Is cyclosporine (CsA) safe to use during pregnancy?

Cyclosporine Safety During Pregnancy

Cyclosporine is generally considered safe during pregnancy when the benefit to the mother outweighs the potential risk to the fetus, as it does not appear to be teratogenic but may be associated with increased rates of prematurity and low birth weight. 1

Safety Profile in Pregnancy

• Cyclosporine does not appear to be teratogenic based on extensive experience in transplant recipients and patients with autoimmune conditions 1
• The drug has been classified as FDA pregnancy category C, meaning it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus 1, 2
• No specific birth defects or pattern of malformations have been linked to cyclosporine exposure during pregnancy 1, 2
• There is no evidence that maternal cyclosporine use during pregnancy causes renal damage in exposed children, despite concerns raised in animal studies 1

Potential Pregnancy Complications

• Increased rates of prematurity have been observed in human studies of women taking cyclosporine during pregnancy 1, 2
• Lower birth weight and increased prenatal and postnatal mortality have been reported in animal studies 1, 2
• Pregnancy complications may include:
  • Preterm delivery (reported in up to 56% of pregnancies) 3, 4
  • Low birth weight infants (reported in approximately 50% of pregnancies) 3, 4
  • Hypertension and preeclampsia (may be confounded by underlying maternal conditions) 1, 2

Use in Specific Conditions

• In rheumatology practice, cyclosporine is considered compatible with pregnancy and is included among medications that can be continued during pregnancy 1
• For inflammatory bowel disease, cyclosporine can be used during pregnancy when needed for severe disease, with no significant increase in fetal malformations 1
• For dermatologic conditions like psoriasis, cyclosporine has been used effectively during pregnancy, including for generalized pustular psoriasis 1

Monitoring and Management During Pregnancy

• Women should be informed of the risks associated with cyclosporine during pregnancy before starting therapy 1
• Regular monitoring of blood pressure is essential, as cyclosporine-induced hypertension occurs in approximately 20% of patients 5
• Early morning resting blood pressure is a sensitive indicator of early nephrotoxicity and should be monitored regularly 1, 5
• If hypertension develops during pregnancy:
  • Consider dose reduction of cyclosporine 1, 5
  • Calcium channel blockers are the preferred antihypertensive agents if medication is needed 1, 5
  • Avoid thiazide diuretics as they may enhance nephrotoxicity 1

Breastfeeding Considerations

• Cyclosporine passes into breast milk and contains ethanol that will be orally absorbed by the nursing infant 1, 2
• A decision should be made whether to discontinue breastfeeding or discontinue cyclosporine based on the importance of the drug to the mother 1, 2
• Some studies report breastfeeding during cyclosporine therapy without adverse outcomes, though practice varies 1

Important Caveats

• The decision to use cyclosporine during pregnancy should involve careful consideration of the risk-benefit ratio 1
• Pregnancy outcomes may be confounded by maternal comorbidities and concomitant medications, particularly in transplant recipients 6, 3
• For women with autoimmune disorders, cyclosporine may be a safer alternative than other immunosuppressants during pregnancy 6, 7
• Discontinuation of necessary immunosuppression during pregnancy may lead to disease flares or transplant rejection, which could pose greater risks to both mother and fetus than continuing treatment 1