Cyclosporine During Pregnancy
Cyclosporine can and should be continued during pregnancy when clinically indicated, as it does not appear to be teratogenic and the risks of uncontrolled disease typically outweigh medication risks. 1, 2
Safety Profile
Cyclosporine is not teratogenic based on extensive human data. Multiple guidelines and studies confirm no specific pattern of birth defects or increased malformation rates compared to the general population 1, 2, 3. A meta-analysis of 410 patients found an overall malformation prevalence of 4.1%, which does not differ substantially from the general population, with an odds ratio of 3.83 that did not achieve statistical significance 3.
The American College of Rheumatology 2020 guidelines classify cyclosporine as compatible with pregnancy, recommending continuation with blood pressure monitoring 1. Similarly, the 2016 consensus on acute severe ulcerative colitis states that cyclosporine can be used during pregnancy when needed, with no increased fetal malformations demonstrated 1.
Expected Pregnancy Complications
While not teratogenic, cyclosporine is associated with specific pregnancy complications:
Prematurity: Increased rates consistently reported across studies, with preterm delivery rates >40% in transplant populations 1, 2, 4. Meta-analysis showed 56.3% overall prevalence of prematurity, though the odds ratio of 1.52 did not reach statistical significance 3.
Lower birth weight: Documented in both human studies and animal models 1, 2, 4.
Maternal hypertension and preeclampsia: Common complications, though potentially confounded by underlying disease 1, 4.
Importantly, no evidence exists that maternal cyclosporine causes renal damage in exposed children, despite animal studies showing reduced nephron counts 1, 2, 5.
Dosing Recommendations
Continue standard dosing of 2.5-5.0 mg/kg/day in 2 divided doses 1. Adjust downward by 0.25-1.0 mg/kg if hypertension or decreased renal function develops 1.
Monitoring Requirements During Pregnancy
Blood pressure monitoring is the critical surveillance parameter 1, 2:
- Monitor blood pressure every 2 weeks during the first 3 months, then monthly 1
- Early morning resting blood pressure is the most sensitive indicator of early nephrotoxicity 2
- If hypertension develops, reduce cyclosporine dose and use calcium channel blockers as preferred antihypertensive agents 2
Additional monitoring includes 1:
- BUN and creatinine every 2 weeks for 3 months, then monthly
- Monthly CBC, liver function tests, lipid profile, magnesium, uric acid, and potassium
- Pregnancy testing if indicated
Disease-Specific Considerations
For inflammatory bowel disease: The management of acute severe ulcerative colitis in pregnancy does not change—use cyclosporine as needed in all stages of pregnancy 1. Active IBD during pregnancy poses greater risks (preterm birth, stillbirth, neonatal death) than cyclosporine exposure 1.
For rheumatic diseases: The American College of Rheumatology recommends conditional continuation during pregnancy with blood pressure monitoring 1.
For dermatologic conditions: The American Academy of Dermatology notes lower birth weight and shorter pregnancy duration in transplant patients but confirms cyclosporine appears non-teratogenic 1.
Breastfeeding Considerations
A decision must be made to either discontinue breastfeeding or discontinue cyclosporine 1, 2. Cyclosporine passes into breast milk and contains ethanol that will be absorbed by the nursing infant 1. One case report documented therapeutic blood concentrations in a breastfed infant, though without adverse effects 1. The decision should be based on the importance of therapy to the mother 1, 2.
Critical Clinical Pitfalls
Do not discontinue cyclosporine solely due to pregnancy, as disease flares or transplant rejection pose greater maternal-fetal risks than continued therapy 2, 6.
Avoid nephrotoxic combinations: Aminoglycosides and NSAIDs increase nephrotoxicity risk 1.
Monitor for hyperkalemia: Potassium-sparing diuretics can potentiate dangerous potassium elevation 1.
Watch for drug interactions: Cyclosporine is metabolized by CYP3A4, creating interactions with statins, calcium channel blockers, and warfarin 1.
Evidence Quality
The strongest evidence comes from transplant populations with extensive follow-up data 1, 4, 3. Data in autoimmune diseases is more limited but consistently reassuring 1, 6, 7. A 2016 study of 29 pregnancies in patients with systemic autoimmune diseases showed 86.2% live birth rate with no increase in maternal-fetal complications compared to the general population 6.