RR-TB in Pregnancy and Breastfeeding

• All non-pregnant women of childbearing potential should be appropriately counselled throughout RR-TB treatment and offered family planning as part of routine RR-TB care.
• Healthcare providers can initiate RR-TB treatment for pregnant patients without NCAC approval. A pregnancy registry will be developed so that this cohort can be more formally monitored and data collected nationally.
• Pregnant women with RR-TB do not qualify for the short BPaL-L regimen because the safety of pretomanid has not been established in pregnancy. Based on the experience from the BEAT Tuberculosis study ^[22] pregnant patients with RR-TB may benefit from a 6-month treatment regimen containing Group A and B drugs with delamanid. That is bedaquiline, delamanid, linezolid and levofloxacin.
• Pregnant women on treatment will be closely monitored. Regular reports will be shared with the National Essential Medicines List Committee and all stakeholders. A pregnancy registry will also be put in place in due course.
• Bedaquiline is currently considered one of the safer drugs to use in pregnant women based on animal studies, and there is growing experience with the safe use of bedaquiline in pregnancy.
• There are limited data on the use of linezolid, levofloxacin, moxifloxacin, clofazimine, terizidone and delamanid during pregnancy, but emerging data from cohort studies (including from South Africa) indicate that many of these medications may be used safely with appropriate monitoring and guidance. Several studies are underway to assess pharmacokinetics and safety of second-line TB medications during pregnancy and breastfeeding.
• Amikacin should not be used in pregnancy given the associated foetal ear toxicity.
• Ethionamide should only be used if there are no other treatment options since it has been potentially associated with neural tube defects and can exacerbate pregnancy-associated nausea and vomiting.
• Breastfeeding should be encouraged in most women, and the medications used to treat RR-TB are not a contraindication to breastfeeding. However, appropriate infection control measures must be followed.
• The health of the fetus, neonate and infant is likely to be optimized if their mother is healthy, thus, most interventions that are likely to improve the health and well-being of pregnant and breastfeeding women would be in the best interests of their babies.

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National Department of Health Clinical Management of Rifampicin-Resistant Tuberculosis, September 2023

RR-TB in Pregnancy and Breastfeeding