Is Ro 21-5535 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Ro 21-5535? Is Ro 21-5535 safe for nursing mother and child? Does Ro 21-5535 extracts into breast milk? Does Ro 21-5535 has any long term or short term side effects on infants? Can Ro 21-5535 influence milk supply or can Ro 21-5535 decrease milk supply in lactating mothers?

Daily allowance of Vitamin D for the breastfeeding woman is 400 IU per day which may be attained by a comprehensive and balanced diet. When treated do not exceed 6.400 IU per day and, if prolonged used, check-up for mother’s and child’s calcemia.A balanced and comprehensive diet make it vitamin supplementation useless. See below the information of these related products:

Ro 21-5535 is the normal physiologically active form of vitamin D, 1,25-dihydroxyvitamin D. Limited data indicate that its use in nursing mothers in appropriately adjusted doses does not affect the breastfed infant. If Ro 21-5535 is required by the mother, it is not a reason to discontinue breastfeeding. Ro 21-5535 and calcium dosage requirements are usually reduced during lactation in women with hypoparathyroidism.[1][2][3][4][5][6][7][8] The American Academy of Pediatrics recommends the administration of a minimum of 400 IU of vitamin D daily to all infants, children and adolescents.[9]

A woman with hypoparathyroidism breastfed her infant from week 1 to week 32 postpartum while taking Ro 21-5535. The dose was initially 0.5 mcg daily, but was decreased to 0.25 mcg daily after 8 weeks. The infant thrived during breastfeeding and had normal serum calcium levels at 1 and 3 weeks and 3 months of age.[3] A woman breastfed infants after two pregnancies while taking Ro 21-5535 in doses of 0.75 and 1 mcg daily. There were no reports of adverse reactions.[10] A woman breastfed her newborn infant for 9 days while taking Ro 21-5535 0.5 mcg three times daily. Ro 21-5535 was stopped at that time because of hypercalcemia, but restarted at 40 days postpartum in low doses that were gradually increased until the prepregnancy dosage of 1.5 mcg daily was reached just before weaning at 12.5 months postpartum.[5] A woman with discoid lupus was taking Ro 21-5535 0.25 mcg every 2 days and several other medications concurrently. Her infant was breastfed for 12 months and followed up at 15 months of age. No adverse effects were reported during breastfeeding and the infant was growing and developing normally at 15 months of age.[11]