Molcovir 200 Use In Pregnancy & Lactation

Pregnancy: Risks in summary: Based on data on laboratory animals Molnupiravir may cause harm to infants when administered in pregnant women, but there is no data on the use of molnupiravir in pregnant women to assess the risk of birth defects. Therefore, molnupiravir is not recommended during pregnancy. Based on the information found in reproductive studies in laboratory animals, oral administration of molnupiravir to pregnant rats at the period of organogenesis were found the death of embryo and teratogenesis when given NHC at a dose 8 times the recommended dose in humans. Decreased foetal body weights at a dose 3 times the recommended dose in humans.
Oral administration of molnupiravir to pregnant rabbits during the period of organogenesis showed that the weight of the embryo decreased when receiving the NHC at a dose of 18 times the recommended dose in humans. If it is determined that molnupiravir must be administered in pregnant women, the prescribing physician must communicate the benefits and risks of molnupiravir during pregnancy to the pregnant woman. Only if the doctor determines that the benefits outweigh the risks for a particular patient. If it is decided to take molnupiravir in women during pregnancy, the prescribing physician must have a document explaining the benefits and risks of molnupiravir during pregnancy to the pregnant woman. However, there are other risks to mothers and fetuses in pregnant women who have not been treated for COVID-19 (see Clinical considerations as follows).
The likelihood of birth defects and miscarriages in general is still unknown. In general, all pregnant women are at risk of developing birth defects. The chances of birth defects and general miscarriages in the U.S. pregnant population are 2-4 percent and 15-20 percent, respectively.
Clinical considerations: Diseases associated with maternal and/or fetal risks: Pregnant women with COVID-19 is associated with problems in mothers and foetuses such as preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and infant death in the womb.
Data: Data in animals: In an embryofoetal development (EFD) study in rats, Molnupiravir was administered orally to pregnant rats at 0, 100, 250 or 500 mg/kg/day from gestation days (GDs) 6 to 17. Molnupiravir was also administered orally to pregnant rats at up to 1,000 mg/kg/day from GDs 6 to 17 in a preliminary EFD study. Developmental toxicities included post-implantation losses, malformations of the eye, kidney, and axial skeleton, and rib variations at 1,000 mg/kg/day (8 times the human NHC exposure at the RHD) and decreased foetal body weights and delayed ossification at ≥500 mg/kg/day (3 times the human NHC exposure at the RHD). There were no developmental toxicities at ≤250 mg/kg/day (less than the human NHC exposure at the RHD). Maternal toxicities included decreased food consumption and body weight losses, resulting in the early sacrifice of individual animals at 1,000 mg/kg/day, and decreased body weight gain at 500 mg/kg/day.
In an EFD study in rabbits, Molnupiravir was administered orally to pregnant rabbits at 0, 125, 400, or 750 mg/kg/day from GDs 7 to 19. Developmental toxicity was limited to reduced foetal body weights at 750 mg/kg/day (18 times the human NHC exposures at the RHD). There was no developmental toxicity at ≤400 mg/kg/day (7 times the human NHC exposures at the RHD). Maternal toxicities included reduced food consumption and body weight gains, and abnormal faecal output at 750 mg/kg/day.
In a pre- and post-natal developmental study, molnupiravir was administered orally to female rats at doses up to 500 mg/kg/day (close to the human NHC exposure at the RHD) from gestation day (GD) 6 through lactation day 20. No effects were observed in offspring.
Breast-feeding: Risks in summary: It is unknown whether Molnupiravir or its metabolites are present in human milk. NHC was detected in the plasma of nursing pups from lactating rats administered molnupiravir. It is unknown whether molnupiravir affect human milk production, or have effect on the breastfed infant.
Based on the potential for adverse reactions on the infant from Molnupiravir. Therefore, it is recommended to refrain from breastfeeding during treatment with molnupiravir until 4 days after receiving the last dose. In some cases, breastfeeding may be considered to stop breastfeeding while discarding pumped milk during treatment with molnupiravir until 4 days after receiving the final dose.
Data: Studies of embryo development either prenatal or postpartum, molnupiravir was administered to lactating rats at ≥250 mg/kg/day, NHC was detected in plasma of nursing pups.
Fertility: Females and males who are childbearing: From animal studies molnupiravir can cause harm to the baby when administered in pregnant women.
Pregnancy Tests: Before starting treatment with molnupiravir, evaluate whether a person of childbearing age is pregnant, in the case of clinical indications.
Birth control: Female: Women of childbearing age are advised to use effective contraceptive methods (used correctly and regularly) during treatment up to 4 days after receiving the last dose of molnupiravir.
Male: Despite the low risk, nonclinical studies evaluating the effects on children of men treated with molnupiravir have not been completed. It is recommended to those who have sex with women of childbearing age to use effective contraceptive methods (use correctly and regularly). The risk is still unknown after receiving the last dose of molnupiravir for 3 months due to the ongoing project.
As a result of tests, in vivo mutations of molnupiravir give unclear results at first (no clear positive or negative results are shown). The analysis of reticulocytes and the number of red blood cells reflects the initial impact on hematopoietic stem cells derived from the bone marrow. When the second assessment was conducted by testing in vivo mutations in the liver (somatic cells and stem cells) of transgenic rats with molnupiravir for 28 days, it was found that molnupiravir does not cause mutations, in contrast to somatic cells. Genetic information can be passed on to the cub generation. The study plan, which will study the germ cells of the testes of male rats undergoing gene modified, will evaluate the feasibility of molnupiravir whether it will affect the offspring generation of men treated with molnupiravir.