For clinicians

Tacrolimus

Prograf, calcineurin inhibitor

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Bottom lineBottom line: compatible across pregnancy, lactation, and paternal exposure (EULAR 2024). A useful pregnancy-compatible immunosuppressant, including in lupus nephritis. Drug levels may shift in pregnancy, so monitor and dose-adjust.

By reproductive phase

PhasePositionDetailEvidence
Pre-conceptionContinueContinue; compatible.[1, 2]●●●moderate evidencestrong
1st trimesterContinueContinue.[2]●●●moderate evidenceconditional
2nd/3rd trimesterContinueContinue; monitor levels as clearance changes in pregnancy.[2]●●●moderate evidenceconditional
BreastfeedingContinueCompatible with lactation.[2]●●●moderate evidencestrong
PaternalContinueCompatible with paternal exposure.[2]●●○○low evidenceconditional

Guideline comparison

GuidelinePositionStrength
ACR 2020Conditionally recommend tacrolimus (a calcineurin inhibitor) as compatible before and during pregnancy at the lowest effective dose, with blood-pressure monitoring. Breastfeeding: conditionally compatible (low transfer). Paternal: conditionally recommend continuing.[1]Conditional (compatible, monitor blood pressure)
EULAR 2024Compatible with pregnancy (2b/B) and lactation (2a/B); continuable in men (2b/B).[2]Oxford LoE/GoR as shown
BSR 2022/23Compatible across peri-conception, both trimesters, breastfeeding, and paternal exposure; monitor maternal blood pressure, renal function, blood glucose, and drug levels in pregnancy.[3]Verified against BSR Table 1
=Guideline agreement. VERIFIED AGREEMENT. EULAR 2024 (pregnancy 2b/B, lactation 2a/B, male 2b/B) and BSR 2023 (compatible across all five phases, with monitoring) agree.

Key points

PointEvidence
Monitor levels; clearance and dosing requirements can change through pregnancy.[2]●●○○low evidenceconditional

Monitoring

References

  1. Sammaritano LR, et al. 2020 ACR Guideline for the Management of Reproductive Health in RMD. Arthritis Rheumatol. 2020;72(3):529-556. https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.41191
  2. Ruegg L, et al. EULAR recommendations for antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025;84(6):910-926. https://ard.eular.org/article/S0003-4967(25)00818-0/fulltext
  3. Russell MD, et al. BSR guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory drugs and corticosteroids. Rheumatology (Oxford). 2023;62(4):e48-e88. https://academic.oup.com/rheumatology/article/62/4/e48/6783012