DMARDs in Pregnancy

📋 Key Information Summary

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Safe DMARDs to continue: Hydroxychloroquine (all trimesters), sulfasalazine with folic acid (5 mg/day), azathioprine up to 2 mg/kg/day, low-dose prednisolone (≤7.5 mg/day preferred), and ciclosporin if clinically required
Must stop before conception: Methotrexate — discontinue at least 3 months before planned conception and ensure folate repletion
Leflunomide washout: Cholestyramine 8 g TDS for 11 days (or activated charcoal) required before conception; confirm plasma teriflunomide level <0.02 mg/L before proceeding
Mycophenolate mofetil: Discontinue at least 6 weeks before conception; high risk of first-trimester pregnancy loss and congenital malformations
Safest biologic in pregnancy: Certolizumab pegol — no Fc portion, minimal transplacental transfer, safe across all trimesters
Biologics with Fc — stop at 20–30 weeks: Etanercept and adalimumab should be discontinued by week 20–30 to reduce neonatal immunosuppression
Avoid in pregnancy: Rituximab, abatacept, tocilizumab, and JAK inhibitors — insufficient safety data or known teratogenicity
Live vaccines in infants: If a biologic was administered in the second or third trimester, live vaccines (including rotavirus) are contraindicated for the first 6 months of the infant's life
Pre-conception counselling is essential — ideally 6–12 months before planned conception to allow washout of teratogenic drugs and disease stabilisation
Active disease is harmful: Uncontrolled rheumatic disease increases the risk of pre-eclampsia, preterm birth, low birth weight, and disease flares — benefit of disease control often outweighs theoretical drug risk
Contraception counselling is mandatory for all women of childbearing age on teratogenic DMARDs (MTX, LEF, MMF, cyclophosphamide)
Multidisciplinary team: Rheumatologist, obstetric medicine, obstetrician, and GP should coordinate care throughout pregnancy and postpartum
Breastfeeding: Hydroxychloroquine, sulfasalazine, azathioprine, low-dose prednisolone, and certolizumab are generally considered compatible with breastfeeding

Introduction & Australian Epidemiology

Rheumatic diseases disproportionately affect women of childbearing age, making the safety of disease-modifying anti-rheumatic drugs (DMARDs) in pregnancy a critical clinical consideration. In Australia, rheumatoid arthritis (RA) affects approximately 2% of women, with peak incidence between ages 25 and 50 years. Systemic lupus erythematosus (SLE), psoriatic arthritis, axial spondyloarthritis, and vasculitis similarly present during reproductive years, creating a large population of women who require DMARD therapy before, during, and after pregnancy.

Pre-conception planning is essential for all women with rheumatic disease considering pregnancy. The goals are to minimise exposure to teratogenic medications, maintain disease remission or low disease activity, and establish a safe medication regimen that can be continued throughout gestation. Active maternal disease is itself associated with adverse pregnancy outcomes, including pre-eclampsia, preterm delivery, intrauterine growth restriction, and low birth weight — therefore, undertreating disease to avoid medication exposure is not a risk-free strategy.

Australian data from the Australasian Rheumatology Association and AIHW indicate that unplanned pregnancy remains common among women on DMARDs, highlighting the need for routine contraception counselling and pregnancy planning discussions at every clinical encounter. Aboriginal and Torres Strait Islander women experience higher rates of rheumatic disease with later presentation, compounding barriers to safe pre-conception planning (see ATSI section).

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Key principle: Active uncontrolled rheumatic disease carries greater risk to mother and baby than most compatible DMARDs. The priority is to maintain disease control with the safest available agents rather than discontinuing all therapy.

This guideline provides a practical framework for Australian clinicians managing DMARD therapy in women with rheumatic disease who are planning pregnancy, currently pregnant, or breastfeeding. It is aligned with EULAR 2016 recommendations, ACR 2020 reproductive health guidelines, BSR guidelines on prescribing biologics in pregnancy, and Australian prescribing information.

Safe DMARDs: Compatible with Pregnancy

The following DMARDs have established safety data in pregnancy and can be continued throughout gestation to maintain disease control. These agents form the backbone of rheumatic disease management during pregnancy in Australian practice.

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Hydroxychloroquine

Plaquenil® · Generic · Antimalarial DMARD

Adult dose 200–400 mg PO daily (≤5 mg/kg/day actual body weight)

Pregnancy Continue throughout all trimesters — do NOT discontinue

Breastfeeding Compatible — continue as normal

Renal adjustment No dose adjustment; avoid in severe renal impairment (eGFR <30)

Key notes Reduces SLE flares in pregnancy; prevents neonatal lupus; risk of retinal toxicity with long-term use requires annual ophthalmology review

PBS status ✔ PBS General Benefit

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Sulfasalazine

Salazopyrin® · Generic · Sulfonamide DMARD

Adult dose 1–3 g PO daily in divided doses

Pregnancy Continue throughout pregnancy — must be co-prescribed with folic acid 5 mg daily

Breastfeeding Compatible — infant risk minimal

Key notes Reversible oligospermia in males — stop 3 months before conception if male partner planning conception. Monitor FBC and LFTs quarterly

PBS status ✔ PBS General Benefit

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Azathioprine

Imuran® · Generic · Thiopurine immunosuppressant

Adult dose Up to 2 mg/kg/day PO (based on actual body weight)

Pregnancy Continue at ≤2 mg/kg/day — do NOT stop abruptly (disease flare risk)

Breastfeeding Compatible — AAP and BSR endorsed

TPMT testing Test before initiation; dose reduce or avoid if TPMT deficient or homozygous low

Key notes Widely used in SLE, vasculitis, and inflammatory bowel disease in pregnancy. Monitor FBC and LFTs monthly

PBS status ✔ PBS General Benefit

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Prednisolone

Solone® · Panafcortelone® · Generic · Corticosteroid

Adult dose ≤7.5 mg/day PO preferred; higher doses for flares with rapid taper

Pregnancy Low dose (≤7.5 mg/day) compatible; minimise dose; avoid first trimester if possible

Breastfeeding Compatible — dose <20 mg/day; consider waiting 4 hours after dose if >20 mg

Key notes Doses >20 mg/day associated with cleft lip/palate (first trimester), preterm rupture of membranes, gestational diabetes, pre-eclampsia. Monitor glucose. Use budesonide for IBD where possible

PBS status ✔ PBS General Benefit

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Ciclosporin

Neoral® · Sandimmun® · Calcineurin inhibitor

Adult dose 2.5–5 mg/kg/day PO in two divided doses

Pregnancy Use if clinically needed — no increased teratogenic risk; monitor levels

Breastfeeding Generally compatible with caution — monitor infant

Key notes Associated with maternal hypertension and pre-eclampsia; monitor BP, renal function, and drug trough levels. Tacrolimus is an alternative with similar safety profile

PBS status ⚠ PBS Restricted Benefit

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Core message: Hydroxychloroquine, sulfasalazine + folic acid, azathioprine ≤2 mg/kg/day, low-dose prednisolone, and ciclosporin are the backbone of safe DMARD therapy in pregnancy. Discontinuing these medications exposes mother and baby to the risks of active disease.

Contraindicated DMARDs: Must Stop Before Conception

The following DMARDs are teratogenic or have unacceptable risk in pregnancy. They must be discontinued before conception with appropriate washout periods. Pre-conception counselling should include reliable contraception during washout.

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Critical safety alert: All women of childbearing potential on methotrexate, leflunomide, or mycophenolate mofetil must be on reliable contraception. Pregnancy testing should be performed before each methotrexate refill in at-risk patients.

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Methotrexate

Methoblastin® · Generic · Antifolate DMARD

Adult dose 7.5–25 mg PO/SC once weekly with folic acid 5 mg (non-dosing day)

Pregnancy ABSOLUTELY CONTRAINDICATED — Category X

Pre-conception Stop at least 3 months before planned conception; continue folic acid 5 mg daily for at least the washout period

Teratogenicity Neural tube defects, limb anomalies, cranial dysostosis, cleft palate — methotrexate embryopathy

Breastfeeding Contraindicated

Male partners BSR: men on low-dose MTX may continue — no significant spermatogenic effect; some guidelines recommend 3-month washout

PBS status ✔ PBS General Benefit

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Leflunomide

Arava® · Generic · Pyrimidine synthesis inhibitor

Adult dose 10–20 mg PO daily

Pregnancy ABSOLUTELY CONTRAINDICATED — Category X

Washout protocol Cholestyramine 8 g PO TDS for 11 days or activated charcoal 50 g QDS for 11 days. Confirm plasma teriflunomide level <0.02 mg/L (ideally two levels ≥14 days apart) before allowing conception

Teratogenicity Skeletal malformations, CNS defects, microphthalmia — long plasma half-life (~14 days; effective half-life ~18–19 days)

Breastfeeding Contraindicated

PBS status ⚠ PBS Restricted Benefit

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Mycophenolate mofetil

CellCept® · Myfortic® · Inosine monophosphate dehydrogenase inhibitor

Adult dose 1–2 g PO daily in divided doses

Pregnancy ABSOLUTELY CONTRAINDICATED — Category X

Pre-conception Stop at least 6 weeks before planned conception; switch to azathioprine as bridge therapy

Teratogenicity Increased rate of first-trimester pregnancy loss (~45–49%); congenital malformations including ear anomalies, cleft lip/palate, cardiovascular defects

Breastfeeding Contraindicated

PBS status ⚠ PBS Restricted Benefit

Additional Contraindicated Agents

Drug	Class	Reason	Washout
Cyclophosphamide	Alkylating agent	High teratogenicity — gonadotoxic	Stop ≥3 months before conception
Methotrexate (high dose)	Antifolate	Methotrexate embryopathy	≥3 months (as above)
JAK inhibitors (tofacitinib, baricitinib, upadacitinib)	JAK inhibitor	Animal data: teratogenic; insufficient human data	Stop ≥4 weeks (1 week washout of drug)
Thalidomide / Lenalidomide	Immunomodulatory	Severe limb defects — absolutely contraindicated	Thalidomide Pregnancy Prevention Programme mandatory

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Bridge therapy: When stopping methotrexate, leflunomide, or mycophenolate before conception, switch to a pregnancy-compatible DMARD (hydroxychloroquine, sulfasalazine, azathioprine, or low-dose prednisolone) to prevent disease flare. Abrupt discontinuation without bridge therapy is associated with relapse rates of 50–80%.

Biologics in Pregnancy

Biologic DMARDs are increasingly used in women of childbearing age for RA, axial spondyloarthritis, psoriatic arthritis, and SLE. The key pharmacological distinction in pregnancy is the presence or absence of an Fc portion on the immunoglobulin molecule, which determines transplacental transfer via the neonatal Fc receptor (FcRn).

Certolizumab Pegol — Safest Biologic in Pregnancy

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Certolizumab pegol

Cimzia® · PEGylated anti-TNF Fab' fragment

Adult dose 200 mg SC every 2 weeks or 400 mg SC every 4 weeks

Pregnancy Safe — continue throughout all trimesters

Mechanism of safety PEGylated Fab' fragment — lacks Fc portion — minimal to no transplacental transfer via FcRn

CRIB study data Infant certolizumab levels ≤0.042 μg/mL at birth (negligible); no detectable drug in most infants

Breastfeeding Compatible — minimal transfer

Infant vaccines Live vaccines NOT contraindicated — standard immunisation schedule applies

PBS status 🔒 PBS Authority Required

Anti-TNF Agents with Fc — Stop at 20–30 Weeks

The following anti-TNF agents contain an Fc portion and undergo active transplacental transfer during the second and third trimesters via the neonatal Fc receptor. Concentrations in the infant at birth can exceed maternal levels by 2–4 fold, increasing the risk of neonatal immunosuppression.

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Adalimumab

Humira® · Fully human anti-TNF monoclonal antibody

Adult dose 40 mg SC every 1–2 weeks

Pregnancy First trimester safe — discontinue by week 20–30

Infant vaccines Live vaccines contraindicated for 6 months after birth if exposed in T2/T3

PBS status 🔒 PBS Authority Required

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Etanercept

Enbrel® · Etacept® · Anti-TNF receptor fusion protein

Adult dose 50 mg SC weekly or 25 mg SC twice weekly

Pregnancy First trimester safe — discontinue by week 30–32 (lower placental transfer than adalimumab)

Infant vaccines Live vaccines contraindicated for 6 months after birth if exposed in T2/T3

PBS status 🔒 PBS Authority Required

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Infliximab

Remicade® · Inflectra® · Renflexis® · Chimeric anti-TNF monoclonal antibody

Adult dose 3–5 mg/kg IV at weeks 0, 2, 6 then every 8 weeks

Pregnancy Consider stopping by week 20–24 — highest placental transfer of all anti-TNF agents

Infant vaccines Live vaccines contraindicated for 6 months after birth if exposed in T2/T3

PBS status 🔒 PBS Authority Required

Biologics to Avoid in Pregnancy

Biologic	Class	Recommendation	Rationale
Rituximab	Anti-CD20	Avoid — stop ≥6 months before conception	B-cell depletion in neonate; neonatal pancytopenia reported; prolonged pharmacodynamic effect
Abatacept	CTLA-4 Ig	Avoid — stop ≥10 weeks before conception (5 × half-life)	Transplacental transfer; theoretical risk of immune suppression in fetus
Tocilizumab	Anti-IL-6R	Avoid — stop ≥3 months before conception	Animal data: embryotoxicity at high doses; limited human pregnancy data
Secukinumab / Ixekizumab	Anti-IL-17	Avoid — insufficient data	Minimal human pregnancy exposure data; animal data not reassuring
Ustekinumab	Anti-IL-12/23	Consider if no alternative — registry data growing but limited	Pregnancy registry data (moderate numbers) largely reassuring; BSR cautious endorsement
Belimumab	Anti-BLyS	Avoid — limited data	BRIGHTE study: limited human data; animal studies show B-cell reduction in offspring

Live Vaccine Guidance for Infants

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Infant live vaccine contraindication: If the mother received a biologic with Fc-mediated placental transfer (adalimumab, etanercept, infliximab, rituximab, abatacept, tocilizumab) during the second or third trimester, live vaccines are contraindicated in the infant for the first 6 months of life. This includes rotavirus vaccine (administered at 2 and 4 months) and BCG (if indicated). Non-live vaccines (including all NIP schedule vaccines) can be given as normal. Certolizumab does NOT carry this restriction.

Pre-Conception Planning & Counselling

Pre-conception counselling should be offered to all women of childbearing age with rheumatic disease, ideally 6–12 months before planned conception. This allows adequate time for teratogenic drug washout, transition to pregnancy-compatible regimens, and disease stabilisation.

1

Review Medications (6–12 months pre-conception)

Identify all teratogenic DMARDs and biologics
Commence washout protocols (MTX ≥3 months, LEF cholestyramine washout, MMF ≥6 weeks)
Ensure reliable contraception during washout period
Check TPMT if azathioprine will be used as bridge

2

Stabilise Disease (3–6 months pre-conception)

Target remission or low disease activity before conception
Transition to pregnancy-compatible DMARDs (HCQ, SSZ, AZA, low-dose prednisolone)
Select biologic: certolizumab pegol preferred; plan stop date for Fc-containing biologics
Baseline bloods: FBC, LFTs, renal function, anti-Ro/SSA and anti-La/SSB antibodies (risk of neonatal lupus)

3

Folic Acid & General Health

Folic acid 5 mg daily (high dose due to prior MTX exposure and rheumatic disease)
Cease MTX and continue folic acid throughout washout and into first trimester
Smoking cessation, alcohol cessation, BMI optimisation
Review teratogenic medications beyond DMARDs (ACE inhibitors, statins, NSAIDs — stop at 32 weeks)
Update vaccinations (MMR, varicella — wait 4 weeks before conceiving)

4

Multidisciplinary Team

Rheumatologist — medication management, disease monitoring
Obstetric medicine physician — high-risk pregnancy coordination
Obstetrician — delivery planning, monitoring for pre-eclampsia/IUGR
GP — ongoing coordination, contraception, postpartum care
Consider maternal–fetal medicine referral for SLE with antiphospholipid syndrome, anti-Ro/La antibodies, or renal involvement

Management During Pregnancy & Postpartum

Monitoring Schedule

Each trimester

FBC, LFTs, renal function, ESR/CRP (note: ESR physiologically elevated in pregnancy — CRP more reliable), urate, disease activity score (DAS28, CDAI)

Monthly

If on azathioprine (FBC, LFTs), ciclosporin (drug levels, BP, creatinine), or prednisolone ≥15 mg (glucose tolerance)

18–20 weeks

Anomaly scan — timing to stop Fc-containing biologics if applicable; echocardiography if anti-Ro/La positive (risk of fetal heart block)

26–28 weeks

Gestational diabetes screening (especially if on corticosteroids); growth scan

32 weeks onwards

Fortnightly reviews; growth surveillance; anti-Ro/La: weekly fetal heart monitoring from 16 weeks; stop NSAIDs at 32 weeks

Managing Flares During Pregnancy

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Flare management options (all trimesters):

Increase prednisolone to control flare — short courses of high-dose prednisolone with rapid taper are acceptable
Intra-articular corticosteroid injections are safe and effective for localised joint flares
NSAIDs (ibuprofen, naproxen) — use lowest dose, shortest duration; stop at 32 weeks (premature ductus arteriosus closure risk)
Consider initiating or increasing certolizumab pegol
IV methylprednisolone pulses (500–1000 mg) for severe SLE flares — safe in pregnancy

Labour & Delivery Considerations

Stress-dose corticosteroids (hydrocortisone 50–100 mg IV) for women on ≥7.5 mg prednisolone daily for >3 weeks in the preceding 6 months
Vaginal delivery preferred unless obstetric indication for caesarean section
Epidural analgesia is safe and encouraged for pain management
Thromboprophylaxis — women with SLE, APS, or immobility are at increased VTE risk; follow local obstetric thromboprophylaxis guidelines
If anti-Ro/SSA positive: neonatal assessment for congenital heart block and neonatal lupus at delivery

Postpartum Management

Restart pre-conception DMARDs promptly postpartum to prevent flares — 50–75% of women with RA experience postpartum flare
All pregnancy-compatible DMARDs (HCQ, SSZ, AZA, low-dose prednisolone, certolizumab) are compatible with breastfeeding
Methotrexate and leflunomide are contraindicated in breastfeeding
Discuss contraception — progesterone-only methods preferred if on teratogenic agents; combined OCP may be used if no APS/vascular contraindication
Screen for postpartum depression — higher rates in women with chronic rheumatic disease
Infant immunisation: follow standard NIP schedule; defer live vaccines (rotavirus, BCG) if maternal biologic exposure in T2/T3

Special Populations

🤰 SLE with Antiphospholipid Syndrome

Low-dose aspirin — 100–150 mg daily from 12 weeks (reduces pre-eclampsia risk by ~20%)

LMWH — enoxaparin 40 mg SC daily (if prior VTE or recurrent miscarriage); add postpartum anticoagulation for 6 weeks

Hydroxychloroquine — reduces flares and may reduce obstetric APS complications; continue throughout

Increased surveillance for pre-eclampsia, IUGR, and preterm delivery

👶 Anti-Ro/SSA and Anti-La/SSB Positive

Risk of neonatal lupus: congenital heart block (2%), neonatal rash, hepatitis, cytopenias

Hydroxychloroquine — reduces recurrence of heart block from 18% to ~7% in subsequent pregnancies

Fetal echocardiography: weekly from 16–28 weeks, then fortnightly to 34 weeks

First-degree heart block may be reversible with dexamethasone 4 mg/day; second/third-degree block is usually permanent

🫘 Renal Impairment (Lupus Nephritis)

Pregnancy is safest when lupus nephritis is in remission for ≥6 months pre-conception

Azathioprine — safe; no dose adjustment for renal impairment

Ciclosporin / Tacrolimus — monitor drug levels more frequently in renal impairment

Avoid NSAIDs if eGFR <60; nephrologist co-management essential

🛡️ Vasculitis in Pregnancy

Achieve remission ≥6 months before conception where possible

Azathioprine — first-line maintenance in ANCA-associated vasculitis in pregnancy

Rituximab — if refractory, administer before conception; avoid in pregnancy

Cyclophosphamide — absolutely contraindicated in pregnancy; use azathioprine or rituximab pre-conception

🫁 Male Partner on DMARDs

Methotrexate — no significant spermatogenic effect at low doses; BSR: can continue; some centres recommend 3-month washout

Sulfasalazine — causes reversible oligospermia; stop 3 months before planned conception if fertility is a concern

Cyclophosphamide — gonadotoxic; consider sperm banking before treatment

Biologics — no paternal teratogenicity signal; can continue

Aboriginal and Torres Strait Islander Health Considerations

Aboriginal and Torres Strait Islander Health

Disease burden

Aboriginal and Torres Strait Islander women experience higher rates of rheumatic disease, including SLE and rheumatic heart disease, often presenting at a younger age and with more severe phenotypes. Earlier onset of childbearing means DMARD safety in pregnancy is an even more critical issue.

Remote access to specialist care

Many Aboriginal and Torres Strait Islander women live in rural and remote areas with limited access to rheumatologists and obstetric medicine specialists. Telehealth rheumatology services through the Australian Telehealth Network and RFDS can facilitate pre-conception counselling and ongoing DMARD monitoring. Local Aboriginal Health Services should be central to care coordination.

Pre-conception counselling barriers

Cultural considerations around pregnancy planning, family structures, and reproductive health discussions may affect engagement with pre-conception counselling. Culturally safe, women-centred care delivered by Aboriginal Health Workers and Practitioners improves uptake and continuity. Avoid judgemental language around contraception and pregnancy timing.

Medication access & PBS

PBS co-payments may be a barrier for some patients. Closing the Gap PBS co-payment measure provides PBS medicines at no cost for eligible Aboriginal and Torres Strait Islander patients — ensure patients are registered. Pharmacy access in remote communities may be limited; consider medication delivery via Remote Area Aboriginal Health Services (RAAHS).

Monitoring & follow-up

Regular blood monitoring for DMARDs (FBC, LFTs, drug levels) may be difficult in remote settings. Point-of-care testing (POCT) for INR, glucose, and basic biochemistry is available at some Aboriginal Medical Services. Establish local pathology pathways through the closest regional hospital. Use My Health Record for shared care documentation across providers.

Maternal & perinatal outcomes

Aboriginal and Torres Strait Islander women have higher rates of pre-eclampsia, preterm birth, and low birth weight babies compared to non-Indigenous women. Active rheumatic disease compounds these risks. Prioritise disease control with pregnancy-compatible DMARDs and ensure access to high-risk obstetric care, including aeromedical retrieval if required.

Immunisation

Ensure maternal immunisation is up to date (influenza, pertussis, COVID-19) prior to pregnancy. For infants exposed to biologics in T2/T3, coordinate live vaccine deferral with the local immunisation provider and Aboriginal Health Service. Aboriginal and Torres Strait Islander children are eligible for additional vaccines under the NIP — ensure no gaps in the schedule.

📚 References

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