post marketing experience. No evidence of harmful effects with respect to labor and delivery have been observed. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women in labor.
Lactation: Only limited experience in human lactation has been gained. Endogenous erythropoietin is excreted in breast milk and readily absorbed by neonatal gastrointestinal tract. A decision on whether to continue or discontinue breastfeeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin beta therapy to the woman.
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