MonoFer Use In Pregnancy & Lactation

Effects on fertility: There are no data on the effect of ferric derisomaltose on human fertility.
In a fertility study with Ferric derisomaltose in rats no effects on female fertility or male reproductive performance and spermatogenic parameters were found at the dose levels tested.
Ferric derisomaltose did not affect fertility in male or female rats when administered IV at up to 19 mg/kg/day in males and 32 mg/kg/day in females (4 and 7 times the maximum recommended weekly clinical dose, respectively). Atrophy of prostate and seminal vesicles, seminiferous epithelium degeneration of testes, and degenerative germ cells in epididymides were observed in rats at 80 mg/kg/day thrice weekly (8 times the maximum recommended weekly clinical dose).
Use in pregnancy: There are no adequate and well-controlled trials of ferric derisomaltose in pregnant women. A careful risk/benefit evaluation is therefore required before use during pregnancy and ferric derisomaltose should not be used during pregnancy unless clearly necessary.
Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with ferric derisomaltose should be confined to the second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus. In rare cases, foetal bradycardia has been observed in pregnant women with hypersensitivity reactions.
Iron complexes have been reported to be teratogenic and embryocidal in non-anaemic pregnant animals at high single doses above 125 mg iron/kg body weight. The highest recommended dose in clinical use is 20 mg iron/kg body weight.
In embryofetal development studies in rats and rabbits, there was a dose-dependent increase in bent ribs in rats at all doses (3-32 mg/kg/day, 0.7-8 times the maximum recommended weekly clinical dose) and fetal malformations (including hydrocephaly, microglossia, narrow pectoral region) in rabbits at >= 25 mg/kg/day (>= 6 times the maximum recommended weekly clinical dose). There was a significant reduction in viable fetuses and mean fetal weight and an increase in late resorption in rabbits at 43 mg/kg/day (10 times the maximum recommended weekly clinical dose).
Use in lactation: No formal clinical studies investigating excretion of ferric derisomaltose have been performed. In clinical study P-PP-01, a maternal milk sample was collected on day 3 from a total of 65 subjects. Overall, mean maternal milk iron level was higher in the iron isomaltoside 1000 group (0.000721 g/L) than in the standard medical care group (0.000400 g/L) at day 3. However, at week 1 the mean maternal milk iron level in the iron isomaltoside 1000 group had decreased to the same level as in the standard medical care group (0.000468 g/L and 0.000442 g/L, respectively).