Pregnancy and the Use of Disease-Modifying Therapies in Patients with Multiple Sclerosis: Benefits versus Risks
Table 1
Overview of labelling recommendations relating to pregnancy or breastfeeding for disease-modifying therapies for multiple sclerosis.
DMT
Europe (EU)
USA
Interferon
No absolute contraindication, discuss risks and benefits with the patient. Discontinue either therapy or breastfeeding.
Pregnancy category C: consider risks and benefits in pregnancy. Apply caution when prescribed for a nursing mother.
Glatiramer acetate
Contraindicated in pregnancy. Consider risks and benefits during breastfeeding.
Pregnancy category B: use “only when clearly needed”. Use with caution during breastfeeding.
Teriflunomide
Contraindicated during pregnancy. Patients must not breastfeed on treatment.
Pregnancy category X: contraindicated. Patients must not breastfeed on treatment.
Dimethyl fumarate
Not recommended in pregnancy. Consider risks and benefits for use during breastfeeding.
Pregnancy category C: consider risks and benefits in pregnancy. Use with caution during breastfeeding.
Natalizumab
Consider discontinuation if pregnancy occurs. Patients should not breastfeed on treatment.
Pregnancy category C: consider risks and benefits in pregnancy. Risks during breastfeeding unknown, no recommendation provided.
Alemtuzumab
Not recommended in pregnancy. Patients should not breastfeed on treatment or for 4 months afterwards.
Pregnancy category C: consider risks and benefits in pregnancy. Contraindicated during breastfeeding: discontinue either breastfeeding or treatment.
Fingolimod
Contraindicated during pregnancy. Contraindicated during breastfeeding.
Pregnancy category C: consider risks and benefits in pregnancy. Contraindicated during breastfeeding: discontinue either breastfeeding or treatment.
Mitoxantrone
Avoid pregnancy during and for at least 6 months after treatment. Do not breastfeed during treatment or for 28 days afterwards.
Pregnancy category D: test for pregnancy before each dose; discuss risks to the foetus if pregnancy occurs. Contraindicated during breastfeeding: discontinue either breastfeeding or treatment.
From European Summaries of Product Characteristics and US full prescribing information for Rebif (interferon-), Betaferon®/Betaseron (interferon-), Copaxone®, Aubagio®, Tecfidera®, Tysabri®, Lemtrada®, Gilenya, and Novantrone [20]. Selected information only shown: consult full Prescribing Information before prescribing for a patient. Pregnancy categories (A, B, C, D, and X, see https://chemm.nlm.nih.gov/pregnancycategories.htm for definitions) in US regulatory documentation are being gradually phased out but are included here as they currently appear in the Prescribing Information for these treatments.
