Table 1.
DMT | Pre-Pregnancy Washout | Pregnancy | Breastfeeding | Newborn Precautions |
---|---|---|---|---|
Beta interferon | Not required | EMA: May be considered during pregnancy FDA: Use only if the benefit justifies the potential risk to the fetus. |
Can be used during breastfeeding | |
Glatiramer acetate | Not required | Use only if the benefit justifies the potential risk to the fetus | Limited data. Considered safe | |
Teriflunomide | Accelerated elimination procedure until plasma concentrations are less than 0.02 mg/L | Contraindicated during pregnancy | Contraindicated during breastfeeding | Risk of birth defects |
Dimethyl fumarate | Not required | Use only if the benefit justifies the potential risk to the fetus | Limited data. Risks not excluded. Use with caution | |
Fingolimod | 2 months (risk of rebound effect) | Contraindicated during pregnancy | Contraindicated during breastfeeding | Risk of fetal loss and birth defects in animal models |
Siponimod | 10 days | Contraindicated during pregnancy | Contraindicated during breastfeeding | Risk of fetal loss and birth defects in animal models |
Ozanimod | 3 months | Contraindicated during pregnancy | Contraindicated during breastfeeding | Risk of fetal loss and birth defects in animal models |
Natalizumab | Not required (risk of rebound effect) | Use only if the benefit justifies the potential risk to the fetus at least until first trimester or 30–34 weeks | EMA: Contraindicated during breastfeeding FDA: Use only if the benefit justifies the potential risk to the infant |
Risk of hematological abnormalities in infants exposed in the third trimester |
Alemtuzumab | 4 months after last dose | Use only if the benefit justifies the potential risk to the fetus | EMA: Discontinue during each course and for 4 months following the last infusion. Benefits may outweigh the risks for the infant FDA: Discontinue either alemtuzumab or breastfeeding |
Untreated maternal hypothyroidism increases the risk for miscarriage and may have effects on the fetus. Risk of neonatal Graves` disease in mothers with Graves` disease |
Ocrelizumab | EMA: 12 months FDA: 6 months |
Use only if the benefit justifies the potential risk to the fetus | EMA: Contraindicated during breastfeeding FDA: Use only if benefit justifies the potential risk to the infant |
Risk of B-cell depletion after intrauterine or breast milk exposure |
Cladribine | 6 months after last dose | Contraindicated during pregnancy | Breastfeeding contraindicated during treatment and for 1 week after the last dose | Risk of congenital anomalies |
Ofatumumab271 | 6 months after last dose | Use only if the benefit justifies the potential risk to the fetus | Use only if benefit justifies the potential risk to the infant. | Risk of B-cell depletion after intrauterine or breast milk exposure |
Ponesimod272 | 1 week after last dose | Contraindicated during pregnancy | Contraindicated during breastfeeding | Risk of fetal loss and birth defects in animal models |
Abbreviations: DMT, disease-modifying therapy; EMA, European Medicines Agency; FDA, United States Food and Drug Administration.